Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Agregex (Clopidogrel Actavis)
75 mg, coated tablets
Clopidogrelum
Agregex and Clopidogrel Actavis are different brand names of the same medicine.
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Contents of the leaflet

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 (in the form of clopidogrel hydrogen sulfate) 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 blood clots (thrombi) in atherosclerotic blood vessels (arteries), which may lead to serious atherosclerotic events (such as stroke, heart attack or death).
Agregex has been prescribed for you to prevent blood clots and reduce the risk of such serious events because:

you have hardening of the arteries (also known as atherosclerosis), and
you have previously had a heart attack, stroke, or have a condition known as 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 effective 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 transient ischemic 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 you cannot take medicines called "oral anticoagulants"
(antagonists of vitamin K), 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 taking Aggregex.
Warnings and precautions
Before starting treatment with 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 that makes internal bleeding (bleeding into tissues, organs or joints) more likely,
recent serious injury,
recent surgery (including dental surgery),
planned surgery (including dental surgery) within the next seven days.
if the patient has been diagnosed with 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 had an allergic reaction or other adverse reaction to medications used in treatment,
if the patient has previously experienced a non-traumatic brain haemorrhage.

While taking Aggregex:

Inform your doctor if the patient is scheduled for surgery (including dental surgery).
Also inform your doctor immediately if the patient develops a medical condition (called thrombotic thrombocytopenic purpura), which includes fever and bruising under the skin, 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 the way the medicine works, as it prevents the formation of blood clots. This usually does not cause problems after 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 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 (not 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 during pregnancy and breastfeeding is not recommended.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, 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 speak with 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 soya lecithin (soybean oil) (E 322)
Do not use this medicine if the patient is allergic to peanuts or soya.

3. How to take Agregex

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
ask your doctor or pharmacist.
The recommended dose, including for patients with a condition called "atrial fibrillation" (irregular
heartbeat), is one Agregex tablet, 75 mg, once daily, taken orally with or without food, at the same
time each day.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe
a single initial dose of 300 mg or 600 mg (4 or 8 tablets of 75 mg). After that, the recommended dose
is one 75 mg Agregex tablet daily, taken as described above.
If you have experienced symptoms of stroke that resolve quickly (also known as transient ischaemic
attack) or a mild stroke, your doctor may prescribe a single initial dose of 300 mg Agregex (4 tablets
of 75 mg). After that, the recommended dose is one Agregex tablet, 75 mg, once daily, as described
above, together with acetylsalicylic acid for 3 weeks. After this period, your doctor may prescribe
Agregex or acetylsalicylic acid separately.
Continue taking Agregex for as long as your doctor recommends.
Taking more Agregex than you should
Contact your doctor or the nearest hospital emergency department immediately, as there is an
increased risk of bleeding.
If you forget to take Agregex
If you forget to take a dose of Agregex but remember within 12 hours, take the tablet immediately,
then take the next tablet at your usual time.
If you forget for more than 12 hours, simply take the next single dose at your usual time. Do not take
a double dose to make up for a missed dose.
For 28-tablet packs, you can check the day you last took your Agregex tablet using the calendar
printed on the blister. See also section (at the end of the leaflet):
“Translation of abbreviations for days of the week appearing on the blister”.
Stopping Agregex
Do not stop taking this medicine unless your doctor tells you to. Before stopping treatment,
contact your doctor or pharmacist.
If you have any further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact the treating physician immediately if the patient experiences:

fever, signs of infection, or a feeling of extreme fatigue. This may be due to a rare reduction in the number of certain blood cells (blood cells)
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 rashes and itching, skin blisters. These may be symptoms of allergic reactions.

The most common adverse reaction reported during treatment with Aggregex is
bleeding.
Bleeding may occur as gastrointestinal bleeding, bruising, haematomas (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. A small number of cases of bleeding in the eye, brain, lungs, or joints have also been reported.
If prolonged bleeding occurs while taking Aggregex
In case of cuts or injuries, the time it takes for bleeding to stop may be slightly longer than usual. This is related to the mechanism of action of the medicine, as it prevents the formation of blood clots. This usually does not cause problems with minor cuts or injuries, such as shaving cuts. 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 (enlargement of the breasts in males).
Very rare (may affect up to 1 in 10,000 patients):
Jaundice, severe abdominal pain with or without back pain, fever, breathing difficulties, 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, 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.
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 your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 Aggregex

Keep this medicine out of 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.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Agregex contains

The active substance is clopidogrel (as clopidogrel hydrogen sulfate). Each coated tablet contains 75 mg of clopidogrel.
The other ingredients are: lactose, microcrystalline cellulose, crospovidone (type A), glyceryl dibehenate, talc. Coating Opadry II 85G34669 Pink: polyvinyl alcohol, talc, polyethylene glycol 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
Pink, round, biconvex coated tablet with a diameter of 9 mm, embossed with "I" on one side.
Al/Al blisters containing 28, 30, 60 or 90 coated tablets, packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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 Marketing Authorisation Numbers, country of export: OGYI-T-21097/01
OGYI-T-21097/03
OGYI-T-21097/05
OGYI-T-21097/09
Parallel Import Licence Number: 801/15
Translation of weekday abbreviations appearing on the blister:
H - Monday
K - Tuesday
SZE - Wednesday
CS - Thursday
P - Friday
SZO - Saturday
V - Sunday