Acetylsalicylic acid Teva 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylsalicylic Acid TEVA 100 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Acetylsalicylic Acid TEVA is and what it is used for
2. What you need to know before taking Acetylsalicylic Acid TEVA
3. How to take Acetylsalicylic Acid TEVA
4. Possible side effects
5. How to store Acetylsalicylic Acid TEVA

Pack contents and additional information

1. What is Acetylsalicylic Acid TEVA 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 cause blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off the supply of oxygen. When this occurs in the heart, it may cause a heart attack or angina; in the brain, it may cause a stroke.

Acetylsalicylic Acid TEVA is taken to reduce the risk of blood clot formation and thereby prevent:

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

Acetylsalicylic Acid TEVA is also used to prevent blood clot formation after certain types of cardiac surgery intended to widen or unblock blood vessels.

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

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

Do not take Acetylsalicylic Acid TEVA:

• if you are allergic (hypersensitive) to acetylsalicylic acid or to any of the other components of this medicine (listed in section 6).
• if you are allergic to other salicylates or to non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are commonly used for arthritis or rheumatism and pain.
• if you have ever had an asthma attack or swelling of certain body parts, 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 cerebral hemorrhage.
• 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 must 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 exceeding 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 have asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger 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 adverse effects, e.g., unusual bleeding symptoms, severe skin reactions, or any other sign of a serious allergic reaction (see section “Possible side effects”).

Inform your doctor if you have planned any surgical procedure (including minor procedures such as dental extraction), as acetylsalicylic acid is an anticoagulant and may increase the risk of bleeding.

Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a very rare condition affecting the brain and liver and may be life-threatening. For this reason, Acetylsalicylic Acid TEVA must not be given to children under 16 years of age unless directed 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 lead to impaired renal function.

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

If you are in any of the above situations, or if you are unsure, consult your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take Acetylsalicylic Acid TEVA 100 mg.

Taking Acetylsalicylic Acid TEVA with other medicines

Inform your doctor or pharmacist about any other medicines you are taking, have recently taken, or might need to take.

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

• preventing blood clots (e.g., warfarin, heparin, clopidogrel).
• preventing rejection of a transplanted organ (cyclosporine, tacrolimus).
• treating high blood pressure (e.g., diuretics and ACE inhibitors).
• regulating heart rhythm (digoxin).
• bipolar disorder (lithium).
• pain and inflammation (e.g., NSAIDs such as ibuprofen, or steroids).
• gout (e.g., probenecid).
• epilepsy (valproate, phenytoin).
• glaucoma (acetazolamide).
• cancer or rheumatoid arthritis (methotrexate; at 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 the adrenal glands or pituitary gland have been destroyed or removed, or medicines used to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids).
• if administered concomitantly with metamizole, it may reduce the antiplatelet effect of acetylsalicylic acid and therefore should be used with caution in patients taking it for cardioprotection.

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 as instructed by your doctor, use Acetylsalicylic Acid TEVA exactly as directed by your doctor and do not exceed the recommended dose.

Pregnancy – third trimester

Do not take Acetylsalicylic Acid TEVA at doses exceeding 100 mg per day if you are in the last three months of pregnancy, as it could harm the 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 may delay or prolong labor more than expected.

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

Pregnancy – first and second trimester

You should not take Acetylsalicylic Acid TEVA during the first six months of pregnancy unless absolutely necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, if taken for more than a few days, Acetylsalicylic Acid TEVA may cause kidney problems in your fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

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

Driving and using machines

Acetylsalicylic Acid TEVA is unlikely to affect your ability to drive or 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 instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

Prevention of heart attacks:

• The recommended dose is 75–160 mg once daily.

Prevention of strokes:

• The recommended dose is 75–325 mg once daily.

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

• The recommended dose is 75–160 mg once daily.

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

• The recommended dose is 75–160 mg once daily.

Elderly patients

Dosage is 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 must not be given to children and adolescents under 16 years of age unless prescribed by a doctor (see section “Take special care with Acetylsalicylic Acid TEVA”).

Method of administration

Oral use.

The tablets should be swallowed whole with sufficient liquid (half a glass of water). The tablets have an enteric coating that prevents irritating effects in the intestine; therefore, they must 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 must inform your doctor immediately, contact the nearest emergency service, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

Show the doctor the medicine or empty packaging.

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 abnormally rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar levels, coma, and shock.

If you forget to take Acetylsalicylic Acid TEVA

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

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse 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).
• Skin redness with blistering or peeling, which may be associated with high fever and joint pain. This could be 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.

Frequent adverse effects (may affect up to 1 in 10 people):

• Indigestion.
• Increased tendency to bleed.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Hives.
• Runny nose.
• Difficulty breathing.

Rare adverse effects (may affect up to 1 in 1,000 people):

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

Adverse effects of unknown frequency:

• Ringing in the ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Kidney function disorder.
• Liver function disorder.
• High levels of uric acid in the blood.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es

By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

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

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid TEVA

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

Appearance of the product and contents of the container

Acetylsalicylic Acid TEVA 100 mg tablets are round, biconvex and white. They are coated with a gastro-resistant coating that prevents the immediate release of acetylsalicylic acid in the stomach, allowing delayed release in the duodenum. The product is supplied 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, 1st floor
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 the most recent revision of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/