Zuellig Pharma


Zuellig Pharma
Concise Prescribing Info
Premenstrual syndrome (PMS) including premenstrual tension & depression. Luteal phase support as part of an assisted reproductive technology (ART) for women.
Dosage/Direction for Use
PMS 200-400 mg once daily-bd by vag or rectal insertion on day 14 of menstrual cycle & continue until onset of menstruation. If symptoms are present at ovulation, start on day 12. Luteal phase support as part of an ART treatment 400 mg bd administered vaginally starting at oocyte retrieval, continued for 38 days if pregnancy has been confirmed.
Hypersensitivity. Undiagnosed vag bleeding, known or suspected progesterone sensitive malignant tumours, porphyria, history or active arterial or venous thromboembolism or severe thrombophlebitis. Severe hepatic dysfunction or disease. Known missed abortion/ectopic pregnancy.
Special Precautions
Discontinue in the event of missed miscarriage. Discontinue use if MI, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis or retinal thrombosis are suspected & symptoms of depression worsens. Epilepsy, migraine, asthma, cardiac dysfunction, diabetes; hormone-sensitive conditions. Use rectally if barrier methods of contraception are used or if patients suffer from vag infection (especially moniliasis) or recurrent cystitis or have recently given birth. Use vaginally if patients suffer from colitis or fecal incontinence. Hepatic & renal dysfunction. Not to be used during pregnancy & lactation.
Adverse Reactions
Somnolence; hot flush; breast pain; fatigue. Early or delayed menstruation. Rectally: Soreness, diarrhoea & flatulence.
Drug Interactions
Decreased bioavailability w/ CYP450 3A4 inducers eg, rifampicin, carbamazepine or phenytoin. Not recommended w/ other vag products.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Cyclogest pessary 400 mg
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