Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Gemfibrozil
Pfizer Australia Pty Ltd
Medicine Registered
JEZIL™ _contains the active ingredient gemfibrozil_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Jezil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Jezil against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT JEZIL IS USED FOR Jezil is used to help control high levels of cholesterol and triglycerides, which are fat-like substances in the blood. Jezil belongs to a group of medicines called fibric acid derivatives or fibrates. The exact way in which Jezil works is not known but it is thought to work by reducing the "bad" (LDL) cholesterol and triglycerides while raising the "good" (HDL) cholesterol. This helps keep your blood vessels unblocked and decreases the risk of heart disease to prevent heart attacks, angina and stroke. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY JEZIL HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Jezil for another reason. Jezil is not recommended for use in children, as its safety and effectiveness in children have not been established. Jezil is available only with a doctor's prescription. There is no evidence that Jezil is addictive. BEFORE YOU TAKE JEZIL _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE JEZIL IF YOU ARE ALLERGIC TO: • medicines containing gemfibrozil (e.g. Lopid, Gemhexal or Lipazil), • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include • skin rash, itching or hives • swelling of the face, lips, mouth, throat or neck • difficulty in swallowing or breathing • wheezing or shortness of breath. DO NOT TAKE JEZIL IF YOU HAVE: • severe liver disease • severe kidney disease • gallstones or gall bladder diseas Read the complete document
Version: pfpjezit10913 Supersedes: pfpjezit10310 Page: 1 of 13 PRODUCT INFORMATION JEZIL ® (GEMFIBROZIL) NAME OF MEDICINE JEZIL (gemfibrozil) 600 mg tablets. JEZIL contains the active ingredient gemfibrozil. Gemfibrozil is a nonhalogenated phenoxypentanoic acid with the following structural formula: - O - C H 2 - C H 2 - C H 2 - C - C O O H C H 3 C H 3 C H 3 C H 3 Chemical name: 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid Molecular formula: C 15 H 22 0 3 Molecular weight: 250.35 CAS registry number: 25812-30-0. DESCRIPTION Gemfibrozil is a white, waxy powder which is stable under ordinary conditions. The melting point is 58-61 C. Its solubility is 0.0019% (w/v) in water and in acid and over 1% in dilute base. Each film-coated tablet contains 600 mg gemfibrozil. JEZIL tablets also contain colloidal anhydrous silica, pregelatinised starch, polysorbate 80, microcystalline cellulose, hypromellose, calcium stearate, hydroxypropylcellulose, methyl hydroxybenzoate, propyl hydroxybenzoate, macrogol 3500, opaspray white and candelilla wax. PHARMACOLOGY MECHANISM OF ACTION Gemfibrozil’s mechanism of action has not been definitely established. In man, Gemfibrozil inhibits peripheral lipolysis and decreases the hepatic extraction of free fatty acids, thus reducing hepatic triglyceride production. Gemfibrozil also inhibits synthesis and increases clearance of apolipoprotein B, which is a carrier of VLDL, leading to a decrease in VLDL production. Gemfibrozil is a lipid regulating agent which decreases serum triglycerides and total cholesterol, and increases Read the complete document