Agregex

Leaflet accompanying the packaging: information for the user

Agregex, 75 mg, coated tablets

Clopidogrel

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Agregex and what is it used for

Agregex contains clopidogrel and belongs to a group of medicines called antiplatelet medicines. Platelets are very small cells in the blood that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the chance of blood clots forming (a process called thrombosis). Agregex is used in adult patients to prevent the formation of clots (thrombi) in hardened arteries (arteries affected by atherosclerosis) that can lead to events such as stroke, heart attack, or death. The patient has been prescribed Agregex to prevent blood clots and reduce the risk of these serious events, because:

• the patient has hardened arteries (also known as atherosclerosis) and
• the patient has had a heart attack, stroke, or has a condition known as peripheral arterial disease, or
• the patient has had severe chest pain known as "unstable angina" or "myocardial infarction" (heart attack). To treat this condition, the doctor may place a stent in a blocked or narrowed artery to restore blood flow. The 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)
• the patient has had symptoms of a stroke that have resolved quickly (called a transient ischemic attack) or a mild stroke. The doctor may also prescribe acetylsalicylic acid within the first 24 hours.
• the patient has an irregular heartbeat, known as "atrial fibrillation", and cannot take medicines called "oral anticoagulants" (vitamin K antagonists), which prevent the formation of new blood clots and the growth of existing ones. The doctor should inform the patient that oral anticoagulants are more effective in these cases than acetylsalicylic acid or the combined use of Agregex with acetylsalicylic acid. If oral anticoagulants cannot be used and there is no risk of severe bleeding, the doctor should prescribe Agregex with acetylsalicylic acid.

v/24
1

2. Important information before taking Agregex

When not to take Agregex

• if the patient is allergic to clopidogrel, soybean oil, arachis oil, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has a condition that is currently causing bleeding, such as a stomach ulcer or bleeding in the brain
• if the patient has severe liver disease.

If the patient thinks they may have any of the above problems or has any other doubts, they should consult their doctor before taking Agregex.

Warnings and precautions

Before starting to take Agregex, the patient should discuss it with their doctor or pharmacist.

• if there is a risk of bleeding, such as:
• a condition that increases the risk of internal bleeding (e.g., stomach ulcer)
• a blood disorder that makes the patient prone to 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 the patient has had a blood clot in the brain (ischemic stroke) within the last seven days
• if the patient has kidney or liver disease
• if the patient has had an allergic reaction or other reaction to medicines used during treatment
• if the patient has had a non-traumatic brain hemorrhage in the past.

During treatment with Agregex:

• The patient should inform their doctor if they are planning to have surgery (including dental surgery).
• The patient should also immediately inform their doctor if they experience a condition (called thrombotic thrombocytopenic purpura), which includes fever and bruising under the skin, appearing as red, pinpoint spots with or without unexplained extreme fatigue, disorientation, yellowing of the skin or eyes (jaundice) (see section 4).
• In case 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 the medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts and injuries, such as cuts during shaving. However, if bleeding occurs, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").
• The doctor may order blood tests.

Children and adolescents

This medicine should not be used in children, as it has not been shown to be effective in this group of patients.

Agregex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken. Some other medicines may affect the action of Agregex or vice versa. In particular, the patient should inform their doctor if they are taking medicines such as:

• medicines that may increase the risk of bleeding, such as:

v/24
2

• oral anticoagulants, medicines used to reduce blood clotting
• non-steroidal anti-inflammatory medicines, usually used to treat painful and/or inflammatory conditions of the muscles or joints
• heparin or any other medicine given by injection, used to reduce blood clotting
• ticlopidine and other antiplatelet medicines
• selective serotonin reuptake inhibitors (including, but not limited to, fluoxetine and 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: if the patient is being treated with clopidogrel, they should inform their doctor before being prescribed opioids (used to treat severe pain)
• rosuvastatin (used to lower cholesterol levels)

In patients who have had severe chest pain (unstable angina or myocardial infarction), a transient ischemic attack, or a mild stroke, Agregex may be prescribed together 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 the doctor.

