Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Agregex (Clopidogrel Actavis), 75 mg, film-coated tablets
Clopidogrelum
Agregex and Clopidogrel Actavis are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Table of contents:

What Agregex is and what it is used for
Important information before taking Agregex
How to take Agregex
Possible side effects
How to store Agregex
Contents of the pack and other information

1. What Agregex is and what it is used for

Agregex contains clopidogrel and belongs to a group of medicines called antiplatelet agents.
Platelets are very small blood cells that clump together during blood clotting.
By preventing this clumping, antiplatelet medicines reduce the risk of blood clots (a process known as thrombosis).
Agregex is used in adult patients to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries) due to atherosclerosis, which may lead to serious events in symptomatic atherosclerotic disease (such as stroke, heart attack, or death).
You have been prescribed Agregex to prevent blood clots and reduce the risk of these serious events because:

you have hardening of the arteries (also known as atherosclerosis), and
you have previously had a heart attack, stroke, or have peripheral arterial disease, or
you have experienced severe chest pain known as "unstable angina" or "myocardial infarction" (heart attack). To treat this condition, your doctor may have inserted a stent into a blocked or narrowed artery to restore adequate blood flow. Your doctor should 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 experienced symptoms of a transient ischaemic attack (TIA) or a mild stroke. Your doctor may also prescribe acetylsalicylic acid within the first 24 hours.
you have an irregular heartbeat known as "atrial fibrillation" and cannot take medicines called "oral anticoagulants" (vitamin K antagonists), which prevent the formation of new clots and the enlargement of existing ones. Your doctor should inform you that oral anticoagulants are more effective in such cases than acetylsalicylic acid or the combination of Agregex with acetylsalicylic acid. If oral anticoagulants cannot be used and there is no risk of severe bleeding, your doctor should prescribe Agregex together with acetylsalicylic acid.

2. Important information before using Aggregex

When not to use Aggregex

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

If the patient thinks any of the above apply or has any other
doubts, they should consult their doctor before using Aggregex.
Warnings and precautions
Before starting to use Aggregex, discuss this with your doctor or pharmacist.

if there is a risk of bleeding, such as:
a medical condition that increases the risk of internal bleeding (e.g. stomach ulcer)
a blood disorder making the patient prone to internal bleeding (bleeding into tissues, organs or joints)
recent serious injury
recent surgery (including dental surgery)
planned surgery (including dental surgery) within the next seven days
if the patient has had a blood clot in the brain (ischaemic stroke) that occurred within the last seven days
if the patient has kidney or liver disease
if the patient has previously experienced an allergic reaction or other adverse reaction to medications used during treatment
if the patient has previously had a non-traumatic brain haemorrhage.

While using Aggregex:

Inform your doctor if the patient is scheduled for surgery (including dental procedures).
Also inform your doctor immediately if the patient develops a medical condition called thrombotic thrombocytopenic purpura, which may include fever and skin bruising appearing as red pinpoint spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4).
In case of cuts or injuries, the time it takes for bleeding to stop may be slightly longer than usual. This is related to how the medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts or injuries, such as shaving cuts. However, if bleeding occurs, contact your doctor immediately (see section 4).
Your 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.
Aggregex with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken.
Some other medicines may affect the action of Aggregex or vice versa.
In particular, inform your doctor if the patient is taking:

medicines that may increase the risk of bleeding, such as:
oral anticoagulants, medicines used to reduce blood clotting,
non-steroidal anti-inflammatory drugs (NSAIDs), usually used to treat pain and/or inflammation of muscles or joints,
heparin or any other injectable medicine 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 in the treatment of depression,
rifampicin (used to treat serious infections)
omeprazole or esomeprazole, medicines used to treat stomach problems
fluconazole or voriconazole, medicines used to treat fungal infections
efavirenz or other antiretroviral medicines (used in 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 experienced severe chest pain (unstable angina or heart attack), transient ischaemic attack, or mild stroke, Aggregex may be prescribed together 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 within 24 hours) should not usually cause problems, but long-term use in other circumstances should be discussed with the doctor.
Aggregex with food and drink
Aggregex can be taken with or without food.
Pregnancy and breastfeeding
Use of this medicine is not recommended during pregnancy and breastfeeding.
If the patient is pregnant, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine. If the patient becomes pregnant while taking Aggregex, she should consult her doctor immediately, as clopidogrel is not recommended during pregnancy.
Breastfeeding should not be undertaken while taking this medicine.
If the patient is breastfeeding or planning to breastfeed, she should talk to her doctor before taking this medicine.
Before taking any medicine, consult your doctor or pharmacist.
Driving and using machines
It is unlikely that Aggregex will affect the ability to drive or operate machinery.
Aggregex contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Aggregex contains soybean lecithin (soybean oil) (E 322). Do not use this medicine if the patient is allergic to peanuts or soy.

