Package leaflet: Information for the user

Anopyrin, 75 mg, enteric-coated tablets
Acetylsalicylic acid
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
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 or pharmacist. See section 4.
If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet

What Anopyrin is and what it is used for
Important information before taking Anopyrin
How to take Anopyrin
Possible side effects
How to store Anopyrin
Contents of the pack and other information

1. What Anopyrin is and what it is used for

Anopyrin contains acetylsalicylic acid, which in low doses belongs to a group of medicines known as antiplatelet agents. Platelets are small blood cells that cause blood clots to form and are involved in thrombosis. When a clot forms in an artery, it blocks blood flow and cuts off oxygen supply. If this occurs in the heart, it may cause a heart attack or angina; in the brain, it may cause a stroke.
Anopyrin is used to reduce the risk of blood clots forming, thereby helping to prevent:

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

Anopyrin is also used to prevent blood clots after certain cardiovascular surgical procedures performed to widen or unblock blood vessels.
This medicine is not recommended for use in situations requiring emergency treatment.

2. Important information before using Anopyrin

When not to use Anopyrin

if the patient is allergic to acetylsalicylic acid, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs are commonly used to treat joint inflammation, rheumatism, or pain), or to any of the other ingredients of this medicine (listed in section 6).
if salicylates or NSAIDs have previously triggered an asthma attack in the patient.
if the patient currently has or has had a history of gastric or small intestine ulcers.
if the patient has a history of gastrointestinal bleeding or perforation (stomach or intestinal failure) caused by previous treatment with NSAIDs.
if the patient has a history of recurrent peptic ulcer disease/bleeding episodes associated with ulceration or bleeding, or any other bleeding, e.g. stroke.
if the patient has ever had blood clotting disorders.
if the patient has severe liver or kidney function impairment.
if the patient is in the third trimester of pregnancy; in this case, the medicine must not be taken in doses exceeding 100 mg per day (see section "Pregnancy and breastfeeding").
if the patient is taking a medicine called methotrexate (used, for example, in cancer or rheumatoid arthritis treatment) in doses exceeding 15 mg per week.

Warnings and precautions
Before using Anopyrin, consult a doctor if:

the patient has impaired kidney, liver, or heart function.
the patient has or has previously had ulcers or bleeding (e.g. in the stomach or small intestine).
the patient has uncontrolled high blood pressure.
the patient has bronchial asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack.
the patient has ever had gout.
the patient experiences heavy or prolonged menstrual bleeding.
the patient has been diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

If symptoms worsen or severe or unexpected adverse effects occur,
such as unusual bleeding, serious skin reactions, or any signs of severe allergic reaction,
immediate medical attention must be sought (see section 4 "Possible side effects").
Inform your doctor before any planned surgical procedure (even minor ones, such as
tooth extraction), as acetylsalicylic acid thins the blood and may increase the risk of
bleeding.
Avoid dehydration (the patient may feel thirsty and have a dry mouth), as taking acetylsalicylic acid may cause
kidney function disturbances.
This medicine is not suitable for relieving pain or reducing fever.
If any of the situations described above apply to the patient, consult a doctor or
pharmacist.
Children and adolescents
Acetylsalicylic acid used in children may cause Reye's syndrome. Reye's syndrome is a very
rare condition affecting the brain and liver, potentially life-threatening. Therefore, Anopyrin must not be given to children under 16 years of age, unless prescribed by a doctor.
Anopyrin 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 use.
Taking acetylsalicylic acid together with certain other medicines may affect treatment efficacy. These include medicines used:

