Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Clomid 50 mg Tablets (Clomifene Citrate BP) is indicated for the treatment of ovulatory failure in women desiring pregnancy. Clomid 50 mg Tablets is indicated only for patients in whom ovulatory dysfunction is demonstrated. Other causes of infertility must be excluded or adequately treated before giving Clomid 50 mg Tablets.
The recommended dose for the first course of Clomid 50 mg Tablets (Clomifene Citrate BP) is 50 mg (1 tablet) daily for 5 days. Therapy may be started at any time in the patient who has had no recent uterine bleeding. If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs before therapy, the regimen of 50 mg daily for 5 days should be started on or about the fifth day of the cycle. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment.
If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one. Increase of the dosage or duration of therapy beyond 100 mg/day for 5 days should not be undertaken.
The majority of patients who are going to respond will respond to the first course of therapy, and 3 courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occurred, the diagnosis should be re-evaluated. Treatment beyond this is not recommended in the patient who does not exhibit evidence of ovulation.
Not recommended.
Efficacy and safety of clomifene for more than 6 treatment cycles have not been demonstrated.
Special care with lower dosage or duration of treatment is particularly recommended if unusual sensitivity to pituitary gonadotrophin is suspected, such as in patients with polycystic ovary syndrome (see section 5.1).
Oral.
Toxic effects of acute overdosage of Clomid 50 mg Tablets have not been reported but the number of overdose cases recorded is small. In the event of overdose, appropriate supportive measures should be employed.
3 years.
Store in original container, do not store above 25°C.
Base: 250 micron PVC.
Foil: 20 micron hard-tempered aluminium.
(in cardboard cartons)
Pack sizes: 30 and 100 tablets.
None.
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