ACETIC ACID SALICYLIC TEVA 100 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Acetylsalicylic Acid TEVA

Do not take Acetylsalicylic Acid TEVA:

• if you are allergic (hypersensitive) 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 drugs (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 small intestine 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 three months of pregnancy, you should not use doses higher than 100 mg per day (see section "Pregnancy and breastfeeding")
• if you are taking a medicine called methotrexate (e.g. to treat cancer or rheumatoid arthritis) in doses higher than 15 mg per week

Warnings and precautions

Before starting treatment with Acetylsalicylic Acid TEVA, inform your doctor:

• if you have kidney, liver or heart problems
• if you have or have ever had stomach or small intestine 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 have scheduled surgery (even minor surgery, such as tooth extraction) as acetylsalicylic acid is an anticoagulant, and there may be an increased risk of bleeding.

Acetylsalicylic acid can cause Reye's syndrome when administered 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 TEVA should not be given to children under 16 years of age, unless indicated by a doctor.

You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth) as using 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 cases, or if you are not sure, consult your doctor or pharmacist.

Consult your doctor or pharmacist before starting treatment with Acetylsalicylic Acid TEVA 100 mg.

Taking Acetylsalicylic Acid TEVA with other medicines

Inform your doctor or pharmacist that you are taking, have recently taken or may take 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 (e.g. warfarin, heparin, clopidogrel)
• prevent organ rejection after transplantation (cyclosporin, 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)
• treat gout (e.g. probenecid)
• treat epilepsy (valproate, phenytoin)
• treat glaucoma (acetazolamide)
• treat cancer or rheumatoid arthritis (methotrexate; in doses less than 15 mg per week)
• treat diabetes (e.g. glibenclamide)
• treat depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• are used as hormone replacement therapy when adrenal or pituitary glands have been destroyed or removed, or medicines to treat inflammation, including rheumatic and inflammatory bowel diseases (corticosteroids)
• if administered concomitantly with metamizole, it may reduce the effect of acetylsalicylic acid to decrease platelet aggregation (antiplatelet) and therefore should be used with caution in patients taking it to protect the heart (cardioprotector)

Taking Acetylsalicylic Acid TEVA with alcohol

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

Pregnancy and breastfeeding

If you continue or start treatment with Acetylsalicylic Acid TEVA during pregnancy, following your doctor's instructions, use Acetylsalicylic Acid TEVA as indicated by your doctor and do not use a dose higher than recommended.

Pregnancy - last trimester

Do not take Acetylsalicylic Acid TEVA at doses higher than 100 mg per day if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed, and delay or prolong delivery more than expected.

If you take Acetylsalicylic Acid TEVA at low doses (up to 100 mg per day), you will need strict obstetric monitoring as indicated by your doctor.

Pregnancy - first and second trimester

You should not take Acetylsalicylic Acid TEVA during the first 6 months of pregnancy unless it is absolutely necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, if taken for more than a few days, Acetylsalicylic Acid TEVA may cause kidney problems in your fetus, which may 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 during a period longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Women who are breastfeeding should not take acetylsalicylic acid unless indicated by their doctor.

Driving and using machines

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

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Acetylsalicylic Acid TEVA

Follow exactly the administration instructions of this medicine 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.

Children

Acetylsalicylic acid should not be administered to children and adolescents under 16 years of age, unless prescribed by a doctor (see section "Special warnings and precautions for use").

Method of administration

Oral use.

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 TEVA than you should

If you (or someone else) accidentally take too many tablets, you should inform 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 TEVA

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

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

If you have any further questions on 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 TEVA 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 patients):

• Indigestion.
• Increased tendency to bleed.

Uncommon side effects (may affect up to 1 in 100 patients):

• Hives.
• Runny nose.

• Difficulty breathing.

Rare side effects (may affect up to 1 in 1,000 patients):

• 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.
• Bruises with purple spots (bleeding into the skin).
• Severe skin reactions such as a rash known as erythema multiforme, and can be life-threatening, 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:

• Ringing in your ears (tinnitus) or reduced hearing.
• Headache.
• Dizziness.
• Ulcers in the stomach or small 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 side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use, Website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylsalicylic Acid TEVA

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 carton after EXP. The expiry date is the last day of the month shown.

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 protect the environment.

Store below 30°C. Do not refrigerate. Store in the original package.

6. Contents of the pack and further information

Composition of Acetylsalicylic Acid TEVA

• The active substance is acetylsalicylic acid
• The other ingredients are: powdered cellulose, pregelatinized starch (from maize), Acryl-EZE Clear (93F19255) (methacrylic acid copolymer type C, talc, macrogol, colloidal anhydrous silica, sodium bicarbonate and sodium lauryl sulfate).

Appearance of the product and contents of the pack

Acetylsalicylic Acid TEVA 100 mg tablets are round, biconvex and white. They are coated with a gastro-resistant coating that makes acetylsalicylic acid not released immediately in the stomach, but delayed in the duodenum. They are available in packs of 30 tablets in PVC-Al/PVC-PVDC blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TEVA PHARMA S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108– Alcobendas (Madrid)

Spain

Manufacturer

TOLL MANUFACTURING SERVICES S.L.

c/ Aragoneses 2-

28108 – Alcobendas - Madrid

Spain

or

FARMALIDER S.A.

c/ Aragoneses 15-

28108 – Alcobendas – Madrid

Spain

or

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana, 26, Torrejón de Ardoz 28850 (Madrid)

Spain

Date of last revision of this leaflet: June 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/