in cancer or rheumatoid arthritis (methotrexate). Do not take Anopyrin if the patient is taking methotrexate in doses exceeding 15 mg per week. Consult a doctor if the patient is taking methotrexate in doses below 15 mg per week.
to thin the blood or 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).
in bipolar disorder (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) when used concomitantly. Therefore, caution is advised when using metamizole in patients receiving low-dose acetylsalicylic acid for cardiovascular protection.
in gout (e.g. probenecid).
in epilepsy (valproate, phenytoin).
in glaucoma (acetazolamide).
in diabetes (e.g. glibenclamide, insulin).
in depression (selective serotonin reuptake inhibitors (SSRIs), such as sertraline or paroxetine).
in hormone replacement therapy in patients with adrenal or pituitary gland damage or after their removal, or in the treatment of inflammation, including rheumatoid diseases and inflammatory bowel disease (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, 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 take acetylsalicylic acid unless advised by a doctor.
Anopyrin must not be used during the last three months of pregnancy unless prescribed by a doctor, and in such cases the daily dose must not exceed 100 mg (see section "When not to use Anopyrin"). Regular use of this medicine or taking high doses in late pregnancy may lead to serious complications in the mother or child.
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 operating machinery
Anopyrin is not expected to affect the ability to drive or operate machinery.
Anopyrin contains lactose and orange yellow (E110)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Orange yellow may cause allergic reactions.

3. How to use Anopyrin

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 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.

Do not take this medicine in higher doses unless instructed by a doctor. The dose should not exceed 300 mg per day.
Elderly patients
The recommended dose is the same as for adults. In general, elderly patients should use acetylsalicylic acid cautiously due to increased susceptibility to adverse effects. Regular medical follow-up is advised.
Use in children and adolescents
Acetylsalicylic acid should not be given to children and adolescents under 16 years of age unless directed by a doctor (see section "Warnings and precautions").
Method of administration
For oral use.
Tablets should be swallowed whole with an adequate amount of liquid (half a glass of water). The tablets have an enteric coating that protects them from gastric acid, thereby preventing irritation of the intestine; therefore, they must not be crushed, broken, or chewed.
Accidental overdose of Anopyrin
If a patient (or someone else) accidentally takes too many tablets, seek immediate medical advice from a doctor or the nearest hospital emergency department. Show the doctor any remaining tablets or the empty packaging.
Symptoms of overdose may include: tinnitus, 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 a patient forgets to take a dose, they should wait until the next scheduled dose and then continue with the regular dosing schedule. Do not take a double dose to make up for the missed dose.
Stopping Anopyrin
Do not stop taking Anopyrin without first discussing it with 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, stop using Anopyrin and contact a doctor immediately:

Sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
Reddening of the skin with blistering or peeling, possibly 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, blood in vomit, blood in urine, black stools.
Changes in behaviour with nausea and vomiting, which may be early signs of Reye's syndrome, a life-threatening condition requiring immediate treatment (see also section 2 "Children and adolescents").

Other adverse reactions:
Common (may occur in less than 1 in 10 people):

Nausea, vomiting, diarrhoea.
Dyspepsia.
Increased tendency to bleed.

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

Urticaria.
Rhinitis.
Breathing difficulties.

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

Severe bleeding in the stomach or intestines, cerebral haemorrhage, change in blood cell count.
Bronchospasm, asthma attack.
Vasculitis.
Purpura with purple spots (skin bleeding).
Hypersensitivity reactions such as swelling of lips, face or body, or anaphylactic shock.
Unusually heavy or prolonged menstrual bleeding.

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

Ringing in the ears (tinnitus) or hearing impairment.
Headache.
Dizziness.
Gastric or small intestinal ulceration and perforation.
Prolonged bleeding time.
Renal function disorders, acute kidney failure.
Liver function disorders, increased liver enzyme activity.
High levels of uric acid or low blood sugar levels.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 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 or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Anopyrin

Keep this medicine out of sight and reach of children.
Do not store at temperatures 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 anhydrous silica; potato starch; talc; triacetin; methacrylic acid and ethyl acrylate copolymer (1:1); polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); carmine (E120); orange yellow, aluminium lake (E110).

What Anopyrin looks like and contents of the pack
Pink, round, biconvex, coated tablet with a diameter of approximately 7.2 mm.
Pack sizes
60 enteric-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Denmark, Poland: Anopyrin
For any further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00