ASPIRINA 500 mg Tablet

Зміст інструкції

1. Aspirina 500 mg granules
   1. What is Aspirina 500 mg granules and what is it used for
   2. What you need to know before taking Aspirina 500 mg granules
   3. How to take Aspirina 500 mg granules
   4. Possible side effects
   5. How to store Aspirina 500 granules
   6. Contents of the pack and other information
2. Aspirina 325 mg tablets
   1. What is Aspirina 325 mg and what is it used for
   2. What you need to know before taking Aspirina 325 mg
   3. How to take Aspirina 325 mg
   4. Possible side effects
   5. How to store Aspirina 325 mg
   6. Contents of the pack and other information
3. Aspirina Rapida 500 mg chewable tablets
   1. What is Aspirina Rapida and what is it used for
   2. What you need to know before taking Aspirina Rapida
   3. How to take Aspirina Rapida
   4. Possible side effects
   5. How to store Aspirina Rapida
   6. Contents of the pack and other information
4. Aspirina 400 mg effervescent tablets with Vitamin C
   1. What is Aspirina 400 mg effervescent tablets with Vitamin C and what is it used for
   2. How to take Aspirina 400 mg effervescent tablets with Vitamin C
   3. Possible side effects
   4. How to store Aspirina 400 mg effervescent tablets with Vitamin C
   5. Package Contents and Other Information
5. Aspirina 400 mg effervescent granules with Vitamin C
   1. What is Aspirina 400 mg effervescent granules with Vitamin C and what is it used for
   2. How to take Aspirina 400 mg effervescent granules with Vitamin C
   3. Possible side effects
   4. How to store Aspirina 400 mg effervescent granules with Vitamin C
   5. Contents of the pack and other information
6. Aspirina 500 mg tablets
   1. What is Aspirina 500 mg tablets and what is it used for
   2. What you need to know before taking Aspirina 500 mg tablets
   3. How to take Aspirina 500 mg tablets
   4. Possible side effects
   5. How to store Aspirina 500 mg tablets
   6. Contents of the pack and other information

Aspirina 500 mg granules

acetylsalicylic acid

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3-5 days.

Contents of this leaflet:

• 1. What Aspirina 500 mg granules is and what it is used for
• 2. What you need to know before you take Aspirina 500 mg granules
• 3. How to take Aspirina 500 mg granules
• 4. Possible side effects
• 5. How to store Aspirina 500 mg granules
• 6. Contents of the pack and other information

1. What is Aspirina 500 mg granules and what is it used for

Aspirina is an analgesic (pain reliever: reduces pain), anti-inflammatory and antipyretic (antifebrile: reduces
fever).
Aspirina is used for the symptomatic treatment of feverish conditions and flu-like and cold syndromes and
for the symptomatic treatment of headache, toothache, neuralgia, menstrual pains, rheumatic and
muscular pains
The use of this product is reserved for adult patients only.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3-5 days.

2. What you need to know before taking Aspirina 500 mg granules

Do not take Aspirina 500 mg granules

• if you are allergic to acetylsalicylic acid, to other analgesics (pain relievers) / antipyretics (fever reducers) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from gastroduodenal ulcer (ulcer in the stomach or in the first part of the intestine);
• if you suffer from hemorrhagic diathesis (tendency to bleeding);
• if you suffer from severe kidney (reduced kidney function) or liver (liver) or heart (heart) failure;
• if you suffer from glucose-6-phosphate dehydrogenase deficiency (an enzyme whose absence, genetically determined, leads to a disease characterized by reduced survival of red blood cells);
• if you are already taking methotrexate(at doses of 15 mg/week or more) or warfarin(see: “Other medicines and Aspirina 500 mg granules”);
• if you have suffered in the past from asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are in the last trimester of pregnancy or if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
• if you are under the age of 16 (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirina 500 mg granules.
Take the medicine only on a full stomach.
Before administering any medicine, you must take all useful precautions to prevent adverse reactions:

• exclude the existence of previous allergic reactions to this or other medicines;
• exclude the existence of other contraindications or conditions that may expose you to the risk of potentially serious side effects. If in doubt, consult your doctor or pharmacist.
• do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time. Allergic reactionsAcetylsalicylic acid and other NSAIDs can cause allergic reactions [including asthma attacks, rhinitis (runny nose), angioedema (swelling of the skin and mucous membranes) or urticaria (small spots on the skin accompanied by itching)]. The risk is higher in subjects who have previously experienced an allergic reaction after using this type of medicine (see “Do not take Aspirina 500 mg granules”) and in subjects who present allergic reactions (for example skin reactions, itching, urticaria) to other substances. In subjects with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria, reactions may be more frequent and severe.

Tell your doctor if:

• you are to undergo surgery (even minor surgery such as a tooth extraction), as the pre-operative use of this medicine may make it more difficult to stop bleeding during surgery (intraoperative hemostasis);
• you need to perform an occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe the administration of this medicine only after
a careful evaluation of the risk/benefit ratio:

• if you have a higher risk of allergic reactions, for example if you suffer from asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria;
• if you have a higher risk of gastrointestinal lesions, as acetylsalicylic acid and other NSAIDs can cause serious side effects at the gastrointestinal level (bleeding, ulcer, perforation); for this reason, these medicines should not be used in subjects who suffer or have suffered in the past from gastrointestinal ulcer or gastrointestinal bleeding (see “Do not take Aspirina 500 mg granules”) or who use large amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood coagulation defects or if you are following treatment with anticoagulant medicines (used to slow down or inhibit the blood coagulation process);
• if you suffer from impaired kidney, heart or liver function;
• if you suffer from asthma;
• if you have hyperuricemia/gout (increased level of uric acid in the blood);

It is advisable to consult your doctor even in cases where the disorders listed above have occurred in the past.

• if you are taking medicines that are not recommended or that require special precautions or a dosage adjustment (see “Other medicines and Aspirina 500 granules”);
• if you are over 70 years of age, especially in the presence of concomitant therapies;
• if you are in the first or second trimester of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• if you are following a low-sodium diet (low in sodium).

Children and adolescents
This medicine should not be taken by children and adolescents under the age of 16.

Elderly
The risk of serious side effects is higher in elderly subjects.
If you are over 70 years of age, consult your doctor before taking this medicine.

Patients with impaired kidney and liver function
This medicine should be used with caution (see “warnings and precautions”).

Other medicines and Aspirina 500 mg granules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.

Do not take Aspirina 500 mg granules together with these medicines(see “Do not take Aspirina 500
mg granules”):

• Methotrexate (used in some cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin [used to make the blood more fluid (anticoagulant)].

Take Aspirina 500 mg granules together with these medicines only on prescription and under
medical supervision:

• Selective Serotonin Re-uptake Inhibitors (SSRIs) (used against depression);
• ACE inhibitors (used against high blood pressure);
• Acetazolamide (used in some types of edema (swelling));
• Valproic acid (used in epilepsy);
• Other NSAIDs (except those for local use);
• Antacids (used against digestive disorders);
• Antiplatelet agents (used for the prevention and treatment of blood clots in the arteries);
• Thrombolytics (used to dissolve blood clots) or anticoagulants (used to slow down or inhibit the blood coagulation process) taken orally or by injection;
• Antidiabetics, for example insulin and oral hypoglycemic agents (used to stimulate insulin production by the pancreas);
• Digoxin (used in heart failure);
• Diuretics (used to increase the amount of urine produced);
• Phenytoin (used in case of epilepsy);
• Corticosteroids (cortisone, excluding those for local use and those used in adrenal insufficiency replacement therapy);
• Metoclopramide (used against vomiting);
• Methotrexate (doses less than 15 mg/week);
• Uricosuric agents, for example probenecid, benzbromarone (used to increase the elimination of uric acid);
• Zafirlukast (used against asthma).

Aspirina 500 mg granules contains buffer systems that may reduce the effects of the thyroid hormone
Levothyroxine.
Do not take other medicines orally within 1 or 2 hours of using this medicine.

Aspirina 500 mg granules with alcohol
The combined effects of alcohol and acetylsalicylic acid increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.

Pregnancy
Do not take Aspirina 500 mg granules in the last trimester of pregnancy.
In the first and second trimester of pregnancy, take this medicine only after consulting your doctor and
assessing with him the risk/benefit ratio in your case.

Breastfeeding
Do not take Aspirina 500 mg granules during breastfeeding.

Fertility
If you are a woman with fertility problems or are undergoing fertility investigations, keep in mind that the use of
acetylsalicylic acid, like any medicine that inhibits the synthesis of prostaglandins and
cyclooxygenase, may interfere with fertility.

Driving and operating machinery
Due to the possible onset of headache or dizziness, this medicine may impair the ability
to drive vehicles and operate machinery.

Aspirina 500 mg granules contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially “sodium-free”.

Aspirina 500 mg granules contains aspartame
This medicine contains 5 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may
be harmful if you suffer from phenylketonuria, a rare genetic disease that causes the accumulation of
phenylalanine because the body is unable to dispose of it properly

Aspirina 500 mg granules contains ethanol
This medicine contains 0.001 mg of alcohol (ethanol) in each sachet. The amount in each sachet of
this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this
medicine will not produce significant effects.

3. How to take Aspirina 500 mg granules

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended doseis 1 or 2 sachets of granules, as a single dose, repeating, if necessary, the dose at intervals of 4-8 hours, up to 2-3 times a day. Do not exceed the maximum dosage of 2 sachets 3 times a day (maximum 6 sachets per day).
Aspirina 500 mg granules can be placed directly on the tongue. It dissolves with saliva; this allows its use without water.
Take the product on a full stomach, preferably after main meals.

Warning: do not exceed the indicated doses without your doctor's advice. Elderly patients should adhere to the minimum dosages indicated above.
Always use the minimum effective dosage and increase it only if it is not sufficient to relieve symptoms (pain or fever).
Subjects more exposed to the risk of serious adverse effects, who can only use the medicine if prescribed by a doctor, must strictly follow their instructions.
Do not take the product for more than 3-5 days without consulting your doctor. Consult your doctor if the symptoms persist. Use the medicine for the shortest possible period.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.

If you take more Aspirina 500 mg granules than you should
In case of accidental ingestion of an excessive dose of Aspirina 500 mg granules, immediately notify your doctor or go to the nearest hospital.
Salicylate toxicity (a dosage greater than 100 mg/kg/day for 2 consecutive days can induce toxicity: in a 70 kg individual, for example, salicylate toxicity manifests with the intake of more than 7 g of acetylsalicylic acid per day, equivalent to more than 14 sachets of Aspirina 500 mg granules) may be the consequence of chronic excessive doses or acute overdose, potentially life-threatening and including accidental ingestion in children.

• Chronic intoxication (repeated use of considerable doses):symptoms include dizziness, vertigo, tinnitus (a sound or ringing in the ear), deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage.
• Acute intoxication:signs and symptoms/results of biochemical and instrumental investigations may include:
• Signs and symptoms of mild/moderate overdose: tachypnea (rapid breathing), hyperventilation (breathing too deeply), respiratory alkalosis (alteration of the acid-base balance following changes in breathing), sweating, nausea, vomiting, headache, vertigo.
• Signs and symptoms of moderate/severe overdose: respiratory alkalosis with compensatory metabolic acidosis (alteration of the acid-base balance following changes in breathing and accumulation of acids in the body), fever, hyperventilation (breathing too deeply), pulmonary edema (water in the lungs), respiratory failure, asphyxia, arrhythmias (irregular heartbeat), hypotension (low blood pressure), cardiorespiratory arrest (cessation of heartbeat), dehydration, oliguria (decreased urine) up to renal failure (reduced kidney function), ketosis (“acetone”), hyperglycemia (increased blood sugar level), severe hypoglycemia (severe decrease in blood sugar level), tinnitus (a sound or ringing in the ear), deafness, gastrointestinal bleeding, gastric ulcer, coagulopathy (alteration of blood coagulation), iron deficiency anemia, encephalopathy (brain damage) and depression of the central nervous system, with manifestations ranging from lethargy (deep drowsiness) and confusion to coma and convulsions, cerebral edema (swelling of brain tissue), liver damage.
• At high doses, alterations of taste and skin eruptions (acneiform, erythematous, scarlatiniform, eczematoid, desquamative, bullous, purpuric), itching may also appear.
• Other signs and symptoms: conjunctivitis, anorexia (loss of appetite), reduced visual acuity (ability to distinguish objects clearly), drowsiness.
• Rarely, the following may occur: aplastic anemia (failure to produce red blood cells), agranulocytosis (lack of blood cells called granulocytes), disseminated intravascular coagulation (widespread presence of numerous blood clots), pancytopenia (deficiency of all types of blood cells), leukopenia (deficiency of white blood cells), thrombocytopenia (deficiency of platelets), eosinopenia (deficiency of blood cells called eosinophils), purpura (reddish spots on the skin), eosinophilia (increase in eosinophils) associated with drug-induced hepatotoxicity, renal toxicity (tubulo-interstitial allergic nephritis), hematuria (presence of blood in the urine).

