Prospect: information for the user

Acid Acetilsalicilic TecniGen 100 mg gastro-resistant tablets

Read this prospect thoroughly before starting to take this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

- This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

TecniGen Acetylsalicylic Acidcontains 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.

Acetylsalicylic acid 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)

This medication 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 Ácido Acetilsalicílico TecniGen

- if you are allergic to acetylsalicylic acid, other salicylates, or nonsteroidal anti-inflammatory drugs (NSAIDs; NSAIDs are often used to treat arthritis or rheumatism and pain) or any of the other ingredients in this medicine (listed in section 6)

- if you have had an asthma attack or swelling of some parts of your body, for example, face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs

- if you currently have or have had a stomach or small intestine ulcer at any time

- if you have a history of bleeding or perforation (gastric or intestinal) caused by a previous treatment with NSAIDs

- if you have a history of recurrent stomach or intestinal ulcers or bleeding, 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 have severe heart problems, which can cause difficulty breathing and swelling of the ankles

- if you are in the last 3 months of pregnancy; do not take doses greater 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 greater than 15 mg per week

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine:

- if you have kidney, liver, or heart problems

- if you have or have had ulcers or bleeding (e.g., in the 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 trigger an asthma attack

- if you have ever had gout

- if you have heavy menstrual bleeding

- if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD)

You should consult a doctor immediately if your symptoms worsen or if you experience severe or unexpected side effects, such as 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 surgery (including minor surgery, such as a tooth extraction) as acetylsalicylic acid is an anticoagulant, which may increase the risk of bleeding.

You should 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 medicine 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.

Children and adolescents

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, this medicine should not be administered to adolescents/children under 16 years of age, unless a doctor indicates otherwise.

Other medicines and Ácido Acetilsalicílico TecniGen

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

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

- prevent the formation of blood clots (e.g., warfarin, heparin, clopidogrel, altepasa)

- prevent the rejection of a transplanted organ (ciclosporina, tacrolimus)

- treat high blood pressure (e.g., diuretics and ACE inhibitors)

- regulate heart rhythm (digoxina)

- treat manic-depressive disorder (litio)

- pain and inflammation (e.g., NSAIDs such as ibuprofen, or steroids)

- Metamizol (substance to reduce pain and fever) 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 (valproato, fenitoína)

- glaucoma (acetazolamida)

- cancer or rheumatoid arthritis (metotrexato; in doses less than 15 mg per week)

- diabetes (e.g., glibenclamida, insulina)

- depression (selective serotonin reuptake inhibitors (SSRIs) such as sertralina or paroxetina)

- 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)

Ácido Acetilsalicílico TecniGen 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 their doctor indicates otherwise. Do not take this medicine 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 Ácido Acetilsalicílico TecniGen"). Normal or high doses of this medicine 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 their doctor indicates otherwise.

Acetylsalicylic acid may affect female fertility by affecting ovulation. This effect is reversible after stopping treatment.

Driving and operating machinery

This medicine should not affect your ability to drive and use machines.

Ácido Acetilsalicílico TecniGen contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication 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 100 mg once a day.

Prevention of strokes:

- The recommended dose is 100 mg once a day.

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

- The recommended dose is 100 mg once a day.

Prevention of thrombus formation after certain types of cardiac surgery:

- The recommended dose is 100 mg once a day.

This medication should not be used in higher doses unless advised by a doctor. The dose should not exceed 300 mg per 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.

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.

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

If you take more Acetylsalicylic Acid TecniGen 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, pulmonary edema, coma, and shock.

If you forget to take Acetylsalicylic Acid TecniGen

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 interrupt treatment with Acetylsalicylic Acid TecniGen

Do not stop taking this medication without consulting your doctor.

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

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

If you notice any of the following serious side effects, stop taking this medicine and contact your doctor immediately:

- Sudden difficulty breathing, swelling of your lips, face, or body, hives, fainting, or difficulty swallowing (severe allergic reaction).

- Skin redness 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.

Other side effects are:

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

- Nausea, vomiting, diarrhea.

- 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)

- Severe bleeding in the stomach or intestines, cerebral hemorrhage; altered blood cell count.

- Coughing up mucus, 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.

- Reye's syndrome (a very rare disease in children that affects the brain and liver (see section 2 "Children and adolescents").

- Abnormally heavy or prolonged menstrual bleeding.

Unknown frequency(frequency cannot be estimated from available data)

- Ringing in your ears (tinnitus) or reduced hearing ability.

- Headache.

- Dizziness.

- Ulcers in the stomach or small intestine and perforation.

- Prolonged bleeding time.

- Renal function disorder, acute renal insufficiency.

- Liver function disorder, increased liver enzymes.

- High levels of uric acid or low blood sugar levels.

Reporting side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: 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.

Do not store at a temperature above 30°C.

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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Acetilsalicilic Acid TecniGen

• The active ingredient is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The other components are:

• Tablet core:Lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, and potato starch.
• Gastro-resistant coating film: Talc, triacetin, and copolymer of methacrylic acid and ethyl acrylate (1:1), dispersion of, at 30%.

Appearance of the product and contents of the packaging

White, round, biconvex tablets, coated with a film, with a diameter of approximately 8.1 mm and a thickness of approximately 3.5 mm.

Carton packaging with PVC/Al blister that contains 30 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TecniMed Spain Pharmaceutical Industry, S.A.

Avda. de Bruselas, 13, 3rd D. Edificio América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

G.L. Pharma GmbH

Industriestrasse 1, A-8502 Lannach

Austria

or

G.L. Pharma GmbH

Schlossplatz 1, A-8502 Lannach

Austria

This medication is authorizedinthe member states of the European Economic Area with the following names:

Italy:Acido Acetilsalicilico Tecnigen 100 mg gastroresistant tablets

Portugal:Acido Acetilsalicilico Biofarmoz 100 mg gastro-resistant tablets

Spain:Acido Acetilsalicilico Tecnigen 100 mg gastro-resistant tablets

Date of the last review of this leaflet:January 2022

Detailed information about this medication is available on the website of theSpanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/