TIBILIVE Tablet Ref.[51185] Active ingredients: Tibolone

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Pharma Dynamics (Pty) Ltd, 1<sup>st</sup> Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa

4.1. Therapeutic indications

TIBILIVE 2,5 MG is indicated for:

  • symptomatic treatment of hot flushes and associated sweating resulting from natural or surgical menopause
  • prevention of post-menopausal osteoporosis
  • improvement of bone-mineral density in patients with established post-menopausal osteoporosis.

4.2. Posology and method of administration

Posology

The dosage is 1 tablet per day. A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the latter case, the missed dose should be skipped and the next dose should be taken at the normal time. Improvement of symptoms generally occurs within a few weeks but optimal results are obtained when therapy is continued for at least 3 months.

Starting TIBILIVE 2,5 MG

Women experiencing a natural menopause should commence treatment with TIBILIVE 2,5 MG at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with TIBILIVE 2,5 MG may commence immediately.

Any irregular/unscheduled vaginal bleeding, either on or off hormone replacement therapy (HRT), should be fully investigated to exclude malignancy before starting TIBILIVE 2,5 MG.

Method of administration

Oral use.

TIBILIVE 2,5 MG should be swallowed whole with some water or other drink, preferably at the same time each day.

4.9. Overdose

Signs and symptoms

In cases of acute overdose nausea, vomiting and vaginal bleeding in females may occur.

h3.Management of overdose

No specific antidote is known. Symptomatic treatment can be given if necessary.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store at or below 30°C.

Store in the original package in order to protect from light and moisture.

6.5. Nature and contents of container

TIBILIVE 2,5 MG tablets are packed in PVC/Aluminium foil, blisters of 10 tablets, then placed in an outer carton. Each carton contains 30, 90 or 180 tablets.

6.6. Special precautions for disposal and other handling

No special requirements.

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