Acute allergic reactions following intake of acetylsalicylic acid can be treated, if necessary, with administration of adrenaline, corticosteroids and an antihistamine.

If you forget to take Aspirina 500 mg granules
Continue therapy as per the recommended dose. Do not take a double dose to compensate for missing the dose.

If you stop taking Aspirina 500 mg granules
Discontinuing treatment has no effect.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects observed most frequently affect the gastrointestinal tract.
These disorders can be partially relieved by taking the medicine on a full stomach. Most of the side effects are dependent on both the dose and the duration of treatment.
The side effects observed with acetylsalicylic acid are generally common to other NSAIDs.

The following side effects may occur:
Effects on the blood

• prolongation of bleeding time,
• anemia due to gastrointestinal bleeding,
• reduction of platelets (thrombocytopenia) in extremely rare cases. Following bleeding, post-hemorrhagic/iron deficiency anemia may occur (due, for example, to occult microbleeds) with the related changes in laboratory parameters and related signs and symptoms, such as asthenia (fatigue), pallor and hypoperfusion (reduced blood flow to tissues).

Effects on the nervous system

• headache,
• dizziness. Rarely, it may manifest as:
• Reye's syndrome (*), an acute disease affecting the brain and liver, potentially fatal, which almost exclusively affects children.

From rarely to very rarely, the following may occur:

• cerebral hemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and/or undergoing therapy with anticoagulants (medicines used to slow down or inhibit the blood clotting process), which, in isolated cases, may be potentially fatal.

Effects on the ear

• tinnitus (ringing/buzzing/humming/whistling in the ear).

Effects on the respiratory system

• Respiratory disease exacerbated by acetylsalicylic acid
• asthmatic syndrome,
• rhinitis (runny nose)
• nasal congestion (stuffy nose) (associated with allergic reactions);
• epistaxis (nosebleed).

Effects on the heart

• cardiorespiratory distress (severe and acute respiratory failure) (associated with allergic reactions).

Effects on the eye

• conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal tract

• gastrointestinal bleeding (occult),
• gastric discomfort,
• pyrosis (heartburn),
• gastrointestinal pain,
• gingival bleeding (bleeding gums),
• vomiting,
• diarrhea,
• nausea,
• cramping abdominal pain (associated with allergic reactions). Rarely, the following may occur:
• gastrointestinal inflammation,
• gastrointestinal erosion,
• gastrointestinal ulceration,
• hematemesis (vomiting blood or “coffee grounds” material),
• melena (emission of black, tarry stools),
• esophagitis (inflammation of the esophagus). Very rarely, the following may occur:
• hemorrhagic and/or perforated gastrointestinal ulcer with related signs and symptoms and changes in laboratory parameters. May occur with unknown frequency (especially in long-term treatment):
• Intestinal diaphragm disease

Effects on the liver

• rarely: hepatotoxicity (hepatocellular damage generally mild and asymptomatic) which manifests with an increase in transaminases.

Effects on the skin

• skin rash,
• edema (swelling),
• urticaria (hives),
• pruritus (itching),
• erythema (redness),
• angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract

• alteration of renal function and acute renal injury (in the presence of conditions of altered blood flow to the kidneys),
• urogenital bleeding (of the urinary and genital tract).

Effects on the whole organism

• procedural bleeding (immediately before, during and immediately after surgery),
• hematomas (collections of blood outside blood vessels).

Effects on the immune system

• rarely: anaphylactic shock (severe allergic reaction, potentially fatal) with related changes in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (RS)
RS initially manifests with vomiting (persistent or recurrent) and with other signs of encephalic suffering of varying severity: from apathy, drowsiness or personality changes (irritability or aggressiveness) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture should be kept in mind: even vomiting may be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following an episode of influenza (or flu-like or varicella or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates have been administered, the doctor's attention should immediately be directed to the possibility of RS.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aspirina 500 granules

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store at a temperature below 25° C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aspirina 500 mg contains

• The active ingredient is acetylsalicylic acid. One sachet contains 500 mg of acetylsalicylic acid.
• The other ingredients are: monosodiumcitrate, sodiumhydrogen carbonate, citric acid, mannitol, ascorbic acid, cola flavour (contains ethanol), orange flavour, aspartame.

Description of the appearance of Aspirina 500 mg and contents of the pack
Aspirina 500 mg granules are presented as granules for oral use.
The pack contains 2, 4, 10 or 20 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa 130 - Milan

Manufacturer
Bayer Bitterfeld GmbH (Germany)

Aspirina 325 mg tablets

acetylsalicylic acid

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3-5 days.

Contents of this leaflet:

• 1. What Aspirina 325 mg is and what it is used for
• 2. What you need to know before you take Aspirina 325 mg
• 3. How to take Aspirina 325 mg
• 4. Possible side effects
• 5. How to store Aspirina 325 mg
• 6. Contents of the pack and other information

1. What is Aspirina 325 mg and what is it used for

Aspirina is an analgesic (pain reliever: reduces pain), anti-inflammatory and antipyretic (antifebrile: reduces
fever).
Aspirina is used for the symptomatic treatment of febrile states and influenza and common cold syndromes and
for the symptomatic treatment of headache, toothache, neuralgia, menstrual pains, rheumatic and
muscular pains.
The use of this product is reserved for adult patients only.
Consult your doctor if you do not notice any improvement or if you experience a worsening of symptoms after 3-5 days.

2. What you need to know before taking Aspirina 325 mg

Do not take Aspirina 325 mg

• if you are allergic to acetylsalicylic acid, to other analgesics (pain relievers) / antipyretics (fever reducers) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from gastroduodenal ulcer (ulcer in the stomach or the first part of the intestine);
• if you suffer from hemorrhagic diathesis (tendency to bleeding);
• if you suffer from severe kidney (reduced kidney function) or liver (liver) or heart (heart) failure;
• if you suffer from glucose-6-phosphate dehydrogenase deficiency (an enzyme whose absence, genetically determined, results in a disease characterized by reduced survival of red blood cells);
• if you are already taking methotrexate(at doses of 15 mg/week or more) or warfarin(see “Other medicines and Aspirina 325 mg”);
• if you have previously suffered from asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are in the last trimester of pregnancy or if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
• if you are under the age of 16 (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirina 325 mg.
Take the medicine only on a full stomach.
Before administering any medicine, you should take all useful precautions to prevent adverse reactions:

• exclude the existence of previous allergic reactions to this or other medicines;
• exclude the existence of other contraindications or conditions that may expose you to the risk of potentially serious adverse effects. If in doubt, consult your doctor or pharmacist.
• do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time.

Allergic reactions
Acetylsalicylic acid and other NSAIDs can cause allergic reactions [including asthma attacks, rhinitis (runny nose), angioedema (swelling of the skin and mucous membranes) or urticaria (small spots on the skin accompanied by itching)].
The risk is higher in subjects who have previously experienced an allergic reaction after using this type of medicine (see “Do not take Aspirina 325 mg”) and in subjects who present allergic reactions (for example skin reactions, itching, urticaria) to other substances.
In subjects with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be more frequent and severe.

Inform your doctor if:

• you are to undergo a surgical operation (even a minor one such as a tooth extraction), as the pre-operative use of this medicine may make it more difficult to stop bleeding during the operation (intraoperative hemostasis);
• you need to perform an occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe the administration of this medicine only after a careful evaluation of the risk/benefit ratio:

• if you have a higher risk of allergic reactions, for example if you suffer from asthma and/or rhinitis (with or without nasal polyps) and/or urticaria;
• if you have a higher risk of gastrointestinal lesions, as acetylsalicylic acid and other NSAIDs can cause serious adverse effects at the gastrointestinal level (bleeding, ulcer, perforation); for this reason these medicines should not be used in subjects who suffer or have suffered in the past from gastrointestinal ulcer or gastrointestinal bleeding (see “Do not take Aspirina 325 mg”) or who consume large amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood coagulation defects or if you are following treatment with anticoagulant medicines (used to slow down or inhibit the blood clotting process);
• if you suffer from impaired kidney, heart or liver function;
• if you have asthma;
• if you have hyperuricemia/gout (increased level of uric acid in the blood);

It is advisable to consult your doctor even in cases where the disorders listed above have occurred in the past.

• if you are taking medicines that are not recommended or that require special precautions or dosage adjustments (see “Other medicines and Aspirina 325 mg);
• if you are over 70 years of age, especially if you are taking concomitant therapies;
• if you are in the first or second trimester of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• if you are following a low-sodium diet (low in sodium).

Children and adolescents
This medicine should not be taken by children and adolescents under the age of 16.

Elderly
The risk of serious adverse effects is higher in elderly subjects.
If you are over 70 years of age, consult your doctor before taking this medicine.

Patients with impaired kidney and liver function
This medicine should be used with caution (see “Warnings and precautions”).

Other medicines and Aspirina 325 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Aspirina 325 mg together with these medicines(see “Do not take Aspirina 325 mg”):

• Methotrexate (used in some cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin [used to make the blood more fluid (anticoagulant)].

Take Aspirina 325 mg together with these medicines only under prescription and under the control of your doctor:

• Selective Serotonin Re-uptake Inhibitors (SSRIs) (used against depression);
• ACE inhibitors (used against high blood pressure);
• Acetazolamide (used in some types of edema (swelling));
• Valproic acid (used in epilepsy);
• Other NSAIDs (except those for local use);
• Antacids (used against digestive disorders);
• Antiplatelet agents (used for the prevention and treatment of blood clots in the arteries);
• Thrombolytics (used to dissolve blood clots) or anticoagulants (used to slow down or inhibit the blood clotting process) taken orally or by injection;
• Antidiabetics, for example insulin and oral hypoglycemic agents (used to stimulate insulin production by the pancreas);
• Digoxin (used in heart failure);
• Diuretics (used to increase the amount of urine produced);
• Phenytoin (used in case of epilepsy;
• Corticosteroids (cortisone, excluding those for local use and those used in replacement therapy in adrenal insufficiency);
• Metoclopramide (used against vomiting);
• Methotrexate (doses less than 15 mg/week);
• Uricosuric agents, for example probenecid, benzbromarone (used to increase the elimination of uric acid);
• Zafirlukast (used against asthma).

Aspirina 325 mg contains buffering systems that may reduce the effects of the thyroid hormone Levothyroxine.
Do not take other medicines orally within 1 or 2 hours of using this medicine.

Aspirina 325 mg with alcohol
The sum of the effects of alcohol and acetylsalicylic acid increases the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
Do not take Aspirina 325 mg in the last trimester of pregnancy.
In the first and second trimester of pregnancy, take this medicine only after consulting your doctor and discussing the risk/benefit ratio in your case.

Breastfeeding
Do not take Aspirina 325 mg during breastfeeding.

Fertility
If you are a woman with fertility problems or are undergoing fertility investigations, keep in mind that the use of acetylsalicylic acid, like any medicine that inhibits the synthesis of prostaglandins and cyclooxygenase, may interfere with fertility.

Driving and operating machinery
Due to the possible occurrence of headache or dizziness, this medicine may impair your ability to drive vehicles and operate machinery.

Aspirina 325 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Aspirina 325 mg

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended doseis 1 or 2 tablets as a single dose, repeating, if necessary, the dose at intervals of 4-8 hours, up to 2-3 times a day.
The Aspirina 325 mg tablet should be taken with water.
Take the product on a full stomach, preferably after main meals.

Warning: do not exceed the indicated doses without your doctor's advice. Elderly patients should adhere to the minimum dosages indicated above.
Always use the minimum effective dosage and increase it only if it is not sufficient to relieve symptoms (pain and fever).
Subjects more exposed to the risk of serious adverse effects, who can only use the medicine if prescribed by a doctor, must strictly follow their instructions.
Do not take the product for more than 3-5 days without consulting your doctor. Consult your doctor if the symptoms persist. Use the medicine for the shortest possible period.
Consult your doctor if the disorder recurs or if you have noticed any recent change in its characteristics.

