Clopidogrel Medreg

Package Leaflet: Information for the Patient

Clopidogrel Medreg, 75 mg, Film-Coated Tablets

Clopidogrel

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

• You should 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Clopidogrel Medreg and what is it used for
• 2. Important information before taking Clopidogrel Medreg
• 3. How to take Clopidogrel Medreg
• 4. Possible side effects
• 5. How to store Clopidogrel Medreg
• 6. Contents of the pack and other information

1. What is Clopidogrel Medreg and what is it used for

Clopidogrel Medreg contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small blood cells which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chance of blood clots forming.

Clopidogrel Medreg is used to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries) in adults, which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).

Clopidogrel Medreg is given to prevent blood clots and reduce the risk of these serious events because:

• the patient has a condition called atherothrombosis (which can lead to a heart attack or stroke), and
• the patient has previously experienced a heart attack, stroke, or has a condition known as peripheral arterial disease, or
• the patient has experienced severe chest pain (unstable angina or myocardial infarction). To treat this condition, a doctor may place a stent in the blocked or narrowed artery to restore effective 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 experienced symptoms of a stroke that have resolved within a short period (called a transient ischaemic attack) or a mild ischaemic 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 known as 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 combination of acetylsalicylic acid and Clopidogrel Medreg. If oral anticoagulants cannot be used and there is no risk of severe bleeding, the doctor should prescribe Clopidogrel Medreg with acetylsalicylic acid.

2. Important information before taking Clopidogrel Medreg

When not to take Clopidogrel Medreg

• if the patient is allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6)
• if the patient has a condition that is currently 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 these apply to them, or have any other concerns, they should discuss this with their doctor before taking Clopidogrel Medreg.

Warnings and precautions

Before starting treatment with Clopidogrel Medreg, the patient should discuss the following with their doctor or pharmacist:

• if there is a risk of bleeding, such as:
• a condition that increases the risk of internal bleeding (such as a stomach ulcer)
• a blood disorder that increases the risk of internal bleeding (bleeding into tissues, organs, or joints)
• a recent severe injury
• a recent surgical procedure (including dental surgery)
• a planned surgical procedure (including dental surgery) within the next seven days
• if the patient has had a blood clot in the brain (ischaemic stroke) within the last seven days
• if the patient has kidney or liver disease
• if the patient has had an allergy or hypersensitivity to any medicines used to treat this condition
• if the patient has had a non-traumatic brain haemorrhage.

While taking Clopidogrel Medreg:

• The patient should inform their doctor if they are planning to have surgery (including dental surgery).
• The patient should also immediately inform their doctor if they experience a condition known as thrombotic thrombocytopenic purpura (TTP), characterized by fever, bruising under the skin, and extreme fatigue, with or without confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• In the event of a cut or injury, the time it takes for the bleeding to stop may be slightly longer than usual. This is due to the way the medicine works, as it prevents the formation of blood clots. This usually does not cause problems with minor cuts and injuries, such as cuts while shaving. However, if bleeding occurs, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").
• 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 group of patients.

Clopidogrel Medreg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, including those obtained without a prescription.

Some medicines may affect the way Clopidogrel Medreg works, or Clopidogrel Medreg may affect the way other medicines work.

In particular, the patient should inform their doctor if they are taking:

• medicines that may increase the risk of bleeding, such as:
• oral anticoagulants, medicines used to prevent blood clotting
• non-steroidal anti-inflammatory medicines, usually used to treat painful and/or inflammatory conditions of the muscles or joints
• heparin or other injectable medicines used to reduce blood clotting
• ticlopidine and other antiplatelet medicines
• selective serotonin reuptake inhibitors (including fluoxetine and fluvoxamine), medicines usually 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: during treatment with clopidogrel, the patient should inform their doctor before being prescribed any opioid (medicines used to treat severe pain)
• rosuvastatin (a medicine used to reduce cholesterol levels).

Patients who have experienced severe chest pain (unstable angina or myocardial infarction), a transient ischaemic attack, or a mild ischaemic stroke may be prescribed Clopidogrel Medreg in combination 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 a doctor.

Clopidogrel Medreg with food and drink

Clopidogrel Medreg can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor for advice before taking this medicine.

If the patient becomes pregnant while taking Clopidogrel Medreg, they should immediately consult their doctor.

This medicine should not be used during pregnancy.

This medicine should not be used during breastfeeding.

If the patient is breastfeeding or plans to breastfeed, they should ask their doctor for advice before taking this medicine.

Before taking any medicine, the patient should ask their doctor or pharmacist for advice.

Driving and using machines

Clopidogrel Medreg is unlikely to affect the ability to drive or use machines.

Clopidogrel Medreg contains lactose

If the patient has been told they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

Clopidogrel Medreg contains hydrogenated castor oil

This may cause stomach upset or diarrhoea.

3. How to take Clopidogrel Medreg

This medicine should always be taken exactly as the doctor or pharmacist has told the patient.

If the patient is unsure, they should ask their doctor or pharmacist.

