Anopirin

Leaflet accompanying the packaging: information for the user

Anopyrin, 75 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 leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If the patient does not improve and feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Anopyrin and what is it used for

Anopyrin contains acetylsalicylic acid, which in small doses belongs to a group of medicines called antiplatelet agents. Platelets are small cells that cause blood clots to form and participate in the formation of thrombosis. When a clot forms in an artery, it blocks blood flow and cuts off oxygen supply. If this happens in the heart, it can cause a heart attack or angina pectoris; in the brain, it can cause a stroke.

Anopyrin is used to reduce the risk of blood clots, and thus prevent subsequent:

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

Anopyrin is also used to prevent blood clots after certain cardio-surgical procedures performed to widen or unblock blood vessels.

This medicine is not recommended for use in situations requiring emergency assistance.

2. Important information before taking Anopyrin

When not to take Anopyrin

Warnings and precautions

Before taking Anopyrin, the patient should discuss with their doctor if:

• they have kidney, liver, or heart problems.
• they have or have had ulcers or bleeding (e.g., in the stomach or small intestine).
• they have uncontrolled high blood pressure.
• they have asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may cause an asthma attack.
• they have had gout.
• they have heavy or prolonged menstrual bleeding.
• they have been diagnosed with a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

In case of worsening symptoms or severe or unexpected side effects, such as unusual bleeding, severe skin reactions, or any symptoms of severe allergic reactions, the patient should seek medical help immediately (see section 4 "Possible side effects").

The patient should inform their doctor before planned surgery (even minor, e.g., tooth extraction), as acetylsalicylic acid thins the blood and may increase the risk of bleeding.

The patient should not become dehydrated (may feel thirsty and dry mouth), as taking acetylsalicylic acid may cause kidney problems.

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

If any of these situations apply to the patient, they should consult their doctor or pharmacist.

Children and adolescents

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

Anopyrin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

Taking acetylsalicylic acid with certain other medicines may affect the treatment effect. These include medicines used:

• for cancer or rheumatoid arthritis (methotrexate). Anopyrin should not be taken if the patient is taking methotrexate in doses greater than 15 mg per week. The patient should discuss with their doctor if they are taking methotrexate in doses less than 15 mg per week.
• to thin the blood/prevent blood clots (e.g., warfarin, heparin, clopidogrel, alteplase).
• to prevent organ rejection after transplantation (cyclosporine, tacrolimus).
• for high blood pressure (e.g., diuretics and ACE inhibitors).
• to regulate heart function (digoxin).
• for manic-depressive illness (lithium).
• for pain and inflammation (e.g., NSAIDs (such as ibuprofen) or steroids).
• Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) if these medicines are taken together. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid in small doses for cardiovascular protection.
• for gout (e.g., probenecid).
• for epilepsy (valproate, phenytoin).
• for glaucoma (acetazolamide).
• for diabetes (e.g., glibenclamide, insulin).
• for depression (selective serotonin reuptake inhibitors (SSRIs), such as sertraline or paroxetine).
• for hormone replacement therapy in patients with adrenal or pituitary gland damage or removal, or for the treatment of inflammation, including rheumatoid diseases and colitis (corticosteroids).

Anopyrin 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Women who are pregnant should not take acetylsalicylic acid unless advised by a doctor.

Anopyrin should not be taken during the last 3 months of pregnancy, unless advised by a doctor, and the daily dose should not exceed 100 mg (see section "When not to take Anopyrin"). Regular intake of this medicine or high doses in late pregnancy may cause serious complications in the mother or child.

Women who are breastfeeding should not take acetylsalicylic acid unless advised by a doctor.

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

Driving and using machines

Anopyrin is unlikely to affect the ability to drive or use machines.

Anopyrin contains lactose and orange yellow (E110)

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Orange yellow may cause allergic reactions.

3. How to take Anopyrin

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Adults

Prevention of heart attack:

• The recommended dose is 75 mg to 150 mg once daily, e.g., one or two tablets per day.

Prevention of strokes:

• The recommended dose is 75 mg to 300 mg once daily, e.g., one to four tablets per day.

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

• The recommended dose is 75 mg to 150 mg once daily, e.g., one or two tablets per day.

Prevention of blood clots after certain heart surgeries:

• The recommended dose is 75 mg to 150 mg once daily, e.g., one or two tablets per day.

The medicine should not be taken in higher doses unless advised by a doctor. The dose should not exceed 300 mg per day.

Elderly

The recommended dose is the same as for adults. However, elderly patients should take acetylsalicylic acid with caution due to the increased risk of side effects. The treatment should be regularly discussed with the doctor.

Children and adolescents

Acetylsalicylic acid should not be given to children and adolescents under 16 years of age unless advised 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 (1/2 glass of water). The tablets have a coating that protects them from stomach acid, which prevents irritating effects on the intestine, and therefore they should not be crushed, broken, or chewed.

Overdose of Anopyrin

If the patient (or someone else) has taken too many tablets, they should immediately contact a doctor or the nearest hospital emergency department. The patient should show the doctor the remaining tablets or the empty packaging of the medicine.

Symptoms of overdose may include: ringing in the ears, hearing disturbances, headache, dizziness, confusion, nausea, vomiting, and abdominal pain. Significant overdose may cause rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar, pulmonary edema, coma, and shock.

Missed dose of Anopyrin

If the patient forgets to take a dose, they should wait until the next dose is due and then continue taking the medicine as usual. The patient should not take a double dose to make up for the missed dose.

Stopping Anopyrin treatment

The patient should not stop taking Anopyrin without first discussing it with their doctor.

If the patient has any further questions about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Anopyrin and contact their doctor immediately:

• Sudden wheezing, swelling of the lips, face, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).

Redness of the skin with blistering or peeling, may be accompanied by high fever and joint pain. This may be erythema multiforme, Stevens-Johnson syndrome, or Lyell's syndrome.

• Unusual bleeding, e.g., coughing up blood, vomiting blood, blood in urine, black stool.
• Changes in behavior with nausea and vomiting, which may be early symptoms of Reye's syndrome, a life-threatening disease that requires immediate treatment (see also section 2 "Children and adolescents").

Other side effects:

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• Hives.
• Runny nose.
• Breathing difficulties.

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

• Severe bleeding in the stomach or intestines, cerebral hemorrhage, changes in blood cell count.
• Bronchospasm, asthma attack.
• Vasculitis.
• Purpura with purple spots (skin bleeding).
• Hypersensitivity reactions, such as swelling, e.g., of the lips, face, or body, or anaphylaxis.
• Unusually heavy or prolonged menstrual bleeding.

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

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

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, 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 or its representative.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Anopyrin

The medicine should be stored out of sight and reach of children.

Do not store above 25°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the carton or blister after EXP.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Anopyrin contains

• The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 75 mg of acetylsalicylic acid.
• The other ingredients are: lactose monohydrate; microcrystalline cellulose; colloidal silica anhydrous; potato starch; talc; triacetin; methacrylic acid and ethyl acrylate copolymer (1:1), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), carmines (E120), orange yellow, aluminum lake (E110).

What Anopyrin looks like and contents of the pack

Pink, round, biconvex, film-coated tablet with a diameter of approximately 7.2 mm.

Pack sizes

60 enteric-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

• G. L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

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

Denmark, Poland: Anopyrin

For further information, please contact the local representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, Poland, tel.: +48 22 375 92 00

Date of last revision of the leaflet: