Kliovance

Kliovance general information

What is Kliovance used for?

Kliovance tablets (also known as Activelle) are a continuous combination hormone replacement therapy (HRT) for women with an intact uterus, used to substitute for a lack of oestrogen production by the ovaries during menopause. Kliovance tablets help relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy; while at the same time protecting against endometrial (lining of the uterus) cancer. Kliovance tablets also are also used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. Continuous use of Kliovance tablets prevents regular withdrawal bleeding associated with cyclic or sequential HRT.

How does Kliovance work?

Kliovance tablets (also known as Activelle) contain a combination of two hormones used in combination for continuous hormone replacement therapy (HRT). 17β-oestradiol is a synthetic oestrogen that is chemically and biologically identical to endogenous human oestradiol and substitutes for the loss of oestrogen production in menopausal women. Oestrogen is the female steroid hormone produced by the ovaries that binds to specific receptors inside oestrogen-responsive cells and stimulates them to make proteins involved in several aspects of female secondary characteristics including regulating the menstrual cycle. Oestrogen also has several other actions in various metabolic processes including maintaining bone mass and lipid (fat) metabolism. Kliovance tablets also contain norethisterone, a synthetic derivative of the hormone progesterone, which means that its chemical structure closely resembles that of naturally produced progesterone and it therefore works in a similar way. Progesterone in pre-menopausal women acts on the endometrium (lining of the uterus) converting the proliferating phase to the secretory phase. This causes the endometrium, which has thickened in response to oestrogen during the first half of the cycle, to stop growing and start secreting hormones and other proteins needed to maintain a pregnancy, if conception occurs; if not, levels of oestrogen and progesterone fall and the endometrium is shed (menstruation). Norethisterone in Kliovance tablets works in the same way but in menopausal women, its role is to prevent excess growth of the endometrium in response to the oestrogens present in Kliovance tablets and this helps prevent endometrial cancer.

What does Kliovance contain?

Kliovance tablets contain a the active ingredients 17β-oestradiol (1mg), a synthetic oestrogen hormone and norethisterone (0.5mg), a synthetic progestogen hormone, used in combination for continuous hormone replacement therapy (HRT). They also contain lactose monohydrate, maize starch, copolyvidone, talc, magnesium stearate, hypromellose, triacetin.

Treating symptoms of menopause with with Kliovance

Kliovance tablets are used for hormone replacement therapy (HRT) for women with intact uterus and contain a combination of two female hormones, 17β-oestradiol, a synthetic oestrogen and norethisterone, a synthetic progestogen. 17β-oestradiol substitutes for the lack of oestrogen production by the ovaries that happens during menopause, to relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy. Oestrogen also has several other beneficial actions in various metabolic processes including bone turnover, and helps prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. Progesterone prevents excess growth of the endometrium (lining of the uterus) in response to oestrogen and protects against endometrial cancer.

Kliovance for hormone replacement therapy (HRT)

Kliovance tablets are used for continuous hormone replacement therapy (HRT) for women with intact uterus and contain a combination of two female hormones, 17β-oestradiol, a synthetic oestrogen and norethisterone, a synthetic progestogen. 17β-oestradiol substitutes for a lack of oestrogen production by the ovaries during menopause, to relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy. Oestrogen also has several other beneficial actions in various metabolic processes including bone turnover and helps prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. Progesterone prevents excess growth of the endometrium (lining of the uterus) in response to oestrogen and protects against endometrial cancer. Continuous use of Kliovance tablets also prevents regular withdrawal bleeding associated with cyclic or sequential HRT.

What are the side effects of Kliovance?

The most commonly reported side effects when taking Kliovance include: breast tenderness and pain; vaginal haemorrhage (excessive bleeding), vaginal inflammation (vaginitis) and thrush, fluid retention, depression, back pain, headache and nausea.

What are the health risks of Premia Continuous?

Long-term hormone replacement therapy (HRT) with Kliovance tablets does have associated health risks, particularly increased risk of breast and ovarian cancer compared with oestrogen alone HRT, but it does reduce risk of endometrial cancer. Combined HRT with oestrogen and progestogen therapy has been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism.

When should Kliovance not be used?

You should not use Kliovance tablets if you:

• are allergic to 17β-oestradiol or norethisterone or any ingredients in Kliovance
• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have a history of thrombosis (blood clots) or stroke
• have abnormal vaginal bleeding of unknown cause
• have high blood pressure that is not well controlled
• have liver disease
• are pregnant or are breastfeeding
• have porphyria (a metabolic disease with disturbed production of blood pigment).
• are taking medications that may interact with Kliovance, such as anticonvulsants like phenytoin and carbamazepin; anti-infectives like rifampicin, rifabutin, nevirapine and efavirenz; the antifungal ketoconazole, and herbal medicines containing St John's wort

How should Kliovance be taken?

You should take your Kliovance tablets with a glass of water, once daily, at the same time each day, and with or without food. Each pack contains 28 tablets for one month’s supply and when you have finished one pack you should start a new pack the next day. You should take your Kliovance tablets until your symptoms improve or as long as your doctor recommends.

How long should you take Kliovance?

You should take your Kliovance tablets until your symptoms improve or as long as your doctor recommends.

Missed dose of Kliovance

If you miss a dose of Kliovance 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.

How should Kliovance be stored?

You should store your Kliovance tablets below 25°C in a cool dry place, but do not refrigerate.