Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
drospirenone, Quantity: 3 mg; ethinylestradiol, Quantity: 30 microgram
Lupin Australia Pty Limited
Drospirenone,ethinylestradiol
Tablet
Excipient Ingredients: lactose monohydrate; maize starch; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; macrogol 400
Oral
2 x 28 Tablets (21 active and 7 placebo), 4 x 28 Tablets (21 active and 7 placebo), 1 x 28 Tablets (21 active and 7 placebo), 3 x 28 Tablets (21 active and 7 placebo)
(S4) Prescription Only Medicine
For use as an oral contraceptive
Visual Identification: White to off-white coloured, round, biconvex, film coated tablets, plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-01-20
_Draft v0.1, 26 July 2011 _ DROSPIRENONE/ ETHINYLOESTRADIOL-GH CMI Page 1 of 13 DROSPIRENONE/ ETHINYLOESTRADIOL-GH TABLETS 3 MG/ 30 ΜG Contraceptive tablets for women _drospirenone and ethinyloestradiol _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Drospirenone/ Ethinyloestradiol-GH . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Drospirenone/ Ethinyloestradiol-GH against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS, OR ARE UNSURE ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST FOR MORE ADVICE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DROSPIRENONE/ ETHINYLOESTRADIOL-GH IS USED FOR Drospirenone/ Ethinyloestradiol-GH is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. Drospirenone/ Ethinyloestradiol-GH is used to prevent pregnancy. Drospirenone/ Ethinyloestradiol-GH contains drospirenone which has antiandrogenic properties and may be of some benefit in androgen-related acne, skin conditions or greasy hair. You may also experience the following benefits: • improvement in symptoms like bloating, swelling or weight gain related to fluid retention • more regular and shorter periods and a decrease in the amount of blood you lose each month • a decrease in anaemia (iron deficiency) • a decrease in period pain. _Draft v0.1, 26 July 2011 _ DROSPIRENONE/ ETHINYLOESTRADIOL-GH CMI Page 2 of 13 Some medical conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy and disorders of the uterus (womb), ovaries and breast are less common in women taking oral contraceptives. When taken correctly, it prevents you from becoming pregnant in several ways: • inhibiting the egg release by stopping it maturing • changing the cervical mucus consistency, making it more diff Leggi il documento completo
_ _ DROSPIRENONE/ ETHINYLOESTRADIOL-GH PI_v2 Page 1 of 32 PRODUCT INFORMATION DROSPIRENONE/ ETHINYLOESTRADIOL-GH TABLETS (3 MG/30 ΜG) NAME OF THE MEDICINE Drospirenone/ Ethinyloestradiol-GH is a combined oral contraceptive tablet containing the synthetic progestogen, drospirenone and the synthetic oestrogen, ethinyloestradiol. Ethinyloestradiol is an oestrogen. Chemically, ethinyloestradiol is 19-nor-17α-pregna- 1,3,5(10)-trien-20-yne-3, 17β–diol and has the following structural formula: Chemical Formula: C 20 H 24 O 2 Molecular Weight: 296.41 CAS No: 57-63-6 Drospirenone is a progestogen. The chemical name for drospirenone is 3-0xo-6α, 7α, 15α, 16α-tetrahydro-3' _H,3"H-_ dicydopropa[6,7:15,16]-17α-pregn-4-en-21,17-carbolactone and has the following structural formula: Chemical formula: C 24 H 30 O 3 Molecular weight: 366.50 _ _ DROSPIRENONE/ ETHINYLOESTRADIOL-GH PI_v2 Page 2 of 32 CAS No: 67392-87-4 DESCRIPTION Ethinyloestradiol is a white or slightly yellowish-white, crystalline powder. It is practically insoluble in water, freely soluble in ethanol (96 per cent). It dissolves in dilute alkaline solutions. Drospirenone is a white to off-white crystalline powder. It is freely soluble in methylene chloride, soluble in acetone, methanol, sparingly soluble in ethylacetate and ethanol 96% (v/v) and practically insoluble in hexane and water. Each yellow active tablet contains drospirenone 3 mg and ethinyloestradiol 30 μg and the excipients: lactose, maize starch, pregelatinised maize starch, magnesium stearate and Opadry Complete Film Coating System 03F82726 Yellow (containing hypromellose, macrogol 6000, purified talc, titanium dioxide and iron oxide yellow). Each white inactive tablet contains lactose, maize starch, pregelatinised maize starch, magnesium stearate and Opadry Complete Film Coating System 03B28796 White (containing hypromellose, macrogol 400 and titanium dioxide). PHARMACOLOGY PHARMACODYNAMIC PROPERTIES The contraceptive effect of combined oral contraceptives is based on the interaction of Leggi il documento completo