If you take more Aspirina 325 mg than you should
In case of accidental ingestion of an excessive dose of Aspirina 325 mg, immediately notify your doctor or go to the nearest hospital.
Salicylate toxicity (a dosage greater than 100 mg/kg/day for 2 consecutive days can induce toxicity: in a 70 kg individual, for example, salicylate toxicity manifests with the intake of more than 7 g of acetylsalicylic acid per day, equivalent to more than 21 Aspirina 325 mg tablets) may be the consequence of chronic excessive doses or acute overdose, potentially life-threatening and including accidental ingestion in children.

• Chronic intoxication (repeated use of considerable doses) :symptoms include dizziness, vertigo, tinnitus (a sound or ringing in the ear), deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage
• Acute intoxication:signs and symptoms/results of biochemical and instrumental investigations may include:
• Signs and symptoms of mild/moderate overdose:tachypnea (rapid breathing), hyperventilation (breathing too deeply), respiratory alkalosis (alteration of the acid-base balance following changes in breathing), sweating, nausea, vomiting, headache, vertigo.
• Signs and symptoms of moderate/severe overdose:respiratory alkalosis with compensatory metabolic acidosis (alteration of the acid-base balance following changes in breathing and accumulation of acids in the body), fever, hyperventilation (breathing too deeply), pulmonary edema (water in the lungs), respiratory failure, asphyxia, arrhythmias (irregular heartbeat), hypotension (low blood pressure), cardiorespiratory arrest (cessation of heartbeat), dehydration, oliguria (decreased urine output) up to renal failure (reduced kidney function), ketosis (“acetone”), hyperglycemia (increased blood sugar level), severe hypoglycemia (severe decrease in blood sugar level), tinnitus (a sound or ringing in the ear), deafness, gastrointestinal bleeding, gastric ulcer, coagulopathy (alteration of blood coagulation), iron deficiency anemia, encephalopathy (brain damage), and central nervous system depression, with manifestations ranging from lethargy (deep sleepiness) and confusion to coma and convulsions, cerebral edema (swelling of brain tissue), liver damage.
• At high doses, alterations in taste and skin rashes (acneiform, erythematous, scarlatiniform, eczematoid, desquamative, bullous, purpuric), itching may also appear.
• Other signs and symptoms: conjunctivitis, anorexia (loss of appetite), reduced visual acuity (ability to distinguish objects clearly), drowsiness.
• Rarely, the following may occur:aplastic anemia (failure to produce red blood cells), agranulocytosis (lack of granulocyte blood cells), disseminated intravascular coagulation (widespread presence of numerous blood clots), pancytopenia (deficiency of all types of blood cells), leukopenia (deficiency of white blood cells), thrombocytopenia (deficiency of platelets), eosinopenia (deficiency of eosinophil blood cells), purpura (reddish spots on the skin), eosinophilia (increase in eosinophils) associated with drug-induced hepatotoxicity, renal toxicity (allergic tubulo-interstitial nephritis), hematuria (presence of blood in the urine).

Acute allergic reactions resulting from taking acetylsalicylic acid can be treated, if necessary, with administration of adrenaline, corticosteroids and an antihistamine.

If you forget to take Aspirina 325 mg
Continue therapy as per the recommended dose. Do not take a double dose to make up for the missed dose.

If you stop taking Aspirina 325 mg
Discontinuing treatment has no effect.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them
.
The side effects observed most frequently affect the gastrointestinal system.
These disorders can be partially alleviated by taking the medicine on a full stomach. Most of the side effects are dependent on both the dose and the duration of treatment. The side effects observed with acetylsalicylic acid are generally common to other NSAIDs.

The following side effects may occur:
Effects on the blood

• prolongation of bleeding time,
• anemia due to gastrointestinal bleeding,
• reduction of platelets (thrombocytopenia) in extremely rare cases. Following bleeding, post-hemorrhagic/iron deficiency anemia (due to iron deficiency) may occur (due, for example, to occult microbleeds) with the related changes in laboratory parameters and related clinical signs and symptoms such as asthenia (fatigue), pallor and hypoperfusion (reduced blood supply to tissues).

Effects on the nervous system

• headache,
• dizziness. Rarely, it may manifest as:
• Reye's syndrome(*), an acute disease affecting the brain and liver, potentially fatal, which almost exclusively affects children. From rarely to very rarely, it may manifest as:
• cerebral hemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and/or undergoing therapy with anticoagulants (medicines used to slow down or inhibit the blood clotting process), which, in isolated cases, may be potentially fatal.

Effects on the ear

• tinnitus (ringing/buzzing/humming/whistling in the ear).

Effects on the respiratory system

• - Respiratory disease exacerbated by acetylsalicylic acid
• asthmatic syndrome,
• rhinitis (runny nose)
• nasal congestion (stuffy nose) (associated with allergic reactions);
• epistaxis (nosebleed).

Effects on the heart

• cardiorespiratory distress (severe and acute respiratory failure) (associated with allergic reactions).

Effects on the eye

• conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal system

• gastrointestinal bleeding (occult),
• gastric discomfort,
• pyrosis (heartburn),
• gastrointestinal pain,
• gingivorrhagia (bleeding gums),
• vomiting,
• diarrhea,
• nausea,
• cramping abdominal pain (associated with allergic reactions). Rarely, the following may occur:
• gastrointestinal inflammation,
• gastrointestinal erosion,
• gastrointestinal ulceration,
• hematemesis (vomiting blood or "coffee grounds" material),
• melena (emission of black, tarry stools),
• esophagitis (inflammation of the esophagus). Very rarely, the following may occur:
• gastrointestinal hemorrhagic and/or perforated ulcer with related clinical signs and symptoms and changes in laboratory parameters. May occur with unknown frequency (especially with long-term treatment):
• Intestinal diaphragm disease

Effects on the liver

• rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular damage) which manifests with an increase in transaminases.

Effects on the skin

• skin rash,
• edema (swelling),
• urticaria (hives),
• pruritus (itching),
• erythema (redness),
• angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract

• alteration of renal function and acute renal injury (in the presence of conditions of altered blood circulation in the kidneys),
• urogenital hemorrhage (of the urinary and genital tract).

Effects on the whole organism

• procedural bleeding (immediately before, during and immediately after surgery),
• hematomas (collections of blood outside the blood vessels).

Effects on the immune system

• rarely: anaphylactic shock (severe allergic reaction, potentially fatal) with related changes in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (RS)
RS initially manifests with vomiting (persistent or recurrent) and with other signs of encephalic suffering of varying severity: from sluggishness, drowsiness or personality changes (irritability or
aggressiveness) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture should be considered: even vomiting may be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following an influenza episode (or flu-like or varicella or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates have been administered, the doctor's attention should immediately be directed to the possibility of RS.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor
or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store Aspirina 325 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aspirina 325 mg contains

• The active ingredient is acetylsalicylic acid. One tablet contains 325 mg of acetylsalicylic acid.
• The other ingredients are: magnesium hydroxide 100 mg, aluminum dihydroxy aminoacetate 50 mg, corn starch, sodium croscarmellose.

Description of the appearance of Aspirina 325 mg and contents of the pack
Aspirina 325 mg is presented in the form of tablets.
The pack contains 4, 10 and 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa 130 - Milan

Manufacturer
Bayer HealthCare Manufacturing S.r.l. - via delle Groane 126, Garbagnate Milanese (MI)

Aspirina Rapida 500 mg chewable tablets

acetylsalicylic acid

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 -5 days.

Contents of this leaflet:

• 1. What Aspirina Rapida is and what it is used for
• 2. What you need to know before taking Aspirina Rapida
• 3. How to take Aspirina Rapida
• 4. Possible side effects
• 5. How to store Aspirina Rapida
• 6. Contents of the pack and other information

1. What is Aspirina Rapida and what is it used for

Aspirina is an analgesic (pain reliever: reduces pain), anti-inflammatory and antipyretic (antifebrile: reduces
fever).
Aspirina is used for the symptomatic treatment of feverish conditions and flu-like and cold syndromes and
for the symptomatic treatment of headache, toothache, neuralgia, menstrual pain, rheumatic and
muscular pain.
The use of this product is reserved for adult patients only.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3-5 days.

2. What you need to know before taking Aspirina Rapida

Do not take Aspirina Rapida

• if you are allergic to acetylsalicylic acid, other analgesics (pain relievers) / antipyretics (fever reducers) / non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from gastroduodenal ulcer (ulcer in the stomach or the first part of the intestine);
• if you suffer from hemorrhagic diathesis (tendency to bleeding);
• if you suffer from severe renal (kidney) or hepatic (liver) or cardiac (heart) insufficiency;
• if you suffer from glucose -6 -phosphate dehydrogenase deficiency (an enzyme whose absence, genetically determined, causes a disease characterized by reduced red blood cell survival);
• if you are already taking methotrexate(at doses of 15 mg/week or more) or warfarin(see “Other medicines and Aspirina Rapida”);
• if you have previously suffered from asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are in the last trimester of pregnancy or if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
• if you are under 16 years of age (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirina Rapida.
Take the medicine only on a full stomach.
Before administering any medicine, you should take all useful precautions to prevent adverse reactions:

• exclude the existence of previous allergic reactions to this or other medicines;
• exclude the existence of other contraindications or conditions that may expose you to the risk of potentially serious adverse effects. If in doubt, consult your doctor or pharmacist.
• do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time.

Allergic reactions
Acetylsalicylic acid and other NSAIDs can cause allergic reactions [including asthma attacks, rhinitis (runny nose), angioedema (swelling of the skin and mucous membranes) or urticaria (small spots on the skin accompanied by itching)].
The risk is greater in subjects who have previously experienced an allergic reaction after use of this type of medicine (see “Do not take Aspirina Rapida”) and in subjects who present allergic reactions (for example skin reactions, itching, urticaria) to other substances.
In subjects with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria, reactions may be more frequent and severe.

Inform your doctor if:

• you are to undergo surgery (even minor surgery such as tooth extraction), as the pre-operative use of this medicine may make it more difficult to stop bleeding during surgery (intraoperative hemostasis);
• you need to perform an occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe the administration of this medicine only after a careful evaluation of the risk/benefit ratio:

• if you have a higher risk of allergic reactions, for example if you suffer from asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria;
• if you have a higher risk of gastrointestinal lesions, as acetylsalicylic acid and other NSAIDs can cause serious adverse effects at the gastrointestinal level (bleeding, ulcer, perforation); for this reason, these medicines should not be used in subjects who suffer or have suffered in the past from gastrointestinal ulcer or gastrointestinal bleeding (see “Do not take Aspirina Rapida”) or who use large amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood coagulation defects or if you are following treatment with anticoagulant medicines (used to slow down or inhibit the blood coagulation process);
• if you suffer from impaired kidney, heart or liver function;
• if you have asthma;
• if you have hyperuricemia/gout (increased levels of uric acid in the blood).

It is advisable to consult your doctor even in cases where the above-mentioned disorders have occurred in the past.

• if you are taking medicines that are not recommended or that require special precautions or dosage adjustments (see “Other medicines and Aspirina Rapida”);
• if you are over 70 years of age, especially in the presence of concomitant therapies;
• if you are in the first or second trimester of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• if you are following a low-sodium diet.

Children and adolescents
This medicine should not be taken by children and adolescents under 16 years of age.

Elderly
The risk of serious adverse effects is greater in elderly subjects.
If you are over 70 years of age, consult your doctor before taking this medicine.

Patients with impaired kidney and liver function
This medicine should be used with caution (see “Warnings and precautions”).

Other medicines and Aspirina Rapida
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Aspirina Rapida together with these medicines (see “Do not take Aspirina Rapida”):

• Methotrexate (used in some tumors and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin [used to make the blood more fluid (anticoagulant)].

