Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MEGESTROL ACETATE
IMEKS PHARMA SDN. BHD.
MEGESTROL ACETATE
20 pouches x 20 ml
DAEWON PHARM CO LTD
_CONSUMER _ _MEDICATION _ _INFORMATION _ _LEAFLET _ _(RIMUP)_ MEGEX-I SUSPENSION ® 800MG/20ML Megestrol Acetate (800mg/20ml) _ _ 1 WHAT IS IN THE LEAFLET 1. What Megex-I Suspension is used for 2. How Megex-I Suspension works 3. Before you use Megex-I Suspension 4. How to use Megex-I Suspension 5. While you are using it 6. Side effects 7. Storage and Disposal of Megex-I Suspension 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT MEGEX-I SUSPENSION IS USED FOR Megex-I Suspension helps to increase appetite and/or to overcome loss of weight which often occurs in patients who are suffering from cancer or AIDS. HOW MEGEX-I SUSPENSION WORKS Megex-I Suspension contains the active ingredient megestrol acetate. It belongs to a group of medicines called progestogens. Megestrol acetate has a unique characteristic to boost up appetite in patients. However, the exact mechanism of how it functions remain unknown. BEFORE YOU USE MEGEX-I SUSPENSION - _When you must not use it_ Do not take Megex-I Suspension: • If you have known hypersensitivity to megestrol acetate or any ingredients listed at the end of this leaflet. • If you are pregnant or think that you may be pregnant. • If you are breastfeeding. _If you are not sure whether you should start _ _taking this product, consult your doctor. _ - _Before you start to use it _ • Tell your doctor if you are pregnant or intent to become pregnant. This medication must not be used during pregnancy as it may cause harm to your unborn baby. Women of child-bearing age should use an effective form of birth control while taking this medication. • Breastfeeding is not recommended while using this product as megestrol may pass into breast milk and could have undesirable effects on nursing infant. If it is necessary for you to take this medicine, breastfeeding should be discontinued. Tell your doctor if you: • have severe liver problems. • have a history of suffering from blood clots (thrombophlebitis). • have diabetes, as Megex-I Lue koko asiakirja
MEGEX-I SUSPENSION 800MG/20ML DESCRIPTION White to cream coloured suspension with orange fragrant and taste. CONTENTS Each 20ml of suspension contains megestrol acetate 800mg. Preservative: Sodium Benzoate 0.1% w/v PHARMACODYNAMICS Megestrol acetate exhibits classical progestational activity. It possesses little or no estrogenic, androgenic or adreno- corticoid action. The anti-tumour action of megestrol acetate on carcinoma of the breast is unclear. However, it is known to compete for progesterone, androgen and glucocorticoid receptors, and affect pituitary functions. Megestrol acetate is even used to enhance appetite in patients with cachexia and anorexia. The precise mecha- nism of this is unknown but the efficacy of megestrol acetate in cachexia and anorexia has been established with statistically significant improvement in appetite. The gain in weight while taking megestrol acetate, particularly at high doses, is usually not associated with water reten- tion, but is associated with an increased appetite/food intake and an increase in fat and body cell mass. PHARMACOKINETICS Mechanism of Action The appetite enhancing property of megestrol acetate and its possible use in cachexia have been recorded. However, the exact mechanism on how megestrol acetate produces effects in anorexia and cachexia remain unknown. Absorption and Distribution The oral absorption of megestrol acetate appeared to be variable. Estimates of the plasma concentrations of mege- strol acetate are dependent, not only on the measurement method used, but also on intestinal and hepatic inactiva- tion of the drug, which may be affected by intestinal tract motility, intestinal bacteria, antibiotics administered, body weight, diet, and hepatic function. There is no difference in safety following administration of megestrol acetate under fasting and fed conditions, there- fore megestrol acetate could be taken without regard to meals. Metabolism and Excretion Metabolites have accounted for only 5% to 8% of an administered dose of megestrol acetate. Lue koko asiakirja