Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
progesterone, Quantity: 200 mg
Besins Healthcare Australia Pty Ltd
progesterone
Capsule, soft
Excipient Ingredients: glycerol; lecithin; titanium dioxide; Gelatin; purified water; Sunflower Oil
Oral
30 capsules, 15 capsules, 90 capsules, 84 capsules, 14 capsules, 56 capsules, 28 capsules
(S4) Prescription Only Medicine
PROMETRIUM 100 mg and 200 mg, soft capsules are indicated for:,Treatment of menstrual irregularities,- In women with menstrual abnormalities or secondary amenorrhoea due to normogonadotrophic amenorrhoea (see dosage and administration),Hormone replacement therapy,- Hormone replacement therapy ? adjunctive use with an oestrogen in postmenopausal women with an intact uterus
Visual Identification: Slightly yellow, ovoid soft capsule containing whitish oily suspension; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2016-06-20
PROMETRIUM 100 AND 200 MG, SOFT CAPSULE CONSUMER INFORMATION CMI _PROMETRIUM 100+200_0222 Page 1 of 5 CONSUMER MEDICINE INFORMATION PROMETRIUM 100 AND 200 MG Progesterone (micronised) 100 and 200 mg, soft capsule _(For oral use) _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Prometrium. The leaflet 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 Prometrium against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PROMETRIUM IS USED FOR Prometrium is provided as a soft capsule that contains the natural female hormone, progesterone for oral use. Prometrium is for women for the treatment of menstrual abnormalities or secondary amenorrhoea (no menstrual periods) and as hormone replacement therapy (HRT) in combination with estrogen in postmenopausal women with an intact uterus (womb). Your doctor may have prescribed Prometrium for another purpose. Ask your doctor if you have any questions why this medicine has been prescribed for you. Prometrium is available only with a doctor’s prescription. This medicine is not addictive. This medicine is not a contraceptive. BEFORE YOU TAKE PROMETRIUM _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE PROMETRIUM IF YOU HAVE AN ALLERGY TO: • ANY MEDICINE CONTAINING PROGESTERONE • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include: • skin rash, itching or hives • swelling of the face, lips, tongue or other parts of the body • shortness of breath, wheezing or difficulty breathing DO NOT TAKE PROMETRIUM IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING CONDITIONS: • if you are allergic to soya • unusual vaginal bleeding that has not been evaluated by your doctor • known missed abortions o Læs hele dokumentet
PROMETRIUM 100 AND 200, SOFT CAPSULE PRODUCT INFORMATION PI-v1-11-21 1/14 AUSTRALIAN PRODUCT INFORMATION - PROMETRIUM 100 AND 200 (PROGESTERONE) SOFT CAPSULES 1. NAME OF THE MEDICINE Progesterone 2. QUANTITATIVE AND QUALITATIVE COMPOSITION Prometrium capsules contain the active ingredient: Progesterone (micronised) 100 mg or 200 mg. Excipient with known effect: Soyabean lecithin. For the full list of excipients, see section 6.1 List of Excipients 3. PHARMACEUTICAL FORM Prometrium 100: Round, slightly yellow, soft capsule containing a whitish oily suspension. Prometrium 200: Ovoid slightly yellow, soft capsule, containing a whitish oily suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prometrium 100 and 200, soft capsules are indicated for: _TREATMENT OF MENSTRUAL IRREGULARITIES _ • In women with menstrual abnormalities or secondary amenorrhoea due to normogonadotrophic amenorrhoea (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION) _HORMONE REPLACEMENT THERAPY _ • Hormone replacement therapy – adjunctive use with an estrogen in postmenopausal women with an intact uterus 4.2 DOSE AND METHOD OF ADMINISTRATION In women receiving estrogen replacement therapy with intact uterus, the adjunctive use of progesterone at a dose of 200 mg daily at bedtime should be administered for twelve days in the last half of each therapeutic cycle (beginning on day 15 of the cycle and ending on day 26). Withdrawal bleeding may occur in the following week. Alternatively, 100 mg can be given at bedtime from day 1 to day 25 of each therapeutic cycle, withdrawal bleeding being less with this treatment schedule. In women with secondary amenorrhoea, the treatment may be given as a single daily dose of 400 mg (2 capsules 200 mg) at bedtime for 10 days. Prior to use for this indication, other causes of secondary amenorrhoea such as outflow obstruction, pregnancy, prolactinoma, thyroid disorders, pituitary and hypothalamic disorders should be excluded. The standard daily dosage regimen is 200 to 300 mg of progesterone taken Læs hele dokumentet