Abrea

Patient Information Leaflet: User Information

Abrea, 75 mg, enteric-coated tablets

Abrea, 100 mg, enteric-coated tablets

Abrea, 160 mg, enteric-coated tablets

Acetylsalicylic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or if you feel worse, consult your doctor.

Table of Contents of the Leaflet

• 1. What is Abrea and what is it used for
• 2. Important information before taking Abrea
• 3. How to take Abrea
• 4. Possible side effects
• 5. How to store Abrea
• 6. Contents of the pack and other information

1. What is Abrea and what is it used for

Abrea contains acetylsalicylic acid, which in low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood clots to form and are involved in thrombosis. When a blood clot forms in an artery, it can block the flow of blood and cut off oxygen supply. If this happens in the heart, it can cause a heart attack or angina; in the brain, it can cause a stroke. Taking Abrea can reduce the risk of blood clots forming and thus prevent subsequent:

• heart attacks
• strokes
• cardiovascular disease in patients with stable or unstable angina (a type of chest pain).

Abrea is also used to prevent blood clots after heart surgery to widen or unblock blood vessels. The decision to start treatment and the appropriate dosage should be made by a doctor. This medicine is not recommended for use in situations requiring emergency assistance. It can only be used for prevention.

2. Important information before taking Abrea

When not to take Abrea

• if you are allergic to acetylsalicylic acid or any of the excipients (listed in section 6);
• if you are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used to treat arthritis, rheumatism, and pain;
• if you have ever had an asthma attack or swelling of certain parts of the body, such as the face, lips, throat, or tongue (angioedema), after taking salicylates or NSAIDs;
• if you currently have or have had stomach or duodenal ulcers, or any type of bleeding, such as a stroke;
• if you have ever had bleeding disorders;
• in case of severe liver or kidney dysfunction;
• if you have severe heart function disorders causing shortness of breath and swelling of the ankles;
• during the third trimester of pregnancy; do not take doses greater than 100 mg per day (see also section "Pregnancy and breastfeeding");
• if you are taking methotrexate (e.g., for cancer or rheumatoid arthritis) at a dose greater than 15 mg per week.

Warnings and precautions

Before starting Abrea, consult your doctor or pharmacist:

• if you have kidney, liver, or heart function disorders;
• if you have or have had stomach or small intestine disorders;
• in case of uncontrolled high blood pressure;
• in case of asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may cause an asthma attack;
• if you have ever had gout;
• in case of heavy menstrual bleeding;
• if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

You should immediately consult your doctor if symptoms worsen or if you experience severe or unexpected side effects, such as unusual bleeding, severe skin reactions, or any other symptoms of severe hypersensitivity (see section "Possible side effects"). You should inform your doctor about taking Abrea before undergoing surgery (even minor, such as tooth extraction), as acetylsalicylic acid has blood-thinning properties, which may increase the risk of bleeding. You should be careful not to become dehydrated (feeling thirsty and dry mouth), as acetylsalicylic acid taken at this time may cause kidney function disorders. This medicine should not be used as a pain reliever or to reduce fever. If any of the above situations apply to you, consult your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid can cause Reye's syndrome when used in children. This is a very rare disease that affects the brain and liver and can be life-threatening. Therefore, Abrea should not be given to children under 16 years of age unless recommended by a doctor.

Abrea with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Other medicines taken at the same time as acetylsalicylic acid may affect the outcome of treatment:

• antiplatelet agents - preventing blood clots or dissolving clots (e.g., warfarin, heparin, clopidogrel, alteplase);
• medicines to prevent transplant rejection after transplantation (cyclosporine, tacrolimus);
• antihypertensive medicines (e.g., diuretics and ACE inhibitors);
• medicines to regulate heart rhythm (digoxin);
• medicines used to treat manic-depressive states (lithium);
• pain relievers and anti-inflammatory medicines (e.g., NSAIDs like ibuprofen or steroids);
• pain relievers and antipyretics (metamizol), the effect of acetylsalicylic acid on platelet aggregation may be reduced after concomitant administration with metamizol.
• medicines used to treat gout (e.g., probenecid);
• medicines used to treat epilepsy (valproate, phenytoin);
• medicines used to treat glaucoma (acetazolamide);
• medicines used to treat cancer or rheumatoid arthritis (methotrexate at a dose less than 15 mg per week);
• medicines used to treat diabetes (e.g., glibenclamide, insulin);
• medicines used in depression (selective serotonin reuptake inhibitors like sertraline or paroxetine);
• medicines used in hormone replacement therapy in patients with adrenal or pituitary gland damage or removal, or in the treatment of inflammation, including rheumatoid diseases and enteritis (corticosteroids).

Abrea with food, drink, and alcohol

Drinking alcohol may 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 have a child, consult your doctor or pharmacist before taking this medicine. Pregnant women should not take acetylsalicylic acid unless recommended by a doctor. During the last three months of pregnancy, do not take Abrea unless recommended by a doctor, and the dose should not exceed 100 mg per day (see section "When not to take Abrea"). Regular intake of the medicine or taking large doses during the last months of pregnancy may cause serious complications in the mother or child. Breastfeeding women should not take acetylsalicylic acid unless recommended by a doctor.

Driving and using machines

Abrea does not affect the ability to drive or use machines.

Abrea contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. Abrea 75 mg contains orange yellow S (E 110),which may cause allergic reactions.

