AGREGEX 75 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
3. Agregex (Clopidogrel Actavis)
4. 75 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
5. What is Aggregex and what is it used for
   1. Children and Adolescents
   2. Agregex and Other Medicines
   3. Agregex with Food and Drink
   4. Pregnancy and Breastfeeding
   5. 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 Contact Their Doctor Immediately if They Experience:
   2. The Most Common Side Effect Reported 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 Pack and Other Information
   1. What Aggregex Contains
   2. What Aggregex Looks Like and Contents of the Pack
   3. Marketing Authorization Holder in Hungary, Country of Export:
   4. Manufacturer:
   5. Parallel Importer:
   6. Repackaged by:
   7. Parallel Import Authorization Number: 801/15
   8. Translation of Abbreviations for Days of the Week on the Blister Pack:
   9. Date of Approval of the Leaflet: 14.11.2024

Package Leaflet: Information for the User

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

Agregex (Clopidogrel Actavis)

75 mg, coated tablets

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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 pack 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 blood cells 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 blood 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 Aggregex to prevent blood clots and reduce the risk of these serious events, because:

• the patient has atherosclerosis (also known as hardening of the arteries) 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 Aggregex with acetylsalicylic acid. If oral anticoagulants cannot be used and there is no risk of severe bleeding, the doctor should prescribe Aggregex with acetylsalicylic acid.

During treatment with Aggregex:

• The doctor should be informed if the patient is scheduled to have surgery (including dental surgery).
• The doctor should also be informed immediately if the patient experiences 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 injury or trauma, the time it takes for 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 injuries, such as cuts during shaving. However, if bleeding occurs, the patient should contact their doctor immediately (see section 4).
• 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 patient group.

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 Aggregex or vice versa.
In particular, the doctor should be informed if the patient is taking medicines such 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 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 heart attack), transient ischemic attack, or mild stroke, Aggregex may be prescribed 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 Aggregex, they should contact their doctor immediately, 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.

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, at the same time every day.
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 is one Aggregex 75 mg tablet per day, taken as described above.
If the patient has had symptoms of a stroke that have resolved quickly (called a transient ischemic attack) or a mild stroke, the doctor may prescribe a single dose of 300 mg 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 packs of 28 tablets, the patient can check the day they last took a tablet of Aggregex in the calendar printed on the blister pack.

Stopping Treatment with Aggregex

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 questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible Side Effects

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

The Patient Should Contact Their Doctor Immediately 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")
• 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 with Aggregex is

Bleeding.
Bleeding may occur as stomach or intestinal 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 Prolonged Bleeding Occurs While Taking Aggregex

In case of injury or trauma, the time it takes for 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 injuries, such as cuts during shaving. However, if bleeding occurs, the patient should contact their doctor immediately (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, rash, itching, dizziness, 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 discomfort (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.

Reporting Side Effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, National Institute of Pharmacy and Nutrition, Alkotás utca 3-5, 1051 Budapest, Hungary, phone: +36 1 888 6792, fax: +36 1 888 6791, website: https://www.ogyei.gov.hu. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to Store Aggregex

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
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 Pack and Other Information

What Aggregex Contains

• The active substance 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 (type 102), crospovidone (type A), glycerol dibehenate, talc. Tablet coating: Opadry II 85G34669 Pink:polyvinyl alcohol, talc, macrogol 3350, soybean oil, titanium dioxide (E 171), iron oxide red (E 172).

What Aggregex Looks Like and Contents of the Pack

Pink, round, biconvex, coated tablet, 9 mm in diameter, with "I" embossed on one side.
Al/Al blisters, containing 28, 30, 60, or 90 coated tablets, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Hungary, Country of Export:

Actavis Group PTC ehf
Dalshraun 1
220 Hafnarfjordur, Iceland

Manufacturer:

Actavis Ltd.
BLB015-016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Actavis Group PTC ehf
Dalshraun 1
220 Hafnarfjordur, Iceland
Balkanpharma-Dupnitsa AD
3 Samakovsko Shosse Str.
Dupnitsa, 2600
Bulgaria

Parallel Importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Hungarian, Country of Export Marketing Authorization Number: OGYI-T-21097/01
OGYI-T-21097/03
OGYI-T-21097/05
OGYI-T-21097/09

Parallel Import Authorization Number: 801/15

Translation of Abbreviations for Days of the Week on the Blister Pack:

H

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

Date of Approval of the Leaflet: 14.11.2024

[Information about the trademark]