Cyclo-Progynova 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

Viatris UK Healthcare Ltd

ATC code:

G03CA53

Pharmaceutical form:

Not applicable

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 06040101; GTIN: 5060035240029

Patient Information leaflet

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

Summary of Product characteristics

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