The recommended dose of Clopidogrel Medreg is one 75 mg tablet per day, to be taken orally, at the same time each day, with or without food. This dosage applies to patients with a condition known as atrial fibrillation (irregular heartbeat).

If the patient has experienced severe chest pain (unstable angina or myocardial infarction), the doctor may prescribe an initial dose of 300 mg or 600 mg of clopidogrel (4 or 8 tablets of 75 mg). Then, the recommended dose of Clopidogrel Medreg is one 75 mg tablet per day, as described above.

If the patient has experienced symptoms of a stroke that have resolved within a short period (called a transient ischaemic attack) or a mild ischaemic stroke, the doctor may prescribe an initial dose of 300 mg of Clopidogrel Medreg (1 tablet of 300 mg or 4 tablets of 75 mg). Then, the recommended dose is one 75 mg tablet of Clopidogrel Medreg per day, as described above, with acetylsalicylic acid for 3 weeks. Then, the doctor may prescribe Clopidogrel Medreg or acetylsalicylic acid separately.

Clopidogrel Medreg should be taken for as long as the doctor has prescribed.

What to do if the patient takes more Clopidogrel Medreg than they should

The patient should contact their doctor or the nearest hospital emergency department immediately, due to an increased risk of bleeding.

What to do if the patient forgets to take Clopidogrel Medreg

If the patient forgets to take a dose of Clopidogrel Medreg, but remembers within 12 hours of the time the dose was due, they should take the tablet immediately, and then take the next tablet at the scheduled time.

If the patient forgets for more than 12 hours, they should take the next single dose at the scheduled time. The patient should not take a double dose to make up for the forgotten tablet.

What to do if the patient stops taking Clopidogrel Medreg

The patient should not stop treatment unless their doctor tells them to.Before stopping treatment, the patient should contact their doctor or pharmacist.

If the patient has any further questions on the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately contact their doctor if they experience:

• fever, signs of infection, or extreme fatigue. This could be due to a rare decrease in the number of certain blood cells.
• signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, which appears under the skin as red pinpoint dots, and/or confusion (see section 2 "Warnings and precautions").
• swelling of the mouth or skin disorders, such as rashes and itching, blisters. These could be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Medreg is bleeding

Bleeding may occur as stomach or intestine bleeding, bruising, haematoma (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, inside the head, lungs, or joints.

If the patient experiences prolonged bleeding when taking Clopidogrel Medreg

In the event of a cut or injury, the time it takes for the bleeding to stop may be slightly longer than usual. This is due to the way the medicine works, as it prevents the formation of blood clots. This usually does not cause problems with minor cuts and injuries, such as cuts while shaving. However, if bleeding occurs, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").

Other side effects include:

Common(may affect up to 1 in 10 people):

Diarrhoea, abdominal pain, indigestion, or heartburn.

Uncommon(may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, feeling of tingling or numbness.

Rare(may affect up to 1 in 1,000 people):

Vertigo, gynaecomastia (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 associated with cough; generalized allergic reactions (for example, general feeling of heat with sudden general malaise leading to fainting); swelling of the mouth; blistering skin; skin allergy; stomatitis (inflammation of the mucous membrane of the mouth); low blood pressure; confusion; 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 low blood sugar.

The doctor may also find changes in the results of blood or urine tests.

Reporting of side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, [insert contact details], or to the manufacturer.

5. How to store Clopidogrel Medreg

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date refers to the last day of that month.

There are no special storage conditions for this medicine.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines no longer required.

This will help to protect the environment.

6. Contents of the pack and other information

What Clopidogrel Medreg contains

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogensulphate).
• The other ingredients are: Tablet core: lactose, hypromellose, hydroxypropylcellulose, microcrystalline cellulose, hydrogenated castor oil, colloidal silica, anhydrous Tablet coating: hypromellose, Opadry II 31K34575 Pink (lactose monohydrate, hypromellose 15cP, titanium dioxide (E 171), triacetin, iron oxide red (E 172)).

What Clopidogrel Medreg looks like and contents of the pack

Pink, round, biconvex film-coated tablets (approximately 8.7 mm in diameter), smooth on both sides.

The tablets are available in blisters of OPA/Aluminium/PVC/Aluminium, in a cardboard box.

Available pack sizes: 14, 20, 28, 30, 56, 60, 84, 90, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Medreg s.r.o.

Na Florenci 2116/15

Nové Město

110 00 Prague 1

Czech Republic

Phone: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.

Výrobní závod Bolatice

Průmyslová 961/16

747 23 Bolatice

Czech Republic

Pharmazet Group s.r.o.

Třtinová 260/1

Čakovice

196 00 Prague 9

Czech Republic

This medicine is authorised in the Member States of the European Economic Area under the following names:

Czech Republic:

Clopidogrel Medreg

Poland:

Clopidogrel Medreg

Romania:

Clopidogrel Gemax Pharma 75 mg film-coated tablets

Slovakia:

Clopidogrel Medreg

Date of last revision of the package leaflet: