Instructions for Velledien (tibolone) 28 pills
English Product Name
Velledien
Release Form
Tablets
Description Velledien
The tablets are white, round, flat-cylindrical.
1 tab
tibolone 2.5 mg
Auxiliary substances: lactose monohydrate - 69.44 mg, microcrystalline cellulose - 17.36 mg, ascorbil palmitate - 0.2 mg, corn starch - 10 mg, magnesium stearate - 0.5 mg.
28 pcs - blisters (1) - cardboard packs.
ATX codes
G03CX01 Tibolone
Clinical and pharmacological groups / Group affiliation Velledien
Antimenopausal estrogen
Active ingredient Velledien
tibolone
Pharmacotherapeutic group Velledien
Other estrogens
Retention conditions
The drug tibolone should be stored in a place inaccessible to children at a temperature not exceeding 25 °C.
Expiration date Velledien
The shelf life is three years. Do not use the drug after expiration date.
Pharmacological effect Velledien
this drug lies in its ability to selectively regulate estrogen-like activity in tissues and to be a tissue selective regulator. The basis of its pharmacodynamic properties are three pharmacologically active metabolites of tibolone: 3-alpha-hydroxytibolone and 3-beta-hydroxytibolone, which have estrogen-like activity, and the delta-4-isomer has progestagenic and weak androgen-like activity.
This drug successfully corrects estrogen deficiency that occurs during the postmenopausal period and thus relieves associated symptoms such as hot flashes, depression, nocturnal hypersweating, and headache. It also has a positive effect on libido and mood, increasing the concentration of central and peripheral opioids. It also has a trophic effect on vaginal mucosa without causing endometrial proliferation. It also prevents bone loss after menopause or ovarian removal and reduces plasma phosphate and calcium concentrations.
Main indications for use Velledien
it is used to treat postmenopausal women's symptoms of estrogen deficiency (at least 1 year after the last menstrual period when menopause was natural or immediately after menopausal surgery) and to prevent postmenopausal osteoporosis in women at high risk of fractures when other drugs used to treat osteoporosis are intolerable or contraindicated.
The method of use, course and dosage of this preparation tibolone
consists in the internal administration of 1 tablet per day, without chewing, drinking water, preferably at the same time, continuously. In this case, the tablet from the cell of the upper row marked with the day of the week corresponding to the day on which the tablet is started is taken first. All subsequent tablets are taken sequentially from the cells in the direction of the arrow on the calendar package until all the tablets are taken.
Treatment of postmenopausal symptoms should be started only for those symptoms that adversely affect a woman’s quality of life. The drug should be started at least 12 months after the last menstrual period, when menopause is natural. Patients with fresh operative menopause can begin the drug immediately. In either case, carefully evaluate the risk and benefit of treatment at least once every 6 months and continue the drug only when benefit of therapy over risk predominates.
- Nosology tibolone (ICD codes)
- M80.0
- Postmenopausal osteoporosis with abnormal fracture
- M80.1
- Osteoporosis with abnormal fracture after ovarian removal
- M81.0
- Osteoporosis postmenopausal
- M81.1
- Osteoporosis post ovarian removal
- N95.1
- Menopause and menopausal state in women
- N95.3
- Artificially induced menopause conditions