Take Aspirina Rapida together with these medicines only under prescription and under medical supervision:

• Selective Serotonin Re-uptake Inhibitors (SSRIs) (used against depression);
• ACE inhibitors (used against high blood pressure);
• Acetazolamide (used in some types of edema (swelling));
• Valproic acid (used in epilepsy);
• Other NSAIDs (except those for topical use);
• Antacids (used against digestive disorders);
• Antiplatelet agents (used for the prevention and treatment of blood clots in the arteries);
• Thrombolytics (used to dissolve blood clots) or anticoagulants (used to slow down or inhibit the blood coagulation process) taken orally or by injection;
• Antidiabetics, for example insulin and oral hypoglycemic agents (used to stimulate insulin production by the pancreas);
• Digoxin (used in heart failure);
• Diuretics (used to increase the amount of urine produced);
• Phenytoin (used in case of epilepsy);
• Corticosteroids (cortisone, excluding those for topical use and those used in replacement therapy in adrenal insufficiency);
• Metoclopramide (used against vomiting);
• Methotrexate (doses less than 15 mg/week);
• Uricosuric agents, for example probenecid, benzbromarone (used to increase the elimination of uric acid);
• Zafirlukast (used against asthma).

Aspirina Rapida contains buffering systems that may reduce the effects of the thyroid hormone Levothyroxine.
Do not take other medicines orally within 1 or 2 hours of using this medicine.

Aspirina Rapida with alcohol
The combined effects of alcohol and acetylsalicylic acid increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
Do not take Aspirina Rapida in the last trimester of pregnancy.
In the first and second trimester of pregnancy, take this medicine only after consulting your doctor and evaluating with him the risk/benefit ratio in your case.

Breastfeeding
Do not take Aspirina Rapida during breastfeeding.

Fertility
If you are a woman with fertility problems or are undergoing fertility investigations, keep in mind that the use of acetylsalicylic acid, like any medicine that inhibits the synthesis of prostaglandins and cyclooxygenase, may interfere with fertility.

Driving and using machines
Due to the possible occurrence of headache or dizziness, this medicine may impair the ability to drive vehicles and operate machinery.

Aspirina Rapida contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

Aspirina Rapida contains aspartame
This medicine contains 16.5 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disease that causes a build-up of phenylalanine because the body cannot properly dispose of it.

Aspirina Rapida contains sunset yellow (E110)
May cause allergic reactions.

3. How to take Aspirina Rapida

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 tablets as a single dose, repeating, if necessary, the dose at intervals of 4 -8 hours, up to 2 -3 times a day.
Aspirina Rapida tablets should be chewed, with or without taking water.
Take the product on a full stomach, preferably after main meals.

Warning:do not exceed the indicated doses without your doctor's advice. Elderly patients should adhere to the minimum dosages indicated above.
Always use the minimum effective dosage and increase it only if it is not sufficient to relieve symptoms (pain and fever).
Subjects more exposed to the risk of serious side effects, who can use the medicine only if prescribed by a doctor, must strictly follow their instructions.
Do not take the product for more than 3 -5 days without medical advice. Consult your doctor if the symptoms persist. Use the medicine for the shortest possible period.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.

If you take more Aspirina Rapida than you should
In case of accidental ingestion of an excessive dose of Aspirina Rapida, immediately inform your doctor or go to the nearest hospital.
Salicylate toxicity (a dosage higher than 100 mg/kg/day for 2 consecutive days can induce toxicity: in a 70 kg individual, for example, salicylate toxicity manifests with the intake of more than 7 g of acetylsalicylic acid per day, equivalent to more than 14 Aspirina Rapida tablets) may be the consequence of chronic excessive doses or acute overdose, potentially life-threatening and including accidental ingestion in children.

• Chronic intoxication (repeated use of considerable doses):symptoms include dizziness, vertigo, tinnitus (a sound or ringing in the ear), hearing loss, sweating, nausea and vomiting, headache, and confusion. These symptoms can be controlled by reducing the dosage.
• Acute intoxication:signs and symptoms/results of biochemical and instrumental investigations may include:
• Signs and symptoms of mild/moderate overdose: tachypnea (rapid breathing), hyperventilation (breathing too deeply), respiratory alkalosis (alteration of the acid-base balance following changes in breathing), sweating, nausea, vomiting, headache, vertigo.
• Signs and symptoms of moderate/severe overdose: respiratory alkalosis with compensatory metabolic acidosis (alteration of the acid-base balance following changes in breathing and accumulation of acids in the body), fever, hyperventilation (breathing too deeply), pulmonary edema (water in the lungs), respiratory failure, asphyxia, arrhythmias (irregular heartbeat), hypotension (low blood pressure), cardiorespiratory arrest (cessation of heartbeat), dehydration, oliguria (decreased urine) up to renal failure (reduced kidney function), ketosis (“acetone”), hyperglycemia (increased blood sugar level), severe hypoglycemia (severe decrease in blood sugar level), tinnitus (a sound or ringing in the ear), hearing loss, gastrointestinal bleeding, gastric ulcer, coagulopathy (alteration of blood coagulation), iron deficiency anemia, encephalopathy (brain damage) and depression of the central nervous system, with manifestations ranging from lethargy (deep drowsiness) and confusion to coma and convulsions, cerebral edema (swelling of brain tissue), liver damage.
• At high doses, alterations of taste and skin eruptions (acneiform, erythematous, scarlatiniform, eczematoid, desquamative, bullous, purpuric), itching may also occur.
• Other signs and symptoms: conjunctivitis, anorexia (loss of appetite), reduced visual acuity (ability to distinguish objects clearly), drowsiness.
• Rarely, the following may occur: aplastic anemia (failure to produce red blood cells), agranulocytosis (lack of blood cells called granulocytes), disseminated intravascular coagulation (widespread presence of numerous blood clots), pancytopenia (deficiency of all types of blood cells), leukopenia (deficiency of white blood cells), thrombocytopenia (deficiency of platelets), eosinopenia (deficiency of blood cells called eosinophils), purpura (reddish spots on the skin), eosinophilia (increase in eosinophils) associated with drug-induced hepatotoxicity, renal toxicity (allergic tubulo-interstitial nephritis), hematuria (presence of blood in the urine).

Acute allergic reactions following intake of acetylsalicylic acid can be treated, if necessary, with administration of adrenaline, corticosteroids and an antihistamine.

If you forget to take Aspirina Rapida
Continue therapy as per the recommended dose. Do not take a double dose to compensate for missing the dose.

If you stop taking Aspirina Rapida
Discontinuation of treatment has no effect.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects observed most frequently affect the gastrointestinal tract.
These disorders can be partially relieved by taking the medicine on a full stomach. Most of the side effects are dependent on both the dose and the duration of treatment. The side effects observed with acetylsalicylic acid are generally common to other NSAIDs.

The following side effects may occur:
Effects on the blood

• prolongation of bleeding time,
• anemia due to gastrointestinal bleeding,
• reduction of platelets (thrombocytopenia) in extremely rare cases. Following bleeding, hemorrhagic/iron deficiency anemia (due to, for example, occult microbleeds) may occur, with related changes in laboratory parameters and related clinical signs and symptoms such as asthenia (fatigue), pallor and hypoperfusion (reduced blood supply to tissues).

Effects on the nervous system

• headache,
• dizziness. Rarely, the following may occur:
• Reye's syndrome (*), an acute disease affecting the brain and liver, potentially fatal, which almost exclusively affects children. From rarely to very rarely, the following may occur:
• cerebral hemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and/or undergoing therapy with anticoagulants (medicines used to slow down or inhibit the blood clotting process), which, in isolated cases, may be potentially fatal.

Effects on the ear

• tinnitus (ringing/buzzing/tintinnitus/whistling in the ear).

Effects on the respiratory system

• Respiratory disease exacerbated by acetylsalicylic acid
• asthmatic syndrome
• rhinitis (runny nose)
• nasal congestion (stuffy nose) (associated with allergic reactions)
• epistaxis (nosebleed).

Effects on the heart

• cardiorespiratory distress (severe and acute respiratory failure) (associated with allergic reactions).

Effects on the eye

• conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal tract

• gastrointestinal bleeding (occult),
• gastric discomfort,
• pyrosis (heartburn),
• gastrointestinal pain,
• gingivorrhagia (bleeding gums),
• vomiting,
• diarrhea,
• nausea,
• cramping abdominal pain (associated with allergic reactions). Rarely, the following may occur:
• gastrointestinal inflammation,
• gastrointestinal erosion,
• gastrointestinal ulceration,
• hematemesis (vomiting blood or “coffee grounds” material),
• melena (emission of black, tarry stools),
• esophagitis (inflammation of the esophagus).

Very rarely, the following may occur:

• hemorrhagic and/or perforated gastrointestinal ulcer with related clinical signs and symptoms and changes in laboratory parameters. May occur with unknown frequency (especially with long-term treatment):
• Intestinal diaphragm disease.

Effects on the liver

• rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular damage) which manifests with an increase in transaminases.

Effects on the skin

• skin rash,
• edema (swelling),
• urticaria (hives),
• pruritus (itching),
• erythema (redness),
• angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract

• impaired renal function and acute renal injury (in the presence of conditions of altered blood circulation in the kidneys),
• urogenital bleeding (of the urinary and genital tract).

Effects on the whole organism

• procedural bleeding (immediately before, during and immediately after surgery),
• hematomas (collections of blood outside blood vessels).

Effects on the immune system

• rarely: anaphylactic shock (severe allergic reaction, potentially fatal) with related changes in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (RS)
RS initially manifests with vomiting (persistent or recurrent) and with other signs of cerebral suffering of varying severity: from listlessness, drowsiness or personality changes (irritability or aggressiveness) to disorientation, confusion or delirium to convulsions or loss of consciousness. The variability of the clinical picture should be kept in mind: even vomiting may be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following an influenza episode (or flu-like or varicella or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates have been administered, the doctor's attention should immediately be directed to the possibility of RS.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store Aspirina Rapida

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aspirina Rapida contains

• The active ingredient is acetylsalicylic acid. One chewable tablet contains 500 mg of acetylsalicylic acid.
• The other ingredients are: calcium stearate, corn starch, mannitol, aspartame, ascorbic acid, anhydrous citric acid, heavy magnesium carbonate, pregelatinized starch, mandarin aroma, orange aroma, sodiumcarbonate anhydrous, sodium carboxymethylcellulose, refreshing lemon aroma, sunset yellow(E110).

Description of the appearance of Aspirina Rapida and contents of the pack
Aspirina Rapida is available in the form of chewable tablets.
The pack contains 2 or 10 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Bayer S.p.A. - Viale Certosa 130 - Milan

Manufacturer
Bayer Bitterfeld GmbH- Greppin-Germany

Aspirina 400 mg effervescent tablets with Vitamin C

acetylsalicylic acid + ascorbic acid

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3-5 days.

Contents of this leaflet:

• 1. What Aspirina 400 mg effervescent tablets with Vitamin C is and what it is used for
• 2. What you need to know before you take Aspirina 400 mg effervescent tablets with Vitamin C
• 3. How to take Aspirina 400 mg effervescent tablets with Vitamin C
• 4. Possible side effects
• 5. How to store Aspirina 400 mg effervescent tablets with Vitamin C
• 6. Contents of the pack and other information

1. What is Aspirina 400 mg effervescent tablets with Vitamin C and what is it used for

Aspirina is an analgesic (pain reliever: reduces pain), anti-inflammatory and antipyretic (fever reducer: reduces
fever).
Aspirina is used for the symptomatic treatment of feverish states and flu-like and cold syndromes and
for the symptomatic treatment of headache and toothache, neuralgia, menstrual pains, rheumatic and muscle pains.
Vitamin C (ascorbic acid) participates in the body's defense system.
The use of this product is reserved for adult patients only.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3-5 days.

• 2. What you need to know before taking Aspirina 400 mg effervescent tablets with Vitamin C

Do not take Aspirina 400 mg effervescent tablets with Vitamin C

• if you are allergic to acetylsalicylic acid, ascorbic acid, other analgesics (pain relievers) / antipyretics (fever reducers) / non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from gastroduodenal ulcer (ulcer in the stomach or the first part of the intestine);
• if you suffer from hemorrhagic diathesis (tendency to bleeding);
• if you suffer from severe kidney (reduced kidney function) or liver or heart failure;
• if you suffer from glucose-6-phosphate dehydrogenase deficiency (an enzyme whose absence, genetically determined, results in a disease characterized by reduced survival of red blood cells);
• if you are already taking methotrexate(at doses of 15 mg/week or more) or warfarin(see “Other medicines and Aspirina 400 mg effervescent tablets with Vitamin C”);
• if you have suffered in the past from asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are in the last trimester of pregnancy or if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
• if you are under the age of 16 (see “Children and adolescents”).
• If you suffer from or have suffered from nephrolithiasis (stones in the urinary tract or kidney)
• If you suffer from hyperoxaluria (increased urinary excretion of calcium oxalate)
• -hemochromatosis (alteration of iron metabolism leading to progressive iron accumulation in the body)

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirina 400 mg effervescent tablets with Vitamin
C.
Take the medicine only on a full stomach.
Before administering any medicine, you should take all useful precautions to prevent undesirable
reactions:

• exclude the existence of previous allergic reactions to this or other medicines;
• exclude the existence of other contraindications or conditions that may expose you to the risk of potentially serious adverse effects. If in doubt, consult your doctor or pharmacist.
• do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time.

