DUOPLAVIN 75 MG/100 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

DuoPlavin 75 mg/75 mg film-coated tablets

DuoPlavin 75 mg/100 mg film-coated tablets

clopidogrel/acetylsalicylic acid

Read all of this leaflet carefully before you start taking 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is DuoPlavin and what is it used for
2. What you need to know before you take DuoPlavin
3. How to take DuoPlavin
4. Possible side effects
5. Storing DuoPlavin
6. Contents of the pack and other information

1. What is DuoPlavin and what is it used for

DuoPlavin contains clopidogrel and acetylsalicylic acid (ASA) and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that clump together to form blood clots. Antiplatelet agents prevent this clumping in certain blood vessels (called arteries), reducing the risk of blood clots (a process called atherothrombosis).

DuoPlavin is given to adults to prevent blood clots in hardened arteries that can cause atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed DuoPlavin instead of taking two separate medicines, clopidogrel and ASA, to help prevent blood clots because you have had a severe type of chest pain known as "unstable angina" or "heart attack" (myocardial infarction). For the treatment of this condition, your doctor may need to place a stent in the blocked or narrowed artery to restore proper blood flow.

2. What you need to know before you take DuoPlavin

Do not take DuoPlavin

• if you are allergic to clopidogrel, acetylsalicylic acid (ASA), or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other products known as non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and/or inflammation of muscles and joints.
• if you have a combination of asthma, nasal polyps (a type of growth in the nose), and rhinitis (runny nose).
• if you have active bleeding, such as a stomach ulcer or bleeding in the brain.
• if you have severe liver disease.
• if you have severe kidney disease.
• if you are in the last trimester of pregnancy.

Warnings and Precautions

Before starting treatment with DuoPlavin, tell your doctor if you are in any of the following situations:

• if you are at risk of bleeding because:

• you have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
• you have a blood disorder that makes you prone to internal bleeding (bleeding in tissues, organs, or joints of the body).
• you have recently had a serious injury.
• you have recently had surgery (including dental surgery).
• you are going to have surgery (including dental surgery) in 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 a history of asthma or allergic reactions, including any medication used to treat your condition.
• if you have gout.
• if you drink alcohol, due to the increased risk of bleeding or gastrointestinal damage.
• if you have a disease known as glucose-6-phosphate dehydrogenase (G6PD) deficiency, due to the risk of a particular type of anemia (reduced number of red blood cells in the blood).

During treatment with DuoPlavin:

• • Tell your doctor:
• if you are scheduled to have surgery (including dental surgery).
• if you have stomach pain or abdominal pain or bleeding in the stomach or intestine (red or black stools).
• Tell your doctor immediately if you develop a disorder known as thrombotic thrombocytopenic purpura (TTP), which 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).
• If you cut or injure yourself, the bleeding may take longer than usual to stop. This is related to the way the medicine works, as it prevents the blood from forming 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.
• You must inform your doctor immediately if you present symptoms or signs of drug reaction with eosinophilia and systemic symptoms (DRESS), which can include symptoms similar to those of the flu and skin rash with fever, swollen lymph nodes, and increased levels of a type of white blood cell (eosinophilia). Other abnormal blood test results may include (among others) elevated liver enzymes (see section 4 "Possible side effects").

Children and adolescents

DuoPlavin is not intended for use in children and adolescents under 18 years of age. There is a possible association between acetylsalicylic acid (ASA) and Reye's syndrome when ASA products are administered to children or adolescents with viral infections. Reye's syndrome is a very rare disease that can be fatal.

Taking DuoPlavin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect the use of DuoPlavin or vice versa.

You must explicitly tell your doctor if you are taking:

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

• oral anticoagulants, medicines used to reduce blood clotting,
• ASA or other non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain and/or inflammation of muscles or joints,
• heparin or any other injectable medicine used to decrease blood clotting,
• ticlopidine, or other antiplatelet agents,
• a selective serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of the same type), medicines used to treat depression,
• rifampicin (used for severe infections),

• omeprazole or esomeprazole, medicines to treat stomach upset,
• methotrexate, a medicine used to treat severe joint disease (rheumatoid arthritis) or skin disease (psoriasis),
• acetazolamide, a medicine used to treat glaucoma (increased eye pressure), epilepsy, or to increase urine flow,
• probenecid, benzobromarone, or sulfinpyrazone, medicines used to treat gout.
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz or tenofovir, or other antiretroviral medicines (used to treat HIV infections),
• valproic acid, valproate, or carbamazepine, medicines to treat some forms of epilepsy,
• varicella vaccine, a medicine used to prevent chickenpox or herpes, within six weeks of taking DuoPlavin or if you have active varicella or herpes infection (see section 2 "Children and adolescents"),
• moclobemide, a medicine for depression,
• repaglinide, a medicine for diabetes treatment,
• paclitaxel, a medicine for cancer treatment,
• nicorandil, a medicine for chest pain (angina pectoris) treatment,
• opioids: if you are being treated with clopidogrel, you must inform your doctor before they prescribe you any opioid (used to treat severe pain),
• rosuvastatin (used to lower cholesterol levels).

