Clopidogrel Krka 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clopidogrel Krka 75 mg film-coated tablets EFG

clopidogrel

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Clopidogrel Krka

3. How to take Clopidogrel Krka

4. Possible adverse effects

5. How to store Clopidogrel Krka

6. Contents of the pack and other information

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

Clopidogrel Krka contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells found in the blood that clump together when blood clots. Antiplatelet medicines prevent this clumping, thereby reducing the possibility of blood clots forming (a process known as thrombosis).

Clopidogrel Krka is given to adults to help prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack or death).

You have been prescribed Clopidogrel Krka to help prevent blood clots and reduce the risk of these serious events because:

• you have a condition causing hardening of the arteries (also called atherosclerosis), and

• you have previously had a heart attack, stroke, or have a condition called peripheral arterial disease, or

• you have experienced a severe type of chest pain known as “unstable angina” or “heart attack”. For the treatment of this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots).

• you have an irregular heartbeat, a condition called “atrial fibrillation”, and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) that prevent new clots from forming and stop existing clots from growing. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Clopidogrel Krka and acetylsalicylic acid for this condition. Your doctor will have prescribed Clopidogrel Krka together with acetylsalicylic acid if you cannot take “oral anticoagulants” and you do not have a high risk of serious bleeding.

2. What you need to know before taking Clopidogrel Krka

Do not take Clopidogrel Krka

• If you are allergic to clopidogrel or to any of the other ingredients of this medicine (listed in section 6);
• If you have active bleeding, such as a stomach ulcer or bleeding in the brain;
• If you have severe liver disease.

If you think any of these may apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel Krka.

Warnings and precautions

Before starting treatment with Clopidogrel Krka, inform your doctor if you are in any of the following situations:

• If you are at risk of bleeding because:

• you have a condition that increases the risk of internal bleeding (such as a stomach ulcer).

• you have a blood disorder that predisposes you to internal bleeding (bleeding into tissues, organs, or joints).

• you have recently suffered a serious injury.

• you have recently undergone surgery (including dental surgery).

• you are scheduled to undergo surgery (including dental surgery) within the next seven days.

• If you have had a blood clot in a brain artery (ischaemic stroke) within the last 7 days.

• If you have liver or kidney disease.

• If you have had an allergy or reaction to any medicine used to treat your condition.

During treatment with Clopidogrel Krka:

• Inform your doctor if you are scheduled for surgery (including dental surgery).

• Inform your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bruises) under the skin which may appear as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).

• If you get a cut or wound, bleeding may take longer than usual to stop. This is related to how the medicine works, as it reduces the blood’s ability to form clots. For minor cuts or wounds, such as those occurring during shaving, this is not significant. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “Possible side effects”).

• Your doctor may ask you to have blood tests.

Children and adolescents

This medicine should not be given to children because it is not effective.

Other medicines and Clopidogrel Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect the use of Clopidogrel Krka or vice versa.

You must specifically inform your doctor if you are taking:

• medicines that may increase the risk of bleeding such as:

  • oral anticoagulants, medicines used to reduce blood clotting,

• non-steroidal anti-inflammatory drugs, medicines generally used to treat pain and/or inflammation of muscles or joints,

• heparin, or any other injectable medicine used to reduce blood clotting,

• ticlopidine, another antiplatelet agent,

• • a serotonin reuptake inhibitor (such as fluoxetine or fluvoxetine and other drugs of the same type), medicines commonly used to treat depression,

• omeprazole or esomeprazole, medicines used to treat stomach discomfort,

• fluconazole or voriconazole, medicines used to treat fungal infections,

• efavirenz, a medicine used to treat HIV (human immunodeficiency virus) infection,

• carbamazepine, a medicine used to treat certain forms of epilepsy,

• moclobemide, a medicine for depression,

• repaglinide, a medicine used to treat diabetes,

• paclitaxel, a medicine used to treat cancer,

• antiretrovirals (medicines used to treat HIV infection).

If you have experienced severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Clopidogrel Krka in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. A single dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) generally should not cause any problems, but prolonged use under other circumstances should be discussed with your doctor.

Taking Clopidogrel Krka with food and drink

Clopidogrel Krka can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you may be pregnant, you must inform your doctor or pharmacist before taking Clopidogrel Krka. If you become pregnant while taking Clopidogrel Krka, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

If you are breastfeeding or plan to breastfeed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unlikely that Clopidogrel Krka will affect your ability to drive or operate machinery.

3. How to take Clopidogrel Krka

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose, including for patients with a condition called “atrial fibrillation” (an irregular heartbeat), is one 75 mg Clopidogrel Krka tablet daily, taken orally, with or without food, and at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 mg of Clopidogrel Krka (4 tablets of 75 mg) to be taken once at the beginning of treatment. After this, the recommended dose is one 75 mg Clopidogrel Krka tablet daily, as described above.

You should take Clopidogrel Krka for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Krka than you should

Contact your doctor or go to the nearest hospital emergency department, as there is an increased risk of bleeding.

If you forget to take Clopidogrel Krka

If you forget to take a dose of Clopidogrel Krka but remember within 12 hours of the scheduled time, take the tablet immediately and then take the next dose at the usual time.

If more than 12 hours have passed, simply take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel Krka

Do not stop your treatment unless your doctor tells you to do so. Contact your doctor or pharmacist before stopping this medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• Fever, signs of infection, or extreme tiredness. These symptoms may be due to a rare decrease in certain blood cells.

• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots and/or confusion (see section 2 “Warnings and precautions”).

• Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequently reported adverse effect with Clopidogrel Krka is bleeding.

Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial, pulmonary or joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel Krka

If you cut yourself or sustain a wound, bleeding may take slightly longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents the blood's ability to form clots. For minor cuts or wounds, such as during shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”).

Other adverse effects include:

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

Diarrhoea, abdominal pain, indigestion or heartburn.

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

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin rashes, itching, dizziness, tingling and numbness.

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

Dizziness, breast enlargement in men.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with coughing; generalized allergic reactions (for example, generalized feeling of warmth with sudden malaise up to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth mucosa (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

Adverse effects with unknown frequency (cannot be estimated from available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

Additionally, your doctor may observe changes in the results of your blood or urine tests.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Krka

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel Krka

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).

• The other components are: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000 and hydrogenated castor oil in the tablet core; and polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000 in the film coating.

Appearance of Clopidogrel Krka and contents of the pack

Film-coated tablets are pink, round and slightly convex.

Packs of 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 film-coated tablets in blisters.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/.