Acetylsalicylic acid Tecnigen

Package leaflet: Information for the user

Acetylsalicylic Acid TecniGen 100 mg gastro-resistant tablets

Read this entire leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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 Acido Acetilsalicilico TecniGen is and what it is used for

Acido Acetilsalicilico TecniGen contains acetylsalicylic acid, which at low doses belongs to a group
of medicines called antiplatelet agents. Platelets are small blood cells that cause clotting and are involved in thrombosis. When a blood clot forms in
an artery, blood flow becomes blocked and oxygen supply is interrupted. When this occurs in the
heart, it may cause a heart attack or angina; in the brain, it may cause a stroke.
Acido Acetilsalicilico TecniGen is taken to reduce the risk of blood clot formation and thus prevent the following conditions:

• heart attacks;
• strokes;
• cardiovascular problems in patients suffering from stable or unstable angina (a type of chest pain).

Acido Acetilsalicilico TecniGen is also used to prevent blood clot formation after
certain heart procedures performed to widen or unblock blood vessels.
This medicine is not recommended for emergency use. It may only be used as a preventive treatment.

2. What you should know before taking Acetylsalicylic Acid TecniGen.

Do not take Acetylsalicylic Acid TecniGen:

• 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 often used for arthritis, rheumatism, or pain;
• if you have previously experienced an asthma attack or swelling of certain body parts, such as 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 failure) caused by previous treatment with NSAIDs;
• if you have a history of recurrent gastric or duodenal ulceration or bleeding, or any other type of bleeding such as a stroke;
• if you have had blood clotting disorders;
• if you suffer from severe liver or kidney problems;
• if you have severe heart problems that may cause shortness of breath or ankle swelling;
• during the last 3 months of pregnancy; you must not take doses exceeding 100 mg per day (see section “Pregnancy and breastfeeding”);
• if you are taking a medicine called methotrexate (for example, to treat cancer or rheumatoid arthritis) at doses exceeding 15 mg per week.

Warnings and precautions
Talk to your doctor before taking Acetylsalicylic Acid TecniGen if:

• you have kidney, liver, or heart problems;
• you have or have had stomach or small intestine problems;
• you have high blood pressure;
• you suffer from asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack;
• you have ever had gout;
• you have heavy menstrual periods;
• you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

You must immediately contact your doctor if your symptoms worsen or if you experience serious or unexpected side effects, such as unusual bleeding symptoms, severe skin reactions, or any other signs of a severe allergic reaction (see section “Possible side effects”).
Inform your doctor if you are about to undergo surgery (even minor procedures, such as tooth extraction). Acetylsalicylic acid makes the blood thinner, thereby increasing the risk of bleeding.
Be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as concomitant use of acetylsalicylic acid may lead to impaired kidney function.
This medicine is not suitable for use as a painkiller or to reduce fever.
If any of the above conditions apply to you, or if you have any doubts, consult your doctor or pharmacist.

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

Other medicines and Acetylsalicylic Acid TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effectiveness of treatment may be affected if acetylsalicylic acid is taken together with other medicines for:

• blood thinning / prevention of blood clots (e.g. warfarin, heparin, clopidogrel, alteplase);
• prevention of organ transplant rejection (cyclosporine, tacrolimus);
• high blood pressure (e.g. diuretics and ACE inhibitors);
• regulation of 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 that clump together to form a clot) when taken concomitantly. Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection;
• gout (e.g. probenecid);
• epilepsy (valproate, phenytoin);
• glaucoma (acetazolamide);
• cancer or rheumatoid arthritis (methotrexate; at doses below 15 mg per week);
• diabetes (e.g. glibenclamide, insulin);
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine);
• use as hormone replacement therapy after destruction or removal of the adrenal glands or pituitary gland, or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids).

