Cyclogest 400mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cyclogest 400mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains 400mg Progesterone PhEur.
3 PHARMACEUTICAL FORM
Off-white pessaries
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
1) Treatment of premenstrual syndrome, including premenstrual tension and depression.
2) Treatment of puerperal depression.
4.2 Posology and method of administration
Posology
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.
Children: Not applicable.
Elderly: Not applicable.
Method of Administration For rectal or vaginal insertion.
4.3 Contraindications
Undiagnosed vaginal bleeding
4.4 Special warnings and precautions for use
Use rectally if barrier methods of contraception are used.
Use vaginally if patients suffer from colitis or faecal incontinence. Use rectally if patients suffer from vaginal infection (especially moniliasis) or recurrent cystitis. Use rectally in patients who have recently given birth.
Progesterone is metabolised in the liver and should be used with caution in patients with hepatic dysfunction.
Cyclogest contains the hormone progesterone which is present in significant concentrations in women during the second half of the menstrual cycle and during pregnancy. This should be borne in mind when treating patients with conditions that may be hormone-sensitive.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
Due to the indications of the product, it is anticipated that it will not be administered to pregnant women. As progesterone is a natural hormone, it is not expected to have adverse effects, however, no evidence is available to this effect.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Menstruation may occur earlier than expected, or, more rarely, menstruation may be delayed.
Soreness, diarrhoea and flatulence may occur with rectal administration.
As with other vaginal and rectal preparations, some leakage of the pessary base may occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard
4.9 Overdose
There is a wide margin of safety with Cyclogest pessaries, but overdosage may produce euphoria or dysmenorrhoea.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: G03D A
Progesterone is a progestational steroid.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Also contains: vegetable fat.
6.2 Incompatibilities
None known
6.3 Shelf life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution Not applicable.
Shelf-life after first opening Not applicable.
6.4 Special precautions for storage
Store below 25 °C in a dry place
6.5 Nature and contents of container
The product may be supplied in strip packs contained in cartons:
Carton: White backed folding box board printed on white.
Strip pack: Aluminium foil lacquer-laminated to 20pm polypropylene foil and coated on the reverse with polythene (20mg/m2). The alternative is thermoplastic film and laminated PVC to 95pm and polyethylene to 27-30pm. Pack sizes: 5s, 12s, 15s.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Actavis UK Limited (Trading style: Actavis)
Whiddon Valley Barnstaple North Devon EX32 8NS
8 MARKETING AUTHORISATION NUMBER
PL 00142/0508
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/08/2000 / 17/11/2004
10 DATE OF REVISION OF THE TEXT
10/04/2015