Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DROSPIRENONE; ETHINYLESTRADIOL
PAHANG PHARMACY SDN. BHD.
DROSPIRENONE; ETHINYLESTRADIOL
3x(24+4)tablet Tablets; 1x(24+4)tablettablet Tablets
Gedeon Richter Plc
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DAYLINA 3MG/0.02MG FILM-COATED TABLETS Drospirenone (3 mg) and Ethinylestradiol (0.02 mg) 1 WHAT IS IN THIS LEAFLET 1. What _Daylina _is used for 2. How _Daylina_ works 3. Before you use _Daylina_ 4. How to use _Daylina_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Daylina_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _DAYLINA_ IS USED FOR Oral contraception. _Daylina_ is used to prevent pregnancy. Treatment of moderate acne vulgaris in women who elect to use oral contraception. Treatment of symptoms of premenstrual dysphoric disorder (PMDD – a severe and disabling form of premenstrual syndrome (physical and emotional symptoms including acne, tender breasts, bloating, feeling tired, irritability, and mood changes that occur in the one to two weeks before a woman’s period) in women who choose to use an oral contraceptive as their method of contraception. HOW _DAYLINA_ WORKS The contraceptive effect of _Daylina_ 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 _DAYLINA_ _ _ - _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 i Les hele dokumentet
PACKAGE INSERT BRAND OR PRODUCT NAME Daylina 3 mg/0.02 mg film-coated tablets NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) 24 white or almost white _(active)_ film-coated tablets: Each active film-coated tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol. Excipients with known effect: 48.53 mg of lactose monohydrate and 0.070 mg of soya lecithin. 4 green placebo _(inactive)_ film-coated tablets: The tablet does not contain active substances. Excipients with known effect: lactose anhydrous 37.26 mg, sunset yellow (E110) 0.003 mg. PRODUCT DESCRIPTION Film-coated tablet. The active tablet is white or almost white, round, biconvex film-coated tablet, diameter about 6 mm. Engraving on one side: “G73”, the other side is without engraving. The placebo tablet is green, round, biconvex film-coated tablet, diameter about 6 mm, without engraving. _Tablet core (active): _ Lactose monohydrate Maize starch Maize starch, pregelatinised Macrogol poly(vinyl alcohol) grafted copolymer Magnesium stearate _Film-coating (active): _ Poly(vinyl alcohol) Titanium dioxide (E171) Talc Macrogol 3350 Lecithin (soya) _Tablet core (placebo): _ Cellulose, microcrystalline Lactose anhydrous Maize starch, pregelatinised Magnesium stearate Silica, colloidal anhydrous _Film-coating (placebo): _ Polyvinyl-alcohol Titanium dioxide (E171) Macrogol 3350 Talc Indigo carmine (E132) Quinoline yellow (E104) Iron oxide black (E172) Sunset yellow FCF (E110) PHARMACODYNAMICS/ PHARMACOKINETICS _PHARMACODYNAMIC PROPERTIES _ Pharmacotherapeutic group: Sex hormones and modulators of the genital system; Progestogens and estrogens, fixed combinations, ATC code: G03AA12 Pearl Index for method failure: 0.41 (upper two-sided 95% confidence limit: 0.85) Overall Pearl Index (method failure + patient failure): 0.80 (upper two-sided 95% confidence limit: 1.30) Mechanism of action The contraceptive effect of Daylina 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 endomet Les hele dokumentet