Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DROSPIRENONE; ETHINYLESTRADIOL
PAHANG PHARMACY SDN. BHD.
DROSPIRENONE; ETHINYLESTRADIOL
21tablet Tablets; 63tablet Tablets
Gedeon Richter Plc
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ VOLINA FILM-COATED TABLETS Drospirenone (3 mg) and Ethinylestradiol (0.03 mg)_ _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What _Volina _is used for 2. How _Volina_ works 3. Before you use _Volina_ 4. How to use _Volina_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Volina_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _VOLINA_ IS USED FOR Volina is a contraceptive pill and is used to prevent pregnancy. HOW _VOLINA_ WORKS The contraceptive effect of Volina is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the endometrium. BEFORE YOU USE _VOLINA _ - _When you must not use it _ if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin- III deficiency, Factor V Leiden or antiphospholipid antibodies. if you need an operation or if you are off your feet for a long time (see section ‘Blood clots’) if you have ever had a heart attack or a stroke if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke symptoms) if you have any of the following diseases that may increase your risk of a clot in the arteries: - severe diabetes with blood vessel damage - very high blood pressure - a very high level of fat in the blood (cholesterol or triglycerides) - a condition known as hyperhomocysteinaemia if you have (or have ever had) a type of migraine called ‘migraine with aura’ if you have (or have ever had) a liver disease and your liver function is still not normal if your kidneys are not working well (renal failure) if you ha Pročitajte cijeli dokument
PACKAGE INSERT BRAND OR PRODUCT NAME Volina 3 mg /0.03 mg film-coated tablets NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 3 mg drospirenone and 0.03 mg ethinylestradiol. Excipients with known effect: Each film-coated tablet contains 48.17 mg of lactose monohydrate and 0.07 mg of soya lecithin. PRODUCT DESCRIPTION White or almost white, round, biconvex film-coated tablet. Engraving on one side: “G63”, other side is without engraving. Diameter approximately 6.0 mm. _Tablet core: _ Lactose monohydrate Pregelatinised maize starch Maize starch Povidone K-25 Magnesium stearate _Film-coating: _ Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Macrogol 3350 Lecithin (soya) PHARMACODYNAMICS/ PHARMACOKINETICS _PHARMACODYNAMIC PROPERTIES _ Pharmacotherapeutic group: Sex hormones and modulators of the genital system; Progestogens and estrogens, fixed combinations, ATC code: G03AA12 Mechanism of action The contraceptive effect of Volina is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the endometrium. Volina is a combined oral contraceptive with ethinylestradiol and the progestogen drospirenone. In a therapeutic dosage, drospirenone also possesses antiandrogenic and mild antimineralocorticoid properties. It has no estrogenic, glucocorticoid and antiglucocorticoid activity. This gives drospirenone a pharmacological profile closely resembling the natural hormone progesterone. _PHARMACOKINETIC PROPERTIES _ - Drospirenone Absorption Orally administered drospirenone is rapidly and almost completely absorbed. Maximum concentrations of the active substance in serum of about 38 ng/ml are reached at about 1-2 h after single ingestion. Bioavailability of drospirenone is between 76 and 85%. Concomitant ingestion of food has no influence on the bioavailability of drospirenone. Distribution After oral administration, serum drospirenone levels decrease in two phases, with terminal half-lives of 31 h. Drospirenone is Pročitajte cijeli dokument