Climara 50

Climara general information

What is Climara used for?

Climara 50 is a transdermal delivery system (skin patch) containing oestrogen that is used as a short-term hormone replacement therapy (HRT) to substitute for a lack of oestrogen production by the ovaries that happens during menopause or following surgical removal of the ovaries. Using Climara 50 patches helps 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. Climara 50 is also used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. Climara 50 stimulates the development of female sexual characteristics, and is used as part of a transgender hormone therapy for male to female transsexuals.

How does Climara work?

Climara 50 is a skin patch containing the active ingredient oestradiol, the major and the most active form of the female hormone oestrogen. When you apply the patch to your skin, the oestradiol diffuses out of the patch through your skin and into your blood, delivering a dose of 50mcg oestradiol per day. Oestrogen is a steroid hormone produced by the ovaries that binds to specific receptors inside oestrogen-responsive cells and stimulates them to make proteins involved in producing secondary sexual characteristics, such as breast development and in regulating the menstrual cycle. Oestrogen also has several other actions in various metabolic processes including maintaining bone mass and lipid (fat) metabolism. Because the oestadiol in Climara 50 enters your blood directly and continuously, it is not metabolised (broken down) by the liver, as happens when you take oral oestrogen tablets, which means that Climara 50 patches are effective at a lower dose and provide more even blood levels similar to the natural release of oestrogen by the ovaries.

What Climara doses are available?

Climara patches are available in two strengths, both in packs of 4 patches:

• Climara 50 contains 3.8 mg of oestradiol in each patch and releases 50mcg oestradiol into your blood per day
• Climara 100 contains 7.6 mg of oestradiol in each patch and releases 100mcg oestradiol into your blood per day

What does Climara contain?

The active ingredient in Climara 50 is oestradiol (3.8 mg of oestradiol in each patch, delivered at 50mcg per day), which is the most active form of the female hormone oestrogen and is responsible for the development of female sexual characteristics and regulation of the menstrual cycle. Climara 50 transdermal delivery system (skin patch) consists of a transparent oval patch containing oestradiol in an acrylate adhesive matrix, with backing layer of translucent polyethylene film. Climara 50 also contains ethyl oleate, isopropyl myristate, glycerol monolaurate, acrylate copolymer

Treating symptoms of menopause with Climara

Climara 50 substitutes for the loss of oestrogen production by the ovaries that occurs during menopause and is the cause of symptoms such as hot flushes, night sweats, sleeplessness, dry vagina, headaches, mood swings, lack of concentration loss of energy and bone loss (osteoporosis). Climara 50 is a transdermal delivery system (skin patch) that contains oestradiol, an active form of the female hormone oestrogen that alleviates moderate to severe menopausal symptoms.

Climara for hormone replacement therapy

Climara 50 is a transdermal delivery system (skin patch) containing oestrogen that is used as a short-term hormone replacement therapy (HRT) to substitute for a lack of oestrogen production by the ovaries during the menopause. Climara 50 is used 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. Climara 50 is also used to help prevent postmenopausal bone loss (osteoporosis), which is also caused by lack of oestrogen, and reduce risk of fracture.

Climara for transgender treatment

Climara 50 can be used as part of a gender reassignment program for male to female transsexuals, by providing a source of oestradiol, an active form of the female hormone oestrogen. Climara 50 is a transdermal delivery system (skin patch) for oestrogen that stimulates the development of female secondary sexual characteristics, such as breast development and also induces metabolic changes such as fat distribution to redefine the general body shape.

Climara for feminising hormone therapy

Climara 50 patches contain oestradiol, the most feminising form of the female hormone oestrogen, which provides a very effective means of feminisation when used as part of a gender reassignment program for male to female transsexuals. Climara 50 is a transdermal delivery system (skin patch) for oestrogen that stimulates the development of female secondary sexual characteristics, such as breast development and also induces metabolic changes such as fat distribution to redefine the general body shape, while at the same time overriding the effects of testosterone. The consistent and prolonged release of oestadiol provides an effective approach to feminising hormone therapy.

What are the side effects of Climara?

The most frequently reported side effects when using Climara 50 patches are: itching under the patch, reddening of the skin after the patch has been removed (but this usually disappears within a few days), breast tenderness, breast pain, abdominal pain, nausea, oedema, and headache, skin rash and itching, insomnia and depression. More severe side effects include changes in liver function at higher doses.

What are the health risks of Climara?

Long-term HRT with Climara 50 does have associated health risks, including an increased risk of breast cancer, endometrial cancer, stroke and deep vein thrombosis. For women with an intact uterus adding a progestogen to an oestrogen replacement regimen like Climara 50 patches is recommended to reduce the risk of endometrial cancer. There is also an increased risk of developing probable dementia in postmenopausal women 65 years of age or older.

When should Climara not be used?

You should not use Climara if you:

• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have deep venous thrombosis, thromboembolic disorders, cerebral vascular accident associated with oestrogen use
• abnormal genital bleeding of unknown cause
• are pregnant or planning to become pregnant
• are allergic to oestradiol or any of the ingredients in Climara patches
• are taking other medications that may interact with Climara, such as anticonvulsants like phenytoin and carbamazepin, anti-infectives like rifampicin, rifabutin, nevirapine, efavirenz or preparations containing St John's Wort.

How should Climara be used?

Climara 50 patches can be used continually or in cycles (interrupted for one week after every 3 weeks) for as long as recommended by your doctor. Each patch should be used only for 7 days and then changed and only one patch should be worn at any time during the 7-days.

1. Before you apply your patch, make sure your skin is clean and dry and is not oily, broken or irritated.
2. Remove the protective liner from the adhesive side of the patch and apply the patch to your skin either on your lower abdomen or buttocks but never on your breasts. Do not put the patch on your waistline where tight clothes may rub it and avoid areas where the skin is hairy or folded or the patch may not stick.
3. Press the patch firmly in place with the palm of the hand for about 10 seconds and make sure the patch sticks well, especially around the edges.
4. Leave the patch in place for 7 days and then remove it and replace with a new patch straight away or as advised by your doctor.
5. Apply the next patch to a different part of your body as you should not use the same area of skin twice running.
6. If your patch accidentally falls off, dry your skin and reapply it or apply a new patch for the remainder of the 7 days dosing period.

How long should you use Climara?

Climara 50 patches can be used continually or in cycles (interrupted for one week after every 3 weeks) for as long as recommended by your doctor.

Missed dose of Climara

Climara 50 patches are intended to last for 7 days. If your patch accidentally falls off, reapply it or apply a new patch for the remainder of the 7 days dosing period. If you lose a patch or forget to replace it for several days, irregular bleeding may occur. Replace the patch as soon as possible.

How should Climara be stored?

Keep Climara 50 patches in their protective pouch until you are about to use one. Store in a cool dry place below 30°C.