Femoston 2/10 mg 28 tablets

Femoston 2/10 mg 28 tablets

Composition:
Each calendar pack contains
14 pink tablets Estradiol 2 mg (as hemihydrate)
14 yellow tablets Estradiol 2 mg (as hemihydrate) and Dydrogesterone 10 mg.
Description:
Femoston 2/10 is a continuous sequential hormone replacement therapy (HRT) for postmenopausal women. It combines estradiol a natural form of estrogen with dydrogesterone a synthetic progestogen to alleviate menopausal symptoms and prevent endometrial hyperplasia caused by estrogen alone.
Indications for use:
Treatment of estrogen deficiency symptoms in postmenopausal women
Prevention of osteoporosis in postmenopausal women at high risk when other options are unsuitable
Femoston 2/10 should be used in women with an intact uterus.
Dosage and administration:
One tablet daily continuously for 28 days 14 pink tablets followed by 14 yellow tablets
Tablets should be swallowed whole with water at the same time each day
A new pack is started the day after the previous one ends
For initiation or continuation of HRT the lowest effective dose should be used for the shortest duration.
Contraindications:
Known past or suspected breast cancer
Known or suspected estrogen-dependent malignant tumors e.g endometrial cancer
Undiagnosed vaginal bleeding
Untreated endometrial hyperplasia
History or presence of venous thromboembolism
Active or recent arterial thromboembolic disease e.g angina myocardial infarction
Acute liver disease or liver function abnormalities
Known hypersensitivity to active substances or excipients
Porphyria.
Precautions:
HRT should only be started for menopausal symptoms that significantly affect quality of life
Periodic evaluation of benefits and risks is required
Use caution in patients with history of estrogen-sensitive cancers thromboembolism liver disorders or endometriosis
Patients should be monitored for signs of cardiovascular disease breast cancer and endometrial pathology
HRT does not prevent dementia or cardiovascular disease.
Pregnancy and lactation:
Femoston is contraindicated during pregnancy and breastfeeding
If pregnancy occurs treatment must be discontinued immediately.
Side effects:
Common side effects may include
Headache breast pain tenderness abdominal pain nausea vaginal discharge menstrual-like bleeding
Uncommon or rare
Migraine mood changes rash weight change edema venous thromboembolism gallstones.
Storage conditions:
Store below 30°C
Keep out of reach of children
Store in the original packaging to protect from moisture and light.
Packaging:
Each carton contains one calendar pack with 28 film-coated tablets (14 pink + 14 yellow) and a package insert.