Cyclogest 200mg Pessary
PDF Leaflet Revision Date: 18 April 2018
Clinical Summary
Quick overview from the medicine insert
Indication
Supplementation of insufficient progesterone in women undergoing fertilisation programmes.
Dosage (summary)
200 mg vaginally daily, may increase to 400 mg twice daily.
Special Populations
- Hepatic dysfunction
- Cardiovascular impairment
- Renal impairment
Pregnancy & Breastfeeding
No adverse effects expected, but no evidence available.
Contraindications
- Undiagnosed vaginal bleeding
- History of thromboembolic disorders
Common side effects
- Gastrointestinal disturbances
- Acne
- Fluid retention
- Weight gain
- Allergic skin rashes
Counselling Points
- Insert pessary as directed
- Report any unusual bleeding
- Monitor for side effects
Serious warnings
- Use with caution in hormone-sensitive conditions
- Monitor liver function
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
CYCLOGEST 200 mg is indicated for the supplementation of insufficient secretion of progesterone in women participating in fertilisation programmes.
4.2 Posology and method of administration
The dosage of CYCLOGEST 200 mg is 200 mg inserted into the vagina daily but can be increased to 400 mg twice daily.
4.3 Contraindications
Undiagnosed vaginal bleeding. A history of thromboembolic disorders.
4.4 Special warnings and precautions for use
Progesterone is metabolised in the liver and should be used with caution in patients with hepatic dysfunction. CYCLOGEST 200 mg 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.
4.6 Fertility, pregnancy and lactation
Progesterone is a natural hormone and is not expected to have adverse effects, but no evidence is available to this effect.
4.8 Undesirable effects
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.
4.9 Overdose
Overdosage may produce euphoria or dysmenorrhoea. Treatment is symptomatic and supportive.
