CYCLOGEST 200MG PESSARIES

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

PROGESTERONE

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

PROGESTERONE

Units in package:

15Tablet Tablets

Manufactured by:

ACCORD-UK LIMITED

Summary of Product characteristics

1
TRADE NAME OF THE MEDICINAL PRODUCT
CYCLOGEST
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains either 200mg or 400mg of the active ingredient
progesterone.
3
PHARMACEUTICAL FORM
Off-white pessaries.
4.1 THERAPEUTIC INDICATIONS
Cyclogest is indicated for the
1) Treatment of premenstrual syndrome, including premenstrual tension
and depression.
2) Luteal phase support as part of an Assisted Reproductive Technology
(ART) treatment for
women. (ONLY FOR CYCLOGEST 400MG PESSARY)
_For the treatment of premenstrual syndrome:_
200mg daily to 400mg twice a day, by vaginal or rectal insertion. For
premenstrual syndrome commence treatment on
day 14 of menstrual cycle and continue treatment until onset of
menstruation. If symptoms are present at ovulation
commence treatment on day 12.
_For luteal phase support as part of an ART treatment:_
400 mg administered vaginally twice a day starting at oocyte
retrieval. The administration of Cyclogest should be
continued for 38 days, if pregnancy has been confirmed.
_Use in special populations:_
There is no experience with use of Cyclogest in patients with impaired
liver or renal function.
_Paediatric population:_
There is no relevant use of Cyclogest in the paediatric population.
_Elderly:_
No clinical data have been collected in patients over age 65.
_Method of Administration:_
For rectal or vaginal insertion.
Cyclogest is not indicated in threatened miscarriage. Treatment should
be discontinued in the event of a missed
miscarriage.
Cyclogest should be discontinued if any of the following conditions
are suspected:
myocardial infarction, cerebrovascular disorders, arterial or venous
thromboembolism (venous thromboembolism or
pulmonary embolism), thrombophlebitis or retinal thrombosis.
Although risk of thromboembolism has been associated with estrogens, a
link with progestins remains questionable.
Therefore, in women with generally recognised risk factors for
thromboembolic events, such as personal or family history,
treatment with Cyclogest may further increase the ri