Acetylsalicylic acid Tecnigen 100 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylsalicylic Acid TecniGen 100 mg gastro-resistant tablets

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents

1. What Acetylsalicylic Acid TecniGen is and what it is used for
2. What you need to know before taking Acetylsalicylic Acid TecniGen
3. How to take Acetylsalicylic Acid TecniGen
4. Possible side effects
5. How to store Acetylsalicylic Acid TecniGen
6. Contents of the pack and other information

1. What is Acetylsalicylic Acid TecniGen and what is it used for

Acetylsalicylic Acid TecniGen contains acetylsalicylic acid, which at low doses belongs to a group of medicines known as 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 is taken to reduce the risk of blood clots and thus prevent:

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

This medicine 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 Ácido Acetilsalicílico TecniGen

Do not take Ácido Acetilsalicílico TecniGen

• if you are allergic to acetylsalicylic acid, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs are commonly used for arthritis or rheumatism and pain), or to any of the other ingredients of this medicine (listed in section 6)
• 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
• if you have a history of gastrointestinal 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 cerebral hemorrhage
• if you have ever had problems with blood not clotting properly
• if you have severe liver or kidney problems
• if you have serious heart problems, which may cause difficulty breathing and swelling of the ankles
• if you are in the last 3 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) at doses higher than 15 mg per week

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking 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 periods
• if you have glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency

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 signs of a serious allergic reaction (see section “Possible side effects”).

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

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 kidney 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.

Children and adolescents

Acetylsalicylic acid may cause Reye's syndrome when given to children. Reye's syndrome is a very rare condition affecting the brain and liver that can be life-threatening. For this reason, this medicine must not be given to adolescents/children under 16 years of age unless directed by a doctor.

Other medicines and Ácido Acetilsalicílico TecniGen

Tell 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, alteplase)
• 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 used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping together to form a 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, insulin)
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• used as 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 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 are planning 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 this medicine during the last 3 months of pregnancy unless instructed by your doctor, and in that case, the daily dose must not exceed 100 mg (see section “Do not take Ácido Acetilsalicílico TecniGen”). Normal or high doses of this medicine during the final stage of pregnancy may cause serious complications in the mother or baby.

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

Acetylsalicylic acid may affect female fertility by its effect on ovulation. This effect is reversible upon discontinuation of treatment.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery.

Ácido Acetilsalicílico TecniGen contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Acetylsalicylic Acid TecniGen

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 100 mg once daily.

Prevention of strokes:

• The recommended dose is 100 mg once daily.

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

• The recommended dose is 100 mg once daily.

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

• The recommended dose is 100 mg once daily.

This medicine should not be used at 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 must 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

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, and therefore must 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 must inform your doctor immediately, contact the nearest emergency service, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Show the medicine or 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, 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 adverse effects

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

If you notice any of the following serious adverse 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).
• 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.

Other adverse effects are:

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

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

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

• Hives (urticaria).
• Runny nose.
• Difficulty breathing.

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

• Severe bleeding in the stomach or intestines, brain haemorrhage; altered number of blood cells.
• 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.
• Reye's syndrome (a very rare disease in children affecting the brain and liver (see section 2 "Children and adolescents")).
• Abnormally heavy or prolonged menstrual periods.

Frequency not known (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, acute renal failure.
• Hepatic function disorder, increased liver enzymes.
• High levels of uric acid or low blood sugar levels.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Acetylsalicylic Acid TecniGen

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

• The other components are:

• Core of the tablet: Monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, and potato starch.

• Gastro-resistant film coating: Talc, triacetin, and copolymer of methacrylic acid and ethyl acrylate (1:1), dispersion at 30%.

Appearance of the product and contents of the container

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

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

Only certain 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 medicinal product is authorized in 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 the most recent review of this leaflet: January 2022

Detailed 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/