Premia 5 Continuous

Premia Continuous general information

What is Premia Continuous used for?

Premia Continuous tablets 0.625mg/5 (also known as Prempro) are a combination hormone replacement therapy (HRT) for women with an intact uterus, used to substitute for a lack of oestrogen production by the ovaries that happens during menopause. Premia Continuous tablets help relieve moderate 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. Premia Continuous tablets also are also used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture.

How does Premia Continuous work?

Premia Continuous tablets 0.625mg/5mg (also known as Prempro) contain conjugated oestrogens, which is a mixture of natural oestrogen in different forms, including estrone, equilin, 17α-estradiol and 17β-estradiol. 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. Premia Continuous tablets also contain medroxyprogesterone, a synthetic derivative of the female sex 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). Medroxyprogesterone in Premia Continuous tablets works in the same way but in menopausal women, its role is to prevent excess growth of the endometrium in response to the conjugated oestrogens present in Premia Continuous tablets and this helps prevent endometrial cancer.

What does Premia Continuous contain?

Premia Continuous tablets contain a two active ingredients; 0.625 mg of conjugated oestrogens, which is a mixture of natural oestrogen in different forms, including estrone, equilin, 17α-estradiol and 17β-estradiol; and 5mg medroxyprogesterone, a synthetic derivative of progesterone, used for combination hormone replacement therapy (HRT). They also contain lactose, methylcellulose, magnesium stearate, shellac, macrogol 20000, glyceryl mono-oleate, microcrystalline cellulose, calcium phosphate, calcium sulfate, sucrose, titanium dioxide, carnauba wax, black ink and the colouring agent iron oxide red CI77491.

What doses of Premia Continuous are available?

Premia Continuous tablets are available from Inhouse Pharmacy in two doses of progestogen but the oestrogen dose is fixed:

• Conjugated Oestrogens 0.625/ Medroxyprogesterone 2.5mg tablets in packets of 28 tablets
• Conjugated Oestrogens 0.625/ Medroxyprogesterone 5mg tablets in packets of 28 tablets

Treating symptoms of menopause with Premia Continuous

Premia Continuous tablets contain a combination of two female hormones, conjugated oestrogens, (which is a mixture of natural oestrogen in different forms) and a synthetic form of progesterone, which are used to relieve moderate 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. Combination HRT is used only for women with an intact uterus as the progesterone component prevents excess growth of the endometrium (lining of the uterus) in response to oestrogen and protects against endometrial cancer.

Premia Continuous for hormone replacement therapy (HRT)

Premia Continuous tablets are used for hormone replacement therapy (HRT) for women with an intact uterus and contain a combination of two female hormones. Oestrogen substitutes for a lack of oestrogen production by the ovaries that happens during menopause, to relieve moderate 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.

What are the side effects of Premia Continuous?

The most commonly reported side effects when taking Premia Continuous tablets include: breast tenderness and pain; abdominal bloating and pain; breakthrough bleeding or spotting with period-like pain or cramps (dysmenorrhoea); vaginal inflammation (vaginitis) and thrush, leg cramps, fluid retention, depression. More severe side effects include jaundice.

What are the health risks of Premia Continuous?

Long-term hormone replacement therapy (HRT) with Premia Continuous 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 Premia Continuous not be used?

You should not use Premia Continuous if you:

• are allergic to conjugated oestrogens, medroxyprogesterone or any ingredients in Premia Continuous tablets
• 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
• are drinking large amounts of grapefruit juice
• are taking other medications that may interact with Premia, such as anticonvulsants like phenytoin and carbamazepin, anti-infectives like rifampicin, cimetidine, the antibiotic erythromycin, the immunosuppressant cyclosporin, and the antifungal ketoconazole, aminoglutethemide, and herbal medicines containing St John's wort.

How should Premia Continuous be taken?

You should take your Premia Continuous 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. Your doctor may change your dose of Premia Continuous tablets, depending on your reaction and symptoms. You should take your Premia Continuous tablets until your symptoms improve or as long as your doctor recommends. Premia Continuous tablets should not be taken indefinitely, due to health risks.

How long should you take Premia Continuous?

You should take your Premia Continuous tablets continually until your symptoms improve or as long as your doctor recommends. Premia Continuous tablets should not be taken indefinitely, due to health risks.

Missed dose of Premia Continuous

If less than 12 hours has passed from since you forgot to take your daily Premia Continuous, take the missed tablet, then take the next tablet at the usual time. If more than 12 hours has passed, discard the missed tablet and take the next tablet at the usual time; do not take a double dose.

How should Premia Continuous be stored?

You should keep your Premia Continuous tablets below 25°C in a cool dry place.