Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
ethinylestradiol, Quantity: 0.03 mg; drospirenone, Quantity: 3 mg
Bayer Australia Ltd
Drospirenone,ethinylestradiol
Tablet, film coated
Excipient Ingredients: titanium dioxide; purified talc; lactose monohydrate; magnesium stearate; hypromellose; microcrystalline cellulose
Oral
1 x 28 tablets: 21 active with 7 placebo, 3 x 28 tablets: 21 active with 7 placebo
(S4) Prescription Only Medicine
INDICATIONS: Petibelle is indicated for use as an oral contraceptive.
Visual Identification: Small, round white tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2014-08-04
2003 PETIBELLE CMI AU 1 PETIBELLE ® (PE-TI-BELL) Contraceptive tablets for women _drospirenone and ethinylestradiol _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PETIBELLE. 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 PETIBELLE 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 PETIBELLE IS USED FOR PETIBELLE is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. PETIBELLE is used to prevent pregnancy. You may also experience the following benefits: • improvement in symptoms like bloating, swelling or weight gain related to fluid retention • more regular and lighter periods – potentially resulting in a decrease in anaemia (iron deficiency) • a decrease in period pain. Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy (where the foetus is carried outside of your womb), lumpy breasts and cancer of the uterus (womb) and 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. When the Pill is taken by women under close observation in clinical trials, it is more than 99% effective in preventing pregnancy. However, in real life the Pill is around 92% effective. This is because pills might be missed, or taken with medicines that may interfere with their effectiveness, or may not be absorbed due to vomiting and diarrhoea. Like all oral contraceptives, PETIBELLE is intended to prevent pregnancy Olvassa el a teljes dokumentumot
180925 PETIBELLE PI Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION PETIBELLE ® (DROSPIRENONE & ETHINYLESTRADIOL) TABLET 1 NAME OF THE MEDICINE PETIBELLE (drospirenone and ethinylestradiol) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each light yellow active tablet contains ethinylestradiol 30 µg and drospirenone 3 mg. Excipients with known effect: Each light yellow active tablet contains 48.17 mg of lactose monohydrate. Each white placebo tablet contains 23.21 mg of lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Each PETIBELLE active tablet is light yellow, round and marked on one side with the letters "DO" in a regular hexagon. Each PETIBELLE placebo tablet is white, round and marked on one side with the letters “DP” in a regular hexagon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PETIBELLE is indicated for use as an oral contraceptive. 4.2 DOSE AND METHOD OF ADMNISTRATION 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. 180925 PETIBELLE PI Page 2 of 27 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. Withdrawal bleeding usually starts on Day 2-3 after starting the white placebo tablets and may not have finished before the next pack is started. HOW TO START PETIBELLE _No preceding hormonal contraceptive use (in the past month) _ Tablet-taking has to start on Day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). The women should be instructed to take a light yellow active tablet from the green section of the pack, corresponding to that day of the week. If started on Day 1 in this way, protection against pregnancy is immediate and no additional methods o Olvassa el a teljes dokumentumot