ASPIRINAACT 800 mg/480 mg Effervescent Tablet

Зміст інструкції

1. Aspirinaact 800 mg / 480 mg effervescent tablets with vitamin C
   1. What is Aspirinaact and what is it used for
   2. What you need to know before taking Aspirinaact
   3. How to take Aspirinaact
   4. Possible side effects
   5. How to store Aspirinaact
   6. Contents of the pack and other information

Aspirinaact 800 mg / 480 mg effervescent tablets with vitamin C

Acetylsalicylic acid and ascorbic acid

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 days (for fever) or 3 - 4 days (for pain).

Contents of this leaflet

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

1. What is Aspirinaact and what is it used for

Aspirinaact contains:

• acetylsalicylic acid, which relieves pain and reduces fever;
• ascorbic acid, also known as vitamin C. Aspirinaact is used
• for the symptomatic treatment of mild to moderate pain, such as headache, toothache and menstrual pain;
• in the common cold or flu symptoms for the symptomatic treatment of pain and fever.
• Vitamin C (ascorbic acid) supports the body's defense system, promoting the action of white blood cells. Aspirinaact is used in adults and adolescents over 16 years of age.

2. What you need to know before taking Aspirinaact

Do not take Aspirinaact:
if you are allergic

• to acetylsalicylic acid, ascorbic acid or any of the other ingredients of this medicine (listed in section 6); or
• to other non-steroidal anti-inflammatory drugs (NSAIDs), which are medicines used to treat pain, fever or inflammation.

if you have too many mast cells (pre-existing mastocytosis). The use of acetylsalicylic acid may induce serious
hypersensitivity reactions (including circulatory shock with flushing, low blood pressure, rapid
heart rate and vomiting).
if you have a history of asthma caused by the use of acetylsalicylic acid or a similar medicine (in
particular NSAIDs);
in the third trimester of pregnancy (if you are more than 24 weeks pregnant);
if you suffer from a stomach or intestinal ulcer;
if you have bleeding or a risk of bleeding (bleeding condition);
if you have severely impaired liver or kidney function;
if you have severely impaired and uncontrolled heart function;
if you are taking methotrexate therapy at doses of 15 mg/week or higher;
if you are taking medicines to thin the blood and prevent it from clotting (oral anticoagulants) and
have a history of stomach or intestinal ulcer;
if you have kidney stones, a condition in which stones form or a history of kidney stones (nephrolithiasis);
if you have excretion of urine with high amounts of calcium oxalate crystals (hyperoxaluria);
if you have a condition that involves an increase in iron accumulation in the body (iron overload-
hemochromatosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Aspirinaact
if you are using other medicines containing acetylsalicylic acid, to avoid the risk of overdose.
if headache episodes occur while taking high doses of painkillers for a long period.
Do not increase the dose; instead, ask your doctor or pharmacist for advice.
if you are using painkillers regularly, especially several painkillers in combination.
This use may lead to persistent kidney damage, with a risk of reduced kidney function.
if you have a history of stomach or intestinal ulcer or bleeding, or inflammation of the stomach (gastritis).
if you are also taking medicines that thin the blood and prevent it from clotting
(anticoagulants).

Stop taking Aspirinaact immediately and see a doctor if you experience
bleeding or stomach or intestinal ulcer.The signs are blood from the mouth, blood in the
stools and black, tarry stools.
if you have reduced kidney function, or heart or circulatory problems, such as in the case of renal
vascular disease, heart failure, recent major surgery or severe bleeding.
Taking acetylsalicylic acid may further reduce kidney function, up to the onset
of acute renal failure. Do not take Aspirinaact if you have severely impaired kidney function or
uncontrolled heart function.
if you have reduced liver function.
Do not take Aspirinaact if you have severely impaired liver function.
if you have heavy menstrual bleeding (the volume and duration of menstruation may be increased).
if you are going to have surgery.
Acetylsalicylic acid increases the risk of bleeding; even at low doses or if taken several days
before. Tell your doctor, surgeon, anesthesiologist or dentist if you are going to have any
surgery, even minor (e.g. tooth extraction).
Acetylsalicylic acid reduces the excretion of uric acid. This may cause gout if you are already prone to
limited excretion of uric acid.
if you have Glucose-6-phosphate dehydrogenase (G6PD) deficiency: an inherited disease that affects red
blood cells. Acetylsalicylic acid must be administered under medical supervision.
if you have increased urinary excretion of oxalate (hyperoxaluria), a tendency to form calcium oxalate
kidney stones or recurrent kidney stones.
if you have iron overload or iron metabolism disorders (Mediterranean anemia, hemochromatosis, sideroblastic
anemia).
if you have asthma.
Do not take this medicine if the third point of section 2 “Do not take Aspirinaact” applies to you.
Acetylsalicylic acid can cause bronchial muscle cramps and asthma attacks or other hypersensitivity reactions. Risk factors are:

• history of asthma
• hay fever
• nasal polyps, long-term (chronic) airway disease or
• allergic reactions, such as skin reactions (e.g. itching, hives). Use during breastfeeding is not recommended.

Children and adolescents
Reye's syndrome, a very rare and potentially fatal disease associated with neurological and liver damage
has been observed in children suffering from diseases caused by viruses (especially influenza and chickenpox),
when acetylsalicylic acid is used. Consequently:

• acetylsalicylic acid should be administered to children and adolescents in these conditions only after medical advice and when other measures have proven ineffective.
• if you experience signs of dizziness or fainting, abnormal behavior or vomiting, stop treatment and inform your doctor immediately.

The use of salicylates should be avoided for 6 weeks after vaccination against varicella virus.
This medicine is not indicated for children and adolescents under 16 years of age.

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

Do not take Aspirinaact if you are taking therapy with:

• methotrexate at doses of 15 mg per week or higher: a medicine to treat severe joint inflammation, cancer and the skin disease called psoriasis. Methotrexate toxicity increases.
• medicines to prevent blood clotting(oral anticoagulants) and have a history of stomach or intestinal ulcer. The risk of bleeding increases.

Ask your doctor or pharmacistbefore taking Aspirinaact if you are using any of the
following medicines:
Combinations not recommended

• medicines to prevent blood clotting(oral anticoagulants) and if you do not have a history of stomach or intestinal ulcer. The risk of bleeding increases.
• clopidogrel(except for indications approved for this combination) and ticlopidine: medicines to inhibit blood clotting. The risk of bleeding increases.
• medicines for the treatment of pain, fever or inflammation belonging to the group of so-called non-steroidal anti-inflammatory drugsThe risk of stomach and intestinal ulcer and bleeding increases.
• heparinsat therapeutic doses (for, e.g., blood clot in a vessel) or in patients aged 65 years or older regardless of the dose of heparin. The risk of bleeding increases. Another painkiller or antipyretic should be used.
• benzbromarone, probenecid:medicines that increase the excretion of uric acid to treat gout The effect of these medicines is reduced.

Combinations that require precautions:
methotrexateused at doses less than 15 mg/week
Methotrexate toxicity increases. Careful monitoring of patients with impaired
renal function and aged 65 years or older is necessary. See also the first point of the first paragraph
“Other medicines and Aspirinaact”.

medicines that increase urine excretion (diuretics)and medicines for treating hypertensionand
other heartdiseases, whose active ingredient names end in “pril” or “sartan” (angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists).
Rapid loss of renal function may occur in dehydrated patients. In addition, there may be
a reduction in the antihypertensive effect.

Clopidogrel (in indications approved for this combination): a medicine to inhibit
blood clotting
The risk of bleeding increases.

medicines that act locally in the stomach or intestine, medicines that neutralize or
bind gastric acids (antacids), or activated charcoal, a medicine to treat diarrhea and acute poisoning
Take these medicines that act in the stomach or intestine at least 2 hours apart from
Aspirinaact.

heparinsat doses used for prevention (e.g. of blood clots) in patients under 65 years of age
The risk of bleeding increases.

medicines to dissolve blood clots (thrombolytics), such as streptokinase
The risk of bleeding increases.
medicines containing cortisoneor substances similar to cortisone(glucocorticoids)except for replacement therapy with hydrocortisone:
The risk of bleeding increases.

selective serotonin reuptake inhibitors, e.g. citalopram, escitalopram, fluoxetine,
fluvoxamine, paroxetine, sertraline: medicines for the treatment of depression
The risk of bleeding increases.

digoxin:a medicine for the treatment of heart failure or irregular heartbeat
The blood concentration of digoxin increases. The doctor must monitor the blood concentration of
digoxin and, if necessary, adjust the dose.

medicines used to lower blood sugar levels (antidiabetics),such as insulinor

sulfonylureas
Blood sugar levels should be monitored.

valproic acid: a medicine for the treatment of epilepsy.
Valproic acid toxicity increases.