Allergic reactions
Acetylsalicylic acid and other NSAIDs can cause allergic reactions [including asthma attacks, rhinitis
(runny nose), angioedema (swelling of the skin and mucous membranes) or urticaria (small spots on the skin
accompanied by itching)].
The risk is higher in subjects who have already experienced an allergic reaction after using
this type of medicine (see “Do not take Aspirina 400 mg effervescent tablets with Vitamin C”) and
in subjects who present allergic reactions (for example skin reactions, itching, urticaria) to other
substances.
In subjects with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be
more frequent and severe.

Inform your doctor if:

• you are to undergo surgery (even minor surgery such as a tooth extraction), as the pre-operative use of this medicine may make it more difficult to stop bleeding during the operation (intraoperative hemostasis);
• you need to perform a fecal occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, the doctor will prescribe the administration of this medicine only after
a careful evaluation of the risk/benefit ratio:

• if you have a higher risk of allergic reactions, for example if you suffer from asthma and/or rhinitis (with or without nasal polyps) and/or urticaria;
• if you have a higher risk of gastrointestinal lesions, as acetylsalicylic acid and other NSAIDs can cause serious adverse effects at the gastrointestinal level (bleeding, ulcer, perforation); for this reason, these medicines should not be used in subjects who suffer from or have suffered in the past from gastrointestinal ulcer or gastrointestinal bleeding (see “Do not take Aspirina 400 mg effervescent tablets with Vitamin C”) or who use large amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood coagulation defects or if you are following treatment with anticoagulant medicines (used to slow down or inhibit the blood clotting process);
• if you suffer from impaired kidney, heart or liver function;
• if you have asthma;
• if you have hyperuricemia/gout (elevated uric acid levels in the blood);
• if you are predisposed to calcium oxalate nephrolithiasis (kidney stones) or recurrent nephrolithiasis. It is advisable to consult a doctor even in cases where the above disorders have occurred in the past.
• if you are taking medicines that are not recommended or that require special precautions or dosage adjustments (see “Other medicines and Aspirina 400 mg effervescent tablets with Vitamin C”);
• if you are over 70 years of age, especially if you are on concomitant therapies;
• if you are in the first or second trimester of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• if you are following a low-sodium diet (low in sodium).

Children and adolescents
This medicine should not be taken by children and adolescents under the age of 16.

Elderly
The risk of serious adverse effects is higher in elderly subjects.
If you are over 70 years of age, consult your doctor before taking this medicine.

Patients with impaired kidney and liver function
This medicine should be used with caution (see “Warnings and precautions”).

Other medicines and Aspirina 400 mg effervescent tablets with Vitamin C
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.

Do not take Aspirina 400 mg effervescent tablets with Vitamin C together with these medicines
(see “Do not take Aspirina 400 mg effervescent tablets with Vitamin C”):

• Methotrexate (used in some cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin [used to thin the blood (anticoagulant)].

Take Aspirina 400 mg effervescent tablets with Vitamin C together with these medicines only
on prescription and under medical supervision:

• Selective Serotonin Re-uptake Inhibitors (SSRIs) (used for depression);
• ACE inhibitors (used for high blood pressure);
• Acetazolamide (used in some types of edema (swelling));
• Valproic acid (used in epilepsy);
• Other NSAIDs (except for topical use);
• Antacids (used for digestive disorders);
• Antiplatelet agents (used for the prevention and treatment of blood clots in the arteries);
• Thrombolytics (used to dissolve blood clots) or oral or injectable anticoagulants (used to slow down or inhibit the blood clotting process);
• Antidiabetics, for example insulin and oral hypoglycemic agents (used to stimulate insulin production by the pancreas);
• Digoxin (used in heart failure);
• Diuretics (used to increase the amount of urine produced);
• Phenytoin (used for epilepsy);
• Corticosteroids (cortisone, excluding those for topical use and those used in replacement therapy for adrenal insufficiency);
• Metoclopramide (used for vomiting);
• Methotrexate (doses less than 15 mg/week);
• Uricosuric drugs, for example probenecid, benzbromarone (used to increase the elimination of uric acid);
• Zafirlukast (used for asthma);
• Deferoxamine (used when there is an excessive amount of iron in the blood).

Aspirina 400 mg effervescent tablets with Vitamin C contains buffering systems that may reduce the
effects of the thyroid hormone Levothyroxine.
Do not take other medicines orally within 1 or 2 hours of using this medicine.

Aspirina 400 mg effervescent tablets with Vitamin C with clinical laboratory tests
Aspirina 400 mg effervescent tablets with Vitamin C contains vitamin C which can cause chemical
interference in laboratory tests such as glucose, creatinine, carbamazepine, uric acid in urine,
in serum and fecal occult blood tests.
Vitamin C can interfere with tests that measure urinary and blood glucose leading to a falsified
reading of the results even if it has no effect on blood glucose levels.

Aspirina 400 mg effervescent tablets with Vitamin C with alcohol
The combined effects of alcohol and acetylsalicylic acid increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor before taking this medicine.

Pregnancy
Do not take Aspirina 400 mg effervescent tablets with Vitamin C in the last trimester of pregnancy.
In the first and second trimester of pregnancy, take this medicine only after consulting your doctor and
assessing with him the risk/benefit ratio in your case.

Breastfeeding
Do not take Aspirina 400 mg effervescent tablets with Vitamin C during breastfeeding.

Fertility
If you are a woman with fertility problems or are undergoing fertility investigations, keep in mind that the use of
acetylsalicylic acid, like any medicine that inhibits the synthesis of prostaglandins and
cyclooxygenase, may interfere with fertility.

Driving and operating machinery
Due to the possible occurrence of headache or dizziness, this medicine may impair the ability
to drive vehicles and operate machinery.

Aspirina 400 mg effervescent tablets with Vitamin Ccontains sodium
This medicine contains 467 mg of sodium (the main component of table salt) per tablet.
This is equivalent to 23% of the recommended daily intake of sodium with the diet for
an adult.

3. How to take Aspirina 400 mg effervescent tablets with Vitamin C

Take this medicine following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.

The recommended doseis 1 or 2 tablets, repeating, if necessary, the dose at intervals of 4-8 hours, up to 3-4 times a day.
The Aspirina 400 mg effervescent tablets with Vitamin C tablet must always be dissolved in half a glass of water before use.
Take the product on a full stomach, preferably after the main meals.

Caution: do not exceed the indicated doses without the advice of your doctor. Elderly patients should adhere to the minimum dosages indicated above.
Always use the minimum effective dosage and increase it only if it is not sufficient to relieve the symptoms (pain and fever).
Subjects more exposed to the risk of serious side effects, who can use the medicine only if prescribed by the doctor, must strictly follow their instructions.
Do not take the product for more than 3-5 days without medical advice. Consult your doctor if the symptoms persist. Use the medicine for the shortest possible period.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.

If you take more Aspirina 400 mg effervescent tablets with Vitamin C than you should
In case of accidental ingestion of an excessive dose of Aspirina 400 mg effervescent tablets with Vitamin C, immediately inform your doctor or go to the nearest hospital.
Salicylate toxicity (a dosage higher than 100 mg/kg/day for 2 consecutive days can induce toxicity: in a 70 kg individual, for example, salicylate toxicity manifests with the assumption of more than 7 g of acetylsalicylic acid per day, equivalent to more than 17 tablets of Aspirina 400 mg effervescent tablets with Vitamin C) may be the consequence of chronic excessive doses or acute overdose, potentially life-threatening and including accidental ingestion in children.

• Chronic intoxication (repeated use of considerable doses) :among the symptoms are dizziness, vertigo, tinnitus (a sound or ringing in the ear), deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage.
• Acute intoxication:signs and symptoms/results of biochemical and instrumental investigations may include:
• Signs and symptoms of mild/moderate overdose: tachypnea (accelerated breathing), hyperventilation (breathing too deeply), respiratory alkalosis (alteration of the acid-base balance following changes in breathing), sweating, nausea, vomiting, headache, vertigo.
• Signs and symptoms of moderate/severe overdose: respiratory alkalosis with compensatory metabolic acidosis (alteration of the acid-base balance following changes in breathing and accumulation of acids in the body), fever, hyperventilation (breathing too deeply), pulmonary edema (water in the lungs), respiratory failure, asphyxia, arrhythmias (alterations of the heartbeat), hypotension (low blood pressure), cardiorespiratory arrest (cessation of heartbeat), dehydration, oliguria (decreased urine) up to renal failure (reduced kidney function), ketosis (“acetone”), hyperglycemia (increased blood sugar levels), severe hypoglycemia (severe decrease in blood sugar levels), tinnitus (a sound or ringing in the ear), deafness, gastrointestinal bleeding, gastric ulcer, coagulopathy (alteration of blood coagulation), iron deficiency anemia, encephalopathy (brain damage), and depression of the central nervous system, with manifestations varying from lethargy (deep drowsiness) and confusion to coma and convulsions, cerebral edema (swelling of brain tissue), liver damage.
• At high doses, alterations of taste and skin rashes (acneiform, erythematous, scarlatiniform, eczematoid, desquamative bullous, purpuric), itching may also appear.
• Other signs and symptoms:conjunctivitis, anorexia (loss of appetite), reduced visual acuity (ability to distinguish objects clearly), drowsiness.
• Rarely, the following may occur:aplastic anemia (failure to produce red blood cells), agranulocytosis (lack of blood cells called granulocytes), disseminated intravascular coagulation

(widespread presence of numerous blood clots), pancytopenia (deficiency of all types of blood cells), leukopenia (deficiency of white blood cells), thrombocytopenia (deficiency of platelets), eosinopenia (deficiency of blood cells called eosinophils), purpura (reddish spots on the skin), eosinophilia (increase in eosinophils) associated with drug-induced hepatotoxicity (liver damage), renal toxicity (allergic tubulo-interstitial nephritis), hematuria (presence of blood in the urine).
Acute allergic reactions following the assumption of acetylsalicylic acid can be treated, if necessary, with the administration of adrenaline, corticosteroids and an antihistamine.
Isolated cases of acute and chronic overdose of ascorbic acid(vitamin C) are known. Overdose of ascorbic acid can cause oxidative hemolysis (destruction of red blood cells) in patients with a deficiency of the glucose-6-phosphate dehydrogenase enzyme (an enzyme whose absence, genetically determined, causes a disease characterized by reduced red blood cell survival), disseminated intravascular coagulation (widespread presence of numerous blood clots) and significantly elevated levels of oxalates (a salt of oxalic acid) in the blood and urine.
It has been shown that increased levels of oxalates lead to the formation of calcium oxalate deposits (an insoluble calcium salt that tends to precipitate in the form of crystals and accumulate in the urinary tract) in patients undergoing dialysis.
High doses of vitamin C can cause calcium oxalate deposits, crystalluria (crystals in the urine) of calcium oxalate in patients predisposed to crystal formation, tubulo interstitial nephropathy (chronic inflammatory kidney diseases that primarily affect the renal tubules and interstitium) and acute renal failure (rapid reduction of kidney function) due to calcium oxalate crystals.

If you forget to take Aspirina 400 mg effervescent tablets with Vitamin C
Continue therapy as per the recommended dose. Do not take a double dose to compensate for missing the dose.

If you stop taking Aspirina 400 mg effervescent tablets with Vitamin C
Stopping treatment has no effect.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects observed most frequently affect the gastrointestinal tract.
These disorders can be partially relieved by taking the medicine on a full stomach. Most of the side effects depend both on the dose and on the duration of treatment.
The side effects observed with acetylsalicylic acid are generally common to other NSAIDs.

