Estradiol +Cyproterone

Climen general information

What is Climen used for?

Climen tablets are a two-phase hormonal preparation that is used in hormone replacement therapy (HRT) for women with an intact uterus, used to substitute for a lack of oestrogen production by the ovaries during menopause. Climen 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 cancer (cancer of the lining of the uterus). Climen tablets also are also used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. Climen tablets are not intended for use as a contraceptive, as they do not prevent ovulation.

How does Climen work?

Climen tablets are a two-phase sequential hormone replacement therapy (HRT) and comprise a mixture of oestrogen only tablets followed by a combination of oestrogen and progestogen tablets. Estradiol is the most active form of natural oestrogen and 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. Cyproterone is a derivative of progesterone and has weak progestational activity (acts like progesterone); it is also an anti-androgen. Although androgens (like testosterone) are considered primarily male hormones, women also produce androgens, although in much smaller amounts, which in women are needed for puberty related changes like pubic hair growth, preventing bone loss, libido and for the production of oestrogen. 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). Cyproterone in Climen tablets works in the same way, but in menopausal women its role is to prevent excess growth of the endometrium in response to the oestrogen present in Climen tablets and this helps prevent endometrial cancer. The sequential hormone combinations in Climen tablets simulate a normal 28-day cycle; the estradiol component provides continuous oestrogen replacement for 21 days and the cyproterone component counteracts the effect of oestrogen on the endometrium for days 12-21. For the final 7 days of a 28-day cycle when you are not taking any tablets, you may have a withdrawal bleed as these are hormone-free days.

What does Climen contain?

Climen tablets contain two active ingredients: the oestrogen estradiol valerate (2mg) and cyproterone acetate (1mg), a progestogen and anti-androgen that are used for 2-phase sequential hormone replacement therapy (HRT). The calendar pack of Climen tablets contains:

• 11 tablets of 2mg estradiol-17-valerate
• 10 tablets of 2mg estradiol-17-valerate plus 1mg cyproterone acetate

Each tablet also contains sucrose, titanium dioxide and ferric oxide pigment

Treating symptoms of menopause with Climen

Climen tablets are a two-phase hormonal preparation that is used in hormone replacement therapy (HRT) for women with an intact uterus. Estradiol valerate, an oestrogen precursor, 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. Cyproterone is a progesterone derivative that has weak progestational activity (acts like progesterone) and prevents excess growth of the endometrium (lining of the uterus) in response to oestrogen and protects against endometrial cancer.

Climen for transgender hormone therapy

Climen tablets contain a combination of estradiol valerate a precursor of oestrogen, and cyproterone acetate, which is a derivative of progestagen and is also an anti-androgen. The cyproterone component can be used as a substitute for spironolactone as the anti-androgen component of transgender feminising hormone therapy for male to female transsexuals, if small doses of anti-androgen are required.

What are the side effects of Climen?

The most commonly reported side effects when taking Climen include: breast tenderness, breast pain, abdominal pain, nausea, oedema, headache, depression, changes in body weight, changes in libido.

When should Climen not be used?

You should not use Climen tablets if you:

• are allergic to estradiol valerate or cyproterone acetate or any ingredients in Climen
• are pregnant or are breastfeeding
• have kidney or liver disease
• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have had deep venous thrombosis, thromboembolic disorders, heart attack or stroke
• have diabetes with changes to the blood vessels
• have endometriosis
• are taking medicines that interact with Climen, including: such as anticonvulsants like phenytoin and carbamazepin, barbiturates, anti-infectives like rifampicin, rifabutin, nevirapine, the antifungal griseofulvin, antibiotics like penicillin, preparations containing St John's Wort

How should Climen be taken?

You should take your Climen tablets with a glass of water, once daily, at the same time each day, and with or without food. Each pack contains 21 tablets for one month’s supply. When you have finished the pack you have 7 tablet free days and then you should start a new pack the next day. You should take your Climen tablets according to the instructions provided to ensure that you are taking them in the correct sequence. You should take your Climen tablets until your symptoms improved or as long as your doctor recommends.

How long should you take Climen?

You should take your Climen tablets until your symptoms improved or as long as your doctor recommends.

Missed dose of Climen

If you miss a dose of Climen tablets 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. If there has been 12 hours between tablets you may have a breakthrough bleed.

How should Climen be stored?

You should store your Climen tablets in their calendar packs until use, below 30°C in a cool dry place.