Acetylsalicylic acid Aurovitas Spain 100 mg gastro-resistant tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Acetylsalicylic Acid Aurovitas Spain 100mg 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Acetylsalicylic Acid Aurovitas Spain is and what it is used for
2. What you need to know before taking Acetylsalicylic Acid Aurovitas Spain
3. How to take Acetylsalicylic Acid Aurovitas Spain
4. Possible side effects
5. How to store 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 cause blood to clot 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 Aurovitas Spain 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 Aurovitas Spain 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 situations. It can only be used as a preventive treatment.

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

Do not take Acetylsalicylic Acid Aurovitas Spain

• If you are allergic to acetylsalicylic acid or to any of the other ingredients 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 previously experienced 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 recurrent stomach discomfort, a stomach or small intestine ulcer, or any other type of bleeding such as a cerebral infarction.
• 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 must not use doses higher than 100 mg per day (see section “Pregnancy, breastfeeding and fertility”).
• If you are taking a medicine called methotrexate (e.g., to treat cancer or rheumatoid arthritis) at doses exceeding 15 mg per week.
• If you are taking anticoagulants.

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 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 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, serious skin reactions, or any other sign of a severe allergic reaction (see section “Possible side effects”).

Inform your doctor if you are scheduled for surgery (even minor procedures, such as a 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 must not be given to children under 16 years of age unless directed by a doctor.

If you need to be vaccinated against varicella, treatment with acetylsalicylic acid should be suspended for 6 weeks after vaccination.

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.

Other medicines and Acetylsalicylic Acid Aurovitas Spain

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

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);
• metamizole (a substance to reduce pain and fever): if administered together, it may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid as a cardioprotective agent;
• 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 to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids);
• nicotinic acid.

Recipients of the varicella vaccine should avoid products containing acetylsalicylic acid for 6 weeks following vaccination, as it may cause a serious illness called Reye's syndrome, which can affect all organs of the body.

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, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Breastfeeding women should not take acetylsalicylic acid unless advised by their doctor.

If you continue or start treatment with acetylsalicylic acid during pregnancy and under medical advice, then use acetylsalicylic acid as directed by your doctor and do not exceed the recommended dose.

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 could harm your fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency and your baby's tendency to bleed and may cause labor to be delayed or prolonged.

If you take low-dose acetylsalicylic acid (up to 100 mg per day inclusive), you require strict obstetric monitoring as directed by your doctor.

Pregnancy: first and second trimester

You should not take acetylsalicylic acid during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days beyond 20 weeks of pregnancy, acetylsalicylic acid may cause kidney problems in the 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 is needed 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 or use machines. However, if you experience symptoms such as dizziness or tinnitus, you should not drive or use machines; these symptoms are usually related to overdose.

Acetylsalicylic Acid Aurovitas Spain contains sodium

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

3. How to take Acetylsalicylic Acid Aurovitas Spain

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 cardiac 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 likely to experience adverse events. Treatment should be reviewed at regular intervals.

Use in children and adolescents

Acetylsalicylic acid must not be administered to children and adolescents under 16 years of age, unless specifically prescribed by a doctor (see section “Warnings and precautions”).

Method of administration

For 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 Aurovitas Spain than you should

If you (or someone else) accidentally take too many tablets, you must inform your doctor immediately, contact the nearest emergency service right away, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken. Show the medicine or the empty packaging to your doctor.

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 Aurovitas Spain

If you forget to take a dose, wait until it is time for your 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Sudden difficulty breathing, swelling of 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.
• Gastric and duodenal ulcer.
• Gastrointestinal haemorrhage.
• Constipation.
• Increased tendency to bleed.
• Allergic reactions.
• Nausea and vomiting.

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

• Urticaria.
• Runny nose.
• Difficulty breathing.
• Reye's syndrome.

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

• Severe bleeding in the stomach or intestines, cerebral haemorrhage; altered blood cell count.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Bruising with purple spots (cutaneous bleeding).
• Severe 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, urogenital bleeding.

Adverse effects with unknown frequency (cannot be estimated from 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.
• Renal function disorder.
• Hepatic function disorder, increased transaminases (liver enzymes whose elevation may indicate liver problems).
• Haemolysis (destruction of red blood cells) and haemolytic anaemia (a type of anaemia caused by haemolysis).
• High levels of uric acid in the blood.
• Drug reaction (hypersensitivity syndrome) with eosinophilia and systemic symptoms (DRESS) or (DHS).

Reporting of adverse effects

If you experience any adverse effect, talk to 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: https://www.notificaram.es. By reporting adverse 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 container: keep the container tightly closed to protect it from moisture.

Blister packs: store in the original packaging to protect it from moisture.

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 collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid Aurovitas Spain

1. The active substance is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.

2. The other components are:

3. Tablet core: microcrystalline cellulose, corn starch, colloidal anhydrous silica, stearic acid.

4. Coating: methacrylic acid–ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Appearance of the medicinal product and contents of the pack

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

Pack sizes:

1. Blister packs: 10, 20, 28, 30, 50, 56, 60, 90, 100 gastro-resistant tablets.
2. Bottle packs: 10, 30, 50, 100, 500 gastro-resistant tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Date of the most recent revision of this leaflet: November 2025.

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