The following side effects may occur:
Effects on the blood

• prolongation of bleeding time,
• anemia due to gastrointestinal bleeding,
• reduction of platelets (thrombocytopenia) in extremely rare cases. Following bleeding, hemorrhagic/iron deficiency anemia (due to iron deficiency) may occur (due, for example, to occult microbleeds) with the related changes in laboratory parameters and related clinical signs and symptoms such as asthenia (fatigue), pallor and hypoperfusion (reduced blood flow to tissues).

Effects on the nervous system

• headache,
• dizziness. Rarely it may manifest as:
• Reye's syndrome (*), an acute disease affecting the brain and liver, potentially fatal, which almost exclusively affects children. From rarely to very rarely it may manifest as:
• cerebral hemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and/or undergoing therapy with anticoagulants (medicines used to slow down or inhibit the blood clotting process), which, in isolated cases, may be potentially fatal.

Effects on the ear

• tinnitus (ringing/buzzing/whistling in the ear).

Effects on the respiratory system

• Respiratory disease exacerbated by acetylsalicylic acid,
• asthmatic syndrome,
• rhinitis (runny nose)
• nasal congestion (stuffy nose) (associated with allergic reactions);
• epistaxis (nosebleed).

Effects on the heart

• cardiorespiratory distress (severe and acute respiratory failure) (associated with allergic reactions).

Effects on the eye

• conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal tract

• gastrointestinal bleeding (occult),
• gastric disorders,
• pyrosis (heartburn),
• gastrointestinal pain,
• gingivorrhagia (bleeding gums),
• vomiting,
• diarrhea,
• nausea,
• cramping abdominal pain (associated with allergic reactions). Rarely, the following may occur:
• gastrointestinal inflammation,
• gastrointestinal erosion,
• gastrointestinal ulceration,
• hematemesis (vomiting blood or "coffee grounds" material),
• melena (emission of black, tarry stools),
• esophagitis (inflammation of the esophagus) Very rarely, the following may occur:
• hemorrhagic and/or perforated gastrointestinal ulcer with related clinical signs and symptoms and changes in laboratory parameters. Frequency not known (especially with long-term treatment):
• Intestinal diaphragm disease.

Effects on the liver

• rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular damage) which manifests with an increase in transaminases.

Effects on the skin

• skin rash,
• edema (swelling),
• urticaria (hives),
• pruritus (itching),
• erythema (redness),
• angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract

• alteration of renal function (in the presence of conditions of altered blood flow to the kidneys) and acute renal injury,
• urogenital bleeding (of the urinary and genital tract).

Effects on the whole organism

• procedural bleeding (immediately before, during and immediately after surgery),
• hematomas (collections of blood outside blood vessels).

Effects on the immune system

• rarely: anaphylactic shock (severe allergic reaction, potentially fatal) with related changes in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (RS)
RS initially manifests with vomiting (persistent or recurrent) and with other signs of brain suffering of varying severity: from apathy, drowsiness or personality changes (irritability or aggressiveness) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture should be kept in mind: even vomiting may be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following an episode of influenza (or flu-like or chickenpox or other viral infection) during which acetylsalicylic acid or other medicines containing salicylates have been administered, the doctor's attention should immediately be directed to the possibility of RS.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aspirina 400 mg effervescent tablets with Vitamin C

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store at a temperature below 25° C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Aspirina 400 mg effervescent tablets with Vitamin C contains

• The active ingredients are acetylsalicylic acid and ascorbic acid (Vitamin C). One tablet contains 0.4 g of acetylsalicylic acid and 0.240 g of ascorbic acid.
• The other ingredients are: monosodium citrate, sodium bicarbonate, sodium carbonate, citric acid.

Description of the appearance of Aspirina 400 mg effervescent tablets with Vitamin C and package contents
Aspirina 400 mg effervescent tablets with Vitamin C is available in the form of effervescent
tablets.
The package contains 10, 12, 20 or 40 tablets.
Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa 130 - Milan

Manufacturer
Bayer Bitterfeld GmbH - Greppin - Germany

Aspirina 400 mg effervescent granules with Vitamin C

acetylsalicylic acid + ascorbic acid

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3-5 days.

Contents of this leaflet:

• 1. What Aspirina 400 mg effervescent granules with Vitamin C is and what it is used for
• 2. What you need to know before you take Aspirina 400 mg effervescent granules with Vitamin C
• 3. How to take Aspirina 400 mg effervescent granules with Vitamin C
• 4. Possible side effects
• 5. How to store Aspirina 400 mg effervescent granules with Vitamin C
• 6. Contents of the pack and other information

1. What is Aspirina 400 mg effervescent granules with Vitamin C and what is it used for

Aspirina is an analgesic (pain reliever: reduces pain), anti-inflammatory and antipyretic (fever reducer: reduces
fever).
Aspirina is used for the symptomatic treatment of feverish states and flu-like and cold syndromes and
for the symptomatic treatment of headache, toothache, neuralgia, menstrual pains, rheumatic and
muscular pains.
Vitamin C (ascorbic acid) participates in the body's defense system.
The use of this product is reserved for adult patients only.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3-5 days.

• 2. What you need to know before taking Aspirina 400 mg effervescent granules with Vitamin C

Do not take Aspirina 400 mg effervescent granules with Vitamin C

• if you are allergic to acetylsalicylic acid, ascorbic acid, other analgesics (pain relievers) antipyretics (fever reducers) / non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from gastroduodenal ulcer (ulcer in the stomach or the first part of the intestine);
• if you suffer from hemorrhagic diathesis (tendency to bleed);
• if you suffer from severe kidney (reduced kidney function) or liver or heart failure;
• if you suffer from glucose -6 -phosphate dehydrogenase deficiency (an enzyme whose absence, genetically determined, results in a disease characterized by reduced red blood cell survival);
• if you are already taking methotrexate(at doses of 15 mg/week or more) or warfarin(see “Other medicines and Aspirina 400 mg effervescent granules with Vitamin C”);
• if you have previously suffered from asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are in the last trimester of pregnancy or if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
• if you are under 16 years of age (see “Children and adolescents”);
• If you suffer from or have suffered from nephrolithiasis (kidney stones or urinary tract stones);
• If you suffer from hyperoxaluria (increased urinary excretion of calcium oxalate);
• hemochromatosis (a disorder of iron metabolism leading to progressive iron accumulation in the body).

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirina 400 mg effervescent granules with Vitamin
C.
Take the medicine only on a full stomach.
Before administering any medicine, you should take all useful precautions to prevent adverse
reactions:

• exclude the existence of previous allergic reactions to this or other medicines;
• exclude the existence of other contraindications or conditions that may expose you to the risk of potentially serious adverse effects. If in doubt, consult your doctor or pharmacist;

Allergic reactions
Acetylsalicylic acid and other NSAIDs can cause allergic reactions [(including asthma attacks, rhinitis
(runny nose), angioedema (swelling of the skin and mucous membranes) or urticaria (small spots on the skin and
accompanied by itching)].
The risk is higher in subjects who have previously experienced an allergic reaction after use of
this type of medicine (see “Do not take Aspirina 400 mg effervescent granules with Vitamin C”) and
in subjects who present allergic reactions (for example, skin reactions, itching, urticaria) to other
substances.
In subjects with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be more
frequent and severe.

Inform your doctor if:

• you are to undergo surgery (even minor surgery such as a tooth extraction), as the preoperative use of this medicine may make it more difficult to stop bleeding during surgery (intraoperative hemostasis);
• you need to perform an occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe the administration of this medicine only after
a careful assessment of the risk/benefit ratio:

• if you have a higher risk of allergic reactions, for example if you suffer from asthma and/or rhinitis (with or without nasal polyps) and/or urticaria;
• if you have a greater risk of gastrointestinal lesions, as acetylsalicylic acid and other NSAIDs can cause serious adverse effects at the gastrointestinal level (bleeding, ulcer, perforation); for this reason, these medicines should not be used in subjects who suffer from or have suffered from gastrointestinal ulcers or gastrointestinal bleeding (see “Do not take Aspirina 400 mg effervescent granules with Vitamin C”) or who use large amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood coagulation defects or if you are following treatment with anticoagulant medicines (used to slow down or inhibit the blood clotting process);
• if you suffer from impaired kidney, heart or liver function;
• if you have asthma;
• if you have hyperuricemia/gout (elevated uric acid levels in the blood);
• if you are predisposed to calcium oxalate nephrolithiasis (kidney stones) or recurrent nephrolithiasis.

It is advisable to consult your doctor even if the disorders listed above have occurred in the past.

• if you are taking medicines that are not recommended or that require special precautions or dosage adjustments (see “Other medicines and Aspirina 400 mg effervescent granules with Vitamin C”);
• if you are over 70 years of age, especially if you are taking concomitant therapies;
• if you are in the first or second trimester of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• if you are following a low-sodium diet (low in sodium).

Children and adolescents
This medicine should not be taken by children and adolescents under 16 years of age.

Elderly
The risk of serious adverse effects is higher in elderly subjects.
If you are over 70 years of age, consult your doctor before taking this medicine.

Patients with impaired kidney and liver function
This medicine must be used with caution (see “Warnings and precautions”).

Other medicines and Aspirina 400 mg effervescent granules with Vitamin C
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take Aspirina 400 mg effervescent granules with Vitamin C together with these medicines (see:
“Do not take Aspirina 400 mg effervescent granules with Vitamin C”):

• Methotrexate (used in some cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin [used to make the blood more fluid (anticoagulant)].

Take Aspirina 400 mg effervescent granules with Vitamin C together with these medicines only
on prescription and under medical supervision:

• Selective Serotonin Re-uptake Inhibitors (SSRIs) (used against depression);
• ACE inhibitors (used against high blood pressure);
• Acetazolamide (used in some types of edema (swelling));
• Valproic acid (used in epilepsy);
• Other NSAIDs (except those for local use);
• Antacids (used against digestive disorders);
• Antiplatelet agents (used for the prevention and treatment of blood clots in the arteries);
• Thrombolytics (used to dissolve blood clots) or anticoagulants (used to slow down or inhibit the blood clotting process) taken orally or by injection;
• Antidiabetics, for example oral hypoglycemic agents (used to stimulate insulin production by the pancreas);
• Digoxin (used in heart failure);
• Diuretics (used to increase the amount of urine produced);
• Phenytoin (used in case of epilepsy);
• Corticosteroids (cortisone, excluding those for local use and those used in replacement therapy in adrenal insufficiency);
• Metoclopramide (used against vomiting);
• Methotrexate (doses less than 15 mg/week);
• Uricosuric agents, for example probenecid, benzbromarone (used to increase the elimination of uric acid);
• Zafirlukast (used against asthma);
• Deferoxamine (used when there is an excessive amount of iron in the blood).

Aspirina 400 mg effervescent granules with Vitamin C contains buffering systems that may reduce the
effects of thyroid hormone Levothyroxine.
Do not take other medicines orally within 1 or 2 hours of using this medicine.

Aspirina 400 mg effervescent tablets with Vitamin C with clinical laboratory tests
Aspirina 400 mg effervescent tablets with Vitamin C contains vitamin C which can cause chemical
interference in laboratory tests such as glucose, creatinine, carbamazepine, uric acid in urine,
in serum and fecal occult blood tests.
Vitamin C can interfere with tests that measure urinary and blood glucose leading to a falsified reading
of the results even if it has no effect on blood glucose levels.

Aspirina 400 mg effervescent granules with Vitamin C with alcohol
The combined effects of alcohol and acetylsalicylic acid increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
Do not take Aspirina 400 mg effervescent granules with Vitamin C in the last trimester of pregnancy.
In the first and second trimester of pregnancy, take this medicine only after consulting your doctor and
assessing with him the risk/benefit ratio in your case.

Breastfeeding
Do not take Aspirina 400 mg effervescent granules with Vitamin C during breastfeeding.

Fertility
If you are a woman with fertility problems or are undergoing fertility investigations, keep in mind that the use of
acetylsalicylic acid, like any medicine that inhibits the synthesis of prostaglandins and
cyclooxygenase, may interfere with fertility.

Driving and operating machinery
Due to the possible occurrence of headache or dizziness, this medicine may impair your ability
to drive vehicles and operate machinery.

Aspirina 400 mg effervescent granules with Vitamin Ccontains sodium
This medicine contains 469 mg of sodium (the main component of table salt) per sachet. This
is equivalent to 23% of the recommended maximum daily intake with the diet of an adult.

