Leaflet: information for the user

Clopidogrel Krka 75 mg film-coated tablets

clopidogrel

Read this 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, as it may harm them.

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

1. How to take Clopidogrel Krka

1. Possible side effects
2. Storage of Clopidogrel Krka

1. Contents of the pack and additional information

Clopidogrel Krka contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells that are found in the blood, and they aggregate when the blood clots. Antiplatelet agents, by preventing this aggregation, reduce the possibility of blood clots (a process known as thrombosis) forming.

Clopidogrel Krka is administered to adults to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, and which may cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

Clopidogrel Krka has been prescribed to help prevent blood clots from forming and reduce the risk of these serious events because:

• you suffer from a process that produces the hardening of the arteries (also known as atherosclerosis), and
• you have previously suffered a myocardial infarction, a cerebral infarction, or suffer from a disease known as peripheral arterial disease, or
• you have previously suffered a severe chest pain, known as “unstable angina” or “myocardial infarction”. For the treatment of this disease, your doctor may have to place a stent in the obstructed or narrowed artery to restore adequate blood flow. It is possible that your doctor has also prescribed acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots from forming).

• you have an irregular heartbeat, a disease known as “atrial fibrillation”, and cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of Clopidogrel Krka and acetylsalicylic acid for this disease. Your doctor has prescribed Clopidogrel Krka with acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

Do not take Clopidogrel Krka

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

If you think this may affect 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 have a risk of bleeding (bleeding) because:

• If you have had a clot in a brain artery (ischemic cerebral infarction) in the last 7 days.

• If you have liver or kidney diseases.

• If you have had an allergy or reaction to any medication used to treat your disease.

During treatment with Clopidogrel Krka:

• Inform your doctor if you have a scheduled 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 hematomas (bruises) under the skin that may appear as localized red spots, accompanied or not by extreme fatigue, confusion, yellow color in the skin or eyes (jaundice) (see section 4 "Possible side effects").

• If you cut or get a wound, bleeding may take longer than usual to stop. This is related to the way the medication works, as it prevents the blood from forming clots. For minor cuts or wounds, such as cutting during shaving, this is not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 4 "Possible side effects").

• Your doctor may ask you to have blood tests.

Children and adolescents

This medication should not be administered to children because it is not effective.

Other medications and Clopidogrel Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

You must inform your doctor explicitly if you are taking:

• Medications that may increase the risk of bleeding, such as:
• • Oral anticoagulants, medications used to reduce blood clotting,

• • An inhibitor of serotonin reuptake (such as fluoxetine or fluvoxamine and other medications of the same type), medications used to treat depression,
• Omeprazole or esomeprazole, medications to treat stomach discomfort,

• Fluconazole or voriconazole, medications to treat fungal infections,
• Efavirenz, a medication to treat HIV infections (human immunodeficiency virus),

• Carbamazepine, a medication to treat some forms of epilepsy,

• Moclobemide, a medication for depression,
• Repaglinide, a medication to treat diabetes,

• Paclitaxel, a medication to treat cancer,

• Antiretrovirals (medications to treat HIV infection).

If you have had 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 medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid administered sporadically (not exceeding 1,000 mg in 24 hours) generally should not cause any problems, but prolonged use in other circumstances should be consulted with your doctor.

Taking Clopidogrel Krka with food and drinks

Clopidogrel Krka can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medication during pregnancy.

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

You should not breastfeed while taking this medication.

If you are breastfeeding or plan to do so, inform your doctor before taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

If you have experienced severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Clopidogrel Krka (4 tablets of 75 mg) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg Clopidogrel Krka tablet per day 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 a higher risk of bleeding.

If you forget to take Clopidogrel Krka

If you forget to take a dose of Clopidogrel Krka but remember before 12 hours have passed since the time you should have taken the medication, take the tablet immediately and the next one at the usual time.

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

If you interrupt treatment with Clopidogrel Krka

Do not stop your treatmentunless your doctor tells you to.Contact your doctor or pharmacist before stopping this medication.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

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

• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), associated or not with bleeding that appears under the skin as red spots and/or confusion (see section 2 “Warnings and precautions”).

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

The most frequent side effect reported with Clopidogrel Krka is bleeding.

Bleeding may occur in the stomach or intestine, bruises, hematomas (abnormal bleeding or bruises under the skin), nasal bleeding, blood in urine. Also, a reduced number of cases of: bleeding of the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding have been reported.

If you experience prolonged bleeding while taking Clopidogrel Krka

If you cut or get a wound, it is possible that bleeding may take a little longer to stop than normal. 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 cutting during shaving, this usually does not matter. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”).

Other side effects include:

Frequent side effects (may affect up to 1 in 10 people):

Diarrhea, abdominal pain, indigestion, or heartburn.

Rare side effects (may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestine, rashes, itching, dizziness, tingling, and numbness.

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

Dizziness, breast enlargement in men.

Very rare side 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 cough; generalized allergic reactions (e.g., feeling of general heat with sudden general discomfort until fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

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

Your doctor may also observe changes in your blood or urine test results.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton and on the blister pack after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. By doing so, you will help protect the environment.

Clopidogrel Krka Composition

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

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

Appearance of Clopidogrel Krka and packaging contents

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

Blister packs containing 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112, and 120 film-coated tablets.

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 more information about this medicine, please contact the local representative of the marketing authorization holder.:

Last review date of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/.