Alepton

Leaflet included in the packaging: patient information

Alepton, 160 mg, enteric-coated tablets

Acetylsalicylic acid
You should carefully read the contents of this leaflet 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 your doctor or pharmacist.
It is recommended to keep this leaflet to be able to read it again if necessary.

• You should keep this leaflet so that you can read it again if necessary.
• If you need advice or additional information, you should 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 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 packaging 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 blood clot in the brain causes a stroke.
Alepton is used to reduce the risk of blood clots forming, and thus the occurrence of:

• heart attacks
• stroke
• 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 surgeries, 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 non-steroidal 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 facial, mouth, throat, or tongue edema (angioedema) after taking salicylates or NSAIDs;
• if the patient currently has or has had stomach or small intestine ulcers;
• if the patient has had bleeding or perforation in the gastrointestinal tract in the past (stomach 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 stroke;
• if the patient has ever had blood clotting disorders;
• in case of severe kidney or liver dysfunction;
• if the patient has severe heart dysfunction causing shortness of breath and swelling of the legs; during the third trimester of pregnancy; the dose should not exceed 100 mg per day (see also the 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 dysfunction;
• if the patient has had ulcers or bleeding (e.g., stomach or small intestine);
• 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 serious 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 undergoing surgical procedures (even minor ones, such as tooth extraction), as acetylsalicylic acid has properties that reduce blood clotting, 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 dysfunction when taken at this time.
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 recommended 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 with acetylsalicylic acid:

• antiplatelet agents and medicines that prevent blood clots 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 (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 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 such as 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 colitis (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.
Pregnant women should not take acetylsalicylic acid unless recommended by a doctor.
During the last three months of pregnancy, Alepton should not be taken unless recommended by a doctor, and the dose should not exceed 100 mg per day (see also the section "When not to take Alepton").
Regular intake of the medicine or taking high doses during the last months of pregnancy may cause serious complications in the mother and child.
Breastfeeding women should not take acetylsalicylic acid unless recommended by a doctor.
Acetylsalicylic acid may affect female fertility by affecting ovulation. This effect is reversible after stopping treatment.

Driving and using machines

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

Alepton contains lactose

If the patient has intolerance to some sugars, they should consult a doctor before taking this medicine.

Alepton 160 mg contains soy lecithin (E322)

If the patient is allergic to peanuts or soy, they should not take this medicine.

3. How to take Alepton

This medicine should always be taken exactly as described in this patient leaflet or as directed 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 blood clots after certain cardiac surgeries:
• The recommended dose is 75-160 mg once a day.

The patient should not take higher doses of this medicine unless recommended by a doctor.
The dose should not exceed 300 mg per day.
Elderly patients
The 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 recommended 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 against stomach acid, which protects the intestines from irritation, and therefore the tablets 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 consult a doctor or go to the nearest hospital emergency department. The patient 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. Severe overdose may cause rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar, pulmonary edema, and coma.

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 the missed dose.

Stopping Alepton treatment

The patient should not stop taking Alepton without consulting a doctor.
If the patient has any further questions about the use of 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 consult a doctor:

• Sudden onset of wheezing, edema of the face, mouth, throat, 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 a condition known as 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.
• Runny nose.
• Breathing difficulties.

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

• Severe bleeding from the stomach or intestines, cerebral bleeding; altered blood cell count.
• Spasms in the lower respiratory tract, asthma attack.
• Vasculitis.
• Purpura with purple spots (bleeding into the skin).
• Severe skin reactions such as erythema multiforme and its life-threatening forms, Stevens-Johnson syndrome, and Lyell's syndrome.
• Hypersensitivity reactions, such as edema, e.g., of the mouth, face, or body, or anaphylaxis.
• Reye's syndrome (a very rare disease that affects the brain and liver, see section 2 "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 small intestine ulcers and perforation.
• Prolonged bleeding time.
• Kidney dysfunction, acute kidney failure.
• Liver dysfunction, 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 or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information 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 25°C.
Store in the original packaging to protect from light and 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 packaging and other information

What Alepton contains

The active substance is acetylsalicylic acid.
Each enteric-coated tablet contains 160 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), 30% dispersion
Coating "Opadry II yellow":
polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin, yellow iron oxide (E172)

What Alepton looks like and contents of the pack

Alepton, 160 mg - yellow, round, biconvex, film-coated tablets with a diameter of approximately 9.2 mm.
Packagesizes:
Blister: 30 or 60 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schloβplatz 1
A-8502 Lannach
Austria