Acetylsalicylic Acid TecniGen 100 mg Gastro-Resistant Tablets

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

Do not take Acetylsalicylic Acid TecniGen

• if you are allergic to acetylsalicylic acid, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs are often used for arthritis or rheumatism and pain) or to any of the other ingredients of this medicine (listed in section 6)
• 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 intestinal ulcer
• if you have a history of bleeding or perforation (gastric or intestinal) caused by previous treatment with NSAIDs
• if you have a history of recurrent gastroduodenal ulcer/bleeding with episodes of ulceration 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 that can cause difficulty breathing and swelling of the ankles
• if you are in the last 3 months of pregnancy; you should not take more 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 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 periods
• 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 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 a dental extraction) as acetylsalicylic acid is an anticoagulant, and there may be an increased 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 kidney function to deteriorate.

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

If you are in any of the above situations, or if you are not sure, consult your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid may 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, this medicine should not be given to adolescents/children under 16 years of age, unless indicated by a doctor.

Other medicines and Acetylsalicylic Acid TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 from forming (e.g. warfarin, heparin, clopidogrel, alteplase)
• prevent organ rejection after transplantation (cyclosporine, 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 like ibuprofen, or steroids)
• Metamizol (a 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 (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate; in doses less than 15 mg per week)
• diabetes (e.g. glibenclamide, insulin)
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• hormone replacement therapy when adrenal or pituitary glands have been destroyed or removed, or medicines to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)

Taking Acetylsalicylic Acid 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 advises them to do so. You should not take this medicine if you are in the last 3 months of pregnancy, unless your doctor advises you to do so, and in that case, the daily dose should not exceed 100 mg (see section "Do not take Acetylsalicylic Acid TecniGen"). Normal or high doses of this medicine during the last phase of pregnancy can cause serious complications in the mother or baby.

Breastfeeding women should not take acetylsalicylic acid unless their doctor advises them to do so.

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

Driving and using machines

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

Acetylsalicylic Acid TecniGen contains lactose

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

3. How to take Acetylsalicylic Acid TecniGen

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in 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 heart surgery:

• The recommended dose is 100 mg once a day.

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

Acetylsalicylic acid should not be given to children and adolescents under 16 years of age, unless prescribed by a doctor (see section "Warnings and precautions").

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 TecniGen 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 can lead to faster than normal breathing (hyperventilation), fever, excessive sweating, restlessness, convulsions, 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 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 stop taking Acetylsalicylic Acid TecniGen

Do not stop taking this medicine without consulting your doctor.

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

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 this medicine 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.

Other side effects are:

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

• Nausea, vomiting, diarrhea.
• Indigestion.
• Increased tendency to bleed.

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

• Hives.
• Runny nose.
• 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.
• Spasms 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.
• 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 periods.

Frequency not known (frequency cannot be estimated from the available data)

• Ringing in your ears (tinnitus) or reduced hearing.
• Headache.
• Dizziness.
• Ulcers in the stomach or intestine and perforation.
• Prolonged bleeding time.
• Disorder of kidney function, acute kidney failure.
• Disorder of liver function, increased liver enzymes.
• High levels of uric acid or low blood sugar levels.

Reporting of side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Acetylsalicylic Acid TecniGen

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the pharmacy. Ask your pharmacist how to dispose of packages and medicines no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid TecniGen

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

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

Appearance of the product and pack contents

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

Carton pack with PVC/Al blister containing 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

G.L. Pharma GmbH

Industriestrasse 1, A-8502 Lannach

Austria

or

G.L. Pharma GmbH

Schlossplatz 1, A-8502 Lannach

Austria

This medicine is authorizedin the Member States of the European Economic Area under the following names:

Italy: Acido Acetilsalicilico Tecnigen 100 mg compresse gastroresistenti

Portugal: Acido Acetilsalicilico Biofarmoz 100 mg comprimidos gastrorresistentes

Spain: Acido Acetilsalicilico Tecnigen 100 mg comprimidos gastrorresistentes

Date of last revision of this leaflet: January 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/