CLOPIDOGREL 75 MG FILM-COATED TABLET
Active substance: CLOPIDOGREL NAPADISILATE MONOHYDRATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIDOGREL 75 mg film-coated tablets Clopidogrel
Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet: 1. 2. 3. 4. 5. 6. What CLOPIDOGREL is and what it is used for Before you take CLOPIDOGREL How to take CLOPIDOGREL Possible side effects How to store CLOPIDOGREL Further information
1.
WHAT CLOPIDOGREL IS AND WHAT IT IS USED FOR
CLOPIDOGREL belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis). CLOPIDOGREL is taken 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 CLOPIDOGREL 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.
2.
BEFORE YOU TAKE CLOPIDOGREL
Do not take CLOPIDOGREL:
If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of CLOPIDOGREL; This medicinal product contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product. 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 think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking CLOPIDOGREL. Take special care with CLOPIDOGREL: If any of the situations mentioned below apply to you, you should tell your doctor before taking CLOPIDOGREL: 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 within the last seven days if you have kidney or liver disease While you are taking CLOPIDOGREL: You should tell your doctor if a surgery (including dental) is planned. You should also tell your doctor immediately if you develop a medical condition (also 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 tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 POSSIBLE SIDE EFFECTS ). 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. CLOPIDOGREL is not intended for use in children or adolescents. Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some other medicines may influence the use of CLOPIDOGREL or vice versa. You should specifically tell your doctor if you take - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, - heparin or any other medicine used to reduce blood clotting, - a proton pump inhibitor (e.g, omeprazole) for upset stomach, - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections, - cimetidine, medicine to treat upset stomach, - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression, - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy,
-
ticlopidine, other antiplatelet agent.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed CLOPIDOGREL in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor. Taking CLOPIDOGREL with food and drink CLOPIDOGREL may be taken with or without food. Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding. If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking CLOPIDOGREL. If you become pregnant while taking CLOPIDOGREL, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant. While taking CLOPIDOGREL, consult your doctor about the breast-feeding of a baby. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines CLOPIDOGREL is unlikely to affect your ability to drive or to use machines.
3.
HOW TO TAKE CLOPIDOGREL
Always take CLOPIDOGREL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of CLOPIDOGREL (4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75-mg tablet of CLOPIDOGREL per day to be taken orally with or without food, and at the same time each day. You should take CLOPIDOGREL for as long as your doctor continues to prescribe it. If you take more CLOPIDOGREL than you should: Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding. If you forget to take CLOPIDOGREL If you forget to take a dose of CLOPIDOGREL, 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 the forgotten individual doses. If you stop taking CLOPIDOGREL Do not stop the treatment. Contact your doctor or pharmacist before stopping. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, CLOPIDOGREL 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 Take special care with CLOPIDOGREL). 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 (affects 1 to 10 patients in 100) reported with CLOPIDOGREL 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 CLOPIDOGREL 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 Take special care with CLOPIDOGREL). Other side effects reported with CLOPIDOGREL are: Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn. Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness. Rare side effect (affects 1 to 10 patients in 10,000): Vertigo. Very rare side effects (affects less than 1 patient in 10,000): jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste. In addition, your doctor may identify changes in your blood or urine test results. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.
HOW TO STORE CLOPIDOGREL
Keep out of the reach and sight of children. Do not use CLOPIDOGREL after the expiry date which is stated on the carton and on the blister. This medicinal product does not require any special storage conditions. Do not use CLOPIDOGREL if you notice any visible sign of deterioration. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What CLOPIDOGREL contains - The active substance is clopidogrel. Each tablet contains 110,69 mg of clopidogrel napadisilate monohydrate, equivalent to 75 mg clopidogrel. The other ingredients are: mannitol (E421), hypromellose, silica, colloidal anhydrous, fumaric acid, crospovidone, copovidone, butylhydroxytoluene, sucrose esters of fatty acids, polyvinyl alcohol, titanium dioxide, talc, lecithin, iron oxide red (E172), xanthan gum, allura red ac aluminium lake, indigo carmine aluminium lake
What CLOPIDOGREL looks like and contents of the pack CLOPIDOGREL tablets are round, pink, film-coated tablets CLOPIDOGREL tablets may be obtained in blisterpacks with 14, 28, 30, 50, 84, 90 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder ALFRED E. TIEFENBACHER (GmbH & Co. KG) 22767 Hamburg Germany Manufacturer Klocke Verpackungs - Service GmbH Max-Becker-Str. 6 76356 Weingarten Germany This medicinal product is authorised in the Member States of the EEA under the following names: Xxx xxx xxx
This leaflet was last approved in
12/2010
Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet: 1. 2. 3. 4. 5. 6. What CLOPIDOGREL is and what it is used for Before you take CLOPIDOGREL How to take CLOPIDOGREL Possible side effects How to store CLOPIDOGREL Further information
1.
