(Anne gel eek)
oestradiol and drospirenone
Consumer Medicine Information
The Women’s Health Initiative (WHI) trial examined the health benefits and risks of combined oestrogen plus progestogen therapy (n=16,608) and oestrogen-alone therapy (n=10,739) in postmenopausal women aged 50 to 79 years.
The oestrogen plus progestogen arm of the WHI trial indicated an increased risk of myocardial infarction (MI), stroke, invasive breast cancer, pulmonary embolism and deep vein thrombosis in postmenopausal women receiving treatment with combined conjugated equine oestrogens (CEE, 0.625 mg/day) and medroxyprogesterone acetate (MPA, 2.5 mg/day) for 5.2 years compared to those receiving placebo.
The oestrogen-alone arm of the WHI trial indicated an increased risk of stroke and deep vein thrombosis in hysterectomized women treated with CEE-alone (0.625 mg/day) for 6.8 years compared to those receiving placebo.
Other doses of oral conjugated oestrogens with medroxyprogesterone acetate, and other combinations and dosage forms of oestrogens and progestogens were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar.
Therefore, the following should be given serious consideration at the time of prescribing:
– Oestrogens with or without progestogens should not be prescribed for primary or secondary prevention of cardiovascular diseases.
– Oestrogens with or without progestogens should be prescribed at the lowest effective dose for the approved indication.
– Oestrogens with or without progestogens should be prescribed for the shortest period possible for the approved indication.
– For the prevention of osteoporosis, oestrogen treatment should be considered in light of other available therapies.
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about Angeliq 1/2 tablets. It does not contain all of 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 Angeliq 1/2 against the benefits they expect it will 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 ANGELIQ 1/2 IS USED FOR
Angeliq 1/2 provides hormone replacement therapy (HRT) for the treatment of menopausal complaints in postmenopausal women. It is also used to treat symptoms due to decreased activity from the sexual organs (hypogonadism), after removal of the ovaries (ovariectomy) or when the ovaries do not work (primary ovarian failure). Angeliq 1/2 is only intended for short term use.
Angeliq 1/2 tablets contain oestradiol, an oestrogen hormone and drospirenone, a progestogen hormone. During menopause, the oestradiol production of the ovaries declines. Although menopause is natural, it often causes distressing symptoms, which are connected with the gradual loss of the hormones produced by the ovaries.
Angeliq 1/2 replaces the hormones that the body no longer makes and prevents or relieves symptoms such as hot flushes, sweats, sleep disturbances and nervousness.
Angeliq 1/2 should only be used by women who have not had their uterus removed (hysterectomy). If you have had a hysterectomy, your doctor will prescribe another form of oestrogen therapy.
Angeliq 1/2 is not a contraceptive. It will not prevent you from falling pregnant.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
BEFORE YOU TAKE ANGELIQ 1/2
When you must not take it
Do not take Angeliq 1/2 if you have an allergy to:
- oestradiol and/or drospirenone, the active ingredients in Angeliq 1/2
- any of the ingredients listed