3. How to take Aggregex

Always take this medicine exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose, including for patients with a condition called "atrial fibrillation" (irregular heartbeat),
is one 75 mg Aggregex tablet daily, taken orally with or without food, at the same time each day.
If a patient has experienced severe chest pain (unstable angina or heart attack), the treating physician may
prescribe an initial single dose of 300 mg or 600 mg (4 or 8 tablets of 75 mg). Afterwards, the recommended
dose is one 75 mg Aggregex tablet daily, taken as described above.
If a patient has experienced transient ischaemic attack symptoms (also known as transient ischaemic attack)
or a mild stroke, the doctor may prescribe a single initial dose of 300 mg Aggregex (4 tablets of 75 mg).
Subsequently, the recommended dose is one 75 mg Aggregex tablet daily, as described above, together with
acetylsalicylic acid for 3 weeks. After that, the doctor may prescribe Aggregex or acetylsalicylic acid separately.
Take Aggregex for as long as your doctor recommends.
Taking more Aggregex than recommended
Contact your doctor or the nearest hospital emergency department immediately due to increased risk of bleeding.
If you forget to take 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 more than 12 hours have passed, the patient should simply take the next single dose at the usual time.
Do not take a double dose to make up for a missed dose.
On the immediate packaging, the patient can check the day on which they last took an Aggregex tablet, using
the calendar printed on the blister pack (see "Translation of weekday symbols next to each tablet on the immediate packaging" at the end of the leaflet).
Stopping Aggregex
Do not stop treatment unless advised by your doctor. Before stopping the medicine, contact your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Contact the treating physician immediately if the patient experiences:

fever, signs of infection, or feeling extremely tired. This may be due to a rare reduction in the number of certain blood cells (blood corpuscles)
symptoms of liver dysfunction, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red pinpoint spots and/or disorientation (see section 2 "Warnings and precautions"),
swelling of the lips or skin disorders such as rash and itching, skin blisters. These may be symptoms of allergic reactions.

The most commonly reported adverse reaction during treatment with Aggregex is bleeding.
Bleeding may occur in the stomach or intestines, bruising, haematomas (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. A small number of cases of bleeding in the eye, inside the head, lungs, or joints have also been reported.
If prolonged bleeding occurs during treatment with Aggregex
In case of cuts or injuries, the time required for bleeding to stop may be slightly longer than usual. This is related to the mechanism of action of the medicine, as it prevents blood clots from forming. This usually does not cause problems with minor cuts or injuries, such as those occurring during shaving. However, if bleeding occurs, contact the treating physician immediately (see section 2 "Warnings and precautions").
Other adverse reactions include:
Common (may affect up to 1 in 10 patients):
Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon (may affect up to 1 in 100 patients):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness.
Rare (may affect up to 1 in 1,000 patients):
Vertigo, gynaecomastia (breast enlargement in males).
Very rare (may affect up to 1 in 10,000 patients):
Jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing, sometimes accompanied by cough, generalized allergic reactions (e.g. feeling of warmth with sudden general discomfort up to fainting), swelling of the lips, skin blisters, skin allergy, oral pain (stomatitis), hypotension (low blood pressure), disorientation, hallucinations, joint pain, muscle pain, disturbances in taste sensation or loss of taste.
Frequency not known (frequency cannot be estimated from available data):
Hypersensitivity reactions with chest pain or abdominal pain, persistent symptoms of low blood sugar levels.
Additionally, the treating physician may detect changes in blood or urine test results.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform the physician or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Agregex

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Aluminium//Aluminium blisters: Do not store above 30°C.
PVC/PE/PVDC//Aluminium blisters: Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Agregex 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, crospovidone (type A), glyceryl dibehenate, talc.
Tablet coating: Opadry II 85G34669 Pink: polyvinyl alcohol, talc, macrogol 3350, soy lecithin (soybean oil) (E 322), titanium dioxide (E 171), iron oxide red (E 172).

What Agregex looks like and contents of the pack
Film-coated tablet.
Pink, round, biconvex film-coated tablet with a diameter of 9 mm, imprinted with "I" on one side.
Pack types:
Aluminum//Aluminum or PVC/PE/PVDC//Aluminum blisters in a cardboard box: 28, 56 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Hungary, 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 in:
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
Marketing authorisation numbers in Hungary, country of export: OGYI-T-21097/03
OGYI-T-21097/04
Parallel import licence number: 93/19
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Cyprus Agregex
Malta Agregex
Poland Agregex
Translation of the day-of-the-week symbols located next to each tablet on the immediate packaging:
H - Monday
K - Tuesday
SZE - Wednesday
CS - Thursday
P - Friday
SZO - Saturday
V - Sunday