CLOPIDOGREL TAW PHARMA 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Clopidogrel Mylan 75 mg film-coated tabletsEFG

clopidogrel

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Clopidogrel Mylan and what is it used for
2. What you need to know before taking Clopidogrel Mylan
3. How to take Clopidogrel Mylan
4. Possible side effects

5 Storage of Clopidogrel Mylan

1. Package contents and additional information

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

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

Clopidogrel Mylan is given to adults to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, myocardial infarction, or death).

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

• You have a condition that causes hardening of the arteries (also called atherothrombosis), and
• You have previously had a myocardial infarction, stroke, or suffer from a disease called peripheral arterial disease, or
• You have had a severe type of chest pain, known as "unstable angina" or "myocardial infarction". For the treatment of this disease, your doctor may need to place a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications 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 medications known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You will have been told that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of Clopidogrel Mylan and acetylsalicylic acid for this disease. Your doctor will have prescribed Clopidogrel Mylan plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before taking Clopidogrel Mylan

Do not take Clopidogrel Mylan:

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

If you think any of these may apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Mylan.

Warnings and precautions

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

• If you have a risk of bleeding (bleeding) because:

• You have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
• You have a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body).
• You have recently had 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 an artery of the brain (ischemic stroke) in the last 7 days.
• If you have liver or kidney disease.
• If you have had an allergy or reaction to any medication used to treat your disease.

During treatment with Clopidogrel Mylan:

• Inform your doctor if you are scheduled to undergo 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 (bleeding under the skin that can appear as red spots), accompanied or not by unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, bleeding may take longer than usual to stop. This is related to the way the medicine works, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").
• Your doctor may ask you to have blood tests.

Use in children and adolescents

Do not give this medicine to children as it has no effect.

Other medicines and Clopidogrel Mylan

Inform your doctor or pharmacist if you are using, have recently used, or may need to use other medicines, including those obtained without a prescription.

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

You must explicitly inform your doctor if you are taking:

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

• oral anticoagulants, medicines used to decrease blood clotting,
• • non-steroidal anti-inflammatory drugs, medicines used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medicine used to decrease blood clotting,
• ticlopidine, another antiplatelet agent,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medications of the same type), medicines 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) infections,
  • carbamazepine, a medicine used to treat some forms of epilepsy,
  • moclobemide, a medicine used to treat depression,
  • repaglinide, a medicine used to treat diabetes,
  • paclitaxel, a medicine used to treat cancer.

If you have had severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Clopidogrel Mylan in combination with acetylsalicylic acid, a substance found in many medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid administered occasionally (not exceeding 1,000 mg in 24 hours) is generally not a problem, but prolonged use in other circumstances should be discussed with your doctor.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

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

Do 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 Mylan will affect your ability to drive or operate machines.

Clopidogrel Mylan contains hydrogenated castor oil

This may cause stomach upset or diarrhea.

3. How to take Clopidogrel Mylan

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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 tablet of Clopidogrel Mylan per day, taken orally with or without food, and at the same time each day.

If you have had severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Clopidogrel Mylan (4 tablets of 75 mg) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg tablet of Clopidogrel Mylan per day, as described above.

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

If you take more Clopidogrel Mylan 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 Mylan

If you forget to take a dose of Clopidogrel Mylan, but remember before 12 hours have passed since the time you should have taken the medicine, 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 the missed tablet.

For pack sizes of 7, 14, 28, 56, 84 tablets (calendar blister), you can check the day you took the last tablet of Clopidogrel Mylan by referring to the calendar printed on the blister.

If you stop taking Clopidogrel Mylan

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience:

• Fever, signs of infection, or severe 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 rashes and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Mylan is bleeding.

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

If you experience prolonged bleeding while taking Clopidogrel Mylan

If you cut or injure yourself, bleeding may take a little 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 injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").

Other side effects reported are:

Common side effects (may affect up to 1 in 10 people): Diarrhea, abdominal pain, indigestion, or heartburn.

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

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, 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., general feeling of heat with general discomfort up to sudden fainting); swelling of the mouth; blisters on the skin, skin allergy; mouth ulcers (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects with unknown frequency (cannot be estimated from available data): Hypersensitivity reactions with chest or abdominal pain.

Your doctor may also observe changes in the results of your blood or urine tests.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Mylan

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

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

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

Do not throw any medicine down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Clopidogrel Mylan Composition

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

The other ingredients are:

• Tablet core: microcrystalline cellulose, anhydrous colloidal silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil (see section 2 'Clopidogrel Mylan contains hydrogenated castor oil').
• Tablet coating: polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc, and macrogol 3000.

Appearance of Clopidogrel Mylan and Package Contents

Film-coated tablets are pink, round, and biconvex.

Boxes of 7, 14, 28, 30, 50, 56, 84, 90, and 100 film-coated tablets in blisters are available.

Calendar blisters of 7, 14, 28, 56, 84 film-coated tablets are available. Boxes of 30x1 and 50x1 film-coated tablets in perforated monodose blisters are available.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Mylan S.A.S., 117 allée des Parcs, 69800 Saint Priest, France

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 medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet: MM/YYYY

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