CYCLOGEST Off-white pessaries Ref.[7851] Active ingredients: Progesterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: L.D. Collins & Co. Ltd., 1st Floor, Gallery Court, 28 Arcadia Avenue, London, N3 2FG, UK

Therapeutic indications

Cyclogest is indicated for the:

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

Posology and method of administration

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.

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.

Overdose

There is a wide margin of safety with Cyclogest pessaries, but overdosage may produce euphoria or dysmenorrhoea.

Shelf life

Three years from the date of manufacture.

Shelf-life after dilution/reconstitution: Not applicable.

Shelf-life after first opening: Not applicable.

Special precautions for storage

Store below 25°C in a dry place.

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 20µm polypropylene foil and coated on the reverse with polythene (20mg/m²). The alternative is thermoplastic film and laminated PVC to 95µm and polyethylene to 27-30µm.

Pack sizes: 5s, 12s, 15s

Special precautions for disposal and other handling

Not applicable.

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