Ubilon 2.5mg

PRESENTATION

Ubilon : Each tablet contains Tibolone INN 2.5 mg.

DESCRIPTION

Tibolone is a synthetic steroid with tissue specific estrogenic, progestogenic and androgenic effect. Following oral

administration tibolone is rapidly metabolized into three compounds, which contribute to the pharmacological effects of tibolone.

Two of these metabolites (3 alpha-hydroxide-tibolone and 3 beta-hydroxide-tibolone) have predominantly estrogenic activity, a

third metabolite (delta 4-isomer of tibolone) and the parent compound have progestogenic and androgenic activities.

INDICATIONS

Ubilon is indicated for the following conditions:

* Treatment of the climacteric symptoms [hot flushes, sweating, vaginal dryness & less elasticity, mood disorders, anxiety etc.]

resulting from the natural or artificial menopause.

* Prevention of postmenopausal and post oophorectomy osteoporosis and improvement of bone-mineral density in patients with

established post-menopausal osteoporosis.

* Vaginal atrophy.

* Prevention of frequent UTI and urinary incontinence in postmenopausal women.

DOSAGE & ADMINISTRATION

Climacteric symptoms & other post-menopausal problems in adults and elderly women: The dosage is 2.5 mg tablet per day, preferably

at the same time of the day. Symptomatic relief occurs within few days, but optimal results are obtained minimum after 3 months.

Osteoporosis: To prevent osteoporosis in post-menopausal women or after oophorectomy an uninterrupted longer (5-10 years) therapy

of 2.5 mg daily is needed.

Starting Ubilon:

In case of natural menopause: To avoid irregular & abnormal bleeding, ubilon should be started at least 12 months after last

natural bleeding.

In case of artificial menopause : Treatment should be started immediately.

In case of switching over from other conventional HRT:

If someone switches from estrogen-only preparation, she should start after a withdrawal bleeding.

If someone switches from sequential HRT preparation she should wait for the completion of the progestogen phase.

If someone switches from continuous combined HRT, she can start any time.

In case of missed pill: If no more than 12 hours have passed, the pill should be taken immediately. Otherwise the next dose should

be continued as before.

SIDE EFFECTS

Generally tibolone is well tolerated. However, a few adverse reactions have been observed like headache, pre-tibial oedema, change

in body mass, dizziness, rash and abdominal pain. Vaginal bleeding may occur mainly during the first 1-3 months of treatment.

PRECAUTIONS

Renal dysfunction.

Epilepsy or migraine.

Impaired carbohydrate metabolism.

Hypercholesterolemia.

Liver diseases.

With anticoagulants.

USE IN PREGNANCY & LACTATION

Tibolone is contraindicated in pregnancy and lactation.

DRUG INTERACTION

Since tibolone may increase blood fibrinolytic activity, it may enhance the effect of anticoagulants. This effect has been

reported with warfarin.

Drugs that induce hepatic microsomal enzymes or other enzyme inducing drugs may accelerate the metabolism of tibolone and thus

lower its activity.

OVER DOSE

The acute toxicity of tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur, even when several

tablets are taken simultaneously. In case of acute overdose nausea, vomiting, withdrawal bleeding etc. may occur. Symptomatic

treatment can be given if necessary.

COMMERCIAL PACK

Ubilon : Each box contains 3 blister strips of 10 tablets.