Agregex

Package leaflet: 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
Clopidogrelum
Agregex and Clopidogrel Actavis are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms of illness are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Agregex is and what it is 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 pack and other information

1. What Agregex is and what it is used for

Agregex contains clopidogrel (as 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 chance of blood clots (a
process known as thrombosis). Agregex is used in adult patients to prevent blood clots (thrombi) in
arteries hardened by atherosclerosis, which could lead to serious events in symptomatic atherosclerotic disease (such as stroke, heart attack or death).
Agregex has been prescribed for you 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 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 placed a stent in a blocked or narrowed artery to restore effective blood flow. Your doctor should also prescribe acetylsalicylic acid (a substance found in many medicines used both to relieve pain and reduce fever, as well as to prevent blood clotting).
• you have experienced transient symptoms of stroke (so-called transient ischaemic attack) 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" (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 high risk of severe bleeding, your doctor should prescribe Agregex with acetylsalicylic acid.

2. Important information before using Aggregex

When not to use Aggregex

• if the patient is allergic to clopidogrel, soy lecithin (soybean oil), arachis 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 Aggregex, discuss this with a 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 causing susceptibility to internal bleeding (bleeding into tissues, organs, or joints)
  • recent serious injury
  • recent surgical procedure (including dental surgery)
  • planned surgical procedure (including dental surgery) within the next seven days
• if the patient has had a cerebral artery clot (ischaemic stroke) 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 non-traumatic intracranial haemorrhage.

While taking Aggregex:

• Inform the doctor if the patient is scheduled for a surgical procedure (including dental surgery).
• Also inform the doctor immediately if the patient develops a medical condition called thrombotic thrombocytopenic purpura, which includes 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 the way the medicine works, as it prevents blood clots. This usually does not cause problems with minor cuts or injuries, such as shaving cuts. However, if bleeding occurs, contact the doctor immediately (see section 4).
• The doctor may order blood tests.

Children and adolescents
Do not use this medicine in children, as it has not been shown to be effective in this patient group.
Aggregex with other medicines
Tell the 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 the doctor if any of the following medicines are being used:

• 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 the 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 myocardial infarction), 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 a problem, 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 plans 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 plans to breastfeed, she should speak with her doctor before taking this medicine.
Before taking any medicine, consult a 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 previously been diagnosed with an intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
Aggregex contains soy 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 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 Aggregex 75 mg tablet once daily, taken orally with or without food, at the same
time each day.
If the patient has experienced severe chest pain (unstable angina or heart attack), the treating doctor
may prescribe an initial loading dose of 300 mg or 600 mg (4 or 8 tablets of 75 mg). After that, the
recommended dose is one 75 mg Aggregex tablet daily, taken as described above.
If the patient has experienced stroke symptoms that resolve quickly (also known as transient
ischaemic attack) or mild stroke, the doctor may prescribe a single loading dose of 300 mg Aggregex
(4 tablets of 75 mg) at the start of treatment. Then 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.
Continue taking Aggregex for as long as your doctor recommends.

Taking more Aggregex than recommended
Contact your doctor or the nearest hospital emergency department immediately, as there is an
increased risk of bleeding.

If you forget to take Aggregex
If you forget to take a dose of Aggregex but remember within 12 hours, take the tablet immediately,
then take the next tablet at your usual time.
If you remember more than 12 hours later, simply take the next single dose at your usual time. Do
not take a double dose to make up for a missed dose.
On the packaging (28 tablets), you can check the day on which you last took an Aggregex tablet.
The translation of abbreviations for days of the week on the immediate packaging is provided below
(see: "Translation of symbols for days of the week located next to each tablet on the immediate packaging" at the end of this leaflet).

Stopping Aggregex
Do not stop treatment unless advised by your doctor. Before stopping the medicine, consult your
doctor or pharmacist.
If you have any further questions about the use of 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 commonly reported adverse reaction 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 into 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 those occurring during shaving. However, if bleeding occurs, you should 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 sensations.
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, 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 also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 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.
PVC/PE/PVDC//Aluminium blisters: Do not store above 25°C.
Aluminium//Aluminium blisters: 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 tablet contains 75 mg of clopidogrel.
• Other ingredients: lactose, microcrystalline cellulose, crospovidone (type A), glycerol dibeheniate, talc. Film-coat 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
Pink, round, biconvex film-coated tablet with a diameter of 9 mm, embossed with "I" on one side.
Pack types:
PVC/PE/PVDC//Aluminium blisters in cardboard box: 28 film-coated tablets.
Aluminium//Aluminium blisters in cardboard box: 28 film-coated 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
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 Samokovsko Shosse Str., Dupnitsa, 2600, Bulgaria

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź

Marketing Authorisation Numbers in Hungary, country of export: OGYI-T-21097/03
OGYI-T-21097/04
Parallel Import Authorisation Number: 94/21

Translation of weekday symbols located next to each tablet on the immediate packaging:
H – Monday
K – Tuesday
SZE – Wednesday
CS – Thursday
P – Friday
SZO – Saturday
V – Sunday