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EFAVA Viên nang cứng Emtricitabine 200 mg
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PIDOGREL Film coated tablet Clopidogrel (besylate form) 75 mg
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MIFE 200 Mifepristone Tablets 200 mg
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HERAPROSTOL Misoprostol 100 mcg, 200 mcg, 600 mcg tablet
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BIOVACOR Pravastatin sodium 10 mg Tablets
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VARDELENA 10mg Vardenafil oral dispersible tablet
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BIOVACOR

BIOVACOR
Pravastatin sodium 10 mg Tablets
 
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 AND CONTENT
Each tablets contains:
Active ingredients:
Pravastatin sodium .....................10 mg
Excipients just enough: Microcrystalline cellulose 102, lactose monohydrate,
copovidon, croscarmellose sodium, magnesium oxid, magnesium stearate, food yellow 13.
DESCRIPTION ABOUT PRODUCT
 Tablets are light yellow, rounded, beveled, 2 flat surfaces, smooth, one surface with “H” word, the other with grooves, intact edge and walls.
PACKAGING:
 Box of 3 blister x 10 Tablets.
PHARMACODYNAMIC
 Biovacor used for  3 cases include: 
  - Cholesterol treament
Pravastatin used for reduction the “bad” cholesterol concentration and increase the “good” cholesterol in blood when changing the diet plan and exsercises do not  improve the medical condition.
  - Averting the blood diseases and cardiovascular
 If the cholesterol concentration in blood is high and advantage factors for morbidity (smoking, obese, high blood pressure or high blood sugar) pravastatin used for averting the cardiovascular deseases and mortality rate by these diseases.
 If the patient have had a stroke or chest pain (angina pectoris) and although have a normal cholesterol level, pravastatin still used for averting heart attacks or strokes may happen and reduce the mortality rate by these diseases.
  - After organ transplantation
 If the patient have had a organ transplants and used drug for preventing the body eliminated the implant, pravastatin used for reducing the increased cholesterol level.
ADMINISTRATION AND DOSAGE
 Always use drug exactly as your doctor or pharmacist decide for you. Checking with your doctor or pharmacist if you are unsure.
 Doctor will advise you on a reasonable low-fat diet during the treatment. Pravastatin can be taken with or without foods, with a half cup of water.
Dosage:
  - Adult
 In the treatment of high cholesterol level, the usual dose is 10 - 40 mg once daily, preferably in the evening.
 In preventing the cardiovascular and blood vessels diseases, the usual dose is 40 mg once a day, preferably in the evening.
 The maximum daily dose of pravastatin should not exceed 40 mg. Doctor will instruct the appropriate dose for each specific case.
 Children and youth (8 – 18 years old) that have genetic disease in increasing the cholesterol level: the usual dose is 10 – 20 mg once a day for children in 8 – 13 years old and 10 – 40 mg once a day for children in 14 -18 years old.
  - After organ transplants:
 Doctor may prescribe an initial dose of 20 mg once a day. Doctor can adjust the dose up to 40 mg.
 If you are also taking a medicine that reduces the body's immune system (ciclosporin), doctor may prescribe a starting dose of 20 mg once a day and may adjust the dose up to 40 mg.           
 If you have kidney disease or severe liver disease, doctor may prescribe a low dose of pravastatin.
 If this effect was verifying is too strong or too weak, please report to doctor or pharmacist.
Duration of treatment
 Doctor will recommended you about the duration of treatment with pravastatin. This drug must be used very frequently and lasts for some time as recommended by the doctor, even for a very long time.
 Do not voluntarily discontinue treatment.
CONTRAINDICATIONS
 Contraindicated use of Pravastatin sodium 10 mg in the following cases:
  - Hypersensitivity to pravastatin or any of the other ingredients.
  - Pregnant
  - Liver failure
  - Blood test results shows abnormal liver function (increased levels of liver enzymes in the blood).
UNDESIRABLE EFFECTS
 Like all other medications, this drug can cause side effects, although not everyone is affected.
 Stop using pravastatin and report to the doctor immediately if you have any of the following known or suspected underlying myalgia, pain, weakness, or cramps, especially if you are feeling unwell or have high temperature at the same time.
In very rare case, the muscle problems can be serious that lead to severe lidney failure or life – threatening.
 Suddenly serious allergic reactions include swollen face, lips, tongue or windpipe, can cause major difficulties during breathing. This is a very rare effect, which can become serious if it occurs. You should tell your doctor immediately if this condition occurs.
Uncommon (can affect more than 1 in 1000 people)
 Nervous system: dizziness, fatigue, headache or sleep disturbance, including insomnia.
 Vision: blurred or double vision.
