CYCLOGEST® 200 mg pessaries
(and dosage form):
CYCLOGEST® 200 mg pessaries
Each pessary, suitable for vaginal insertion, contains 200 mg progesterone BP.
A 21.8.2 Progesterones with or without oestrogens
CYCLOGEST® (progesterone) is a natural progestogen. Progesterone released during the luteal phase of the menstrual cycle leads to the development of a secretory endometrium. Abrupt decline in the release of progesterone from the corpus luteum at the end of the cycle is the main determinant of the onset of menstruation. If the duration of the luteal phase is artificially lengthened, either by sustaining luteal function or by treatment with progesterone, decidual changes in the endometrial stroma similar to those seen in early pregnancy can be induced. The estrogen-induced maturation of the human vaginal epithelium is modified toward the condition of pregnancy by the action of progesterone. Progesterone is important for the maintenance of pregnancy as it suppresses menstruation and uterine contractility.
Recent evidence has revealed that in controlled clinical studies CYCLOGEST® was not shown to be more efficacious than placebo in the treatment of premenstrual syndrome.
CYCLOGEST® is indicated for the supplementation of insufficient secretion of progesterone in women participating in fertilisation programmes.
Undiagnosed vaginal bleeding
A history of thrombo-embolic disorders
WARNINGS AND PRECAUTIONS:
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. Unless progestogens are being used as part of the management of breast carcinoma they should not be given to patients with these conditions.
Use in pregnancy and lactation:
Progesterone is a natural hormone and is not expected to have adverse effects, but no evidence is available to this effect.
DOSAGE AND DIRECTIONS FOR USE:
The dosage of CYCLOGEST® is 200 mg inserted into the vagina daily but can be increased to 400 mg twice daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Progesterones should be used with caution in patients with cardiovascular or renal impairment, diabetes mellitus, asthma, epilepsy, migraine or other conditions which may be aggravated by fluid retention. They should be used with care in persons with a history of mental depression.
Menstruation may occur earlier than expected or, more rarely, menstruation may be delayed.
Leakage of the pessary base may occur.
Side-effects of progesterone may include gastro-intestinal disturbances, acne, fluid retention or oedema, mass gain, allergic skin rashes or urticaria, mental depression, breast changes including discomfort or less frequently gynaecomastia and changes in libido. Alterations in liver function tests have been reported and jaundice has been reported less frequently.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may produce euphoria or dysmenorrhoea. Treatment is symptomatic and supportive.
Cardboard cartons containing 15 pessaries, packed in blister strips of five.
Store below 25°C in a dry place.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OT THE APPLICANT:
326 Marks Street, Waltloo, Pretoria
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
22 February 1994
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