Leaflet: information for the user

DuoPlavin 75 mg /75 mg film-coated tablets

DuoPlavin 75 mg /100 mg film-coated tablets

clopidogrel/acid acetylsalicylic

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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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. What isDuoPlavinand what it is used for

2. What you need to know before starting to takeDuoPlavin

3. How to takeDuoPlavin

4. Possible side effects

5. Storage ofDuoPlavin

6. Contents of the pack and additional information

DuoPlavin contains clopidogrel and acetylsalicylic acid (ASA) and belongs to a group of medications called antiplatelet agents. Platelets are very small cells found in the blood that aggregate when the blood clots. Antiplatelet agents, by preventing this aggregation in some types of blood vessels (called arteries), reduce the likelihood of blood clots (a process called atherothrombosis) forming.

DuoPlavin is administered to adults to prevent blood clots from forming in hardened arteries that may cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

You have been prescribed DuoPlavin in place of two separate medications, clopidogrel and ASA, to help prevent blood clots from forming since you have experienced a severe type of chest pain, known as unstable angina or myocardial infarction (heart attack). For the treatment of this disease, your doctor may need to place a stent in the obstructed or narrowed artery to restore adequate blood flow.

Do not take DuoPlavin

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

Warnings and Precautions

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

• if you have a risk of bleeding because:

• persistent gastrointestinal ulcer disease.
• bleeding disorder (such as hemophilia).
• recent trauma or surgery.
• recent surgery (including dental surgery).
• planned surgery (including dental surgery) in the next 7 days.

• if you have had a blood clot in a cerebral artery (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 known disease called glucose-6-phosphate dehydrogenase (G6PD) deficiency, due to the risk of a particular type of anemia (decrease in the number of red blood cells).

During treatment with DuoPlavin:

• • Inform your doctor:
• if you haveplanned surgery(including dental surgery).
• if you have stomach pain or abdominal pain or bleeding in the stomach or intestines (black or red stools).
• • Inform your doctor immediately if you develop a condition known as thrombotic thrombocytopenic purpura (TTP) that includes fever and hematomas (bruises) under the skin that may appear as red localized spots, accompanied or not by extreme fatigue, confusion, yellow color in the skin or eyes (jaundice) (see section 4).
  • If you cut or get a wound, bleeding may take longer 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 usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 4).
  • Your doctor may ask you to have blood tests.
  • You must inform your doctor immediately if you present symptoms or signs of a drug reaction with eosinophilia and systemic symptoms (DRESS), which may include symptoms similar to 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 levels of liver enzymes (see section 4 "Possible side effects").

Children and adolescents

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

Taking DuoPlavin with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

You must inform your doctor specifically if you are taking:

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

• oral anticoagulants, medications used to reduce blood clotting,
• ASA or other nonsteroidal anti-inflammatory drugs (NSAIDs), medications used generally to treat pain and/or inflammation of muscles or joints,
• heparin or any other injectable medication used to reduce blood clotting,
• ticlopidine, or other antiplatelet agents,
• selective serotonin reuptake inhibitors (such as fluoxetine or fluvoxamine and other medications of the same type), medications used normally to treat depression,
• rifampicin (used for serious infections),

• omeprazole or esomeprazole, medications to treat stomach discomfort,
• methotrexate, a medication used to treat a severe joint disease (rheumatoid arthritis) or skin disease (psoriasis),
• acetazolamide, a medication used to treat glaucoma (increased eye pressure), epilepsy, or to increase urine flow,
• probencid, benzobromarone or sulfinpyrazone, medications used to treat gout.
• fluconazole or voriconazole, medications used to treat fungal infections,
• efavirenz or tenofovir, or other antiretroviral medications (used to treat HIV infections),
• valproic acid, valproate or carbamazepine, medications to treat certain forms of epilepsy,
• the varicella vaccine, a medication used to prevent chickenpox or herpes, within 6 weeks of taking DuoPlavin or if you have an active varicella or herpes infection (see section 2“Children and adolescents”),
• moclobemide, a medication for depression,
• repaglinide, a medication for diabetes treatment,
• paclitaxel, a medication for cancer treatment,
• nicorandil, a medication for chest pain (angina pectoris),
• opioids: if you are taking clopidogrel, inform your doctor before being prescribed any opioid (used to treat intense pain),
• rosuvastatin (used to reduce cholesterol levels).

