Package Leaflet: Information for the User

Acid Acetylsalicylic Aurovitas Spain 100 mg gastro-resistant tablets

Read this 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Acetylsalicylic Acid Aurovitas Spain 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.Storage of Acetylsalicylic Acid Aurovitas Spain

6.Contents of the pack and additional information

This medication contains acetylsalicylic acid, which at low doses belongs to a group of medications 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 occurs in the heart, it can cause a heart attack or angina; in the brain, it can cause a cerebral infarction.

Acido Acetilsalicílico Aurovitas Spain is taken to reduce the risk of blood clot formation and consequently prevent:

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

Acido Acetilsalicílico Aurovitas Spain is also used to prevent blood clot formation after certain types of cardiac surgery to widen or unblock blood vessels.

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

Do not take Aurovitas Spain Acetylsalicylic Acid

• if you are allergic to acetylsalicylic acid or any of the other components of this medication (listed in section 6)
• if you are allergic to other salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used to treat arthritis or rheumatism and pain
• if you have had an asthma attack or swelling of some parts of your body, e.g. face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs
• if you currently have or have ever had an ulcer in your stomach or small intestine 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; do not use doses greater than 100 mg per day (see section "Pregnancy, breastfeeding, and fertility")
• if you are taking a medication 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 any problems with your stomach or small intestine
• 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 bleeding

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

Inform your doctor if you are planning a surgical procedure (including minor procedures, such as a dental extraction) as acetylsalicylic acid is an anticoagulant, which may increase the risk of bleeding.

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

You must be careful not to become dehydrated (you may feel thirsty and have a dry mouth) as the use of acetylsalicylic acid at the same time may cause deterioration of renal function.

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

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

Other medications and Aurovitas Spain Acetylsalicylic Acid

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• prevent blood clot formation (e.g. warfarin, heparin, clopidogrel)
• prevent organ rejection after transplantation (ciclosporin, tacrolimus)
• treat high blood pressure (e.g. diuretics and ACE inhibitors)
• regulate heart rhythm (digoxin)
• manic-depressive disorder (lithium)
• pain and inflammation (e.g. NSAIDs such as ibuprofen, or steroids)
• metamizol (substance to reduce pain and fever): if administered together, it may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clump 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 the adrenal glands or pituitary gland have been destroyed or removed, or medications to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)

Taking Aurovitas Spain Acetylsalicylic Acid 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 medication.

Pregnant women should not take acetylsalicylic acid during pregnancy unless a doctor indicates otherwise. Do not take acetylsalicylic acid if you are in the last 3 months of pregnancy, unless your doctor indicates and in that case, the daily dose should not exceed 100 mg (see section "Do not take Aurovitas Spain Acetylsalicylic Acid"). Normal or high doses of this medication during the last phase of pregnancy may cause serious complications in the mother or baby.

Women who are breastfeeding should not take acetylsalicylic acid unless a doctor indicates otherwise.

If you continue or start treatment with acetylsalicylic acid during pregnancy and according to a doctor's indication, then use acetylsalicylic acid as indicated by your doctor 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 renal and cardiac problems in the fetus. It may affect your tendency and that of your baby to bleed and make labor longer or more prolonged than expected.

If you take acetylsalicylic acid in low doses (up to 100 mg per day inclusive), you need strict obstetric monitoring according to your doctor's indications.

Pregnancy: first and second trimester

You should not take acetylsalicylic acid during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises it. 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 after 20 weeks of pregnancy, acetylsalicylic acid may cause renal problems in the fetus that may cause low amniotic fluid levels 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 operating machinery

Acetylsalicylic acid should not affect your ability to drive and operate machinery.

Aurovitas Spain Acetylsalicylic Acid contains sodium

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

Follow exactly the administration instructions of this medication 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 cardiac surgery:

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

Older patients

The same doses as adults. In general, acetylsalicylic acid should be used with caution in older 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 administered to children and adolescents under 16 years of age, unless prescribed by a doctor (see section “Warnings and precautions”).

Administration form

Oral administration.

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 another person) accidentally take too many tablets, you should inform your doctor immediately, contact the nearest emergency service or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Show your doctor the medication or the empty packaging.

The symptoms of overdose may include ringing in the ears, hearing problems, headaches, dizziness, confusion, nausea, vomiting, and abdominal pain. A large overdose may lead to rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar levels, coma, and shock.

If you forgot to take Acetylsalicylic Acid Aurovitas Spain

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

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Sudden difficulty breathing, swelling of your lips, face, or body, hives, 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.

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

• Indigestion.
• Increased tendency to bleed.

Less frequent side effects (may affect up to 1 in 100 people):

• Urticaria.
• Nasal discharge.
• Difficulty breathing.

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

• Intense bleeding in the stomach or intestines, cerebral hemorrhage; altered number of blood cells.
• Nausea and vomiting.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Bruises with purple patches (cutaneous bleeding).
• Severe skin reactions such as hives known as erythema multiforme, and may present in forms that can put your life at risk, Stevens-Johnson syndrome, and Lyell syndrome.
• Hypersensitivity reactions, such as swelling of, for example, lips, face, or body, or shock.
• Abnormally heavy or prolonged menstrual bleeding.

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

• Tinnitus or reduced hearing capacity.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Renal function disorder.
• Hepatic function disorder.
• High levels of uric acid in the blood.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below25°C.

Blister pack: Keep the blister pack perfectly closed to protect it from moisture.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Acetilsalicilic Acid Aurovitas Spain

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

Appearance of the product and content of the packaging

The gastro-resistant tablets of Acetilsalicilic Acid Aurovitas Spain 100 mg are film-coated, round, white, biconvex tablets with a diameter of7.2 mm.

Packaging sizes:

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

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91.630.86.45

Fax: 91.630.26.64

Responsible for manufacturing

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Date of the last review of this leaflet:January 2025

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