Abrea

Abrea, 75 mg, enteric-coated tablets
Abrea, 100 mg, enteric-coated tablets
Abrea, 160 mg, enteric-coated tablets
Acidum acetylsalicylicum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement in your condition or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Abrea is and what it is used for
2. What you need to know 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 Abrea is and what it is used for

Abrea contains acetylsalicylic acid, which in low doses belongs to a group of medicines known as
antiplatelet drugs. Platelets are small blood cells involved in blood clot formation and thrombosis.
When a blood clot forms in an artery, blood flow becomes blocked and oxygen supply is cut off. If this
occurs in the heart, it may lead to a heart attack or angina; if it occurs in the brain, it may cause a
stroke. Taking Abrea can reduce the risk of blood clot formation and therefore helps prevent:

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

Abrea is also used to prevent blood clots after surgical procedures on the heart aimed at widening or unblocking 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 emergency situations. It is intended solely for prophylactic use.

2. Important information before using Abrea

When not to take Abrea

• if the patient is allergic to acetylsalicylic acid or any of the excipients (listed in section 6);
• in case of allergy to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are commonly used in the treatment of joint inflammation, rheumatism, and pain;
• if asthma attack or swelling of certain body parts (e.g. face, lips, throat, or tongue (angioedema)) has ever occurred in the patient after taking salicylates or NSAIDs;
• if the patient currently has or has previously had a stomach or duodenal ulcer, or any type of bleeding, e.g. stroke;
• if the patient has ever had blood clotting disorders;
• in case of severe liver or kidney function disorders;
• if the patient has severe heart function disorders causing shortness of breath and ankle swelling;
• during the third trimester of pregnancy; doses higher than 100 mg per day must not be used (see also section "Pregnancy and breastfeeding");
• if the patient is taking methotrexate (e.g. for cancer or rheumatoid arthritis treatment) at a dose exceeding 15 mg per week.

Warnings and precautions
Before starting to use Abrea, consult a doctor or pharmacist:

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

Seek immediate medical advice if symptoms worsen or if severe or unexpected adverse effects occur, such as unusual bleeding, severe skin reactions, or any other symptoms of severe hypersensitivity (see section "Possible side effects").
Inform the doctor about the use of Abrea before surgical procedures (even minor ones such as tooth extraction), as acetylsalicylic acid has blood-thinning properties which may increase the risk of bleeding.
Care should be taken to prevent dehydration (feeling thirsty and dry mouth), as acetylsalicylic acid used at this time may cause kidney function disorders.
This medicine should not be used as a painkiller or antipyretic.
If any of the above situations apply to the patient, consult a doctor or pharmacist.

Children and adolescents
Acetylsalicylic acid used in children may cause Reye's syndrome. This is a very rare condition affecting the brain and liver, which may be life-threatening. For this reason, Abrea must not be given to children under 16 years of age, unless specifically recommended by a doctor.

Abrea with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The effectiveness of treatment may be influenced by other medicines taken simultaneously with acetylsalicylic acid:

• antiplatelet drugs – preventing or dissolving blood clots (e.g. warfarin, heparin, clopidogrel, alteplase);
• immunosuppressive drugs used to prevent transplant rejection (cyclosporine, tacrolimus);
• antihypertensive drugs (e.g. diuretics and ACE inhibitors);
• drugs regulating heart rhythm (digoxin);
• drugs used in the treatment of bipolar disorder (lithium);
• painkillers and anti-inflammatory drugs (e.g. NSAIDs such as ibuprofen or steroids);
• painkillers and antipyretics (metamizole); the effect of acetylsalicylic acid on platelet aggregation may be reduced when administered concomitantly with metamizole;
• drugs used in the treatment of gout (e.g. probenecid);
• antiepileptic drugs (valproate, phenytoin);
• drugs used in the treatment of glaucoma (acetazolamide);
• drugs used in cancer treatment or rheumatoid arthritis (methotrexate at doses less than 15 mg per week);
• drugs used in diabetes treatment (e.g. glibenclamide, insulin);
• antidepressants (selective serotonin reuptake inhibitors such as sertraline or paroxetine);
• drugs 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 inflammatory bowel disease (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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnant women should not use acetylsalicylic acid unless advised by a doctor.
Abrea must not be taken during the last three months of pregnancy unless specifically recommended by a doctor, and the dose should not exceed 100 mg per day (see section "When not to take Abrea"). Regular or high-dose use of this medicine during the last months of pregnancy may cause serious complications in the mother or child.
Breastfeeding women should not take acetylsalicylic acid unless advised by a doctor.

