Summary of product characteristic
PIDOGREL
Film coated tablet Clopidogrel (besylate form) 75 mg
Prescription drug.
Read the leaflet carefully before using.
Keep this medicine out of the sight and reach of children.
Immediately notify your doctor or pharmacist of adverse reactions encountered when using medicine.
INGREDIENTS:
Each film-coated tablet contains:
Drug Substance:
Clopidogrelbesylateis equivalent to clopidogrel.....................75 mg
Excipients:MicrocrystallineCellulose, anhydrous lactose, crospovidon XL, polyethylene glycol 6000, hydrogenated vegetable oil category 1, talc, opadry pink II (polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&C red #40).
DESCRIPTION ABOUT PRODUCT
Film coated tablets are pink, gloss, no sticky, circular, two convex sides, one side with “H”, the other side smooth, intact walls.
PACKAGING
Box of 10 blisters x 10 tablets.
INDICATIONS
Pidogrelcontains clopidogrel belonging to the antiplatelet aggregation class. Platelets are tiny blood cells that will stick together during blood clotting. Platelet inhibiting drugs reduce the likelihood of clot formation (also called thrombosis).
Pidogrel is used in adults to prevent the formation of blood clots in the arteries, which can lead to complications like stroke or death.
You are prescribed Pidogrel to prevent blood clots and reduce the risk of serious complications when:
- Have arteriosclerosis
- Have a history of heart attack, stroke, peripheral artery disease, or chest pain such as unstable angina or myocardial infarction. To treat this condition, the doctor may place a stentinside a blocked or narrowed artery for the purpose of maintaining blood flow in the vein effectively. You may also be prescribed the same acetylsalicylic acid (an active ingredient used to relieve pain and reduce fever and block blood clots).
- An abnormal heart rhythm, a condition known as atrial fibrillation, can not be treated with oral anticoagulants (anti vitamin K) to prevent the formation of new blood clots and prevent the development of blood clots. You should be advised that oral anticoagulants are more effective than acetylsalicylic acid or a combination of Pidogrelwith acetylsalicylic acid for this condition. Your doctor will prescribe Pidogrel plus acetylsalicylic acid if you can not take oral anticoagulants and you are not at risk for severe bleeding.
HOW TO TAKE THIS MEDICINE AND DOSAGE
Alway use the medicine exactly as your doctor or pharmacist has prescribed.
Check with your doctor or pharmacist if you are not sure.
Drugs are taken orally, can be taken with or without food and drink at the same time each day.
- The recommended dose for patients with atrial fibrillation (abnormal heart rhythm) is 75 mg clopidogrel per day (1 Pidogrel).
- If you have severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg clopidogrel (four Pidogrel) once at the start of treatment. Then, the recommended dose is 1 tablet 75 mg/day as mentioned above.
- Pidogrel should be taken until the doctor stops prescribing.
WHEN SHOULD NOT TAKE THIS MEDICINE
Do not use Pidogrelif:
- Hypersensitivity to clopidogrelor any component of the drug.
- There are bleeding status such as stomach ulcers or bleeding inside the brain.
- Having a serious liver disease.
If you have or suspect any signs, tell your doctor/pharmacist before taking Pidogrel.
UNDESIRABLE EFFECTS
Like other drugs, Pidogrel can cause some undesirable effects, although not all patients will experience it.
Report to your doctor/pharmacist immediately if any of the following side effects occur:
- Fever, signs of infection or extreme fatigue. This happens possibly due to the reduction of some blood cells.
- Signs of liver problems such as jaundice and/or eyes, whether or not they involve subcutaneous bledding (appearing as small red spots) .
- Swelling of the mouth or skin disorders such as erythema, itching, rash. These may be signs of an allergic reaction.
The most common adverse event reported was bleeding. Bleeding can occur like bleeding in the stomach or intestines, bruising, hematoma, nose bleeding, and bleeding in the urinary tract.
In less cases, bleeding in the eyes, head, lungs or joints is also noted.
If you are injured, it may take longer than usual to stop bleeding, this involves the mechanism of action that prevents the formation of blood clots. For small wounds do not need to worrry. However, if you are worried about your bleeding, you should contact your doctor immediately.
Other side effects include:
Frequent (affects more than 1 in 10 people)
- Diarrhea, abdominal pain, indigestion or heartburn.
Less common(affects more than 1 in100 people)
- Headache, stomach ulcers, nausea, vomiting, constipation, erythema, dizziness, itching and numbness.
Rare (affects more than 1 in1000 people)
- Dizzy, big chest in men.
Very rare (affects more than 1 in10000 people)
- Jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing and sometimes coughing, allergic reaction (eg heat sensitivity from feeling uncomfortable to fainting), swelling of the lips, allergic reaction in skin, burning pain in the mouth, hypotension, confusion, joint pain, altered taste (feeling with food).
