DuoPlavin – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine DuoPlavin, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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.
What is i n this leaflet 1. What DuoPlavin is and what it is used for 2. What you need to know b efore you take DuoPlavin 3. How to take DuoPlavin 4. Possible side effects 5 How to store DuoPlavin 6. Contents of the pack and other information
ℹ️ 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 medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping in som e types of blood vessels (called arteries), antiplatelet medicinal products reduce the chances of blood clots forming (a process called atherothrombosis).
DuoPlavin is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death).
You have been prescribed DuoPlavin in place of the two separate medicines, clopidogrel and ASA, to help prevent blood clots because you have experienced a severe type of chest pain known as ‘unstable angina’ or heart attack (myocardial infarction). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
⚠️ 2. What you need to know b efore 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 called non -steroidal anti -inflammatory products usually used to treat painful and/or inflammatory conditions of muscles or joints.
- if you have a medical condition that include s the combination of asthma, nasal discharge (runny nose) and polyps (a type of growth in the nose).
- if you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
- if you suffer from severe liver disease.
- if you suffer from severe kidney disease.
- if you are in your last trimester of pregnancy .
Warnings and precautions
If any of the situations mentioned below apply to you, you should tell your doctor before taking DuoPlavin :
- if you have a risk of bleeding such as:
- a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
- a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
- a recent serious injury.
- a recent surgery (including dental).
- a planned surgery (including dental) in the next seven days.
- if you have had a clot in an artery of your brain (ischaemic stroke) which occurred in the last seven days .
- if you have kidney or liver disease.
- if you have a history of asthma or allergic reactions including allergy to any medicine used to treat your disease .
- if you have gout.
- if you drink alcohol, because of the increased risk of bleeding or gastrointestinal injury.
- if you have a condition known as glucose -6-phosphate dehydrogenase (G6PD) deficiency because of the risk of a particular form of anaemia (low number of red blood cells).
While you are taking DuoPlavin :
- You should tell your doctor
- if a surgery (including dental) is planned.
- if you have any stomach or abdominal pain or bleeding in the stomach or bowels (red stools or black stools).
- You should also tell your doctor immediately if you develop a medical condition known as Thrombotic Thrombocytopenic Purpura or TTP that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme ti redness, confusion, yellowing of the skin or eyes (jaundice) (see section 4).
- If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects ’).
- Your doctor may order blood tests.
- You should tell your doctor immediately if you develop symptoms or signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) which may include flu -like symptoms and a rash with fever, enlarged lymph nodes and increase in a type of white blood cell (eosinophilia).
Other abnormal blood test results may include (but are not limited to) increased levels of liver enzymes (see section 4 ‘Possible side effects’).
Children and adolescents
DuoPlavin is not intended for use in children or adolescents less than 18 years of age. There is a possible association between acetylsalicylic acid (ASA) and Reye’s Syndrome when products containing ASA are given to children or adolescents with a viral infection. Reye’s Syndrome is a very rare disease which can be fatal.
Other medicines and DuoPlavin
Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.
Some other medicines may influence the use of DuoPlavin or vice versa.
You should specifically tell your doctor if you take
- medicines that may increase your risk of bleeding such as:
44 – oral anticoagulants, medicines used to reduce blood clotting ,
- ASA or another non -steroidal anti -inflammatory medicine usually used to treat painful and/or inflammatory conditions of muscle or joints,
- heparin or any other injectable medicine used to reduce blood clotting,
- ticlopidine, or other antiplatelet agent s,
- a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression ,
- rifampicin (used to treat severe infection s)
- omeprazole or esomeprazole, medicines to treat upset stomach ,
- methotrexate, a medicine used to treat severe joint disease (rheumatoid arthritis) or skin disease (psoriasis),
- acetazolamide, a medicine used to treat glaucoma (increased ocular pressure) or epilepsy or to increase urine flow,
- probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
- fluconazole or voriconazole, medicines to treat fungal infections,
- efavirenz or tenofovir , or other anti -retroviral medicines (used to treat HIV infections),
- valproic acid, valproate or carbamazepine, medicine s to treat some forms of epilepsy,
- the varicella vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks of taking DuoPlavin, or if you have active chickenpox or shingles infection (see section 2 ‘Children and adolescents’),
- moclobemide, medicine to treat depression ,
- repaglinide, medicine to treat diabetes,
- paclitaxel, medicine to treat cancer ,
- nicorandil, medicine to treat cardiac chest pain ,
- opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids (used to treat severe pain ),
- rosuvastatin (used to lower your cholesterol level) .
You should stop other clopidogrel treatment while you are taking DuoPlavin .
An occasional use of ASA (no more than 1,000 mg in any 24 -hour period) should generally not cause a problem, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.
Pregnancy and breast -feeding Do not take DuoPlavin during third trimester of pregnancy.
It is preferable not to take this medicine during first and second trimesters of pregnancy.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking DuoPlavin . If you become pregnant while taking DuoPlavin , consult your doctor immediately as it is recommended not to take DuoPlavin while you are pregnant.
You should not breast -feed while using this medicine.
If you are breast -feeding or planning to breast -feed, talk to your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
DuoPlavin should not affect your ability to drive or to use machines.
DuoPlavin contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
DuoPlavin contains hydrogenated castor oil
This may cause stomach upset or diarrhoea.
