Duoplavin

Patient Information Leaflet: Information for the User

DuoPlavin 75 mg/75 mg film-coated tablets, 75 mg/100 mg film-coated tablets

clopidogrel/acetylsalicylic acid
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.

• If you have any questions, consult your doctor or pharmacist. This medicine has been prescribed for you only. Never give it to other people, even if they have the same symptoms as you, because it could be harmful. If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
  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 platelet aggregation inhibitors. Platelets are microscopic components of the blood that
clump together during blood clotting. By preventing this clumping in certain types of blood vessels (called arteries),
platelet aggregation inhibitors reduce the likelihood of blood clots forming (a process known as atherothrombosis).
DuoPlavin is taken by adults to prevent the formation of blood clots in hardened arteries, which can cause
atherothrombotic events (such as stroke, heart attack, or death).
DuoPlavin has been prescribed to you instead of two separate medicines, clopidogrel and ASA, to help prevent
the formation of blood clots because you have previously suffered from a severe type of chest pain known as
“unstable angina” or a heart attack (myocardial infarction). To treat this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore blood flow.

2. What you should know before taking DuoPlavin

Do not take DuoPlavin
If you are allergic to clopidogrel, acetylsalicylic acid (ASA), or any of the other
components of this medicine (listed in section 6).

• If you are allergic to other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), generally used to treat painful and/or inflammatory conditions of muscles or joints.
• If you have a medical condition that includes the combination of asthma, nasal discharge (runny nose), and nasal polyps (a type of growth in the nose).
• If you are currently experiencing 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
If any of the following situations apply to you, inform your doctor before taking
DuoPlavin:

• If you have an increased 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 within any tissue, organ, or joint of the body),
• A recent serious injury,
• A recent surgical procedure (including dental surgery),
• A planned surgical procedure (including dental surgery) within the next 7 days,
• If you have had a blood clot in an artery of the brain (ischaemic stroke) within the last 7 days,
• If you have kidney or liver disease,
• If you have previously suffered from asthma or had allergic reactions, including a reaction to any medicine used to treat your condition,
• If you have gout,
• If you consume alcohol, due to an increased risk of gastrointestinal bleeding or injury,
• If you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency, due to the risk of a specific type of anaemia (low red blood cell count). While taking DuoPlavin:
• You must inform your doctor if you are scheduled for surgery (including dental surgery), if you experience stomach or abdominal pain, or if you have gastrointestinal bleeding (red or black stools).
• You must inform your doctor immediately if you develop a medical condition known as Thrombotic Thrombocytopenic Purpura (TTP), which includes fever and bruising under the skin appearing as small red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4). If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving or minor cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may prescribe blood tests for you.
• Inform 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, swollen lymph nodes, and an increase in a type of white blood cells (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
The use of DuoPlavin is not recommended in children and adolescents under 18 years of age. There is a possible association between acetylsalicylic acid (ASA) and Reye's syndrome when medicines containing ASA are taken by children or adolescents with a viral infection. Reye's syndrome is a very rare disease that can be fatal.

Other medicines and DuoPlavin
Inform 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 especially inform your doctor if you are taking:
medicines that may increase your risk of bleeding, such as:

• Oral anticoagulants, medicines used to reduce blood clotting,
• ASA or another non-steroidal anti-inflammatory drug (NSAID), generally used to treat painful and/or inflammatory conditions 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 (including, but not limited to, fluoxetine or fluvoxamine), medicines normally used to treat depression,
• Rifampicin (used to treat serious infections),
• Omeprazole or esomeprazole, medicines used to treat stomach problems,
• Methotrexate, a medicine used to treat severe joint disease (rheumatoid arthritis) or a skin condition (psoriasis),
• Acetazolamide, a medicine used to treat glaucoma (increased eye pressure) or epilepsy, or to increase urine flow,
• Probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
• Fluconazole or voriconazole, medicines used to fight fungal infections,
• Efavirenz or tenofovir, or other antiretroviral medicines (used to treat HIV infection),
• Valproic acid, valproate, or carbamazepine, medicines used to treat certain forms of epilepsy,
• The varicella vaccine, a medicine used to prevent chickenpox or herpes zoster, within 6 weeks of taking DuoPlavin, or if you currently have an infection caused by varicella or herpes zoster (see section 2 "Children and adolescents"),
• Moclobemide, a medicine used to treat depression,
• Repaglinide, a medicine used to treat diabetes,
• Paclitaxel, a medicine used to treat cancer,
• Nicorandil, a medicine used to treat heart-related chest pain,
• Opioids: while on clopidogrel therapy, you must inform your doctor before being prescribed any opioid (used to treat severe pain),
• Rosuvastatin (used to lower cholesterol levels).

While taking DuoPlavin, discontinue any other treatment containing clopidogrel. Occasional use of ASA (not exceeding 1,000 mg in 24 hours) should generally not cause problems, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.