Aspirina 400 mg effervescent granules with Vitamin C contains sucrose
Contains 5.6 g of sucrose (sugar) per sachet. To be taken into consideration in people affected by diabetes
mellitus.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

Aspirina 400 mg effervescent granules with Vitamin Ccontains yellow orange (E110)
May cause allergic reactions.

3. How to take Aspirina 400 mg effervescent granules with Vitamin C

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is1 sachet, repeating the dose, if necessary, at intervals of 4-8 hours, up to 3-4 times a day.
The contents of the sachet should be poured into half a glass of water or more and mixed. Before drinking, wait for the slight effervescence to cease.
Take the product on a full stomach, preferably after main meals.

Warning:do not exceed the indicated doses without your doctor's advice. Elderly patients should adhere to the minimum dosages indicated above.
Always use the minimum effective dosage and increase it only if it is not sufficient to relieve symptoms (pain and fever).
Subjects more exposed to the risk of serious side effects, who can only use the medicine if prescribed by a doctor, must strictly follow their instructions.
Do not take the product for more than 3-5 days without consulting your doctor. Consult your doctor if the symptoms persist. Use the medicine for the shortest possible period.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.

If you take more Aspirina 400 mg effervescent granules with Vitamin C than you should
In case of accidental ingestion of an excessive dose of Aspirina 400 mg effervescent granules with Vitamin C, immediately inform your doctor or go to the nearest hospital.
Salicylate toxicity (a dosage greater than 100 mg/kg/day for 2 consecutive days can induce toxicity: in a 70 kg individual, for example, salicylate toxicity manifests with the intake of more than 7 g of acetylsalicylic acid per day, equivalent to more than 17 sachets of Aspirina 400 mg effervescent granules with Vitamin C) may be the consequence of chronic excessive doses or acute overdose, potentially life-threatening and including accidental ingestion in children.

• Chronic intoxication (repeated use of considerable doses):symptoms include dizziness, vertigo, tinnitus (a sound or ringing in the ear), deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage. Tinnitus may occur at blood concentrations between 150 and 300 micrograms/ml, while, at concentrations higher than 300 micrograms/ml, more serious adverse events occur.
• Acute intoxication:signs and symptoms/results of biochemical and instrumental investigations may include:
• Signs and symptoms of mild/moderate overdose: tachypnea (rapid breathing), hyperventilation (breathing too deeply), respiratory alkalosis (alteration of the acid-base balance following alterations in breathing), sweating, nausea, vomiting, headache, vertigo.
• Signs and symptoms of moderate/severe overdose: respiratory alkalosis with compensatory metabolic acidosis (alteration of the acid-base balance following alterations in breathing and accumulation of acids in the body), fever, hyperventilation (breathing too deeply), pulmonary edema (water in the lungs), respiratory failure, asphyxia, arrhythmias (alterations of the heartbeat), hypotension

(low blood pressure), cardiorespiratory arrest (cessation of heartbeat), dehydration, oliguria (decreased urine) up to renal failure (reduced kidney function), ketosis (“acetone”), hyperglycemia (increased blood sugar level), severe hypoglycemia (severe decrease in blood sugar level), tinnitus (a sound or ringing in the ear), deafness, gastrointestinal bleeding, gastric ulcer, coagulopathy (alteration of blood coagulation), iron deficiency anemia, encephalopathy (brain damage), and depression of the central nervous system, with manifestations ranging from lethargy (deep drowsiness) and confusion to coma and convulsions, cerebral edema (swelling of brain tissue), liver damage.

• At high doses, alterations of taste and skin rashes (acneiform, erythematous, scarlatiniform, eczematoid, desquamative, bullous, purpuric), itching may also occur.
• Other signs and symptoms: conjunctivitis, anorexia (loss of appetite), reduced visual acuity (ability to distinguish objects clearly), drowsiness.
• Rarely, the following may occur: aplastic anemia (failure to produce red blood cells), agranulocytosis (lack of blood cells called granulocytes), disseminated intravascular coagulation (widespread presence of numerous blood clots), pancytopenia (deficiency of all types of blood cells), leukopenia (deficiency of white blood cells), thrombocytopenia (deficiency of platelets), eosinopenia (deficiency of blood cells called eosinophils), purpura (reddish spots on the skin), eosinophilia (increased eosinophils) associated with medicinal hepatotoxicity, renal toxicity (allergic tubulo-interstitial nephritis), hematuria (presence of blood in the urine).

Acute allergic reactions following intake of acetylsalicylic acid can be treated, if necessary, with administration of adrenaline, corticosteroids and an antihistamine.
Isolated cases of acute and chronic overdose of ascorbic acid(vitamin C) are known. Ascorbic acid overdose can cause oxidative hemolysis (destruction of red blood cells) in patients with glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency, genetically determined, which causes a disease characterized by reduced red blood cell survival), disseminated intravascular coagulation (widespread presence of numerous blood clots) and significantly elevated levels of oxalates in the blood and urine.
Increased levels of oxalates have been shown to lead to the formation of calcium oxalate deposits (insoluble calcium salt that tends to precipitate in the form of crystals and accumulate in the urinary tract) in patients undergoing dialysis.
High doses of vitamin C can cause calcium oxalate deposits, calcium oxalate crystalluria (crystals in the urine) in patients predisposed to crystal formation, tubulointerstitial nephropathy (chronic inflammatory kidney diseases that primarily affect the renal tubules and interstitium) and acute renal failure (rapid reduction of kidney function) due to calcium oxalate crystals.

If you forget to take Aspirina 400 mg effervescent granules with Vitamin C
Continue therapy as per the recommended dose. Do not take a double dose to make up for the missed dose.

If you stop taking Aspirina 400 mg effervescent granules with Vitamin C
Stopping treatment has no effect.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects observed most frequently affect the gastrointestinal tract.
These disorders can be partially relieved by taking the medicine on a full stomach. Most of the side effects depend both on the dose and on the duration of treatment.
The side effects observed with acetylsalicylic acid are generally common to other NSAIDs.

The following side effects may occur:
Effects on the blood

• prolongation of bleeding time,
• anemia due to gastrointestinal bleeding,
• reduction of platelets (thrombocytopenia) in extremely rare cases. Following bleeding, hemorrhagic/iron deficiency anemia (due to iron deficiency) may occur (for example, due to occult microbleeds) with the related changes in laboratory parameters and related clinical signs and symptoms such as asthenia (fatigue), pallor and hypoperfusion (reduced blood flow to tissues).

Effects on the nervous system

• headache,
• dizziness. Rarely, it may manifest as: Reye's syndrome (*), an acute disease affecting the brain and liver, potentially fatal, which almost exclusively affects children. From rarely to very rarely it may manifest as:
• cerebral hemorrhage, especially in patients with uncontrolled (high blood pressure) and/or undergoing treatment with anticoagulants (medicines used to slow down or inhibit the blood clotting process), which, in isolated cases, may be potentially fatal.

Effects on the ear

• tinnitus (ringing/buzzing/tintinnitus/whistling in the ear).

Effects on the respiratory system

• Respiratory disease exacerbated by acetylsalicylic acid asthma syndrome
• rhinitis (runny nose)
• nasal congestion (stuffy nose) (associated with allergic reactions)
• epistaxis (nosebleed).

Effects on the heart

• cardiorespiratory distress (severe and acute respiratory failure) (associated with allergic reactions).

Effects on the eye

• conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal tract

• gastrointestinal bleeding (occult),
• gastric discomfort,
• pyrosis (heartburn),
• gastrointestinal pain,
• gingivorrhagia (bleeding gums),
• vomiting,
• diarrhea,
• nausea,
• cramping abdominal pain (associated with allergic reactions). Rarely, the following may occur:
• gastrointestinal inflammation,
• gastrointestinal erosion,
• gastrointestinal ulceration,
• hematemesis (vomiting blood or “coffee grounds” material),
• melena (emission of black, tarry stools),
• esophagitis (inflammation of the esophagus). Very rarely, the following may occur:
• hemorrhagic and/or perforated gastrointestinal ulcer with related clinical signs and symptoms and changes in laboratory parameters. Frequency not known (especially with long-term treatment):
• Intestinal diaphragm disease.

Effects on the liver

• rarely: hepatotoxicity (hepatocellular damage generally mild and asymptomatic) which manifests with an increase in transaminases.

Effects on the skin

• skin rash,
• edema (swelling),
• urticaria (hives),
• pruritus (itching),
• erythema (redness),
• angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract

• alteration of renal function (in the presence of conditions of altered blood circulation in the kidneys) and acute renal injury,
• urogenital bleeding (of the urinary and genital tract).

Effects on the whole organism

• procedural bleeding (immediately before, during and immediately after surgery),
• hematomas (collections of blood outside the blood vessels).

Effects on the immune system

• rarely: anaphylactic shock (severe allergic reaction, potentially fatal) with related changes in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (RS)
RS initially manifests with vomiting (persistent or recurrent) and with other signs of encephalic suffering of varying severity: from sluggishness, drowsiness or personality changes (irritability or aggressiveness) to disorientation, confusion or delirium to convulsions or loss of consciousness. The variability of the clinical picture should be borne in mind: even vomiting may be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following an episode of influenza (or flu-like or chickenpox or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates have been administered, the doctor's attention should immediately be directed to the possibility of RS.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse... By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aspirina 400 mg effervescent granules with Vitamin C

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store at a temperature below 25° C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aspirina 400 mg effervescent granules with Vitamin C contains

• The active ingredients are: acetylsalicylic acid and ascorbic acid (vitamin C). One sachet contains 0.4 g of acetylsalicylic acid and 0.240 g of ascorbic acid.
• The other ingredients are: citric acid, sodiummonobasic citrate, sodiumbicarbonate, sodiumcarbonate, orange concentrate, orange flavouring powder , sucrose, saccharin, E 110.

Description of the appearance of Aspirina 400 mg effervescent granules with Vitamin C and pack contents

Aspirina 400 mg effervescent granules with Vitamin C is presented in the form of sachets.
The pack contains 10 sachets or 20 sachets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Bayer S.p.A. - Viale Certosa 130 - Milan

Manufacturer
E-Pharma Trento S.p.A.
Frazione Ravina
Via Provina, 2
38123 Trento (TN)

Aspirina 500 mg tablets

acetylsalicylic acid

Read this leaflet carefully before taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3-5 days.

Contents of this leaflet:

• 1. What Aspirina 500 mg tablets is and what it is used for
• 2. What you need to know before you take Aspirina 500 mg tablets
• 3. How to take Aspirina 500 mg tablets
• 4. Possible side effects
• 5. How to store Aspirina 500 mg tablets
• 6. Contents of the pack and other information

1. What is Aspirina 500 mg tablets and what is it used for

Aspirina is an analgesic (pain reliever: reduces pain), anti-inflammatory and antipyretic (fever reducer: reduces
fever).
Aspirina is used for the symptomatic treatment of feverish states and flu-like and cold syndromes and
for the symptomatic treatment of headache, toothache, neuralgia, menstrual pains, rheumatic and
muscular pains.
The use of this product is reserved for adult patients only.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3-5 days.

2. What you need to know before taking Aspirina 500 mg tablets

Do not take Aspirina 500 mg tablets

• if you are allergic to acetylsalicylic acid, to other analgesics (pain relievers) / antipyretics (fever reducers) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from gastroduodenal ulcer (ulcer in the stomach or the first part of the intestine);
• if you suffer from a bleeding diathesis (tendency to bleed);
• if you suffer from severe kidney (reduced kidney function) or liver or heart failure;
• if you suffer from glucose-6-phosphate dehydrogenase deficiency (an enzyme whose absence, genetically determined, results in a disease characterized by reduced survival of red blood cells);
• if you are already taking methotrexate(at doses of 15 mg/week or more) or warfarin(see “Other medicines and Aspirina 500 mg tablets”);
• if you have previously suffered from asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are in the last trimester of pregnancy or if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
• if you are under the age of 16 years (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirina 500 mg tablets.
Take the medicine only on a full stomach.
Before administering any medicine, you should take all useful precautions to prevent adverse reactions:

• exclude the existence of previous allergic reactions to this or other medicines;
• exclude the existence of other contraindications or conditions that may expose you to the risk of potentially serious side effects. If in doubt, consult your doctor or pharmacist.
• do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time.

