Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Viatris UK Healthcare Ltd
G03CA53
Not applicable
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 06040101; GTIN: 5060035240029
PACKAGING TECHNOLOGY BERLIN SGQWX page 2 Bayer Pharma AG client: JS86 material-no.: 85556738 PZ: 2599F-4A code-no.: 141 name: LF-CYCLO-PROGYNOVA 2MG SCT GB country: GB/-/MEDA colors: BLACK version: 29.09.2016/01 Restricted Document dimension: 160 X 594 MM 85556738 2.9 ENDOMETRIAL CANCER (CANCER OF THE LINING OF THE WOMB) TAKING OESTROGEN-ONLY HRT FOR A LONG TIME CAN INCREASE THE RISK OF CANCER OF THE LINING OF THE WOMB (the endometrium). Taking a PROGESTOGEN as well as the oestrogen helps to lower the extra risk. IF YOU STILL HAVE YOUR WOMB, your doctor will usually prescribe a progestogen as well as oestrogen. These may be prescribed separately, or as a combined HRT product. IF YOU HAVE HAD YOUR WOMB REMOVED (a hysterectomy), your doctor will discuss with you whether you can safely take oestrogen without a progestogen. IF YOU’VE HAD YOUR WOMB REMOVED BECAUSE OF ENDOMETRIOSIS, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen. Your product, CYCLO-PROGYNOVA contains a progestogen. Compare • Looking at women who still have a uterus and who are NOT TAKING HRT – on average 5 IN 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65. • For women who TAKE OESTROGEN-ONLY HRT, the number will be 2 TO 12 TIMES HIGHER, depending on the dose and how long you take it. • The addition of a progestogen to oestrogen- only HRT substantially reduces the risk of endometrial cancer. IF YOU GET BREAKTHROUGH BLEEDING OR SPOTTING, it’s usually nothing to worry about, especially during the first few months of taking HRT. IF THE BLEEDING OR SPOTTING: • CARRIES ON FOR MORE THAN THE FIRST FEW MONTHS • STARTS AFTER YOU’VE BEEN ON HRT FOR A WHILE • CARRIES ON EVEN AFTER YOU’VE STOPPED TAKING HRT. YOU MUST MAKE AN APPOINTMENT TO SEE YOUR DOCTOR. It could be a sign that your endometrium has become thicker. 2.10 OVARIAN CANCER Ovarian cancer is rare – much rarer than breast cancer. It can be difficult to diagnose, b Citiți documentul complet
OBJECT 1 CYCLO-PROGYNOVA 2MG Summary of Product Characteristics Updated 07-Feb-2017 | Meda Pharmaceuticals 1. Name of the medicinal product Cyclo-Progynova ® 2mg. 2. Qualitative and quantitative composition White Tablets - 2mg estradiol valerate Pale Brown Tablets - 500 micrograms norgestrel 2mg estradiol valerate 3. Pharmaceutical form Sugar-coated tablets. 4. Clinical particulars 4.1 Therapeutic indications Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in perimenopausal and postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. (See Section 4.4 Special Warnings & Special Precautions for Use). 4.2 Posology and method of administration Cyclo-Progynova is a cyclic HRT product. One tablet is to be taken orally once a day for 21 days, followed by a 7 day tablet free interval. Therefore each new pack is started after a 28 day cycle. The white tablets should be taken from days 1 to 11 followed by the brown tablets from days 12 to 21. It is recommended that the tablets are taken at the same time every day. For initiation and continuation of treatment of peri- and post-menopausal symptoms the lowest effective dose for the shortest duration (see also Section 4.4) should be used. For the prevention of osteoporosis Cyclo-Progynova 2mg should be used. For women still having periods, the first tablet should be taken on the 5th day of their menstrual period. If menstruation has stopped, or is infrequent or sporadic, then the first tablet can be taken any time. If the patient is being transferred from a continuous HRT product, the patient may start Cyclo-Progynova on any convenient day. For those transferring from a cyclic or sequential product, Cyclo-Progynova should be started following completion of the previous regimen. If a tablet is missed, it should be taken as soon as possible, unless it is more than 12 hours late. In this case the Citiți documentul complet