Alepton

Package Leaflet: Information for the Patient

Alepton, 100 mg, Enteric-Coated Tablets

Acetylsalicylic Acid

Read the package 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 package leaflet for the patient or as advised 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 tell their doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, they should consult a doctor.

Table of Contents of the Leaflet

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

1. What is Alepton and what is it used for

Alepton contains acetylsalicylic acid, which in small doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood to clot and participate in the formation of thrombosis. If a blood clot forms in an artery, it stops blood flow and cuts off oxygen supply. If a blood clot forms in the heart, it causes a heart attack or angina; a clot in the brain causes a stroke.

Alepton is used to reduce the risk of thrombosis formation, and thus the occurrence of:

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

Alepton is also used to prevent blood clots after certain cardiac surgical procedures, to widen or unblock blood vessels.

Alepton is not recommended for emergency situations. Its use is limited to preventive treatment.

2. Important information before taking Alepton

When not to take Alepton

• if the patient is allergic to acetylsalicylic acid, other salicylates, or nonsteroidal anti-inflammatory drugs (NSAIDs, which are often used to treat arthritis, rheumatism, and pain) or any of the excipients (listed in section 6);
• if the patient has ever had an asthma attack or swelling of the face, lips, tongue, or throat (angioedema) after taking salicylates or NSAIDs;
• if the patient currently has or has had a stomach or duodenal ulcer;
• if the patient has had bleeding or perforation in the gastrointestinal tract in the past (gastric or intestinal failure) caused by previous NSAID therapy;
• if the patient has had recurring stomach or duodenal ulcers or bleeding, or other types of bleeding, such as a stroke;
• if the patient has ever had bleeding disorders;
• in case of severe liver or kidney dysfunction;
• if the patient has severe heart function disorders causing shortness of breath and swelling of the ankles;
• during the third trimester of pregnancy; the dose should not exceed 100 mg per day (see also section "Pregnancy, breastfeeding, and fertility");
• if the patient is taking methotrexate (e.g., for cancer or rheumatoid arthritis) in a dose greater than 15 mg per week.

Warnings and precautions

Before starting Alepton, the patient should consult a doctor:

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

The patient should immediately consult a doctor if symptoms worsen or if severe or unexpected side effects occur, such as unusual bleeding, severe skin reactions, or any other symptoms of severe hypersensitivity (see section "Possible side effects").

The patient should inform their doctor about taking Alepton before surgical procedures (even minor ones, such as tooth extraction), as acetylsalicylic acid has blood-thinning properties, which may increase the risk of bleeding.

The patient should be careful not to become dehydrated (feeling thirsty and dry mouth), as acetylsalicylic acid 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 the patient, they should consult a doctor or pharmacist.

Children and adolescents

When used in children, acetylsalicylic acid can cause Reye's syndrome. This is a very rare disease that affects the brain and liver and can be life-threatening. For this reason, Alepton should not be given to children under 16 years of age, unless advised by a doctor.

Alepton and other medicines

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

Other medicines may affect the outcome of treatment when taken at the same time as acetylsalicylic acid:

• antiplatelet agents and medicines that prevent thrombosis or dissolve clots (e.g., warfarin, heparin, clopidogrel, aleplase);
• medicines used to prevent transplant rejection after transplantation (cyclosporine, tacrolimus);
• medicines used to treat high blood pressure (e.g., diuretics and ACE inhibitors);
• medicines that 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);
• metamizole (a substance with pain-relieving 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 at the same time. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid;
• 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 in a dose less than 15 mg per week);
• medicines used to treat diabetes (e.g., glibenclamide, insulin);
• medicines used to treat 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 bowel inflammation (corticosteroids).

Alepton 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 a doctor or pharmacist before taking this medicine.

If the patient continues or starts treatment with Alepton during pregnancy according to the doctor's advice, they should take Alepton as advised and not exceed the recommended dose.

Pregnancy - last trimester

Acetylsalicylic acid should not be taken in a dose greater than 100 mg per day in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Alepton may cause kidney and heart disorders in the unborn child. This may affect the patient's and their child's tendency to bleed and cause delayed or prolonged labor.

If the patient takes acetylsalicylic acid in small doses (up to 100 mg per day), close obstetric monitoring is necessary according to the doctor's advice.

Pregnancy - first and second trimester

Alepton should not be taken during the first 6 months of pregnancy, unless absolutely necessary and advised by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose of the medicine should be used for the shortest possible time. Taking Alepton for a period longer than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, leading to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If longer treatment is necessary, the doctor may advise additional monitoring.

Breastfeeding

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

Fertility

Acetylsalicylic acid may affect female fertility by affecting ovulation. This effect disappears after treatment is stopped.

Driving and using machines

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

Alepton contains lactose

If the patient has an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Alepton

This medicine should always be taken exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.

Adults

Prevention of heart attack:

• The recommended dose is 75-160 mg once a day. Prevention of stroke:
• The recommended dose is 75-300 mg once a day. Prevention of cardiovascular disorders in patients with stable or unstable angina (a type of chest pain):
• The recommended dose is 75-160 mg once a day. Prevention of thrombosis after certain cardiac surgical procedures:
• The recommended dose is 75-160 mg once a day.

The patient should not take higher doses of this medicine unless advised by a doctor.

The dose should not exceed 300 mg per day.

Elderly

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. The treatment should be regularly evaluated.

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 administration.

Tablets should be swallowed whole with a sufficient amount of liquid (1/2 glass of water). The tablets have a coating that protects the intestines from irritation, so they should not be crushed, broken, or chewed.

Taking a higher dose of Alepton than recommended

If the patient (or someone around them) accidentally takes too many tablets, they should immediately contact a doctor or go to the nearest hospital emergency department. They should show the doctor the packaging or remaining tablets.

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

Missing a dose of Alepton

If a dose is missed, the patient should wait until the next dose is due and then continue as usual.

The patient should not take a double dose to make up for a missed dose.

Stopping Alepton treatment

The patient should not stop taking Alepton without consulting a doctor.

If the patient has any further questions about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Alepton and immediately contact a 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 (may affect up to 1 in 10 people):

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

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

• Hives.
• Common cold.
• Breathing difficulties.

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

• Severe gastrointestinal bleeding or 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 in children - see section "Children and adolescents").
• Abnormal heavy or prolonged menstrual bleeding.

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

• Ringing in the ears (tinnitus) or hearing loss.
• Headache.
• Dizziness.
• Stomach or duodenal ulcer and 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 the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides

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, more information can be gathered on the safety of the medicine.

5. How to store Alepton

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

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Alepton contains

The active substance is acetylsalicylic acid.

Each enteric-coated tablet contains 100 mg of acetylsalicylic acid.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, potato starch, talc, triacetin, and methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion

What Alepton looks like and contents of the pack

Alepton, 100 mg - white, round, biconvex, film-coated tablets with a diameter of approximately 8.1 mm.

Package sizes:

Blister: 30 or 60 enteric-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o.

ul. Wałbrzyska 13

60-198 Poznań

tel.: +48 61 66 51 500

fax: +48 61 66 51 505

e-mail: [email protected]

manufacturer

G.L. Pharma GmbH

Schloßplatz 1

A-8502 Lannach

Austria

Date of last revision of the leaflet: July 2025