Combinations to be considered:
deferasirox, deferoxamine: medicines used to remove excess iron from the body
Deferasirox: the risk of stomach and intestinal ulcer and bleeding increases.
The use of deferoxamine and ascorbic acid may increase tissue toxicity of iron, especially for the
heart.

Iron and aluminum: the administration of ascorbic acid increases gastrointestinal absorption. This
should be taken into consideration if you have impaired renal function, in case of iron replacement and the administration of aluminum-containing antacids.

Laboratory tests
Tell your doctor if you are taking Aspirinaact.
Acetylsalicylic acid and ascorbic acid at high doses can affect some laboratory tests,
such as the fecal occult blood test and liver function tests.
Vitamin C can affect laboratory tests, such as measurements for glucose, creatinine,
carbamazepine, uric acid in urine, in serum and fecal occult blood search.
Vitamin C can interfere with investigations measuring glucose in urine and blood leading to
a false reading of the results, despite not having an effect on blood glucose levels.

Aspirinaact with alcohol
Avoid consuming alcohol while taking Aspirinaact.

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

Pregnancy
Do not take this medicine in the third trimester (after 24 weeks) of pregnancyas it could
cause serious harm to you or the baby.
During the first and second trimester of pregnancy (in the first 24 weeks) consult your doctor before
taking this medicine.
If you have taken this medicine during pregnancy, contact your doctor immediately.

Breastfeeding
Treatment with Aspirinaact is not recommended during breastfeedingas it passes into breast milk.

Fertility
Given the limited amount of published data available, studies in humans have not shown any significant effect
of acetylsalicylic acid on impaired fertility and there is no conclusive evidence
in animal studies.

Driving and using machines
This medicine can occasionally cause headache or dizziness. Do not drive vehicles or use
machines if these conditions occur.

Aspirinaact contains sodium
This medicine contains 438 mg of sodium (the main component of table salt) per effervescent tablet.
This is equivalent to 21.9% of the recommended maximum daily intake of sodium for an adult.

3. How to take Aspirinaact

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.

Dosage
For oral use. The effervescent tablet should be dissolved in a glass of water before taking. The effervescent tablet should not be taken on an empty stomach to reduce gastric irritation.
The recommended dose is:

Adults
single dose: 1 effervescent tablet
The single dose can be repeated after a minimum interval of 4 hours, if necessary.
maximum daily dose: 3 effervescent tablets

Use in children and adolescents
Adolescents: From 16 years of age
The lowest effective dose should be used.
The dosage depends on the adolescent's weight. This medicine should only be used in adolescents weighing more than 53 kg. The age indicated is for informational purposes only.
The recommended single dose is 1 effervescent tablet (800 mg of acetylsalicylic acid/480 mg of ascorbic acid), if necessary. The total daily dose should not exceed 3 tablets.
The dosage of Aspirinaact (800 mg of acetylsalicylic acid/480 mg of ascorbic acid) may not be appropriate for the treatment of adolescents.
Other products containing lower doses of acetylsalicylic acid are available for use in this age group.

Children under 16 years of age
Aspirinaact should not be used in children under 16 years of age. In case of accidental administration, see “What you need to know before taking Aspirinaact” and “If you take more Aspirinaact than you should”.

Patients aged 65 years and over, and patients with low body weight
The lowest effective dose should be used due to possible further disorders. See also paragraph 2 “Do not take Aspirinaact” and “Warnings and precautions”.

Patients with reduced liver or kidney function or with circulatory problems
A reduction in dose or prolonged dosing intervals is recommended for patients with mild or moderately reduced liver or kidney function
circulatory problems, such as heart failure and severe bleeding
Do not take Aspirinaact if you have severely reduced kidney or liver function or uncontrolled heart function. See paragraph 2 “Do not take Aspirinaact”.

Duration of treatment
Do not take this medicine for more than 3 days in case of fever or 3 - 4 days in case of pain unless otherwise indicated by your doctor.

If you take more Aspirinaact than you should
Stop treatment and consult your doctor immediately if you suspect an overdose.
Signs of overdose may include:
constant perception of a sound in the ears (tinnitus), feeling of hearing loss
sweating
nausea, vomiting, diarrhea
headache
dizziness
rapid loss of kidney function
In children, an overdose can be fatal starting from a dose of 100 mg/kg of acetylsalicylic acid in a single dose.

