Areplex

Package Leaflet: Information for the Patient

AREPLEX

75 mg, Film-Coated Tablets

Clopidogrel

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What the medicine is and what it is used for

contains clopidogrel and belongs to a group of medicines called antiplatelet medicines. Platelets are very small blood cells that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the chance of blood clots (a process called thrombosis). is used in adult patients to prevent blood clots that can cause a heart attack or stroke. Your doctor may prescribe to prevent blood clots from forming in hardened blood vessels (arteries) that can lead to events related to atherosclerosis (such as stroke, heart attack, or death) because:

• you have atherosclerotic disease (also known as atherosclerosis) and
• you have had a heart attack, stroke, or have a condition known as peripheral arterial disease or
• you have had severe chest pain (unstable angina or myocardial infarction). To treat this condition, your doctor may place a stent in the blocked or narrowed artery to restore blood flow. Your doctor may also prescribe acetylsalicylic acid (a substance found in many medicines, used to relieve pain and reduce fever, as well as to prevent blood clotting).
• you have had symptoms of a stroke that have resolved within a short period (called a transient ischemic attack) or a mild ischemic stroke. Your doctor may also prescribe acetylsalicylic acid within the first 24 hours.
• you have an irregular heartbeat, known as "atrial fibrillation," and you cannot take medicines called "oral anticoagulants" (vitamin K antagonists), which prevent the formation of new and the growth of existing blood clots.

Blood. Your doctor should inform you that oral anticoagulants are more effective in these cases than acetylsalicylic acid, or the simultaneous use of acetylsalicylic acid with . In the absence of the possibility of using oral anticoagulants and the absence of a risk of severe bleeding, your doctor should prescribe with acetylsalicylic acid.

2. Important information before taking the medicine

When not to take the medicine

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• if you have a condition that is currently bleeding, such as a stomach ulcer or bleeding in the brain;
• if you have severe liver disease.

If you think any of these conditions apply to you, or if you have any other concerns, you should consult your doctor before taking .

Warnings and precautions

If any of the following situations apply to you, you should tell your doctor before taking :

• if you have a risk of bleeding, such as:
• a condition that increases the risk of internal bleeding (e.g., stomach ulcer)
• a blood disorder that increases the risk of internal bleeding (bleeding into tissues, organs, or joints)
• a recent severe injury
• a recent surgical procedure (including dental surgery)
• a planned surgical procedure (including dental surgery) within the next seven days
• if you have had a blood clot in the brain (ischemic stroke) within the last seven days
• if you have kidney or liver disease
• if you have had an allergy or hypersensitivity to any of the medicines used to treat this condition
• if you have had a non-traumatic brain hemorrhage in the past.

While taking :

• Tell your doctor if you are planning to have surgery (including dental surgery).
• Also, immediately inform your doctor if you experience a condition (called thrombotic thrombocytopenic purpura, TTP), characterized by fever and purple spots on the skin, which may appear as red, pinpoint spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• In the event of a cut or injury, the time it takes for the bleeding to stop may be slightly longer than usual. This is related to the way works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts and injuries, e.g., cuts while shaving. Nevertheless, if bleeding occurs, you should immediately contact your doctor (see section 4 "Possible side effects").
• Your doctor may order blood tests.

Children and adolescents

should not be used in children, as it has not been shown to be effective in this patient group.

and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take, including those obtained without a prescription.

Some other medicines may affect the action of , and vice versa.

In particular, tell your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as: oral anticoagulants, medicines used to inhibit blood clotting, non-steroidal anti-inflammatory medicines, usually used to treat painful and/or inflammatory conditions of the muscles or joints, heparin or other injectable medicines used to reduce blood clotting, ticlopidine and other antiplatelet medicines, selective serotonin reuptake inhibitors (including fluoxetine or fluvoxamine), medicines usually used to treat depression, rifampicin (used to treat severe infections)
• omeprazole or esomeprazole, medicines used to treat stomach disorders,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz or other antiretroviral medicines (used to treat HIV infection),
• carbamazepine, a medicine used to treat certain types of epilepsy,
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• opioids: while being treated with , you should inform your doctor before being prescribed any opioid (medicines used to treat severe pain) rosuvastatin (a medicine used to lower cholesterol levels).

