AGREGEX 75 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Agregex (Clopidogrel Actavis), 75 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains
   2. Table of contents of the leaflet:
4. What is Aggregex and what is it used for
5. Important information before taking Aggregex
   1. When not to take Aggregex
   2. Warnings and precautions
   3. Children and adolescents
   4. Agregex and other medicines
   5. Agregex with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Aggregex
   1. Taking a higher dose of Aggregex than recommended
   2. Missing a dose of Aggregex
   3. Stopping treatment with Aggregex
7. Possible side effects
   1. The patient should immediately contact their doctor if they experience:
   2. The most common side effect reported during treatment with Aggregex is
   3. If prolonged bleeding occurs while taking Aggregex
   4. Other side effects include:
   5. Reporting side effects
8. How to store Aggregex
9. Contents of the packaging and other information
   1. What Aggregex contains
   2. What Aggregex looks like and what the packaging contains
   3. Packaging types:
   4. Marketing authorization holder in Hungary, the country of export:
   5. Manufacturer:
   6. Parallel importer:
   7. Repackaged by:
   8. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   9. Translation of the symbols of the days of the week on each tablet on the immediate packaging:
   10. Date of leaflet approval: 05.03.2024

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Agregex (Clopidogrel Actavis), 75 mg, film-coated tablets

Clopidogrel
Agregex and Clopidogrel Actavis are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Aggregex 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 (a process called thrombosis).
Agregex is used in adult patients to prevent the formation of blood clots (thrombi) in hardened arteries (arteries) due to atherosclerosis, which can lead to the occurrence of incidents in the course of symptomatic atherosclerosis (such as stroke, heart attack, or death).
The patient has been prescribed Aggregex to prevent the formation of blood clots and reduce the risk of these serious incidents, because:

• the patient has atherosclerosis (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 closed or narrowed artery to restore effective blood flow. The attending physician should also prescribe acetylsalicylic acid (a substance present in many medicines, used both 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 (so-called transient ischemic attack) or a mild stroke. The attending physician may also prescribe acetylsalicylic acid within the first 24 hours.
• the patient has an irregular heartbeat, known as "atrial fibrillation", and the patient cannot take medicines called "oral anticoagulants" (vitamin K antagonists), which prevent the formation of new and enlargement of existing blood clots. The attending physician should inform the patient that oral anticoagulants

are more effective in such cases than acetylsalicylic acid or the simultaneous use of Aggregex with acetylsalicylic acid. If there is no possibility of using oral anticoagulants and there is no risk of severe bleeding, the doctor should prescribe Aggregex with acetylsalicylic acid.

2. Important information before taking Aggregex

When not to take Aggregex

• 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 bleeding, such as a stomach ulcer or bleeding in the brain,
• if the patient has severe liver disease.

If the patient thinks that any of the above problems apply to them or has any other doubts, they should consult their doctor before taking Aggregex.

Warnings and precautions

Before starting to take Aggregex, 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.

While taking Aggregex:

• 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 thrombocytopenic purpura), which includes fever and bruising under the skin, appearing as red, punctate spots with or without unexplained fatigue, disorientation, yellowing of the skin or eyes (jaundice) (see section 4).
• 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 the medicine works, as it prevents the formation of blood clots. This usually does not cause problems with minor cuts and injuries, e.g., cuts during shaving. However, if bleeding occurs, the patient should immediately contact their doctor (see section 4).
• The doctor may order blood tests.

Children and adolescents

This medicine should not be used in children, as it does not have a therapeutic effect in this group of patients.

Agregex and other medicines

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

• medicines that may increase the risk of bleeding, such as:
• 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 in HIV infection)
• carbamazepine medicine used to treat certain types of epilepsy
• moclobemide medicine used to treat depression
• repaglinide, medicine used to treat diabetes
• paclitaxel, 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 the case of patients who have had severe chest pain (unstable angina or heart attack), transient ischemic attack, or mild stroke, Aggregex may be prescribed with acetylsalicylic acid, a substance present 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 attending physician.

Agregex with food and drink

Agregex can be taken with or without food.

Pregnancy and breastfeeding

The use of this medicine is not recommended 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 Aggregex, they should immediately consult their doctor, as the use of 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

It is unlikely that Aggregex will affect the patient's ability to drive or use machines.
Agregex contains lactose.If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking this medicine.
Agregex contains soybean lecithin (soybean oil) (E 322).The patient should not take this medicine if they are allergic to peanuts or soybeans.

3. How to take Aggregex

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 heartbeat), is one Aggregex 75 mg tablet per day, taken orally with or without food, every day at the same time.
If the patient has had severe chest pain (unstable angina or heart attack), the 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 of Aggregex is one 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 of Aggregex (4 tablets of 75 mg) at the start of treatment. Then the recommended dose is one Aggregex 75 mg tablet per day, as described above, with acetylsalicylic acid for 3 weeks. Then the doctor may prescribe Aggregex or acetylsalicylic acid separately.
The patient should take Aggregex for as long as their doctor recommends.

Taking a higher dose of Aggregex 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 Aggregex

If the patient forgets to take a dose of Aggregex, 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 immediate packaging, the patient can check the day they last took an Aggregex tablet, in the calendar printed on the blister pack (see "Translation of the symbols of the days of the week on each tablet on the immediate packaging" at the end of the leaflet).

Stopping treatment with Aggregex

The patient should not stop treatment unless it is recommended by their doctor. Before stopping treatment, the patient should contact their doctor or pharmacist.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately contact their doctor if they experience:

• fever, signs of infection, or unexplained fatigue. This may be due to a rare decrease in the number of certain blood cells (blood cells)
• symptoms of liver dysfunction, such as yellowing of the skin and/or eyes (jaundice), related or unrelated to bleeding, which appears under the skin in the form of red, punctate spots and/or disorientation (see section 2 "Warnings and precautions"),
• swelling of the lips 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 Aggregex is

bleeding.
Bleeding may occur as bleeding in the stomach or intestines, 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 head, lungs, or joints.

If prolonged bleeding occurs while taking Aggregex

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 the medicine works, as it prevents the formation of blood clots. This usually does not cause problems with minor cuts and injuries, e.g., 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, excess gas in the stomach or intestines,
rash, 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 lips, blisters, skin allergy, oral pain (stomatitis), low blood pressure, disorientation, hallucinations, joint pain, muscle pain, taste disturbances 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 levels.
Additionally, the doctor may detect changes in blood or urine test results.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell 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.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Aggregex

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Aluminium/Aluminium blisters: Do not store above 30°C.
PVC/PE/PVDC/Aluminium blisters: Do not store above 25°C.
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 Aggregex contains

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

What Aggregex looks like and what the packaging contains

Film-coated tablet.
Pink, round, biconvex film-coated tablet with a diameter of 9 mm, with "I" embossed on one side.

Packaging types:

Aluminium/Aluminium or PVC/PE/PVDC/Aluminium blisters in a cardboard box: 28, 56 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Hungary, the country of export:

Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland

Manufacturer:

Actavis Ltd
BLB016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Balkanpharma-Dupnitsa AD
3 Samakovsko Shosse Str.
Dupnitsa, 2600
Bulgaria

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Hungary, the country of export:OGYI-T-21097/03
OGYI-T-21097/04
Parallel import authorization number:93/19

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

Cyprus Aggregex
Malta Aggregex
Poland Aggregex

Translation of the symbols of the days of the week on each tablet on the immediate packaging:

H

• Monday K
• Tuesday SZE
• Wednesday CS
• Thursday P
• Friday SZO
• Saturday V
• Sunday.

Date of leaflet approval: 05.03.2024

[Information about the trademark]