Tibolone

Brand(s)

• Tibofem

Manufacturer

• Cipla Pharmaceuticals Ltd.

Disease(s)

Tibolone tablet

What is this medicine?

Tibolone tablets 2.5mg are a hormone replacement therapy (HRT) used to help relieve symptoms of menopause, caused by reduced production of oestrogen after menopause or following surgical removal of the ovaries. These symptoms include, hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy. Tibolone tablets are also used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. Tibolone tablets are intended only for post-menopausal women who are over 60 years and who cannot take other HRT medication for the treatment of oestrogen deficiency or other medication for prevention of bone mineral density loss.

How does Tibolone work?

Tibolone tablets 2.5mg contain tibolone, a synthetic steroid hormone that is broken down by the body’s metabolism into three compounds that act in a similar way to naturally produced oestrogen, progesterone and testosterone. These metabolites are also tissue-specific which means that they only act on certain tissues. Tibolone tablets, once metabolised, have oestrogenic effects on bone, vaginal and breast tissue, whereas it has progestogen activity on the endometrium (lining of the uterus) and androgenic effects (like testosterone) in the brain and liver; these actions help restore the hormonal balance to relieve menopausal symptoms like vaginal atrophy, loss of bone density and osteoporosis, as well as other symptoms, such as reducing hot flushes and improved libido. Tibolone tablets also have other beneficial effects like lowering cholesterol levels, which tend to increase after menopause.

What side effects may I notice from this medicine?

The most commonly reported side effects when taking Tibofem tablets 2.5mg include: lower abdominal pain, abnormal hair growth, vaginal, discharge bleeding or spotting, breast tenderness, haemorrhage, genital itching, vaginal candidiasis (yeast infection), thickened endometrial (lining of the uterus) wall, abnormal growth of the cervix, inflammation of the vagina and vulva (vulvovaginitis).

What should I tell my health care provider before I take this medicine?

You should not use Tibofem tablets 2.5mg if you:

• are allergic to tibolone or any ingredients in Tibofem
• are pregnant or are breastfeeding
• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have a history of thrombosis (blood clots) in the legs( thromboembolism) or lung (pulmonary embolism)
• have a history of heart disease, stroke, severe uncontrolled high blood pressure
• have abnormal vaginal bleeding of unknown cause
• have liver disease or the blood disorder porphyria
• are taking medicines that interact with Tibofem including: anticoagulant like warfarin, anticonvulsants like phenytoin and carbamazepin, anti-infectives like rifampicin, rifabutin, the sedative midazolam

Long-term HRT with Tibofem tablets 2.5mg does have associated health risks, including an increased risk of breast cancer, endometrial cancer, stroke, deep vein thrombosis.

How should I use this medicine?

You should take your Tibofem tablets 2.5mg with a glass of water once daily with or without food. You will generally see an Improvement in your symptoms within a few weeks and you should continue to take your Tibofem tablets 2.5mg for as long as recommended by your doctor, which will usually be for the shortest time period required to improve your symptoms, usually at least 3 months but not more than 6 months without a review.

What if I miss a dose?

If you miss a dose of Tibofem take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose. Do not take a double dose.

Where can I keep my medicine?

You should store your Tibofem below 25°C in a cool dry place.