Report on undesirable effects
If you experience any undesirable effects, inform your doctor or pharmacist immediately. Include unwanted effects that appear outside of the signs listed above.
AVOID TAKING MEDICATION OR FOOD WHEN USING MEDICATION
Clopidogrel is taken with or without food.
Tell your doctor/pharmacist if you are taking, have used or may be taking other medicines, including over the counter medicines.
Some medications may affect the effectiveness of Pidogrelor vice versa.
- Drugs increase the risk of bleeding like:
+ Oral anticoagulants, drugs that reduce blood clots.
+ Nonsteroidal anti-inflammatory drugs, commonly used for pain and/ or muscle or joint inflammation.
+ Heparin or any other injection to reduce blood clots.
+ Ticlopidin, other antiplatelet drugs
+ Selective serotonin reuptake inhibitors, these drugs are often used to treat depression.
- Omeprazoleor esomeprazole, a drug for stomach pain.
- Fluconazole hoặc voriconazole, a drug for fungal infections.
- Efavirenz, medicines for HIV.
- Carbamazepine, a drug for insomnia.
- Moclobemid, a drug for depression.
- Repaglinid, a drug for diabetes.
- Paclitaxel, a drug for cancer.
If you have chest pain (unstable angina or myocardial infarction) you may be give Pidogrel combined with acetylsalicylic acid, a drug used to relieve pain and fever. Taking regular acetylsalicylic acid (more than 1000 mg in 24 hours) dose not cause problems, but long-term use in other cases shoud be consulted with your doctor or pharmacist.
WHAT TO DO WHEN ONE TIME FORGETS TO TAKE MEDICINE
- If you forget to take a dose of Pidogrel, but remember within 12 hours, then take the drug immediately and then take the next dose as normal.
- If you forger more than 12 hours, drink next time on time as usual. Do not drink twice the dose.
STORAGE
The medicine is stored in sealed containers, where the temperature is below 30oC.
SIGNS AND SYMPTOMS OF OVERDOSE
When overdose is recommended, symptoms of acute poisoning may occur, including vomiting, exhaustion, dyspnea, and gastrointestinal bleeding.
WHAT TO DO WHEN OVERDOSE IS RECOMMENDED
Inform your doctor of pharmacist when to use over recommended dosage, as it increases the risk of bleeding.
THINGS TO TAKE CAUTION WHEN TAKING THIS DRUG
Talk to your doctor, pharmacist or health care provider before taking clopidogrel.
- If there is a risk of bleeding with:
- A condition that can cause internal bleeding (such as a stomach ulcer).
- Blood disorders can cause internal bleeding (bleeding within tissues, organs, or joints).
- Recent injuries
- Recent surgery (including teeth).
- Have a plan for surgery within the next 7 days.
- If there is a blood clot in the cerebral artery (stroke due to ischemia) that occurred within the past 7 days.
- If you have liver or kidney disease.
- If you have allergies or reaction to any of the ingredients.
During treatment with Pidogrel:
- Tell your doctor/pharmacist if you have any surgery (including dental) planned.
- Tell your doctor immediately if you have abnormal conditions (also known as thrombocytopenic purpura) including fever and bruising under the skin that may appear such ass redness, with or without unexplained fatigue, confusion, jaundice or eyes.
- If you are injured, it may take longer than usual to stop bleeding. This involves the mechanism by which this drugs works, which prevents the formation of blood clots. For small wounds, such as cutting hands, do not worry. However, if you are worried about your bleeding, you should contact your doctor immediately.
- Doctor may order a blood test.
- Lactose containing products, if you have problems with the tolerability of certain sugars, please inform your doctor..
Use for children and adolescents:
Do not use for children.
Use in pregnant women and nursing mothers
It is better not to take this medicine during pregnancy.
If you are pregnant or suspect you are pregnant, you should inform your doctor or pharmacist before taking Pidogrel. If you are pregnant while taking Pidogrel, consult your doctor immediately. Clopidogrel is not recommended during pregnancy.
You should not breastfeed while taking medicine.
If you are breastfeeding or planning, talk to your doctor before taking the medicine.
Impact on the ability to drive or operate machinery:
Pidogreldose not affect the ability to drive or use machines.
WHEN TO CONSULT A DOCTOR, PHARMACIST
When you have any unwanted effects of the drug, no treatment response or symptoms become worse. Consult your doctor or pharmacist for more information.
SHELF-LIFE
24 months from manufacturing date.
Manufactured by:
HERA BIOPHARMACRUTICAL CO. LTD.
Lot A17, Tu Ha Industrial zone, Tu Ha Ward, Huong Tra Town, Thua Thien Hue Province, Viet Nam.
© 2016 Hera Biopharm. All Rights Reserved. Designed By Herabiopharm
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