If you forget to take Aspirinaact
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop takingAspirinaact and immediately inform your doctoror go to the nearest
hospital if you notice any of the following symptoms:

• swelling of the face, tongue and trachea causing great difficulty in breathing, which is a sign of a severe allergic reaction (angioedema)
• stomach pain, black stools, hematemesis (vomiting blood), vomit that looks like coffee grounds, which are signs of gastric or intestinal bleeding

Side effects can occur with the following frequencies:

Common: may affect up to 1 in 10 people
gastric or intestinal disorders, such as heartburn, diarrhea, nausea, vomiting, indigestion

Uncommon: may affect up to 1 in 100 people
stomach, intestinal and abdominal pain
urticaria, skin rash, itching

Rare: may affect up to 1 in 1,000 people
inflammation and ulceration of the stomach and intestines (inflammation and ulcers of the esophagus, stomach or
intestines). These reactions may or may not be associated with bleeding, and may
occur with any dose of acetylsalicylic acid in patients with or without warning symptoms or
a previous history of serious gastrointestinal events.
hypersensitivity reactions such as asthma symptoms, runny nose and nasal congestion

Very rare: may affect up to 1 in 10,000 people
occult or overt bleeding of the stomach or intestines (blood in vomit, black stools, etc.) which
leads to iron deficiency anemia. The risk of bleeding is related to the dose
perforations of the stomach and intestines
reduced excretion of uric acid, which can lead to gout in patients who have limited
excretion of uric acid

Not known:frequency cannot be estimated from available data
increased levels of liver enzymes called transaminases, reduced liver function
liver injury, primarily to liver cells
reduced number of red blood cells (anemia) as a result of bleeding
fall and destruction of red blood cells in patients with severe glucose-6-phosphate dehydrogenase
(G6PD) deficiency
decreased number of platelets
low blood sugar (hypoglycemia)
skin reactions
hypersensitivity reactions, severe allergic reactions (anaphylactic reactions)
Hypersensitivity reactions can affect skin, airways, circulatory system, stomach and intestines,
especially in patients with asthma. Symptoms include

• swelling of tissues caused by excess fluid
• decrease in blood pressure
• shortness of breath, dyspnea
• cardiac or respiratory distress
• potentially fatal allergic shock reaction
• skin rash, urticaria, itching, severe allergic reaction including swelling of the face or throat
• asthma symptoms, inflammation inside the nose causing sneezing, runny nose and nasal congestion bleeding with prolonged bleeding time, such as nosebleeds, bleeding gums, red spots under the skin, genitourinary organ bleeding The risk of bleeding persists for 4-8 days after stopping treatment with Aspirinaact. It may cause an increased risk of bleeding in case of surgery. Bleeding can also occur inside the skull, stomach or intestines. Bleeding inside the skull can

be fatal, especially if the medicine is given to the elderly.
severe bleeding, cerebral hemorrhage, especially in patients with uncontrolled hypertension and/or
using medicines to inhibit blood clotting (anticoagulants)
In isolated cases, these effects may be potentially fatal.

• fluid in the lungs (non-cardiogenic pulmonary edema) with chronic use and in the context of a hypersensitivity reaction due to acetylsalicylic acid. reduced kidney function, up to rapid loss of kidney function, gallstones due to ascorbic acid diarrhea with high doses of ascorbic acid headache, dizziness, feeling of hearing loss, tinnitus (constant perception of a sound in the ears), which are signs of overdose Reye's syndrome (disturbance of consciousness or abnormal behavior, or vomiting) (see section 2. “What you need to know before taking Aspirinaact”) Intestinal diaphragm disease (narrowing of the intestine) (mainly with long-term treatments).

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 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 Aspirinaact

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store at a temperature above 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 Aspirinaact contains

• The active ingredients are acetylsalicylic acid and ascorbic acid. Each effervescent tablet contains:
• 800 mg of acetylsalicylic acid and
• 480 mg of ascorbic acid
• The other ingredients are: sodium hydrogen carbonate (modified), citric acid, povidone, colloidal anhydrous silica

Description of the appearance of Aspirinaact and contents of the pack
The effervescent tablets of Aspirinaact are from white to off-white in color and round in shape. The
tablets bear the Bayer cross inside a circle.
Aspirinaact is available in aluminum/paper strips in cardboard packs containing 10 or 20 effervescent
tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Bayer Spa
Viale Certosa 130, 20156 Milan

Manufacturer
Bayer Bitterfeld GmbH
Salegaster Chausee 1
06803 Bitterfeld-Wolfen
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy
Aspirinaact