Pregnancy and breastfeeding
Do not use this medicine during the third trimester of pregnancy. It is preferable not to use this medicine during the first and second trimesters of pregnancy. If you are pregnant or suspect 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 recommended not to take DuoPlavin during pregnancy. You must not breastfeed while using this medicine. If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that DuoPlavin affects the ability to drive or use machines.

DuoPlavin contains lactose
If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), consult your doctor before taking this medicine.

DuoPlavin contains hydrogenated castor oil
This may cause stomach upset and diarrhoea.

3. How to take DuoPlavin

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose is one DuoPlavin tablet daily, taken orally with a glass of water, either during or independent of meals.
You should take the medicine at the same time every day.
Depending on your condition, your doctor will determine how long you need to be treated with DuoPlavin. If you have had a heart attack, the medicine should be prescribed for at least 4 weeks. In any case, DuoPlavin must be taken for as long as your doctor considers necessary.

If you take more DuoPlavin than you should
Contact your doctor or 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 but remember within 12 hours of the usual time, take one tablet immediately and then take the next dose at the usual time.
If more than 12 hours have passed, simply take the next dose at the regular time.
Do not take a double dose to make up for the forgotten tablet.
For packs containing 14, 28, or 84 tablets, you can check the day on which the last DuoPlavin tablet was taken by referring to the calendar printed on the blister.

If you stop taking DuoPlavin
Do not stop treatment unless instructed by your doctor. Before stopping or restarting treatment, contact your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience:

• fever, signs of infection, or severe weakness. These effects 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 in the mouth or skin disorders such as rash, itching, blisters. 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 side effect reported with DuoPlavin is bleeding.
  Bleeding may occur in the stomach or intestines, bruising, haematomas (unusual or excessive bruising under the skin), nosebleeds, or blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding (especially in the elderly), in the lungs, and in the joints has also been reported.
  If you experience prolonged bleeding while taking DuoPlavin:
  If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works, as it prevents the formation of blood clots. For minor cuts or injuries, such as shaving cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 2 “Warnings and precautions”).

Other side effects include:
Common side effects (may occur in up to 1 in 10 patients):
Diarrhoea, abdominal pain, indigestion, and stomach burning.

Uncommon side effects (may occur in up to 1 in 100 patients):
Headache, gastric ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, skin rash, itching, dizziness, sensations of tingling and numbness.

Rare side effects (may occur in up to 1 in 1,000 patients):
Dizziness, breast enlargement in males.

Very rare side effects (may occur in up to 1 in 10,000 patients):
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, breathing difficulties sometimes associated with cough; generalized allergic reactions (for example: widespread feeling of warmth with sudden general malaise up to fainting); swelling in the mouth; skin blisters; skin allergy; mouth burning (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste, inflammation of small arterial vessels.

Side effects with unknown frequency (frequency cannot be estimated from the available data):
Perforated ulcer, ringing in the ears, hearing loss, sudden life-threatening allergic reactions or hypersensitivity reactions with abdominal or chest pain, nephropathy, hypoglycaemia, gout (a condition characterized by joint pain and swelling caused by uric acid crystals), worsening of food allergies, and a particular type of anaemia (low number of red blood cells in the blood) (see section 2 “Warnings and precautions”), swelling.

Additionally, your doctor may detect changes in blood or urine tests.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex 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 stated on the carton and blister pack, after Exp. The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25 °C.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 sulfate) and 75 mg of acetylsalicylic acid.
The other components 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 anhydrous colloidal silica,
tablet coating: monohydrate lactose (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 sulfate) and 100 mg of acetylsalicylic acid.
The other components 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 anhydrous colloidal silica,
tablet coating: monohydrate lactose (see section 2 “DuoPlavin contains
lactose”), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide
(E172),
polishing agent: carnauba wax.

Description of the appearance of DuoPlavin and contents of the pack
DuoPlavin 75 mg/75 mg film-coated tablets
DuoPlavin 75 mg/75 mg tablets are oval, slightly biconvex, yellow, film-coated tablets, marked “C75” on one side and “A75” on the other. DuoPlavin is supplied in cardboard boxes containing:

• 14, 28, 30 and 84 tablets in aluminium/aluminium blisters,

• 30x1, 50x1, 90x1 and 100x1 tablets in single-dose aluminium/aluminium blisters.
  DuoPlavin 75 mg/100 mg film-coated tablets
  DuoPlavin 75 mg/100 mg tablets are oval, slightly biconvex, light pink, film-coated tablets, marked “C75” on one side and “A100” on the other. DuoPlavin is supplied in cardboard boxes containing:

• 14, 28 and 84 tablets in aluminium/aluminium blisters,

• 30x1, 50x1, 90x1 and 100x1 tablets in single-dose aluminium/aluminium 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

Manufacturer:
Sanofi Winthrop Industrie
1, Rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France

For any information about DuoPlavin, 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-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
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
From abroad: +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-aventis Sp. z o.o.
Tel: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
From abroad: +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 hf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536 389

Suomi/Finland
SanofiOy
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

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

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