 Gastrointestinal: indigestion, nausea, vomiting, discomfort or stomach pain, diarrhea or constipation and fart.
 Skin and hair: itching, furuncles, urticaria, rash, hair and scalp problems (including hair loss).
 Urinary system and genitourinary system: bladder problems (painful urination or more frequent, night-time sweating) and sexual difficulties.
 Muscles and joints: muscle and joint pain.
Very rare (can affect less than 1 in 1000 people)
 Nervous System: Problems with sensation include hot or tingling, stiffness that may indicate nerve damage.
 Skin: Severe skin disease (Lupus erythematosus)
 Liver: Hepatitis or pancreas, jaundice (recognized by jaundice and eyes, rapid hepatomegaly (hepatic necrosis)).
 Muscle and bone: inflammation of one or more muscles, pain or weakness of the muscles (myositis or polymyositis); pain or weakness of the muscles, tendinitis complicated by ligaments.
 Blood Test: Increased transaminase may be a sign of liver disease. Doctor may take periodic tests to check for this condition.
Unknown
 Muscles and bones: consecutive weakness muscles.
 Dermatitis: A characteristic condition of dermatitis and muscles.
 If you have any side effects, report to doctor or pharmacist.
 Include undesirable effects not listed, including:
 Nightmares.
 Amnesia.
 Depression.
 Breathing problems include persistent coughing and / or shortness of breath or fever.
 Diabetes. This disease is more likely to occur if you have a high blood sugar level and cholesterol level, fat and high blood pressure. Doctor will monitor your medications.
DRUG INTERACTION
Other drugs and Pravastatin
 Notifi your doctor and pharmacist if you have been taking any other medicines recently.
 The drugs list below can lead to increase the risk of muscle development problems.  Inform your doctor if you are being treated by:
  - The drug that reduce the cholesterol level (fibrates, for example: gemfibrozil, fenofibrate).
  -  The drug that reduce the immune system (ciclosporin).
  -  Drug for bacteria infections (antibiotics like erythromycin or clarithromycin).
  - Other drugs that reduce the cholesterol level (nicotinic acid).
 If you have been taking drug that reduce the blood fat (resin like cholestyramin or colestipol), taking pravastatin at least an hour before or four hours after using resin.    Because resin can affect the absorption of pravastatin if two drugs are taken too close together.
 If you are taking drug that preventing blood clots called warfarin, notifi your doctor before using pravastatin. If these two drugs are used concomitantly, it may increase the blood test results used to monitor treatment with drugs like warfarin.
Pravastatin with foods and drinks
 Pravastatin can use with or without foods, with a half cup of water.
 Restricted the alcohol. If you want to know how much alcohol you can take while taking this medicine, discuss to your doctor.
FORGET TAKING DRUG
 If you miss a dose, just take the next usual dose. Do not take double dose to make up for a missed dose.
STORAGE
 Store in a cool, dry place, temperature below 30oC.
OVERDOSE AND TREAMENT
 There are no special symptoms when taking overdose. May cause severe undesirable effects. Recuperate does not leave sequelae.
 Notify your doctor when taking over recommended dose.
CAUTIONS AND RECOMMENDED WHEN TAKING MEDICINE
 Notify your doctor before treatment if you have any of the following:
 Before treatment, discuss with your doctor if you have any medical problems like:
  - Kidney disease.
  - Bad thyroid function (thyroid failure)
  - Liver disease or alcohol problem (taking a large amount of alcohol).
  - Muscular dystrophy from a genetic disease.
  - The muscle problem is due to another drug that belongs to the statin group (the HMG-  CoA reductase inhibition drug) or a kind of drug belongs to the fibrate group. Notify your doctor if you have consecutive muscle weakness. Other tests and drugs may be needed to diagnose and treat this condition.
 If you have had one of these conditions, or are older than 70, your doctor will need to take blood test first and possibly during treatment. Blood tests will be used to assess the risk of muscle-related side effects.
 While using drug, doctor will monitor you closely if you have diabetes or are at risk of diabetes. You have a higher risk of diabetes if you have high blood sugar and fat, obesity or high blood pressure.
 Checking with your doctor or pharmacist before using pravastatin if you have severe respiratory failure.
Pregnant
 Do not use drugs for pregnant women. If you are pregnant, notify your doctor immediately
Breast-feeding women
 Do not taking pravastatin if you intend to breast-feeding because ít can be excreted in milk of mother.
 Ability to drive and operate machines
 Pravastatin usually do not have impact on the ability to drive and operate machines. If you have ever had drowsiness, blurred vision when using drug, make sure that you have ability to drive and operate machines.
CONSULTATION WITH DOCTOR AND PHARMACIST
 When you have any undesirable effects, no treatment respone or the 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.