Acetylsalicylic Acid TecniGen with food, drinks, and alcohol
Consumption of alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Women who are pregnant should not take acetylsalicylic acid during pregnancy unless advised by a doctor.
You must not take Acetylsalicylic Acid TecniGen during the last 3 months of pregnancy, except on medical prescription, and in such cases the daily dose must not exceed 100 mg (see section “Do not take Acetylsalicylic Acid TecniGen”). Regular or high doses of this medicine during the later stages of pregnancy may cause serious complications in the mother or baby.
Breastfeeding women should not take acetylsalicylic acid unless advised by a doctor.
Acetylsalicylic acid may affect female fertility by influencing ovulation. This effect is reversible upon discontinuation of treatment.

Driving and using machines
Acetylsalicylic Acid TecniGen does not affect the ability to drive or use machinery.

Acetylsalicylic Acid contains lactose.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Acido Acetilsalicilico TecniGen

Take this medicine exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Adults
Prevention of heart attacks:

• The recommended dose is 100 mg once daily.

Prevention of stroke:

• The recommended dose is 100 mg once daily.

Prevention of cardiovascular problems in patients suffering from 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 must not be taken at higher doses unless advised by your doctor, and the dose must not exceed 300 mg per day.
Elderly patients
The recommended dose is the same as that indicated for younger adults. In general, acetylsalicylic acid should be used with caution in elderly patients, who are more susceptible to adverse events. Treatment should be regularly re-evaluated.
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.
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 must not be crushed, broken, or chewed.
If you take more Acido Acetilsalicilico TecniGen than you should
If you (or anyone else) accidentally take too many tablets, seek immediate medical advice or contact the nearest emergency department. Show the doctor what is left of the medicine or the empty packaging.
Symptoms of overdose may include ringing in the ears, hearing problems, headache, dizziness, confusion, nausea, vomiting, and abdominal pain. A significant overdose may lead to rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, pulmonary edema, low blood sugar levels, coma, and shock.
If you forget to take Acido Acetilsalicilico TecniGen
If you miss a dose, wait until it is time for your next dose, then continue as usual.
Do not take a double dose to make up for the missed tablet.
If you stop taking Acido Acetilsalicilico TecniGen
Do not stop or discontinue treatment with Acido Acetilsalicilico TecniGen without first discussing it with your doctor.
If you have any doubts about how to use this product, consult 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 rare but serious side effects, stop taking Acetylsalicylic Acid TecniGen and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blisters or peeling which 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 vomit or urine, or dark stools.

Other side effects:

• Common (may affect up to 1 in 10 people): Nausea, vomiting, diarrhoea.
• Indigestion.
• Increased tendency to bleed.
• Uncommon (may affect up to 1 in 100 people): Hives (urticaria).
• Runny nose.
• Breathing difficulties.

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

• Severe stomach or intestinal bleeding, cerebral haemorrhage; altered blood cell counts.
• Cramps in the lower respiratory tract, asthma attacks.
• Inflammation of blood vessels.
• Bruising with purple spots (cutaneous haemorrhage).
• Severe skin reactions such as skin rash known as erythema multiforme and its life-threatening forms, Stevens-Johnson syndrome and Lyell syndrome.
• Hypersensitivity reactions, such as swelling, e.g. of the lips, face or body, or shock.
• Reye's syndrome (a very rare illness in children affecting the brain and liver) (see section 2 “Children and adolescents”).
• Very heavy or prolonged menstrual bleeding.

Not known (frequency cannot be estimated from available data):

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acido Acetilsalicilico 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 pack or blister after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Acido Acetilsalicilico TecniGen contains

• The active substance is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The other excipients are:
• Tablet core: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, and potato starch.
• Gastro-resistant coating film: talc, triacetin, and methacrylic acid-ethyl acrylate copolymer.

Description of the appearance of Acido Acetilsalicilico TecniGen and package contents
White, round, biconvex tablet with a diameter of approximately 8.1 mm and a thickness of approximately 3.5 mm.
Cardboard box containing a PVC/Al blister with 30 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Tecnigen S.r.l.
via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy.

Manufacturer
GLPharma GmbH
Industriestrasse 1, A-8502 Lannach
Austria.
GL Pharma GmbH
Schlossplatz 1, A-8502
Lannach
Austria.

This medicinal product is authorized in the EEA Member States under the following names:

This leaflet was last reviewed in {MM/YYYY}.