Duoplavin 75 mg/100 mg film-coated tablets

Package leaflet: Information for the user

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 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, and you should 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What DuoPlavin is and what it is used for

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

DuoPlavin is given to adults to help prevent blood clots forming in hardened arteries, which could otherwise lead to atherothrombotic events (such as stroke, heart attack, or death).

Your doctor has prescribed DuoPlavin instead of two separate medicines, clopidogrel and ASA, to help prevent blood clots because you have experienced a serious type of chest pain known as "unstable angina" or a "heart attack" (myocardial infarction). For the treatment of this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore proper blood flow.

2. What you need to know before taking 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 medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), commonly used to treat pain and/or inflammation of muscles and joints.
• if you have a combination of asthma, runny nose (nasal discharge), and nasal polyps (a type of tissue growth in the 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 three months of pregnancy.

Warnings and precautions

Before starting treatment with DuoPlavin, inform your doctor if any of the following apply to you:

• if you are at risk of bleeding because:

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

• you have a blood disorder that makes you prone 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 have surgery (including dental surgery) within the next seven days.

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

• if you have liver or kidney disease.

• if you have a history of asthma or allergic reactions, including reactions to any medicines used to treat your condition.

• if you have gout.

• if you drink alcohol, due to increased risk of bleeding or gastrointestinal damage.

• if you have a known condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency, due to the risk of a specific type of anaemia (reduction in the number of red blood cells).

During treatment with DuoPlavin:

• • Inform your doctor:
• if you are scheduled for surgery (including dental surgery).
• if you experience stomach or abdominal pain or bleeding in the stomach or intestines (red or black stools).
  • Inform your doctor immediately if you develop a disorder known as thrombotic thrombocytopenic purpura (TTP), which includes fever and bruising (bruises) under the skin that may appear as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4).
  • If you get a cut or injury, bleeding may take longer than usual to stop. This is related to how the medicine works, as it prevents blood from forming clots. For minor cuts or injuries, such as during shaving, this is usually not a concern. However, if you are concerned about blood loss, contact your doctor immediately (see section 4).
  • Your doctor may request blood tests.
  • You must inform your doctor immediately if you experience symptoms or signs of drug reaction with eosinophilia and systemic symptoms (DRESS), which may include flu-like symptoms and skin rash with fever, swollen lymph nodes, and an increase in a type of white blood cells (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 or adolescents under 18 years of age. There is a possible association between acetylsalicylic acid (ASA) and Reye's syndrome when ASA-containing products are given to children or adolescents with a viral infection. Reye's syndrome is a very rare condition that can be fatal.

Taking DuoPlavin with other medicines

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

Some medicines may affect the use of DuoPlavin 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,

• ASA or other non-steroidal anti-inflammatory drugs (NSAIDs), medicines commonly used to treat pain and/or inflammation of muscles or joints,

• heparin or any other injectable medicine used to reduce 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 commonly used to treat depression,

• rifampicin (used for serious infections),

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

• 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 used to treat certain forms of epilepsy,

• varicella vaccine, a medicine used to prevent chickenpox or herpes, within six weeks of taking DuoPlavin or if you have active chickenpox or herpes infection (see section 2 "Children and adolescents"),

• moclobemide, a medicine for depression,

• repaglinide, a medicine used to treat diabetes,

• paclitaxel, a medicine used to treat cancer,

• nicorandil, a medicine used to treat chest pain (angina),

• opioids: if you are being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),

• rosuvastatin (used to lower cholesterol levels).

You must stop any other treatment with clopidogrel while taking DuoPlavin.

An occasional dose of ASA (not exceeding 1,000 mg in 24 hours) is generally not expected to cause 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 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 DuoPlavin is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

If you are breastfeeding or planning to breastfeed, 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 operate machinery.

DuoPlavin contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), consult with him before taking this medicine.

DuoPlavin contains hydrogenated castor oil

This may cause stomach discomfort or diarrhoea.

3. How to take DuoPlavin

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

The recommended dose is one DuoPlavin tablet daily, taken orally with a glass of water, with or without food.

You should take your medicine at the same time each day.

Depending on your condition, 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 continue taking it for as long as your doctor prescribes.

If you take more DuoPlavin 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 DuoPlavin

If you forget to take a dose of DuoPlavin but remember within 12 hours of the time you were supposed to take it, take the tablet immediately and then take the next dose 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 packs, you can check the last day you took a DuoPlavin tablet by looking at the calendar printed on the blister.

If you stop taking DuoPlavin

Do not stop your treatment unless instructed by your doctor. Contact your doctor before stopping or restarting your treatment.

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

4. Possible adverse effects

Like all medicines, DuoPlavin may have 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 reduction 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.
• A serious reaction affecting the skin, blood, and internal organs (DRESS) (see section 2 “Warnings and precautions”).

The most common adverse effect observed with DuoPlavin 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 bleeding (especially in elderly patients), pulmonary or joint bleeding.

If you experience prolonged bleeding while taking DuoPlavin

If you cut yourself or sustain an injury, bleeding may take slightly longer than normal to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or injuries, 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 are:

Frequent 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 (yellowing of the skin and/or eyes); burning sensation in the stomach and/or oesophagus (throat); severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (for example, feeling of generalized warmth with sudden malaise up to fainting); swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste, inflammation of small blood vessels.

Adverse effects with unknown frequency (cannot be estimated from available data):

Perforated ulcer, ringing in the ears (tinnitus), hearing loss, sudden and life-threatening allergic reactions or hypersensitivity reactions with chest pain or abdominal pain, kidney disease, low blood sugar, gout (a painful disease with joint inflammation caused by uric acid crystals), worsening of food allergies, a particular type of anaemia (reduction in the number of red blood cells) (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 adverse effects

If you experience any type of 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 included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 25 °C.

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

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

6. Contents of the pack and other information

Composition of DuoPlavin

DuoPlavin 75 mg/75 mg film-coated tablets

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

Other components 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 colloidal anhydrous silica.
• Tablet coating: lactose monohydrate (see section 2 “DuoPlavin contains lactose”), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172).
• Polish: carnauba wax.

DuoPlavin 75 mg/100 mg film-coated tablets

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

Other components 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 colloidal anhydrous silica.
• Tablet coating: lactose monohydrate (see section 2 “DuoPlavin contains lactose”), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172).
• Polish: carnauba wax.

Description 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 colour, with “C75” engraved on one side and “A75” on the other.

DuoPlavin is available in cardboard packs containing:

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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.

Further information on this medicinal product is available upon request to the Marketing Authorisation Holder's local representative.

Date of the most recent review of this leaflet:

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