Allergic reactions
Acetylsalicylic acid and other NSAIDs can cause allergic reactions [including asthma attacks, rhinitis (runny nose), angioedema (swelling of the skin and mucous membranes) or urticaria (small spots on the skin accompanied by itching)].
The risk is higher in subjects who have previously experienced an allergic reaction after using this type of medicine (see “Do not take Aspirina 500 mg tablets”) and in subjects who present allergic reactions (for example skin reactions, itching, urticaria) to other substances.
In subjects with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be more frequent and severe.

Inform your doctor if:

• you are to undergo surgery (even minor surgery such as a tooth extraction), as the pre-operative use of this medicine may make it more difficult to stop bleeding during the operation (intraoperative hemostasis);
• you need to perform a fecal occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe the administration of this medicine only after a careful evaluation of the risk/benefit ratio:

• if you have a higher risk of allergic reactions, for example if you suffer from asthma and/or rhinitis (with or without nasal polyps) and/or urticaria;
• if you have a higher risk of gastrointestinal lesions, as acetylsalicylic acid and other NSAIDs can cause serious side effects at the gastrointestinal level (bleeding, ulcer, perforation); for this reason these medicines should not be used in subjects who suffer or have suffered in the past from gastrointestinal ulcer or gastrointestinal bleeding (see “Do not take Aspirina 500 mg tablets”) or who use large amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood coagulation defects or if you are following treatment with anticoagulant medicines (used to slow down or inhibit the blood clotting process);
• if you suffer from impaired kidney, heart or liver function;
• if you have asthma;
• if you have hyperuricemia/gout (elevated levels of uric acid in the blood).

It is advisable to consult your doctor even in cases where the disorders listed above have occurred in the past.

• if you are taking medicines that are not recommended or that require special precautions or a dosage adjustment (see “Other medicines and Aspirina 500 mg tablets”);
• if you are over 70 years of age, especially if you are taking concomitant therapies;
• if you are in the first or second trimester of pregnancy (see “Pregnancy, breastfeeding and fertility”).

Children and adolescents
This medicine should not be taken by children and adolescents under the age of 16 years.

Elderly
The risk of serious side effects is higher in elderly subjects.
If you are over 70 years of age, consult your doctor before taking this medicine.

Other medicines and Aspirina 500 mg tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Aspirina 500 mg tablets together with these medicines(see “Do not take Aspirina 500 mg tablets”):

• Methotrexate (used in some cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin [used to make the blood more fluid (anticoagulant)]. Take Aspirina 500 mg tablets together with these medicines only under prescription and under medical supervision:
• Selective Serotonin Re-uptake Inhibitors (SSRIs) (used against depression);
• ACE inhibitors (used against high blood pressure);
• Acetazolamide (used in some types of edema (swelling));
• Valproic acid (used in epilepsy);
• Other NSAIDs (except those for local use);
• Antacids (used against digestive disorders);
• Antiplatelet agents (used for the prevention and treatment of blood clots in the arteries);
• Thrombolytics (used to dissolve blood clots) or anticoagulants (used to slow down or inhibit the blood clotting process) taken orally or by injection;
• Antidiabetics, for example insulin and oral hypoglycemic agents (used to stimulate insulin production by the pancreas);
• Digoxin (used in heart failure);
• Diuretics (used to increase the amount of urine produced);
• Phenytoin (used in case of epilepsy);
• Corticosteroids (cortisone, excluding those for local use and those used in replacement therapy in adrenal insufficiency);
• Metoclopramide (used against vomiting);
• Methotrexate (doses less than 15 mg/week);
• Uricosuric agents, for example probenecid, benzbromarone (used to increase the elimination of uric acid);
• Zafirlukast (used against asthma).

Do not take other medicines orally within 1 or 2 hours of using this medicine.

Aspirina 500 mg tablets with alcohol
The combined effects of alcohol and acetylsalicylic acid increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
Do not take Aspirina 500 mg tablets in the last trimester of pregnancy.
In the first and second trimester of pregnancy, take this medicine only after consulting your doctor and discussing with him the risk/benefit ratio in your case.

Breastfeeding
Do not take Aspirina 500 mg tablets during breastfeeding.

Fertility
If you are a woman with fertility problems or are undergoing fertility investigations, keep in mind that the use of acetylsalicylic acid, like any medicine that inhibits the synthesis of prostaglandins and cyclooxygenase, may interfere with fertility.

Driving and operating machinery
Due to the possible occurrence of headache or dizziness, this medicine may impair your ability to drive vehicles and operate machinery.

3. How to take Aspirina 500 mg tablets

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 tablets as a single dose, repeating, if necessary, the dose at intervals
of 4-8 hours, up to 2-3 times a day.
The Aspirina tablet should always be swallowed with water, tea, lemonade, etc.
Take the product on a full stomach, preferably after main meals.

Warning:do not exceed the indicated doses without your doctor's advice. Elderly patients should adhere to the
minimum dosages mentioned above.
Always use the minimum effective dosage and increase it only if it is not sufficient to relieve symptoms (pain
and fever).
Subjects more exposed to the risk of serious side effects, who can use the medicine only if
prescribed by a doctor, must scrupulously follow their instructions.
Do not take the product for more than 3-5 days without consulting your doctor. Consult your doctor if the
symptoms persist. Use the medicine for the shortest possible period.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change
in its characteristics.

If you take more Aspirina 500 mg tablets than you should
In case of accidental ingestion of an excessive dose of Aspirina, immediately inform your doctor or
go to the nearest hospital.
Salicylate toxicity (a dosage greater than 100 mg/kg/day for 2 consecutive days can induce
toxicity: in a 70 kg individual, for example, salicylate toxicity manifests with the intake of more than 7 g
of acetylsalicylic acid per day, equivalent to more than 14 Aspirina 500 mg tablets C) may
be the consequence of chronic excessive doses or acute overdose,
potentially life-threatening and including accidental ingestion in children.

• Chronic intoxication (repeated use of considerable doses) :symptoms include dizziness, vertigo, tinnitus (a sound or ringing in the ear), hearing loss, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage. Acute intoxication:signs and symptoms/results of biochemical and instrumental investigations may include:
• Signs and symptoms of mild/moderate overdose: tachypnea (rapid breathing), hyperventilation (breathing too deeply), respiratory alkalosis (alteration of the acid-base balance following alterations in breathing), sweating, nausea, vomiting, headache, vertigo.
• Signs and symptoms of moderate/severe overdose: respiratory alkalosis with compensatory metabolic acidosis (alteration of the acid-base balance following alterations in breathing and accumulation of acids in the body), fever, hyperventilation (breathing too deeply), pulmonary edema (water in the lungs), respiratory failure, asphyxia, arrhythmias (irregular heartbeat), hypotension (low blood pressure), cardiorespiratory arrest (cessation of heartbeat), dehydration, oliguria (decreased urine) up to renal failure (reduced kidney function), ketosis (“acetone”), hyperglycemia (increased blood sugar level), severe hypoglycemia (severe decrease in blood sugar level), tinnitus (a sound or ringing in the ear), hearing loss, gastrointestinal bleeding, gastric ulcer, coagulopathy (alteration of blood coagulation), iron deficiency anemia, encephalopathy (brain damage) and depression of the central nervous system with manifestations ranging from lethargy (deep drowsiness) and confusion to coma and convulsions, cerebral edema (swelling of brain tissue), liver damage.
• At high doses, alterations of taste and skin eruptions (acneiform, erythematous, scarlatiniform, eczematoid, desquamative, bullous, purpuric), itching may also appear.
• Other signs and symptoms:conjunctivitis, anorexia (loss of appetite), reduced visual acuity (ability to distinguish objects clearly), drowsiness.
• Rarely, the following may occur:aplastic anemia (failure to produce red blood cells), agranulocytosis (lack of blood cells called granulocytes), disseminated intravascular coagulation (widespread presence of numerous blood clots), pancytopenia (deficiency of all types of blood cells), leukopenia (deficiency of white blood cells), thrombocytopenia (deficiency of platelets), eosinopenia (deficiency of blood cells called eosinophils), purpura (reddish spots on the skin), eosinophilia (increased eosinophils) associated with drug-induced hepatotoxicity, renal toxicity (allergic tubulo-interstitial nephritis), hematuria (presence of blood in the urine).

Acute allergic reactions resulting from taking acetylsalicylic acid can be treated, if
necessary, with the administration of adrenaline, corticosteroids and an antihistamine.

If you forget to take Aspirina 500 mg tablets
Continue therapy as per the recommended dose. Do not take a double dose to compensate for the forgotten
dose.

If you stop taking Aspirina 500 mg tablets
Stopping treatment has no effect.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects observed most frequently affect the gastrointestinal tract.
These disorders can be partially alleviated by taking the medicine on a full stomach. Most of the side
effects depend both on the dose and on the duration of treatment.
The side effects observed with acetylsalicylic acid are generally common to other NSAIDs.

The following side effects may occur:
Effects on the blood

• prolongation of bleeding time,
• anemia due to gastrointestinal bleeding,
• reduction of platelets (thrombocytopenia) in extremely rare cases. Following bleeding, acute and chronic
  post-hemorrhagic/iron-deficiency anemia (due to, for example, occult microbleeds) may occur, with the
  related changes in laboratory parameters and related clinical signs and symptoms such as asthenia
  (fatigue), pallor and hypoperfusion (reduced blood flow to tissues).

Effects on the nervous system

• headache,
• dizziness. Rarely it may manifest as:
• Reye's syndrome (*), an acute disease affecting the brain and liver, potentially fatal, which almost
  exclusively affects children. From rarely to very rarely it may manifest as:
• cerebral hemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and/or
  in therapy with anticoagulants (medicines used to slow down or inhibit the blood clotting process), which,
  in isolated cases, may be potentially fatal.

Effects on the ear

• tinnitus (ringing/buzzing/whistling/hissing in the ear).

Effects on the respiratory system

• asthmatic syndrome,
• rhinitis (runny nose)
• nasal congestion (stuffy nose) (associated with allergic reactions);
• epistaxis (nosebleed).

Effects on the heart

• cardiorespiratory distress (severe and acute respiratory failure) (associated with allergic reactions).

Effects on the eye

• conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal tract

• gastrointestinal bleeding (occult),
• gastric discomfort,
• pyrosis (heartburn),
• gastrointestinal pain,
• gingivorrhagia (bleeding gums),
• vomiting,
• diarrhea,
• nausea,
• cramping abdominal pain (associated with allergic reactions). Rarely, the following may occur:
• gastrointestinal inflammation,
• gastrointestinal erosion,
• gastrointestinal ulceration,
• hematemesis (vomiting blood or “coffee grounds” material),
• melena (emission of black, tarry stools),
• esophagitis (inflammation of the esophagus). Very rarely, the following may occur:
• gastrointestinal ulcer with/or perforation with the related clinical signs and symptoms and changes in
  laboratory parameters.

Effects on the liver

• rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular damage) which manifests with an
  increase in transaminases. Effects on the skin
• skin rash,
• edema (swelling),
• urticaria (hives),
• pruritus (itching),
• erythema (redness),
• angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract

• alteration of renal function (in the presence of conditions of altered blood flow to the kidneys),
• urogenital bleeding (of the urinary and genital tract).

Effects on the whole organism

• peri-operative bleeding (immediately before, during and immediately after surgery),
• hematomas (collections of blood outside blood vessels).

Effects on the immune system

• rarely: anaphylactic shock (severe allergic reaction, potentially fatal) with the related changes in laboratory
  parameters and clinical manifestations.

(*) Reye's Syndrome (RS)
RS initially manifests with vomiting (persistent or recurrent) and with other signs of brain suffering of
varying severity: from sluggishness, drowsiness or personality changes (irritability or aggressiveness) to
disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the
clinical picture should be considered: even vomiting may be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following an episode of influenza (or flu-like or chickenpox
or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates have
been administered, the doctor's attention should immediately be drawn to the possibility of RS.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aspirina 500 mg tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Blister: store at a temperature below 30 °C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aspirina 500 mg tablets contains

• The active ingredient is acetylsalicylic acid. One tablet contains 500 mg of acetylsalicylic acid.
• The other ingredients are: corn starch, powdered cellulose.

Description of the appearance of Aspirina 500 mg tablets and contents of the pack
Aspirina is presented as swallowable tablets.
The pack contains 4, 20, 24 or 30 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Bayer S.p.A. - Viale Certosa 130 - Milan

Manufacturer
Bayer Bitterfeld GmbH - Greppin – Germany