You must discontinue another treatment with clopidogrel while taking DuoPlavin.

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

Pregnancy and breastfeeding

Do not take DuoPlavin during the third trimester of pregnancy.

It is recommended not to take this medication during the first and second trimesters of pregnancy.

If you are pregnant or think you may be pregnant, 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 should not breastfeed your child while using this medication.

If you are in a breastfeeding period or plan to breastfeed your child, inform your doctor before taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

DuoPlavin should not affect your ability to drive or operate machinery.

DuoPlavin contains lactose

If your doctor has indicated that you have an intolerance to certain sugars (e.g. lactose), consult with him before taking this medication.

DuoPlavin contains hydrogenated ricin oil

This may cause stomach discomfort or diarrhea.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 should take your medication at the same time every day.

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

If you take more DuoPlavin 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 DuoPlavin

If you forget to take a dose of DuoPlavin, but remember before 12 hours have passed since the time when 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 compensate for a missed 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 interrupt treatment with DuoPlavin

Do not interrupt your treatment unless your doctor tells you to Contact your doctor before interrupting or restarting your treatment.

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

Like all medicines, DuoPlavin 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.
• A severe reaction affecting 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 appear in the stomach or intestine, bruises, hematomas (abnormal bleeding or bruises under the skin), nasal bleeding, blood in urine. There have also been reported a reduced number of cases of: bleeding of the blood vessels of the eyes, intracranial bleeding (especially in elderly patients), pulmonary or joint bleeding.

If you experience prolonged bleeding while taking DuoPlavin

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 medication, 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 are:

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, blisters on the skin.

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) burning; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with coughing; 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 mouth (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 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 (disease with pain that courses with inflammation of the joints caused by uric acid crystals) and worsening of food allergies, a particular form of anemia (decrease in the number of red blood cells) (see section 2 “Warnings and precautions”), swelling.

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

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about 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 below 25 °C.

Do not use this medication if you observe any visible sign of deterioration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of DuoPlavin

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 components are:

- Core: mannitol (E421), macrogol 6000, microcrystalline cellulose, hydroxypropylcellulose, cornstarch, hydrogenated ricin oil (see section 2 “DuoPlavin contains hydrogenated ricin oil”), stearic acid, and colloidal anhydrous silica.

- Tablet coating: lactose monohydrate (see section 2 “DuoPlavin contains lactose”), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), and yellow iron oxide (E172).

- Lacquer: 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 components are:

- Core: mannitol (E421), macrogol 6000, microcrystalline cellulose, hydroxypropylcellulose, cornstarch, hydrogenated ricin oil (see section 2 “DuoPlavin contains hydrogenated ricin oil”), stearic acid, and colloidal anhydrous silica.

- Tablet coating: lactose monohydrate (see section 2 “DuoPlavin contains lactose”), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), and red iron oxide (E172).

- Lacquer: carnauba wax.

Appearance of the product and contents of the pack

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 have “C75” and “A75” engraved on opposite faces.

DuoPlavin is available in cartons containing:

• 14, 28, 30, and 84 tablets in aluminium blisters.
• 30x1, 50x1, 90x1, and 100x1 tablets in aluminium unit-dose 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 have “C75” and “A100” engraved on opposite faces.

DuoPlavin is available in cartons containing:

• 14, 28, and 84 tablets in aluminium blisters.
• 30x1, 50x1, 90x1, and 100x1 tablets in aluminium unit-dose 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 consult the representative of the marketing authorization holder in your country.

Last update of the summary of product characteristics:

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