Agregex with food and drink

Agregex can be taken with or without food.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy and breastfeeding. If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. If the patient becomes pregnant while taking Agregex, they should immediately consult their doctor, as clopidogrel is not recommended during pregnancy. The patient should not breastfeed while taking this medicine. If the patient is breastfeeding or plans to breastfeed, they should talk to their doctor before taking this medicine. Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Agregex contains lactose.If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine. Agregex contains soybean oil. The patient should not take this medicine if they are allergic to peanuts or soy. v/24
3

3. How to take Agregex

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are unsure, they should ask their doctor or pharmacist. The recommended dose, including patients with a condition called "atrial fibrillation" (irregular heart rhythm), is one Agregex 75 mg tablet per day, taken orally with or without food, at the same time every day. If the patient has had severe chest pain (unstable angina or heart attack), their doctor may prescribe a single dose of 300 mg or 600 mg (4 or 8 tablets of 75 mg) to start treatment. Then, the recommended dose is one Agregex 75 mg tablet per day, taken as described above. If the patient has had symptoms of a stroke that have resolved quickly (also known as a transient ischemic attack) or a mild stroke, the doctor may prescribe a single dose of 300 mg Agregex (4 tablets of 75 mg) at the start of treatment. Then, the recommended dose is one Agregex 75 mg tablet per day, as described above, with acetylsalicylic acid for 3 weeks. Then, the doctor may prescribe Agregex or acetylsalicylic acid separately. The patient should take Agregex for as long as their doctor recommends.

Taking a higher dose of Agregex than recommended

The patient should contact their doctor or the emergency department of the nearest hospital due to an increased risk of bleeding.

Missing a dose of Agregex

If the patient forgets to take a dose of Agregex but remembers within 12 hours, they should take the tablet immediately and then take the next tablet at the usual time. If the patient forgets for more than 12 hours, they should simply take the next single dose at the usual time. The patient should not take a double dose to make up for the missed dose. On the packaging of 28 tablets, the patient can check the day they last took a tablet of Agregex in the calendar printed on the blister.

Stopping treatment with Agregex

The patient should not stop treatment unless their doctor tells them to. Before stopping treatment, the patient should consult their doctor or pharmacist. If the patient has any further doubts about taking this medicine, they should talk to their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately contact their doctor if they experience:

• fever, signs of infection, or extreme fatigue. This may be due to a rare decrease in the number of certain blood cells (blood cells)
• signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, which appears as red, pinpoint spots under the skin and/or disorientation (see section 2 "Warnings and precautions")

v/24
4

• swelling of the mouth or skin disorders, such as rashes and itching, blisters. This may be a sign of an allergic reaction.

The most common side effect reported during treatment with Agregex is

bleeding. Bleeding may occur as stomach or intestinal bleeding, bruising, hematomas (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 prolonged bleeding occurs during treatment with Agregex

In case 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 the medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts and injuries, such as cuts during shaving. However, if bleeding occurs, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").

Other side effects include:

Common (may affect up to 1 in 10 people):
Diarrhea, abdominal pain, indigestion, or heartburn.
Uncommon (may affect up to 1 in 100 people):
Headache, stomach ulcer, vomiting, nausea, constipation, gas in the stomach or intestines, rashes, itching, dizziness, feeling of tingling or numbness.
Rare (may affect up to 1 in 1,000 people):
Vertigo of labyrinthine origin, breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people):
Jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing, sometimes accompanied by coughing, generalized allergic reactions (e.g., feeling of heat with sudden general discomfort up to fainting), swelling of the mouth, blisters, skin allergy, oral pain (stomatitis), low blood pressure, disorientation, hallucinations, joint pain, muscle pain, taste disorders, or loss of taste.
Frequency not known (frequency cannot be estimated from the available data):
Hypersensitivity reactions with chest pain or abdominal pain, persistent symptoms of low blood sugar.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. 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 Agregex

The medicine should be stored out of sight and reach of children. v/24
5
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated. Aluminum/Aluminum blisters: Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Agregex contains

• The active substance of Agregex is clopidogrel in the form of hydrogen sulfate. Each tablet contains 75 mg of clopidogrel.
• The other ingredients are: Tablet core: lactose, microcrystalline cellulose (type 102), crospovidone (type A), glyceryl dibehenate, talc. Tablet coating: Opadry II 85G34669 Pink:polyvinyl alcohol, talc, macrogol 3350, soybean lecithin (E 322), titanium dioxide (E 171), iron oxide red (E 172).

What Agregex looks like and contents of the pack

Coated tablet.
Pink, round, biconvex coated tablet with a diameter of 9 mm, with "I" engraved on one side.
Packaging types:
Aluminum/Aluminum blisters: 28, 30, 60, and 90 tablets.
Not all packaging types may be marketed.

Marketing authorization holder

Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Cyprus
Agregex
Malta
Agregex
Poland
Agregex

For further information on this medicine, please contact

the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:October 2022
v/24
6