ACIDO 500 mg Tabletka

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1. ACIDO ACETILSALICILICO L.F.M. 500 mg tablets
   1. What is ACIDO ACETILSALICILICO L.F.M. and what is it for
   2. What you need to know before taking ACIDO ACETILSALICILICO L.F.M.
   3. How to take ACIDO ACETILSALICILICO L.F.M.
   4. Possible side effects
   5. How to store ACIDO ACETILSALICILICO L.F.M.
   6. Contents of the pack and other information

ACIDO ACETILSALICILICO L.F.M. 500 mg tablets

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 to.

• 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 ACIDO ACETILSALICILICO L.F.M. is and what it is used for
• 2. What you need to know before you take ACIDO ACETILSALICILICO L.F.M.
• 3. How to take ACIDO ACETILSALICILICO L.F.M.
• 4. Possible side effects
• 5. How to store ACIDO ACETILSALICILICO L.F.M.
• 6. Contents of the pack and other information

1. What is ACIDO ACETILSALICILICO L.F.M. and what is it for

ACIDO ACETILSALICILICO L.F.M. is an analgesic (pain reliever: reduces pain), anti-inflammatory and
antipyretic (antifebrile: reduces fever).
ACIDO ACETILSALICILICO L.F.M. 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 pain, rheumatic and muscular pain.
The use of this product is reserved for adult patients only.
Consult your doctor if you do not feel better or if you notice a worsening of symptoms after 3-5 days.

2. What you need to know before taking ACIDO ACETILSALICILICO L.F.M.

Do not take ACIDO ACETILSALICILICO L.F.M.

• 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 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 per week or more), or warfarin(see section “Other medicines and ACIDO ACETILSALICILICO L.F.M.”);
• 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”); Pag. 1of 8
• if you are under 16 years of age (see “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACIDO ACETILSALICILICO L.F.M.
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 ACIDO ACETILSALICILICO L.F.M.”) and in subjects who have allergic reactions (e.g. 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.

Tell your doctor if:

• you are to undergo surgery (even minor, 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 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 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 or have suffered in the past from gastrointestinal ulcer or gastrointestinal bleeding (see “Do not take ACIDO ACETILSALICILICO L.F.M.”) 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 treatments 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 level of uric acid in the blood).

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 ACIDO ACETILSALICILICO L.F.M.”);
• 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”).

Pag. 2of 8
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 greater in elderly subjects.
If you are over 70 years of age, consult your doctor before taking this medicine.

Other medicines and ACIDO ACETILSALICILICO L.F.M.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take ACIDO ACETILSALICILICO L.F.M. together with the following medicines(see “Do not take ACIDO ACETILSALICILICO L.F.M.”):

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

Take ACIDO ACETILSALICILICO L.F.M. together with these medicines only under 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 for epilepsy);
• Other NSAIDs (except those for local 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 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 for heart failure);
• Diuretics (used to increase the amount of urine produced);
• Phenytoin (used for epilepsy);
• Corticosteroids (cortisone, excluding those for local use and those used in replacement therapy for adrenal insufficiency);
• Metoclopramide (used for vomiting);
• Methotrexate (doses less than 15 mg/week);
• Uricosuric agents, for example probenecid, benzbromarone (used to increase the elimination of uric acid);
• Zafirlukast (used for the treatment of asthma).

Do not take other medicines orally within 1 or 2 hours of taking this medicine.
Metamizole (a substance used to reduce pain and fever) may decrease the effect of acetylsalicylic acid on platelet aggregation (blood cells that attach and form a blood clot) if taken simultaneously. Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid for cardioprotection.

ACIDO ACETILSALICILICO L.F.M. 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 or pharmacist for advice before taking this medicine.
Pag. 3of 8
Pregnancy

Pregnancy – last trimester
Do not take ACIDO ACETILSALICILICO L.F.M. in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It can cause problems with the kidneys and heart of the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.

Pregnancy – first and second trimester
You should not take ACIDO ACETILSALICILICO L.F.M. in the first 6 months of pregnancy unless absolutely necessary and under the advice of your doctor. If treatment is needed during this period or during attempts to conceive, the lowest dose should be used for the shortest possible time.
From the 20th week of pregnancy, ACIDO ACETILSALICILICO L.F.M. can cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Do not take this medicine if you are breastfeeding.
Fertility
If you are a woman with fertility problems or if you are undergoing fertility investigations, keep in mind that the use of ACIDO ACETILSALICILICO L.F.M., 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 use machinery.

3. How to take ACIDO ACETILSALICILICO L.F.M.

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.
Take the tablets preferably after main meals or, in any case, on a full stomach, always with
water, tea, lemonade, etc.

Warning: do not exceed the indicated doses without your doctor's advice. Elderly patients should adhere to
the minimum dosages mentioned above.
Always take 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.
Take this medicine for the shortest possible period and in any case for no more than 3-5 days without your
doctor's advice. Consult your doctor if 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 ACIDO ACETILSALICILICO L.F.M. than you should
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In case of accidental ingestion of an excessive dose of ACIDO ACETILSALICILICO L.F.M., immediately
inform your doctor or go to the nearest hospital.
Salicylate toxicity (a dosage higher than 100 mg per kg of body weight per 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 tablets of ACIDO
ACETILSALICILICO L.F.M.) 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 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 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 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, they may manifest: 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 the intake of acetylsalicylic acid can be treated, if
necessary, with administration of adrenaline, corticosteroids and an antihistamine.

If you forget to take ACIDO ACETILSALICILICO L.F.M.
Continue therapy as per the recommended dose. Do not take a double dose to make up for the missed dose.
Pag. 5of 8
If you stop taking ACIDO ACETILSALICILICO L.F.M.
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 everyone will experience 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 side effects depend 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, acute and chronic post-hemorrhagic/iron deficiency anemia (due, for example, to occult microbleeds) may occur, with 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, the following may occur:
• Reye's syndrome (*), an acute disease affecting the brain and liver, potentially fatal, which almost exclusively affects children. Very rarely to 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

• asthma,
• respiratory disease exacerbated by acetylsalicylic acid,
• 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),
• gastrointestinal disorders, Pag. 6of 8
• pyrosis (heartburn),
• gastrointestinal pain,
• gum bleeding,
• vomiting,
• diarrhea,
• nausea,
• abdominal pain (associated with allergic reactions). Rarely, the following may occur:
• gastrointestinal inflammation,
• gastrointestinal erosion,
• gastric ulcer,
• hematemesis (vomiting blood or “coffee grounds” material),
• melena (emission of black, tarry stools),
• esophagitis (inflammation of the esophagus). Very rarely, the following may occur:
• ulcer bleeding and/or gastrointestinal perforation with related 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 kidney 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),
• hematoma (collection 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.

Other side effects that may occur:

• delay of labor.

(*) 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 episode of influenza (or flu-like illness 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 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 ACIDO ACETILSALICILICO L.F.M.

Store at a temperature below 25  C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
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 it containsACIDO ACETILSALICILICO L.F.M.

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

Description of the appearance of ACIDO ACETILSALICILICO L.F.M. and contents of the pack
Pack of 20 tablets of 500 mg.

Marketing Authorisation Holder
Laboratorio Farmacologico Milanese S.r.l.
Via Monterosso, 273 - 21042 Caronno Pertusella (VA)
Italy

Manufacturer
Laboratorio Farmacologico Milanese S.r.l.
Via Monterosso, 273 - 21042 Caronno Pertusella (VA)
Italy
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