WHAT CLOPIDOGREL IS AND WHAT IT IS USED FOR
CLOPIDOGREL belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis). CLOPIDOGREL is taken 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 CLOPIDOGREL 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.
2.
BEFORE YOU TAKE CLOPIDOGREL
Do not take CLOPIDOGREL:
If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of CLOPIDOGREL; This medicinal product contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product. 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 think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking CLOPIDOGREL. Take special care with CLOPIDOGREL: If any of the situations mentioned below apply to you, you should tell your doctor before taking CLOPIDOGREL: 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 within the last seven days if you have kidney or liver disease While you are taking CLOPIDOGREL: You should tell your doctor if a surgery (including dental) is planned. You should also tell your doctor immediately if you develop a medical condition (also 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 tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 POSSIBLE SIDE EFFECTS ). 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. CLOPIDOGREL is not intended for use in children or adolescents. Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some other medicines may influence the use of CLOPIDOGREL or vice versa. You should specifically tell your doctor if you take - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, - heparin or any other medicine used to reduce blood clotting, - a proton pump inhibitor (e.g, omeprazole) for upset stomach, - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections, - cimetidine, medicine to treat upset stomach, - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression, - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy,
-
ticlopidine, other antiplatelet agent.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed CLOPIDOGREL in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor. Taking CLOPIDOGREL with food and drink CLOPIDOGREL may be taken with or without food. Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding. If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking CLOPIDOGREL. If you become pregnant while taking CLOPIDOGREL, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant. While taking CLOPIDOGREL, consult your doctor about the breast-feeding of a baby. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines CLOPIDOGREL is unlikely to affect your ability to drive or to use machines.
3.
HOW TO TAKE CLOPIDOGREL
Always take CLOPIDOGREL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of CLOPIDOGREL (4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75-mg tablet of CLOPIDOGREL per day to be taken orally with or without food, and at the same time each day. You should take CLOPIDOGREL for as long as your doctor continues to prescribe it. If you take more CLOPIDOGREL than you should: Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding. If you forget to take CLOPIDOGREL If you forget to take a dose of CLOPIDOGREL, 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 the forgotten individual doses. If you stop taking CLOPIDOGREL Do not stop the treatment. Contact your doctor or pharmacist before stopping. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, CLOPIDOGREL 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 Take special care with CLOPIDOGREL). 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 (affects 1 to 10 patients in 100) reported with CLOPIDOGREL 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 CLOPIDOGREL 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 Take special care with CLOPIDOGREL). Other side effects reported with CLOPIDOGREL are: Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn. Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness. Rare side effect (affects 1 to 10 patients in 10,000): Vertigo. Very rare side effects (affects less than 1 patient in 10,000): jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste. In addition, your doctor may identify changes in your blood or urine test results. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.
HOW TO STORE CLOPIDOGREL
Keep out of the reach and sight of children. Do not use CLOPIDOGREL after the expiry date which is stated on the carton and on the blister. This medicinal product does not require any special storage conditions. Do not use CLOPIDOGREL if you notice any visible sign of deterioration. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What CLOPIDOGREL contains - The active substance is clopidogrel. Each tablet contains 110,69 mg of clopidogrel napadisilate monohydrate, equivalent to 75 mg clopidogrel. The other ingredients are: mannitol (E421), hypromellose, silica, colloidal anhydrous, fumaric acid, crospovidone, copovidone, butylhydroxytoluene, sucrose esters of fatty acids, polyvinyl alcohol, titanium dioxide, talc, lecithin, iron oxide red (E172), xanthan gum, allura red ac aluminium lake, indigo carmine aluminium lake
What CLOPIDOGREL looks like and contents of the pack CLOPIDOGREL tablets are round, pink, film-coated tablets CLOPIDOGREL tablets may be obtained in blisterpacks with 14, 28, 30, 50, 84, 90 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder ALFRED E. TIEFENBACHER (GmbH & Co. KG) 22767 Hamburg Germany Manufacturer Klocke Verpackungs - Service GmbH Max-Becker-Str. 6 76356 Weingarten Germany This medicinal product is authorised in the Member States of the EEA under the following names: Xxx xxx xxx
This leaflet was last approved in
12/2010
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
