Acetylsalicylic acid Aurobindo

Package leaflet: Information for the user

Acetylsalicylic Acid Aurobindo 100 mg gastro-resistant tablets

Read this entire leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Acido Acetilsalicilico Aurobindo contains acetylsalicylic acid, which at low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood clotting and are involved in thrombosis. When a blood clot forms in an artery, blood flow becomes blocked and oxygen supply is interrupted. When this occurs in the heart, it may cause a heart attack or angina; in the brain, it may 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 thus prevent the following:

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

Acido Acetilsalicilico Aurobindo is also used to prevent blood clot formation after certain heart procedures performed to widen or unblock blood vessels.
This medicine is not recommended for emergency use.

2. What you need to know before taking Acetylsalicylic Acid Aurobindo

Do not take Acetylsalicylic Acid Aurobindo if:

• you are allergic to acetylsalicylic acid or to any of the other ingredients of this medicine (listed in section 6);
• you are allergic to other salicylates or to non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis, rheumatism, and pain;
• you have previously experienced an asthma attack or swelling of any parts of your body, such as face, lips, throat, or tongue (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 blood clotting problems;
• you suffer from severe liver or kidney problems;
• you have severe heart problems that may cause shortness of breath or ankle swelling;
• you are in the last 3 months of pregnancy; you must not take doses higher than 100 mg per day (see section “Pregnancy and breastfeeding”);
• you are taking a medicine called methotrexate (for example, to treat cancer or rheumatoid arthritis) at doses exceeding 15 mg per week.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acetylsalicylic Acid Aurobindo if:

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

You must 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 signs of a serious allergic reaction (see section “Possible side effects”).
Inform your doctor if you are about to undergo any surgical procedure (even minor procedures, such as tooth extraction). Acetylsalicylic acid makes the blood thinner, thus increasing the risk of bleeding, which may persist for 4 to 8 days after stopping acetylsalicylic acid.
Be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as concomitant use of acetylsalicylic acid may lead to worsening of kidney function. This medicine is not suitable for use as a painkiller or to reduce fever.
Do not take Acetylsalicylic Acid Aurobindo together with other medicines containing acetylsalicylic acid (such as aspirin) or with other painkillers and anti-inflammatory medicines (NSAIDs, such as ibuprofen).
If any of the above conditions apply to you, or if you are unsure, consult your doctor or pharmacist.

Children and adolescents
Acetylsalicylic acid, when given to children, may cause Reye's syndrome. Reye's syndrome is a very rare condition affecting the brain and liver, which can be life-threatening.
For this reason, Acetylsalicylic Acid Aurobindo must not be given to children and adolescents under 16 years of age, unless advised by a doctor.

Other medicines and Acetylsalicylic Acid Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effectiveness of 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);
• prevention of organ transplant rejection (cyclosporine, tacrolimus);
• high blood pressure (e.g., diuretics, ACE inhibitors, angiotensin II receptor antagonists, calcium channel blockers);
• regulation of heart rhythm (digoxin);
• bipolar disorder (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 below 15 mg per week; for doses above 15 mg per week, see section “Do not take Acetylsalicylic Acid 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 glands or pituitary gland, or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids).

Metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that clump together to form a blood clot) when taken concomitantly. Therefore, this combination should be used with caution.

Acetylsalicylic Acid Aurobindo and alcohol
Consumption of alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time. Therefore, alcohol consumption is not recommended.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Up to 100 mg per day: during pregnancy, your doctor may prescribe low-dose 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 not exceed the prescribed dose.
Between 100 and 500 mg per day: as a precaution, follow the recommendations below unless otherwise prescribed by your doctor:
From 500 mg per day:

• During the first and second trimesters of pregnancy, your doctor will prescribe this medicine only if clearly necessary due to the potential risk of miscarriage or malformation. In such cases, 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 must NEVER take this medicine, as it may have serious or even fatal consequences for your baby, particularly affecting the heart, lungs, and/or kidneys, even after a single dose.

Breastfeeding
Since acetylsalicylic acid is excreted in breast milk, this medicine must not be taken by patients who are breastfeeding.

Fertility
Acetylsalicylic acid belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the drug.

Driving and using machines
Acetylsalicylic Acid Aurobindo does not affect or has negligible effect on the ability to drive and use machines.

Acetylsalicylic Acid Aurobindo contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Acido Acetilsalicilico Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If
you are unsure, consult your doctor or pharmacist.
Adults
Prevention of heart attacks:

• The recommended dose is 100 mg once daily.

Prevention of strokes:

• The recommended dose is 100 mg once daily.

Prevention of cardiovascular problems in patients suffering from stable or unstable angina
(a type of chest pain):

• The recommended dose is 100 mg once daily.

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

• The recommended dose is 100 mg once daily.

Elderly patients
The recommended dose is the same as that indicated for adults. In general, acetylsalicylic acid should be
used with caution in elderly patients, who may be more sensitive to adverse events. Treatment should be
regularly reassessed at regular intervals.
Use in children and adolescents
Acetylsalicylic acid must not be given to children and adolescents under 16 years of age,
unless specifically prescribed by a doctor (see section 2 “Children and adolescents”).
Method of administration
For oral use.
The tablets must be swallowed whole, preferably at least 30 minutes before meals, with a full glass of
water. The tablets have an enteric coating which prevents irritating effects on the intestine, and therefore must not be crushed, broken, or chewed.
If you take more Acido Acetilsalicilico Aurobindo than you should
If you (or anyone else) accidentally take too many tablets, contact your doctor or go to the nearest
emergency department immediately. Show the doctor what is left of the medicine or the empty packaging.
Symptoms of overdose may include ringing in the ears, hearing problems, headache,
dizziness, confusion, nausea, vomiting, and abdominal pain. A significant overdose may lead to
rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures,
hallucinations, low blood sugar levels, coma, and shock.
If you forget to take Acido Acetilsalicilico Aurobindo
If you miss a dose, wait until it is time to take your next dose, then continue as usual.
Do not take a double dose to make up for the missed tablet.
If you stop taking Acido Acetilsalicilico Aurobindo
Do not stop or discontinue treatment with Acido Acetilsalicilico Aurobindo without first
discussing it with your doctor.
If you have any doubts about how to use 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 most common side effects are stomach or intestinal problems, including nausea and vomiting.
If you notice any of the following rare but serious side effects, stop taking Acido Acetilsalicilico Aurobindo and contact your doctor immediately:
Rare side effects, may affect up to 1 in 1,000 people

• Sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling, possibly associated with high fever and joint pain. These symptoms could indicate erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome.
• Unusual bleeding, such as coughing up blood, blood in vomit or urine, or dark stools.
• Changes in behaviour accompanied by nausea and vomiting could be early signs of Reye's syndrome, a potentially life-threatening condition requiring immediate medical treatment (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

• Urticaria.
• Runny nose.
• Breathing difficulties.

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

• Severe stomach or intestinal bleeding, cerebral haemorrhage; altered blood cell count.
• Cramps in the lower respiratory tract, asthma attacks.
• Inflammation of blood vessels.
• Bruising with purple spots (skin haemorrhage).
• Severe skin reactions such as skin rash known as erythema multiforme and its more serious, 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 illness in children affecting the brain and liver) (see section 2 “Children and adolescents”).
• Very heavy or prolonged menstrual bleeding.

Side effects with unknown frequency, frequency cannot be estimated from the available data

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Acetylsalicylic Acid Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Acido Acetilsalicilico Aurobindo contains

• The active substance is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The other ingredients are: Tablet core: Monohydrate lactose, 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 package contents
White, round (8 mm diameter), biconvex gastro-resistant tablets.
PVC-aluminum blisters.
Pack sizes: 30, 84 and 168 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
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