ACIDO 100 mg Tabletka Powlekana

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1. Acido Acetilsalicilico Aurobindo 100 mg gastro-resistant tablets
   1. What is Acido Acetilsalicilico Aurobindo and what is it used for
   2. What you need to know before taking Acido Acetilsalicilico Aurobindo
   3. How to take Acido Acetilsalicilico Aurobindo
   4. Possible side effects
   5. How to store Acido Acetilsalicilico Aurobindo
   6. Contents of the pack and other information

Acido Acetilsalicilico Aurobindo 100 mg gastro-resistant tablets

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Acido Acetilsalicilico Aurobindo and what is it used for

Acido Acetilsalicilico Aurobindo contains acetylsalicylic acid, which at low doses belongs to a
group of medicines called antiplatelet agents. Platelets are small cells in the
blood that cause coagulation and are involved in thrombosis. When a blood clot
forms in an artery, blood flow is blocked and the supply of oxygen is interrupted. When
this occurs in the heart, it can cause a heart attack or angina; in the brain it can cause a
stroke.
Acido Acetilsalicilico Aurobindo can only be used as a preventive treatment. It is taken to
reduce the risk of blood clot formation and therefore prevent the following:

• heart attacks;
• stroke;
• cardiovascular problems in patients suffering from stable or unstable angina (a type of chest pain).

Acido Acetilsalicilico Aurobindo is also used to prevent the formation of blood clots after
some heart surgeries, performed to widen or unblock blood vessels.
This medicine is not recommended in emergency situations.

2. What you need to know before taking Acido Acetilsalicilico Aurobindo

Do not take Acido AcetilsalicilicoAurobindoif:

• you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6);
• you are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain;
• you have had an asthma attack or some parts of your body such as your face, lips, throat or tongue have swollen (angioedema) after taking salicylates or NSAIDs;
• you currently have or have ever had a stomach or small intestine ulcer or any other type of bleeding such as a stroke;
• you have had problems with blood clotting;
• you suffer from severe liver or kidney problems;
• you have serious heart problems that can cause shortness of breath or swelling of the ankles;
• you are in the last 3 months of pregnancy; you should not take doses higher than 100 mg per day (see section “Pregnancy and breastfeeding”);
• you are taking a medicine called methotrexate (for example for the treatment of cancer or rheumatoid arthritis) at doses higher than 15 mg per week.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Acetilsalicilico Aurobindo if:

• you have problems with your kidneys, liver or heart;
• you have or have had problems with your stomach or small intestine;
• you have high blood pressure;
• you have asthma, hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid can cause an asthma attack;
• you have ever had gout;
• you have heavy menstrual periods;
• you suffer from a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme.

You should immediately contact your doctor if your symptoms worsen or if you experience serious or unexpected side effects, such as unusual bleeding symptoms, severe skin reactions or any other sign of a serious allergic reaction (see section “Possible side effects”).
Tell your doctor if you are about to undergo surgery (even a minor procedure, such as a tooth extraction). Acetylsalicylic acid makes the blood more fluid and therefore there may be an increased risk of bleeding which may persist for a period of 4-8 days after stopping acetylsalicylic acid.
You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth) because the simultaneous use of acetylsalicylic acid can cause a deterioration of kidney function. This medicine is not suitable as a pain reliever or to reduce fever.
Do not take Acido Acetilsalicilico Aurobindo with other medicines that contain acetylsalicylic acid (such as aspirin) or with other pain relievers and anti-inflammatory medicines (NSAIDs, such as ibuprofen).
If any of the above conditions apply to you, or if you have any doubts, consult your doctor or pharmacist.

Children and adolescents
Acetylsalicylic acid, if given to children, can cause Reye's syndrome. Reye's syndrome is a very rare condition that affects the brain and liver and can be life-threatening.
For this reason, Acido Acetilsalicilico Aurobindo should not be given to children and adolescents under the age of 16, unless advised by a doctor.