You must stop taking other clopidogrel treatment while taking DuoPlavin.

A single dose of ASA administered occasionally (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.

Pregnancy and breastfeeding

Do not take DuoPlavin during the third trimester of pregnancy.

It is preferable not to take this medicine during the first and second trimester of pregnancy.

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

You must not breastfeed your child while using this medicine.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

DuoPlavin should not affect your ability to drive or use machines.

DuoPlavin contains lactose

If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), consult them before taking this medicine.

DuoPlavin contains hydrogenated castor oil

This may cause stomach upset or diarrhea.

3. How to take DuoPlavin

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is one DuoPlavin tablet per day, administered orally, with a glass of water, with or without food.

You must take your medicine at the same time every day.

Depending on your situation, your doctor will determine how long you need to take DuoPlavin. If you have had a heart attack, it should be prescribed for at least four weeks. However, you should take it for as long as your doctor continues to prescribe it.

If you take more DuoPlavin than you should

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

If you forget to take DuoPlavin

If you forget to take a dose of DuoPlavin, 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 forgotten tablet.

In the 14, 28, and 84 tablet formats, you can check the last day you took a DuoPlavin tablet by looking at the calendar printed on the blister pack.

If you stop taking DuoPlavin

Do not stop your treatment unless your doctor tells you to. Contact your doctor before stopping or restarting your treatment.

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

4. Possible side effects

Like all medicines, DuoPlavin can cause side effects, although not everybody gets 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 rash and itching, blisters on the skin. These can be signs of an allergic reaction.
• A severe reaction that affects the skin, blood, and internal organs (DRESS) (see section 2 "Warnings and Precautions").

The most common side effect seen with DuoPlavin 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 in the eyes, intracranial bleeding (especially in elderly patients), pulmonary or joint bleeding have also been reported.

If you experience prolonged bleeding while taking DuoPlavin

If you cut or injure yourself, the 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 from forming 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 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, feeling of 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 (yellowing of the skin and/or eyes); heartburn and/or esophagus (throat); severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (e.g., feeling of heat with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin, skin allergy; mouth inflammation (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food, inflammation of small blood vessels.

Side effects of unknown frequency (cannot be estimated from the available data):

Perforated ulcer, ringing in the ears, hearing loss, sudden and life-threatening allergic reactions or hypersensitivity reactions with chest pain or abdominal pain, kidney disease, low blood sugar, gout (a disease with pain that is characterized by inflammation of the joints caused by uric acid crystals), and worsening of food allergies, a particular type of anemia (reduced number of red blood cells in the blood) (see section 2 "Warnings and Precautions"), swelling.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects 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. Storing DuoPlavin

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 on the blister pack after EXP. The expiry date is the last day of the month stated.

Store below 25°C.

Do not use this medicine if you notice any visible signs of deterioration.

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

6. Packaging Content and Additional Information

DuoPlavin Composition

DuoPlavin 75 mg /75 mg film-coated tablets

The active ingredients are clopidogrel and acetylsalicylic acid (ASA). Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate) and 75 mg of acetylsalicylic acid.

The other ingredients are:

• Core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low-substituted hydroxypropylcellulose, corn starch, hydrogenated castor oil (see section 2 "DuoPlavin contains hydrogenated castor oil"), stearic acid, and anhydrous colloidal silica.
• Tablet coating: lactose monohydrate (see section 2 "DuoPlavin contains lactose"), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), and yellow iron oxide (E172).
• Varnish: carnauba wax.

DuoPlavin 75 mg /100 mg film-coated tablets

The active ingredients are clopidogrel and acetylsalicylic acid (ASA). Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate) and 100 mg of acetylsalicylic acid.

The other ingredients are:

• Core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low-substituted hydroxypropylcellulose, corn starch, hydrogenated castor oil (see section 2 "DuoPlavin contains hydrogenated castor oil"), stearic acid, and anhydrous colloidal silica.
• Tablet coating: lactose monohydrate (see section 2 "DuoPlavin contains lactose"), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), and red iron oxide (E172).
• Varnish: carnauba wax.

Product Appearance and Packaging Content

DuoPlavin 75 mg /75 mg film-coated tablets

DuoPlavin 75 mg/75 mg film-coated tablets (tablets) are oval, slightly biconvex, yellow in color, and bear the inscription "C75" on one side and "A75" on the other.

DuoPlavin is available in cardboard boxes of:

• 14, 28, 30, and 84 tablets in aluminum blisters.
• 30x1, 50x1, 90x1, and 100x1 tablets in single-dose aluminum blisters.

DuoPlavin 75 mg /100 mg film-coated tablets

DuoPlavin 75 mg/100 mg film-coated tablets are oval, slightly biconvex, pale pink in color, and bear the inscription "C75" on one side and "A100" on the other.

DuoPlavin is available in cardboard boxes of:

• 14, 28, and 84 tablets in aluminum blisters.
• 30x1, 50x1, 90x1, and 100x1 tablets in single-dose aluminum blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer:

Sanofi Winthrop Industrie

1, Rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France.

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Date of Last Revision of this Leaflet:

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