💊 3. How to take DuoPlavin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of DuoPlavin per day to be 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 the length of time for which you need to take DuoPlavin . If you have had a heart attack, it should be prescribed for at least four weeks. In any case, 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 the nearest hospital emergency department because of the 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 your usual time, take your tablet straightaway and then take your next tablet at the usual time.
If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet .
For the 14, 28 and 84 tablets pack sizes you can check the day on which you last took a tablet of DuoPlavin by referring to the calendar printed on the blister.
If you stop taking DuoPlavin
Do not stop the treatment unless your doctor tells you so. 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, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience:
- fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells.
- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see section 2 ‘Warnings and precautions ’).
- swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the 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 which has been seen with DuoPlavin is bleeding . Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head (especially in elderly ), the lung or the joints has also been reported.
46 If you experience prolonged bleeding when taking DuoPlavin If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions ’).
Other side effects include
Common side effects (may affect up to 1 in 10 people)
Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people)
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Rare side effect (may affect up to 1 in 1000 people) :
Vertigo , enlarged breasts in males .
Very rare side effects (may affect up to 1 in 10,000 people)
Jaundice (yellowing of skin and/or eyes) ; burning in stomach and/or esophagus (gullet) ; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting) ; swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of foods , inflammation of small vessels.
Side effects with frequency not known (frequency cannot be estimated from the available data) :
Ulcer perforation , diaphragmatic bowel disease (narrowing of the intestinal passage) which may cause symptoms such as swelling of the abdomen, abdominal discomfort, blood in stool , ringing in the ears, hearing loss, sudden life -threatening allergic or hypersensitivity reactions with chest or abdominal pain , kidney disease, low blood sugar, gout (a condition of painful, swollen joints caused by uric acid crystals) and worsening of food allergies , a particular form of anaemia (low number of red blood cells) (see section 2 ‘Warnings and precautions’) , swelling . If you experience any of these symptoms, consult a doctor immediately.
In addition, your doctor may identify changes in your blood or urine tests.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store DuoPlavin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister, after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Do not use this medicine if you notice any visible sign of deterioration.
Do not throw away any m edicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
📦 6. Contents of the pack and other information
What DuoPlavin contains
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 sulphate) and 75 mg of acetylsalicylic acid.
The other ingredients are:
- Tablet core : mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize 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)
- Polishing agent : 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 sulphate) and 100 mg of acetylsalicylic acid.
The other ingredients are:
- Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize 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)
- Polishing agent: carnauba wax
What DuoPlavin looks like 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, engraved on one side with ‘C75’ and ‘A75’on the other side. DuoPlavin is supplied in cardboard cartons containing:
- 14, 28 , 30 and 84 tablets in all -aluminium blisters
- 30×1, 50×1, 90×1 and 100×1 tablet in all -aluminium unit -dose blisters.
DuoPlavin 75 mg/100 mg film-coated tablets DuoPlavin 75 mg/100 mg film -coated tablets (tablets) are oval, slightly biconvex, light pink, engraved on one side with ‘C75’ and ‘A100’on the other side. DuoPlavin is supplied in cardboard cartons containing:
- 14, 28 and 84 tablets in all -aluminium blisters
- 30×1, 50×1, 90×1 and 100×1 tablet in all -aluminium unit -dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France 48 Manufacturer:
Sanofi Winthrop Industrie 1, rue de la Vierge, Ambarès & Lagrave, F -33565 Carbon Blanc cedex, France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 България Swixx Biopharma EOOD Тел: +359 (0)2 4942 480 Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 ( Belgique/Belgien) Česká republika Sanofi, s.r.o.
Tel: +420 233 086 111 Magyarország SANOFI -AVENTIS Z rt.
Tel.: +36 1 505 0050 Danmark Sanofi A/S Tlf: +45 45 16 70 00 Malta Sanofi S.r.l.
Tel: +39 02 39394275 Deutschland Sanofi -Aventis Deutschland GmbH Tel.: 0800 52 52 010 Tel. aus dem Ausland : +49 69 305 21 131 Nederland Sanofi B.V.
Tel: +31 20 245 4000 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Norge sanofi -aventis Norge AS Tlf: +47 67 10 71 00 Ελλάδα Sanofi -Aventis Μονοπρόσωπη AEBE Τηλ: +30 210 900 16 00 Österreich sanofi -aventis GmbH Tel: + 43 1 80 185 – 0 España sanofi -aventis, S.A.
Tel: +34 93 485 94 00 Polska Sanofi Sp. z o.o.
Tel: + 48 22 280 00 00 France Sanofi Winthrop Industrie Tél: 0 800 222 555 Appel depuis l’étranger: +33 1 57 63 23 23 Portugal Sanofi – Produtos Farmacêuticos, Lda Tel: + 351 21 35 89 400 Hrvatska Swixx Biopharma d.o.o.
Tel: +385 1 2078 500 România Sanofi Romania SRL Tel: +40 (0) 21 317 31 36 Ireland sanofi -aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00 Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00 Ísland Vistor ehf.
Sími: +354 535 7000 Slovenská republika Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600 49 Italia Sanofi S.r.l.
Tel: 800 536 389 Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 Κύπρος C.A. Papaellinas Ltd.
Τηλ: +357 22 741741 Sverige Sanofi AB Tel: +46 (0)8 634 50 00 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 50 This leaflet was last revised in <Month YYYY >.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information DuoPlavin (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/10/619).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.