Patient with severe chest pain (unstable angina or myocardial infarction) may be prescribed in combination with acetylsalicylic acid, a substance found in many medicines, used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (no more than 1000 mg in 24 hours) should not usually cause a problem, but long-term use in other circumstances should be discussed with your doctor.

Taking with food and drink

can be taken with or without food.

Pregnancy and breastfeeding

should not be used during pregnancy.

If you are pregnant or think you may be pregnant, consult your doctor or pharmacist before taking . If you become pregnant while taking , you should immediately consult your doctor, as taking during pregnancy is not recommended.

should not be used during breastfeeding.

If you are breastfeeding or plan to breastfeed, consult your doctor before taking . Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

contains lactose

If you have been diagnosed with an intolerance to some sugars (e.g., lactose), you should contact your doctor before taking .

contains hydrogenated castor oil

This may cause stomach upset or diarrhea.

3. How to take

should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of is 75 mg once a day, taken orally at the same time each day, with or without food. This dosage also applies to patients with a condition known as "atrial fibrillation" (irregular heartbeat).

If you have had severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe an initial dose of 300 mg or 600 mg (4 or 8 tablets of 75 mg). Then, the recommended dose of is one 75 mg tablet per day (as above).

If you have had symptoms of a stroke that have resolved within a short period (called a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe a single dose of 300 mg (4 tablets of 75 mg) at the start of treatment. Then, the recommended dose is one 75 mg tablet per day, as described above, with acetylsalicylic acid for 3 weeks. Then, your doctor may prescribe or acetylsalicylic acid separately.

should be taken for as long as your doctor recommends.

If you take more than you should

Contact your doctor or the nearest hospital emergency department immediately because of an increased risk of bleeding.

If you forget to take

If you forget to take a dose and remember within 12 hours of the time you should have taken , take the tablet immediately and then take the next tablet at the usual time.

If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking

Do not stop treatment unless your doctor tells you to.Before stopping , consult your doctor or pharmacist.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Immediately contact your doctor if you experience:

• fever, signs of infection, or extreme fatigue. This may be due to a rare decrease in the number of certain blood cells.
• symptoms of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, which appears under the skin as red, pinpoint spots, and/or confusion (see section 2 "Warnings and precautions").
• swelling of the mouth or skin disorders, such as rash and itching, blisters. These may be signs of an allergic reaction.

The most common side effect reported with is bleeding.

Bleeding may occur as stomach or intestine bleeding, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. There have also been reports of a small number of cases of bleeding in the eye, into the brain, lungs, or joints.

If you experience prolonged bleeding while taking

In the event of a cut or injury, the time it takes for the bleeding to stop may be slightly longer than usual. This is related to the way works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts and injuries, e.g., cuts while shaving. Nevertheless, if bleeding occurs, you should immediately contact your doctor (see section 2 "Warnings and precautions").

Other side effects reported with include:

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

Diarrhea, stomach pain, indigestion, or heartburn.

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

Headache, stomach ulcers, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, feeling of weakness or numbness.

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

Vertigo of labyrinthine origin, breast enlargement in men.

Very rare side effects (may affect up to 1 in 10,000 people):

Jaundice, severe stomach pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (e.g., general feeling of heat with sudden general malaise up to fainting); swelling of the mouth; skin blisters; skin allergy; oral mucositis (mouth ulcers); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste.

Side effects of unknown frequency (frequency cannot be estimated from the available data)

Hypersensitivity reactions with chest pain or stomach pain, persistent symptoms of low blood sugar.

Your doctor may also detect changes in your blood or urine test results.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, e-mail: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store

should be stored out of sight and reach of children.

Store in a temperature below 25°C.

Do not use after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that 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 contains

• The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrochloride).
• The other ingredients are: mannitol, pregelatinized starch, microcrystalline cellulose with colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, iron oxide yellow, iron oxide black.

What looks like and contents of the pack

The film-coated tablets are pink, round, and biconvex.

is packaged in cardboard boxes containing 28 or 84 tablets in blisters of PA/Aluminum/PVC/Aluminum.

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, tel. +48 22 732 77 00

Manufacturer

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów

Date of last revision of the leaflet: