Plavix
(Clopidogrel Bisulfate)

What Plavix is and what it is used for

Plavix contains clopidogrel 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, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis)Plavix is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death). You have been prescribed Plavix to help prevent blood clots and reduce the risk of these severe events because:
•You have a condition of hardening of arteries (also known as atherosclerosis), and
•You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or
•You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial infarction’ (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
•You have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use of Plavix and acetylsalicylic acid for this condition. Your doctor should have prescribed Plavix plus acetylsalicylic acid if you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.

How to take Plavix

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, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Plavix per day to be taken orally with or without food, and at the same time each day. If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Plavix (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Plavix per day as described above. You should take Plavix for as long as your doctor continues to prescribe it. If you take more Plavix than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding. 3 SANOFI AMBARES
•FRANCE libellé: NOT PLAVIX 300MG CP DC RL GB Sens d’enroulement Portrait 4aNord/North 4A-4B X Paysage 1aEst/East 1A-2B
•Item Code: 734441 Article : Leaflet/Notice Code laetus : 819 Country : GB Color Nbr : 1 Ref Fiche Technique Based on: 701303 Format : 170X210-DC Font : OCEAN SANS PRO SAN AMBRS-M002187 NOT_S - Proof n°: 3 C. requirement : CRGB-V1-05/2012 Font size : 9PT AMBRS-M002188 NOT_DC AMBRS-M002189 NOT_DP X Creation Date: 08/10/2018 Used Color printable : Pantone Black + dégradé Noprintable color: Plan By : I. SOURBE AMBRS-M002190 NOT_TC AMBRS-M002191 NOT_TP - Modif Date: 30/10/2018 By : I. SOURBE AMBRS-M002192 NOT_QP - If you have any further questions on the use of this medicine, ask your doctor or pharmacist

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. The most common side effect reported with Plavix 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, the lung or the joints has also been reported. If you experience prolonged bleeding when taking Plavix 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; 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 food. Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms. In addition, your doctor may identify changes in your blood or urine test results.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. United Kingdom You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected] Malta You can also report side effects directly via ADR Reporting www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provid e more information on the safety of this medicine.

How to Store Plavix

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. This medicinal product does not require any special storage conditions. Do not use this medicine if you notice any visible sign of deterioration. Do not throw away any medicines 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.