Driving and operating machinery
Abrea does not affect the ability to drive or operate machinery.

Abrea contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Abrea 75 mg contains sunset yellow (E 110), which may cause allergic reactions.

Abrea 160 mg contains lecithin
Do not use if hypersensitivity to peanuts or soybeans has been diagnosed.

3. How to take Abrea

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

Adults

Prevention of myocardial infarction:

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

Prevention of stroke:

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

Prevention of cardiovascular disorders 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 cardiovascular surgical procedures:

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

Higher doses of this medicine should not be used unless specifically prescribed by a doctor, and even then, the dose should not exceed 325 mg per day.

Elderly patients

Dosage is the same as in adult patients. However, acetylsalicylic acid should generally be used with caution in elderly patients, as they are more susceptible to adverse effects. The treatment should be regularly reviewed.

Children and adolescents

Acetylsalicylic acid should not be given to children and adolescents under 16 years of age unless specifically directed by a doctor (see section “Warnings and precautions”).

Method of administration

For oral use.

The tablets should be swallowed whole with an adequate amount of liquid (half a glass of water), at least 30 minutes before a meal. The tablets have an enteric coating that protects them from gastric acid, thus preventing intestinal irritation. Therefore, the tablets must not be crushed, split, or chewed.

If you take more Abrea than you should

If you (or anyone else) accidentally take too many tablets, contact a doctor immediately or go to the nearest hospital emergency department without delay. Show the doctor the packaging or any remaining tablets.

Symptoms of overdose may include tinnitus, hearing disturbances, 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.

If you forget to take Abrea

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

If you stop taking Abrea

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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse reactions, treatment with Abrea must be discontinued and medical advice must be sought immediately:

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

Other adverse reactions:
Common adverse reactions (may affect fewer than 1 in 10 people):

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

Uncommon adverse reactions (may affect fewer than 1 in 100 people):

• Urticaria.
• Rhinitis.
• Breathing difficulties.

Rare adverse reactions (may affect fewer than 1 in 1,000 people):

• Severe gastrointestinal bleeding or cerebral haemorrhage; altered blood cell counts.
• Bronchospasm, asthma attack.
• Vasculitis.
• Purpura with purple spots (bleeding into the skin).
• Severe skin reactions such as erythema multiforme and life-threatening conditions including Stevens-Johnson syndrome and Lyell's syndrome.
• Hypersensitivity reactions such as swelling of the lips, face or body, or anaphylactic shock.
• Reye's syndrome (a very rare condition occurring in children affecting the brain and liver – see section 2 "Children and adolescents").
• Abnormal, heavy or prolonged menstrual bleeding.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Tinnitus (ear ringing) or hearing impairment.
• Headache.
• Dizziness.
• Gastric or small intestinal ulcer or perforation.
• Prolonged bleeding time.
• Renal function disorders, acute renal failure.
• Hepatic function disorders, increased liver enzyme activity.
• High uric acid levels or low blood glucose levels.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Abrea

Keep this medicine out of the sight and reach of children.
Abrea, 75 mg
Do not store above 25°C.
Store in the original packaging 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 packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton following: EXP.
The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Abrea contains

• The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 75 mg, 100 mg or 160 mg of acetylsalicylic acid.
• Other components of Abrea 75 mg: Tablet core: monohydrate lactose, microcrystalline cellulose, colloidal anhydrous silica, potato starch. Composition of the first coating: talc, triacetin, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, sodium dodecyl sulfate* and polysorbate 80*. Composition of the second coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350, talc, carmine (E 120), orange yellow (E 110), aluminium lake of lac dye.
• Other components of Abrea 100 mg: Tablet core: monohydrate lactose, microcrystalline cellulose, colloidal anhydrous silica, potato starch. Composition of the coating: talc, triacetin, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, sodium dodecyl sulfate* and polysorbate 80*.
• Other components of Abrea 160 mg: Tablet core: monohydrate lactose, microcrystalline cellulose, colloidal anhydrous silica, potato starch. Composition of the first coating: talc, triacetin, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, sodium dodecyl sulfate* and polysorbate 80*. Composition of the 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 coated tablets with a diameter of approximately 7.2 mm.
Abrea 100 mg – white, round, biconvex coated tablets with a diameter of approximately 8.1 mm.
Abrea 160 mg – yellow, round, biconvex coated tablets with a diameter of approximately 9.2 mm.
Pack sizes:
Blister packs: 20, 28, 30, 50, 56, 60, 84, 90 or 100 enteric-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: 22 57 37 500
This medicinal product is authorized for marketing in the European Economic Area Member States under the following names: