ACETYLSALICYLIC ACID AUROVITAS SPAIN 100 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Acetylsalicylic Acid Aurovitas Spain 100 mg Gastro-Resistant Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Acetylsalicylic Acid Aurovitas Spain and what is it used for

This medicine contains acetylsalicylic acid, which at low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that produce blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it stops blood flow and cuts off oxygen supply. When this happens in the heart, it can cause a heart attack or angina; in the brain, it can cause a stroke.

Acetylsalicylic Acid Aurovitas Spain is taken to reduce the risk of thrombus formation and consequently prevent:

• heart attacks
• strokes
• cardiovascular problems in patients with stable or unstable angina (a type of chest pain)

Acetylsalicylic Acid Aurovitas Spain is also used to prevent thrombus formation after certain types of heart surgery to widen or unblock blood vessels.

This medicine is not recommended for emergency cases. It can only be used as a preventive treatment.

2. What you need to know before you take Acetylsalicylic Acid Aurovitas Spain

Do not take Acetylsalicylic Acid Aurovitas Spain

• if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other salicylates or non-steroidal anti-inflammatory medicines (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain
• if you have had an asthma attack or swelling of some parts of the body, e.g. face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs
• if you currently have or have ever had a stomach or intestinal ulcer or any other type of bleeding such as a stroke
• if you have ever had a problem with your blood not clotting properly
• if you have severe liver or kidney problems
• if you are in the last 3 months of pregnancy; you should not take more than 100 mg per day (see section “Do not take Acetylsalicylic Acid Aurovitas Spain”)
• if you are taking a medicine called methotrexate (e.g. to treat cancer or rheumatoid arthritis) in doses greater than 15 mg per week

Warnings and Precautions

Consult your doctor or pharmacist before starting to take acetylsalicylic acid:

• if you have kidney, liver or heart problems
• if you have or have ever had stomach or intestinal problems
• if you have high blood pressure
• if you are asthmatic, have hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack
• if you have ever had gout
• if you have heavy menstrual periods

You should consult a doctor immediately if your symptoms worsen or if you experience serious or unexpected side effects, e.g. unusual bleeding symptoms, severe skin reactions or any other sign of severe allergy (see section “Possible side effects”).

Inform your doctor if you are planning to have surgery (even minor surgery, such as a tooth extraction) as acetylsalicylic acid is an anticoagulant, there may be an increased risk of bleeding.

Acetylsalicylic acid may cause Reye's syndrome when given to children. Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening. For this reason, acetylsalicylic acid should not be given to children under 16 years of age, unless prescribed by a doctor.

You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth) as taking acetylsalicylic acid at the same time may cause kidney function to deteriorate.

This medicine is not suitable for relieving pain or reducing fever.

If you are in any of the above situations, or if you are not sure, consult your doctor or pharmacist.

Other medicines and Acetylsalicylic Acid Aurovitas Spain

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as other medicines used to:

• prevent blood clots from forming (e.g. warfarin, heparin, clopidogrel)
• prevent organ rejection after a transplant (ciclosporin, tacrolimus)
• treat high blood pressure (e.g. diuretics and ACE inhibitors)
• regulate heart rhythm (digoxin)
• treat manic-depressive disorder (lithium)
• relieve pain and inflammation (e.g. NSAIDs such as ibuprofen, or steroids)
• metamizole (a substance to reduce pain and fever): if administered together, it may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells stick together and form a blood clot). Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotector.
• gout (e.g. probenecid)
• epilepsy (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate; in doses less than 15 mg per week)
• diabetes (e.g. glibenclamide)
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• used as hormone replacement therapy when adrenal or pituitary glands have been destroyed or removed, or medicines to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)

Taking Acetylsalicylic Acid Aurovitas Spain with food, drinks and alcohol

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by their doctor. You should not take acetylsalicylic acid if you are in the last 3 months of pregnancy, unless your doctor advises you to and in that case, the daily dose should not exceed 100 mg (see section “Do not take Acetylsalicylic Acid Aurovitas Spain”). Normal or high doses of this medicine during the last phase of pregnancy can cause serious complications in the mother or baby.

Breast-feeding women should not take acetylsalicylic acid unless advised by their doctor.

If you continue or start treatment with acetylsalicylic acid during pregnancy and on medical advice, then use acetylsalicylic acid according to your doctor's instructions and do not use a higher dose than recommended.

Pregnancy - last trimester

Do not take more than 100 mg of acetylsalicylic acid per day if you are in the last 3 months of pregnancy, as it may harm your fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency and that of your baby to bleed and make labor longer than expected.

If you take acetylsalicylic acid in low doses (up to 100 mg per day inclusive), you need strict obstetric monitoring as advised by your doctor.

Pregnancy: first and second trimester

You should not take acetylsalicylic acid during the first 6 months of pregnancy unless it is absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If taken for more than a few days from the 20th week of pregnancy, acetylsalicylic acid may cause kidney problems in the fetus that can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Driving and using machines

Acetylsalicylic acid should not affect your ability to drive and use machines.

Acetylsalicylic Acid Aurovitas Spain contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Acetylsalicylic Acid Aurovitas Spain

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

Prevention of heart attacks:

• The recommended dose is 75-160 mg once a day.

Prevention of strokes:

• The recommended dose is 75-325 mg once a day.

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

• The recommended dose is 75-160 mg once a day.

Prevention of thrombus formation after certain types of heart surgery:

• The recommended dose is 75-160 mg once a day.

Elderly patients

Doses are the same as for adults. In general, acetylsalicylic acid should be used with caution in elderly patients who are more prone to adverse events. Treatment should be reviewed 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 “Warnings and Precautions”).

Method of administration

Orally.

The tablets should be swallowed whole with a sufficient amount of liquid (half a glass of water). The tablets have a gastro-resistant coating that prevents irritating effects on the intestine, and therefore should not be crushed, broken or chewed.

If you take more Acetylsalicylic Acid Aurovitas Spain than you should

If you (or someone else) have taken too many tablets, you should contact your doctor immediately, contact the nearest emergency service or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Show your doctor 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 large overdose may lead to faster than normal breathing (hyperventilation), fever, excessive sweating, restlessness, convulsions, hallucinations, low blood sugar, coma and shock.

If you forget to take Acetylsalicylic Acid Aurovitas Spain

If you forget to take a dose, wait until it is time to take the next dose and continue the treatment as usual.

Do not take a double dose to make up for forgotten doses.

If you have any other questions 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.

If you notice any of the following serious side effects, stop taking Acetylsalicylic Acid Aurovitas Spain and contact your doctor immediately:

• Sudden difficulty breathing, swelling of your lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling and may be associated with high fever and joint pain. This could be erythema multiforme, Stevens-Johnson syndrome or Lyell syndrome.
• Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.

Common side effects (may affect up to 1 in 10 people):

• 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 in the stomach or intestines, cerebral hemorrhage; altered blood cell count.
• Nausea and vomiting.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Bruising with purple spots (bleeding into the skin).
• Severe skin reactions such as a rash known as erythema multiforme, and life-threatening forms, Stevens-Johnson syndrome and Lyell syndrome.
• Hypersensitivity reactions, such as swelling of, e.g. lips, face or body, or shock.
• Abnormally heavy or prolonged menstrual periods.

Side effects of unknown frequency (cannot be estimated from the available data):

• Ringing in your ears (tinnitus) or reduced hearing.
• Headache.
• Dizziness.
• Ulcers in the stomach or intestine and perforation.
• Prolonged bleeding time.
• Disorder of kidney function.
• Disorder of liver function.
• High levels of uric acid in the blood.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylsalicylic Acid Aurovitas Spain

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Tablet pack: Keep the pack tightly closed to protect from moisture.

Blister packs: Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid Aurovitas Spain

• The active substance is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The other ingredients are: tablet core:microcrystalline cellulose, maize starch, anhydrous colloidal silica, stearic acid; coating:methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Appearance of the product and pack contents

Acetylsalicylic Acid Aurovitas Spain 100 mg gastro-resistant tablets are round, white, biconvex film-coated tablets with a diameter of 7.2 mm.

Pack sizes:

Blister packs: 10, 20, 28, 30, 50, 56, 60, 90, 100 gastro-resistant tablets.

Tablet packs: 10, 30, 50, 100, 500 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Phone: 91.630.86.45

Fax: 91.630.26.64

Manufacturer

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Date of last revision of this leaflet:January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)