Kliofem

Kliofem, also known as Kliogest, is a continuous combined hormone replacement therapy (HRT) containing oestradiol and norethisterone acetate.

It is prescribed for the relief of menopausal symptoms in postmenopausal women who are at least 12 months past their last natural period, and for the prevention of osteoporosis in postmenopausal women at high risk of fractures who cannot tolerate other preventive treatments.

Oestradiol, the principal oestrogen produced by the ovaries, declines significantly during and after the menopause.

This decline causes vasomotor symptoms such as hot flushes and night sweats, as well as urogenital atrophy, mood changes, and accelerated bone loss.

Kliofem replaces oestradiol to alleviate these symptoms.

Norethisterone acetate, a progestogen, is included to protect the endometrium from the stimulatory effects of unopposed oestrogen, thereby reducing the risk of endometrial hyperplasia and carcinoma.

As a continuous combined preparation, Kliofem is designed to be taken without a break and aims to provide freedom from monthly withdrawal bleeds, which is preferred by many postmenopausal women.

Some irregular spotting may occur during the first few months of treatment but usually settles.

Take one tablet daily by mouth at approximately the same time each day. Swallow with water, with or without food. Tablets are taken continuously without a break between packs.

If you forget a dose, take it as soon as you remember unless more than 12 hours have passed, in which case skip the missed tablet and continue with the next one.

Do not take two tablets to compensate. Irregular bleeding during the first months should be reported to your doctor if it persists beyond 6 months.

One tablet (containing oestradiol 2 mg and norethisterone acetate 1 mg) once daily, taken continuously. Kliofem should only be initiated in women who are at least 12 months postmenopausal.

For women transitioning from a sequential HRT regimen, Kliofem should be started on the day after the previous cycle is completed.

Treatment should be at the lowest effective dose for the shortest duration necessary.

Common (1 in 10 to 1 in 100): breast tenderness, breakthrough bleeding or spotting, headache, abdominal pain, nausea, weight changes.

Uncommon (1 in 100 to 1 in 1,000): mood changes, depression, bloating, leg cramps, migraine.

Rare (1 in 1,000 to 1 in 10,000): venous thromboembolism (deep vein thrombosis, pulmonary embolism), gallbladder disease, altered liver function.

Very rare (less than 1 in 10,000): stroke, myocardial infarction, erythema nodosum, angioedema. Breast tenderness and spotting usually subside after the first few months of treatment.

HRT is associated with a small increased risk of breast cancer with duration of use beyond 5 years, venous thromboembolism, stroke, and coronary heart disease (particularly in women starting HRT more than 10 years after the menopause).

Regular breast screening and cervical smears should be maintained. Treatment should be reviewed at least annually.

HRT should be discontinued and medical advice sought immediately if any symptoms suggestive of thromboembolism occur, such as sudden chest pain, leg swelling, or unexplained breathlessness.

Women with a uterus should not take oestrogen-only HRT.

Do not take Kliofem if you have known or suspected breast cancer, other oestrogen-dependent neoplasia, undiagnosed vaginal bleeding, untreated endometrial hyperplasia, active or recent venous or arterial thromboembolism, active liver disease, porphyria, or known hypersensitivity to any of the ingredients.

It should not be used in women who are premenopausal or less than 12 months postmenopausal.