Abrea 160 mg contains lecithin

Do not use if you are hypersensitive to peanuts or soy.

3. How to take Abrea

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Adults

Prevention of heart attack:

• The recommended dose is 75-160 mg once daily.

Prevention of stroke:

• The recommended dose is 75-325 mg once daily.

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

• The recommended dose is 75-160 mg once daily.

Prevention of blood clots after certain heart surgeries:

• The recommended dose is 75-160 mg once daily.

Do not take higher doses of this medicine unless recommended by a doctor, and even then, the dose should not exceed 325 mg per day. Elderly patients

Dosage is the same as for adult patients. However, acetylsalicylic acid should be used with caution in elderly patients, as they are more prone to side effects. Treatment should be regularly evaluated.

Children and adolescents

Do not give acetylsalicylic acid to children and adolescents under 16 years of age unless recommended by a doctor (see section "Warnings and precautions").

Method of administration

Oral administration.

Swallow the tablets whole with a sufficient amount of liquid (1/2 glass of water) at least 30 minutes before meals. The tablets have a coating that protects the intestines from irritation, and therefore, the tablets should not be crushed, broken, or chewed.

Overdose of Abrea

If you (or someone else) accidentally take too many tablets, immediately consult your doctor or go to the nearest hospital emergency department. Show the doctor the package or remaining tablets. Symptoms of overdose may include: ringing in the ears, hearing disorders, headache, dizziness, confusion, nausea, vomiting, and abdominal pain. Large overdoses may cause rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar, coma, and shock.

Missing a dose of Abrea

If you miss a dose, wait until the next dose is due, and then continue as usual. Do not take a double dose to make up for the missed dose.

Stopping Abrea treatment

Do not stop taking Abrea without consulting your doctor. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Abrea can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Abrea and immediately consult your doctor:

• Sudden onset of wheezing, swelling of the lips, face, or body, rash, fainting, or difficulty swallowing (severe allergic reactions).
• Redness of the skin with blisters or peeling of the skin, which may be associated with high fever and joint pain. This may be erythema multiforme, Stevens-Johnson syndrome, or Lyell's syndrome.
• Unexpected bleeding, such as coughing up blood, blood in vomit or urine, or black stools.

Other side effects:

Common side effects (may occur in less than 1 in 10 people):

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

Uncommon side effects (may occur in less than 1 in 100 people):

• Hives.
• Hay fever.
• Breathing difficulties.

Rare side effects (may occur in less than 1 in 1,000 people):

• Severe bleeding from the stomach or intestines, cerebral bleeding; altered blood cell count.
• Lower respiratory tract spasms, asthma attack.
• Vasculitis.
• Purpura with purple spots (bleeding into the skin).
• Severe skin reactions like erythema multiforme and its life-threatening forms, Stevens-Johnson syndrome, and Lyell's syndrome.
• Hypersensitivity reactions, such as swelling, e.g., of the lips, face, or body, or anaphylaxis.
• Reye's syndrome (a very rare disease that affects the brain and liver - see section 2 "Children and adolescents").
• Abnormal heavy or prolonged menstrual bleeding.

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

• Ringing in the ears (tinnitus) or hearing loss.
• Headache.
• Dizziness.
• Stomach or small intestine ulcers or perforation.
• Prolonged bleeding time.
• Kidney function disorders, acute kidney failure.
• Liver function disorders, increased liver enzyme activity.
• High uric acid levels or low blood sugar levels.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abrea

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

Abrea, 75 mg

Do not store above 25°C.

Store in the original package to protect from light.

Abrea, 100 mg

Do not store above 30°C.

Abrea, 160 mg

Do not store above 30°C.

Store in the original package to protect from light.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.

The batch number is stated on the packaging after the abbreviation "Lot".

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Abrea contains

• The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 75 mg, 100 mg, and 160 mg of acetylsalicylic acid.
• The other ingredients of Abrea, 75 mg are Core:lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, potato starch. First coating:talc, triacetin, methacrylic acid - ethyl acrylate copolymer (1:1), dispersion 30%, sodium dodecyl sulfate* and polysorbate 80*. Second coating:polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350, talc, carmine (E 120), orange yellow S (E 110), aluminum lake.
• The other ingredients of Abrea, 100 mg are Core:lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, potato starch. Coating:talc, triacetin, methacrylic acid - ethyl acrylate copolymer (1:1), dispersion 30%, sodium dodecyl sulfate* and polysorbate 80*.
• The other ingredients of Abrea, 160 mg are Core:lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, potato starch. First coating:talc, triacetin, methacrylic acid - ethyl acrylate copolymer (1:1), dispersion 30%, sodium dodecyl sulfate* and polysorbate 80*. Second coating:polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, lecithin, yellow iron oxide (E 172).

*May contain sodium dodecyl sulfate and polysorbate 80.

What Abrea looks like and contents of the pack

Abrea, 75 mg - pink, round, biconvex enteric-coated tablets with a diameter of about 7.2 mm.

Abrea, 100 mg - white, round, biconvex enteric-coated tablets with a diameter of about 8.1 mm.

Abrea, 160 mg - yellow, round, biconvex enteric-coated tablets with a diameter of about 9.2 mm.

Pack sizes:

Blister: 20, 28, 30, 50, 56, 60, 84, 90, or 100 enteric-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia