Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
ethinylestradiol, Quantity: 20 microgram; drospirenone, Quantity: 3 mg
Lupin Australia Pty Limited
Tablet, film coated
Excipient Ingredients: maize starch; lactose monohydrate; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; macrogol 400
Oral
4 x 28 tablets, 2 x 28 tablets, 1 x 28 tablets, 3 x 28 tablets, 6 x 28 tablets
(S4) Prescription Only Medicine
Bella is indicated for use:,? as an oral contraceptive.,? for the treatment of moderate acne vulgaris in women who seek oral contraception.,? for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of ethinylestradiol/drospirenone 20 microgram/3 mg tablets for PMDD was not assessed beyond 3 cycles. Ethinylestradiol/drospirenone 20 microgram/3 mg tablets have not been evaluated for treatment of PMS (premenstrual syndrome) (see Section 5.1 Pharmacodynamic Properties ? Clinical Trials).
Visual Identification: White to off-white round, biconvex film coated tablets, plain on both the sides.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-09-11
CONSUMER MEDICINE INFORMATION BELLA (DROSPIRENONE AND ETHINYLESTRADIOL) FILM COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bella. 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 Bella 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 BELLA IS USED FOR Bella is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. Bella is used to prevent pregnancy. It is also used to treat symptoms of premenstrual dysphoric disorder (PMDD) in women seeking oral contraception. You may also experience the following benefits: • more regular and lighter periods - potentially resulting in a decrease in anaemia (iron deficiency); • a decrease in period pain; • improvement in symptoms like bloating, swelling or weight gain related to fluid retention. Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy (where the foetus is carried outside of your womb), lumpy breaks and cancer of the uterus (womb), ovaries may be less common in women taking the Pill. When taken correctly, it prevents you from becoming pregnant in several ways, including: • inhibiting the egg release by stopping it maturing; • changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg. _HOW BELLA IS DIFFERENT FROM _ _OTHER CONTRACEPTIVE PILLS _ Bella has 24 active (hormone) tablets and 4 inactive tablets, rather than the traditional 21 active tablets and 7 inactive tablets. This means that with Bella, you take the active (hormone) tablets for three more days. This helps your hormone levels to stay even. When the Pill is taken by women under close observation in clini Les hele dokumentet
AUSTRALIAN PRODUCT INFORMATION – BELLA (DROSPIRENONE AND ETHINYLESTRADIOL) FILM-COATED TABLET 1 NAME OF THE MEDICINE Drospirenone and ethinylestradiol. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bella is a combined oral contraceptive tablet containing the synthetic progestogen, drospirenone and the synthetic oestrogen, ethinylestradiol Each pink active tablet contains 20 µg ethinylestradiol and 3 mg drospirenone. List of excipients with known effects: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ACTIVE TABLETS: Pink, round, biconvex film-coated tablets, plain on one side and "DR1" on the other side. PLACEBO TABLETS: White to off-white round, biconvex film-coated tablets, plain on both the sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bella is indicated for use as: • An oral contraceptive. • Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of ethinylestradiol/drospirenone 20 µg / 3 mg tablet for PMDD was not assessed beyond 3 cycles. Ethinylestradiol/drospirenone 20 µg / 3 mg tablet has not been evaluated for treatment of PMS (premenstrual syndrome) (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS). 4.2 DOSE AND METHOD OF ADMINISTRATION Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. One tablet is taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. A withdrawal bleed usually starts on Day 2-3 after starting the white placebo tablets (last row) and may not have finished before the next pack is started. Bella v2.0 Page 2 of 26 (drospirenone and ethinylestradiol) film-coa Les hele dokumentet