Other medicines and Acido Acetilsalicilico Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effectiveness of the treatment may be altered if acetylsalicylic acid is taken at the same time as other medicines for:

• thinning the blood/preventing blood clots (e.g. warfarin, heparin, clopidogrel, ticlopidine, dipyridamole, cilostazol, alteplase);
• organ transplant rejection (cyclosporine, tacrolimus):
• high blood pressure (e.g. diuretics, ACE inhibitors, angiotensin II receptor antagonists, calcium channel blockers);
• regulating the heartbeat (digoxin);
• manic-depressive illness (lithium);
• pain and inflammation (e.g. NSAIDs such as ibuprofen or steroids, other medicines containing acetylsalicylic acid or steroids);
• gout (e.g. probenecid, sulfinpyrazone);
• epilepsy (valproate, phenytoin);
• glaucoma (acetazolamide);
• cancer or rheumatoid arthritis (methotrexate at doses less than 15 mg per week, for doses higher than 15 mg per week, see the section “Do not take Acido Acetilsalicilico Aurobindo” above);
• diabetes (e.g. glibenclamide, insulin);
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine);
• use as hormone replacement therapy after destruction or removal of the adrenal or pituitary glands, or to treat inflammation, including rheumatic diseases and inflammation of the intestine (corticosteroids).

Metamizole (a substance to reduce pain and fever) can reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that join together and form a blood clot), if taken at the same time. Therefore, this combination should be used with caution.

Acido Acetisalicilico Aurobindo with alcohol
Drinking alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time. Therefore, drinking alcohol is not recommended.

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

Up to 100 mg per day: during pregnancy, if necessary, your doctor may prescribe you low doses of acetylsalicylic acid (100 mg or less per day) in exceptional circumstances requiring specialized monitoring. In this case, you must strictly follow your doctor's instructions and do not exceed the prescribed doses.

Between 100 and 500 mg per day: as a precaution, you should follow these recommendations, unless your doctor prescribes otherwise:

From 500 mg per day:

• During the first and second trimester of pregnancy, your doctor will prescribe this medicine only if it is clearly necessary due to the potential risk of abortion or malformation. In this case, the dose should be kept as low as possible and the duration of treatment as short as possible.
• During the last 3 months of pregnancy, this medicine is contraindicated: you should NEVER take this medicine, as it can have serious or even fatal consequences for your baby, especially on the heart, lungs and/or kidneys, even with a single dose.

Breastfeeding
Because acetylsalicylic acid is excreted in breast milk, this medicine should not be taken by breastfeeding patients.
Fertility
Acetylsalicylic acid belongs to a group of medicines (NSAIDs) that can impair fertility in women. This effect is reversible when the medicine is stopped.

Driving and using machines
Acido Acetilsalicilico Aurobindo does not alter or alters negligibly the ability to drive and use machines.

Acido Acetilsalicilico Aurobindo contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Acido Acetilsalicilico Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Adults

Prevention of heart attacks:

• The recommended dose is 100 mg once a day.

Prevention of strokes:

• The recommended dose is 100 mg once a day.

Prevention of cardiovascular problems in patients suffering from stable or unstable angina

(a type of chest pain):

• The recommended dose is 100 mg once a day.

Prevention of blood clot formation after some types of heart surgery:

• The recommended dose is 100 mg once a day.

Elderly
The recommended dose is the same as indicated for adults. In general, acetylsalicylic acid should be
used with caution in elderly patients who are more sensitive to adverse events. Treatment should be
re-evaluated at regular intervals.

Use in children and adolescents
Acetylsalicylic acid should not be given to children and adolescents under 16 years of age,
unless prescribed by a doctor (see section 2 “Children and adolescents”).
Method of administration
For oral use.
The tablets should be swallowed whole, preferably at least 30 minutes before meals, with a
full glass of water. The tablets have an enteric coating that prevents irritating effects on the intestine and therefore should not be crushed, broken or chewed.

