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CYCLOGEST PESSARY 400 MG [SIN03626P]

Active ingredients: CYCLOGEST PESSARY 400 MG

Last updated 26 October 2025

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Product Info
4.3 Contraindications

Product Info

CYCLOGEST PESSARY 400 MG

[SIN03626P]

Product information

Active Ingredient and Strength

PROGESTERONE - 400 MG

Dosage Form

SUPPOSITORY

Manufacturer and Country

ACCORD-UK LTD - UNITED KINGDOM
FULTON MEDICINALI S.P.A. - ITALY

Registration Number

SIN03626P

Licence Holder

ZUELLIG PHARMA PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

G03DA04

4.1 Therapeutic Indications
Cyclogest is indicated for the

  1. Treatment of premenstrual syndrome, including premenstrual tension and depression.

  2. Treatment of puerperal depression.

  3. Luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women.

4.2 Posology and Method of Administration
For the treatment of premenstrual syndrome and puerperal depression:
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:
400mg 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.

4.3 Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

  • Undiagnosed vaginal bleeding.

  • Known or suspected progesterone sensitive malignant tumours.

  • Porphyria.

  • Severe hepatic dysfunction or disease

  • Known missed abortion or ectopic pregnancy.

  • Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.