Package leaflet: Information for the user

Clopidix 75 mg film-coated tablets
Clopidogrel

Read the entire leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Clopidix is and what it is used for
What you need to know before taking Clopidix
How to take Clopidix
Possible side effects
How to store Clopidix
Contents of the pack and other information

1. What Clopidix is and what it is used for

Clopidix 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).

Clopidix is used in adults to help prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process linked to atherosclerosis, which can lead to serious events such as stroke, heart attack, or death.

Clopidix is prescribed to prevent blood clots and reduce the risk of such serious events when:

you have atherosclerosis (also known as atherosclerotic disease), 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 proper blood flow. Your 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).
you have an irregular heartbeat known as “atrial fibrillation” and you cannot take medicines called “oral anticoagulants” (vitamin K antagonists), which prevent the formation and growth of existing blood clots.

Your doctor should inform you that oral anticoagulants are more effective than acetylsalicylic acid or the combination of acetylsalicylic acid with Clopidix in such cases. If oral anticoagulants cannot be used and there is no high risk of severe bleeding, your doctor may prescribe Clopidix together with acetylsalicylic acid.

2. Important information before using Clopidix

When not to use Clopidix:

if the patient has a known allergy (hypersensitivity) to clopidogrel or to 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 within the brain;
if the patient has severe liver disease.

If the patient thinks any of these conditions apply, or has any other doubts,
they should consult their doctor before taking Clopidix.
Warnings and precautions:
If any of the situations listed below apply to the patient, they should inform their doctor before taking
Clopidix:

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 predisposing to internal bleeding (bleeding within tissues, organs or joints),
- recent severe injury,
- recent surgery (including dental procedures),
- planned surgery (including dental procedures) within the next seven days;
if the patient has been diagnosed with arterial blockage 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 had an allergy or hypersensitivity to any medicines used to treat this condition;
if the patient has previously experienced non-traumatic intracranial haemorrhage.

While taking Clopidix:

The patient should inform their doctor if surgery (including dental procedures) is planned.
The patient should also immediately inform their doctor if they develop a condition called thrombotic thrombocytopenic purpura (TTP), which may present with fever and small, pinpoint, red spots under the skin (petechiae), with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
In case of cuts or injuries, the time it takes for bleeding to stop may be slightly longer than usual. This is due to the way the medicine works, 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,

the patient should contact their doctor immediately (see section 4
"Possible side effects").

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.
Clopidix with other medicines:
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those available without a prescription.
Some other medicines may affect the action of Clopidix and vice versa.
In particular, inform the doctor if the patient is taking:

medicines that may increase the risk of bleeding, such as:
- oral anticoagulants, medicines used to inhibit blood clotting,
- non-steroidal anti-inflammatory drugs (NSAIDs), usually used to treat pain and/or inflammation of muscles or joints,
- heparin or other injectable medicines used to reduce blood clotting,
- ticlopidine or other antiplatelet medicines,
- selective serotonin reuptake inhibitors (SSRIs) (including, but not limited to, fluoxetine or fluvoxamine), medicines usually used to treat 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 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: during treatment with clopidogrel, the patient should inform the doctor before any opioid (medicines used to treat severe pain) is prescribed,
rosuvastatin (a medicine used to lower cholesterol levels).

Patients who have experienced severe chest pain (unstable angina or heart attack) may be prescribed Clopidix in combination 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) usually should not cause a problem, but prolonged use on other occasions should be discussed with the doctor.
Clopidix with food and drink
Clopidix may be taken with or without food.
Pregnancy and breastfeeding:
Use of this medicine during pregnancy is not recommended.
If the patient is pregnant or suspects she might be pregnant, or if she plans to become pregnant, she should consult her doctor or pharmacist before taking Clopidix. If the patient becomes pregnant while taking Clopidix, she should contact her doctor immediately, as use of clopidogrel during pregnancy is not recommended.
This medicine should not be used during breastfeeding.
If the patient is breastfeeding or plans to breastfeed, she should consult her doctor before taking this medicine.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
Clopidix is not expected to affect the ability to drive or operate machinery.
Clopidix contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars (e.g. lactose), they should contact their doctor before taking this medicine.
Clopidix contains soya oil
The medicine contains soya oil. Do not use if there is a known hypersensitivity to peanuts or soya.

3. How to use Clopidix

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended dose of Clopidix is 75 mg once daily, taken orally at the same time each day, with or
without food. This dose also applies to patients with a condition known as "atrial fibrillation" (irregular heartbeat).
If a patient has experienced severe chest pain (unstable angina or heart attack), the treating doctor may
prescribe an initial dose of 300 mg or 600 mg of Clopidix (4 or 8 tablets of 75 mg) immediately at the start
of treatment. Afterwards, the recommended dose of Clopidix is one tablet of 75 mg daily (as described above).
Clopidix should be taken for as long as directed by the treating doctor.
Taking more Clopidix than recommended
Contact your treating doctor or the nearest hospital emergency department due to increased risk of bleeding.
If you forget to take Clopidix:
If a patient forgets to take a dose of Clopidix but remembers within 12 hours of the usual time, 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 tablet.
Stopping treatment with Clopidix
Do not stop treatment unless advised by your doctor. Before stopping the medicine, consult your
treating doctor or pharmacist.
If you have any further doubts 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.
You should contact the doctor 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;
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 confusion (see section 2 "Warnings and precautions");
swelling of the lips or skin disorders such as rashes and itching, or skin blisters. These may be symptoms of allergic reactions. The most common adverse reaction reported during treatment is bleeding. Bleeding may occur as gastrointestinal bleeding, bruising, haematoma (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. A small number of cases of bleeding inside the eye, brain, lungs, or joints have also been reported.

If prolonged bleeding occurs while taking Clopidix
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 from forming. This usually does not cause problems with minor cuts or injuries, such as small cuts while shaving. However, if bleeding occurs, you should contact your doctor immediately (see section 2 "Warnings and precautions").
Other adverse reactions reported during clopidogrel use include:
Common (may affect 1 in 10 people): diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon (may affect 1 in 100 people): headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness.
Rare (may affect 1 in 1,000 people): vertigo, gynaecomastia (enlargement of the breasts in males).
Very rare (may affect 1 in 10,000 people): jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing, sometimes associated with cough, generalized allergic reactions (e.g. general feeling of warmth with sudden general malaise up to fainting), swelling of the lips, skin blisters, skin allergy, inflammation of the oral mucosa (stomatitis), low blood pressure, confusion, hallucinations, joint pain, muscle pain, taste disturbances 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, changes in blood or urine test results may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Clopidix medicine

Keep out of the reach and sight of children.
Do not use Clopidix after the expiry date stated on the carton and blister pack.
Store below 25°C and protect from moisture.
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 pack and other information

What the medicine Clopidix contains
The active substance in Clopidix is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
The other ingredients are:
in the tablet core: stearic acid, hydrogenated vegetable oil, pregelatinized starch 1500, anhydrous colloidal silicon dioxide, mannitol 200SD,
in the coating Opadry II White: hypromellose, lactose monohydrate, polyethylene glycol 3350, titanium dioxide, triacetin.

What Clopidix looks like and contents of the pack
Clopidix 75 mg tablets are film-coated, round, biconvex, with a smooth surface, free from spots and defects, white to cream in colour.
OPA/Aluminum/PVC/Aluminum blisters are packed together with the leaflet in a cardboard box.
The pack contains 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
Ostrzykowizna 14 A
05-170 Zakroczym
tel.: +(48) (22) 785 27 60
fax: +(48) (22) 785 27 60 ext. 106
26.09.2023