If you take more Acido Acetilsalicilico Aurobindo than you should
If you (or anyone else) accidentally takes too many tablets, you should immediately see a
doctor or contact the nearest emergency room. Show the doctor what is left of the medicine
or the empty package.
Symptoms of overdose may include ringing in the ears, hearing problems, headache,
dizziness, confusion, nausea, vomiting, and abdominal pain. A considerable overdose can lead to
rapid breathing (hyperventilation), fever, excessive sweating, restlessness, convulsions,
hallucinations, low blood sugar levels, coma, and shock.

If you forget to take Acido Acetilsalicilico Aurobindo
If you forget a dose, wait until the time to take the next dose, then proceed as usual.
Do not take a double dose to make up for a missed tablet.

If you stop taking Acido Acetilsalicilico Aurobindo
Do not stop or discontinue treatment with Acido Acetilsalicilico Aurobindo without first
agreeing it with your doctor.
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.
The most common side effects are stomach or intestinal disorders, including nausea and vomiting.

If you notice any of the following rare but serious side effects, stop taking Acido Acetilsalicilico Aurobindo and tell your doctor immediately:

Rare side effects, may affect up to 1 in 1,000 people

• Sudden wheezing, swelling of the lips, face or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin reddening with blisters or peeling that may be associated with high fever and joint pain. This condition may indicate the presence of erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome.
• Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.
• Changes in behaviour with nausea and vomiting may be early signs of Reye's syndrome, a potentially fatal illness, which requires immediate medical attention (see also section 2 “Children and adolescents”).

Other side effects:

Common side effects, may affect up to 1 in 10 people

• Nausea, vomiting, diarrhoea.
• Indigestion.
• Increased tendency to bleed.

Uncommon side effects, may affect up to 1 in 100 people

• Hives.
• Runny nose.
• Difficulty breathing.

Rare side effects, may affect up to 1 in 1,000 people

• Severe bleeding of the stomach or intestines, cerebral haemorrhage; altered number of blood cells.
• Cramps in the lower respiratory tract, asthma attacks.
• Inflammation of blood vessels.
• Bruising with purplish spots (skin haemorrhage).
• Severe skin reactions such as a rash known as erythema multiforme and its other life-threatening forms, Stevens-Johnson syndrome and Lyell's syndrome.
• Hypersensitivity reactions, such as swelling e.g. of the lips, face or body, or anaphylactic shock.
• Reye's syndrome (a very rare childhood illness affecting the brain and liver (see section 2 “Children and adolescents”).
• Very heavy or prolonged menstrual bleeding.

Side effects with unknown frequency, which cannot be estimated on the basis of the available data

• Ringing in the ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Impaired kidney function, acute renal failure.
• Impaired liver function, increased liver enzymes.
• High levels of uric acid or low levels of sugar in the blood.
• Widespread destruction of red blood cells in subjects who have an inherited blood disorder (G6PD deficiency).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Acido Acetilsalicilico Aurobindo

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 packaging after “EXP”. 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 Acido Acetilsalicilico Aurobindo contains

• The active ingredient is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The other ingredients are: Tablet core: Lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, potato starch. Tablet coating: Talc, triacetin, Methacrylic acid - ethyl acrylate copolymer (1:1).

Description of the appearance of Acido Acetilsalicilico Aurobindo and contents of the pack
White, round (diameter 8 mm) and biconvex gastro-resistant tablets.
PVC-Aluminum blisters.
Packs: 30, 84 and 168 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Aurobindo Pharma (Italia) S.r.l. – via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer
G.L. Pharma GmbH - Schlossplatz, 1 - Lannach 8502 - Austria

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium: ASA AB 100 mg, maagsapresistente tabletten
ASA AB 100mg, comprimés gastro-résistants
ASA AB 100mg, magensaftresistente Tabletten
France: Aspirine Arrow 100 mg, comprimé gastro-résistant
Italy: Acido Acetilsalicilico Aurobindo
Sweden: Acetylsalicylsyra Aurobindo 100 mg enterotabletter