Alepton

Patient Information Leaflet

Alepton, 100 mg, enteric-coated tablets
Acetylsalicylic acid
Please read this leaflet carefully before taking this medicine, as 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 adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If you do not get better or if you feel worse, consult your doctor.

Leaflet Contents

1. What Alepton is and what it is 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 Alepton is and what it is used for

Alepton contains acetylsalicylic acid, which in low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood clotting and are involved in the formation of thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off the supply of oxygen. If a clot forms in the heart, it can cause a myocardial infarction (heart attack) or angina attack; a clot in the brain leads to stroke.
Alepton is used to reduce the risk of clot formation, and thus to prevent:

• 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 procedures aimed at widening or unblocking blood vessels.

Alepton is not intended for emergency use. It is intended solely for preventive treatment.

2. Important information before taking Alepton

When not to take Alepton

• if the patient is allergic to acetylsalicylic acid, other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs, commonly used to treat joint inflammation, rheumatism and pain), or to any of the excipients (listed in section 6);
• if the patient has previously experienced an asthma attack or swelling of the face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs;
• if the patient currently has or has previously had a gastric or duodenal ulcer;
• if the patient has previously experienced gastrointestinal bleeding or perforation (stomach or intestinal failure) caused by previous NSAID therapy;
• if the patient has had recurrent gastric or duodenal ulcers or bleeding episodes with ulceration or bleeding, or other types 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 breathlessness and ankle swelling;
• during the third trimester of pregnancy; doses exceeding 100 mg per day should not be used (see also section "Pregnancy, breastfeeding and effects on fertility");
• if the patient is taking methotrexate (e.g. for cancer or rheumatoid arthritis) in doses exceeding 15 mg per week.

Warnings and precautions
Before starting treatment with Alepton, consult a doctor:

• if the patient has impaired kidney, liver or heart function;
• if the patient currently has or has previously had gastrointestinal ulcers or bleeding (e.g. stomach or small intestine);
• in case of uncontrolled high blood pressure;
• if the patient suffers from asthma, high fever, nasal polyps or other chronic respiratory diseases; 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 serious or unexpected adverse reactions occur, such as unusual bleeding, severe skin reactions or any other signs of severe hypersensitivity (see section "Possible adverse effects").
Inform the doctor about taking Alepton before any surgical procedures (even minor ones, such as tooth extraction), because acetylsalicylic acid reduces blood clotting, which may increase the risk of bleeding.
Care should be taken to avoid dehydration (feeling thirsty or dry mouth), as acetylsalicylic acid taken during this time may cause kidney function disorders.
This medicine should not be used as a pain-relieving or fever-reducing agent.
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 and may be life-threatening. For this reason, Alepton should not be given to children under 16 years of age, unless specifically recommended by a doctor.

Alepton and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken or planned for use.
Other medicines taken simultaneously with acetylsalicylic acid may affect treatment outcomes:

• antiplatelet agents and anticoagulants or thrombolytics (e.g. warfarin, heparin, clopidogrel, alteplase);
• immunosuppressive drugs used to prevent transplant rejection (cyclosporine, tacrolimus);
• medicines used for high blood pressure (e.g. diuretics and ACE inhibitors);
• medicines regulating heart rhythm (digoxin);
• medicines used in the treatment of bipolar disorder (lithium);
• painkillers and anti-inflammatory drugs (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 should be exercised when using metamizole in patients receiving acetylsalicylic acid;
• medicines used in the treatment of gout (e.g. probenecid);
• medicines used in epilepsy treatment (valproate, phenytoin);
• medicines used in glaucoma treatment (acetazolamide);
• medicines used in cancer or rheumatoid arthritis treatment (methotrexate at doses less than 15 mg per week);
• medicines used in diabetes treatment (e.g. glibenclamide, insulin);
• medicines used in depression (selective serotonin reuptake inhibitors such as sertraline or paroxetine);
• medicines used 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).

Alepton with food, drink and alcohol
Drinking alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
If the patient continues or starts treatment with Alepton during pregnancy as advised by a doctor, she should take Alepton according to the doctor's instructions and should not exceed the recommended dose.

Pregnancy – third trimester
Acetylsalicylic acid should not be used in doses exceeding 100 mg per day during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Treatment with Alepton may cause kidney and heart disorders in the unborn child. It may also affect the tendency to bleed in both the mother and her child and may delay or prolong labour.

If the patient takes acetylsalicylic acid in low doses (up to 100 mg per day inclusive), strict obstetric monitoring according to the doctor's recommendations is required.

Pregnancy – first and second trimester
Alepton should not be taken during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is required during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration. Alepton taken for longer than a few days, starting from the 20th week of pregnancy, may cause kidney dysfunction in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is necessary, the doctor may recommend 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 influencing ovulation. This effect reverses after discontinuation of treatment.

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

Alepton contains lactose
If the patient has an intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to take Alepton

This medicine should always be taken exactly as described in this patient information 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 75–300 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 clot formation after certain cardiovascular surgical procedures:

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

Do not take higher doses than recommended unless instructed by your doctor.
The dose should not exceed 300 mg per day.

Elderly patients
Dosage is the same as for adult patients. Generally, acetylsalicylic acid should be used with caution in elderly patients, as they are more susceptible to adverse effects. Treatment should be monitored regularly.

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
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 and prevents intestinal irritation; therefore, the tablets must not be crushed, broken, or chewed.

Taking more Alepton than recommended
If a patient (or anyone else) accidentally takes too many tablets, seek immediate medical advice from a doctor 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 impairment, 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.

If you forget to take Alepton
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 a missed dose.

Stopping Alepton
Do not stop taking Alepton 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 Alepton 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).
• Skin redness with blisters or skin peeling, 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 tarry stools.

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

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

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

• Urticaria.
• Runny nose.
• Breathing difficulties.

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

• Severe gastrointestinal bleeding, cerebral haemorrhage; altered blood cell counts.
• Constriction in the lower respiratory tract, 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 e.g. of lips, face or body, or 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 periods.

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

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this
leaflet, the patient should inform their 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Alepton

Keep this medicine 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 pack following: EXP.
The expiry date refers to the last day of the stated month.
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 Alepton contains
The active substance is acetylsalicylic acid.
Each enteric-coated tablet contains 100 mg of acetylsalicylic acid.
Other ingredients are: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica,
potato starch, talc, triacetin, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion.

What Alepton looks like and contents of the pack
Alepton 100 mg – white, round, biconvex coated tablets with a diameter of approximately 8.1 mm.
Pack sizes:
Blister packs: 30 or 60 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
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