UTOVLAN Tablet Ref.[7887] Active ingredients: Norethisterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK

Therapeutic indications

At low dose: Dysfunctional uterine bleeding, endometriosis, polymenorrhoea, menorrhagia, metropathia, haemorrhagia, postponement of menstruation and premenstrual syndrome.

At high dose: Disseminated carcinoma of the breast.

Posology and method of administration

Posology

Low dose

Dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, dysmenorrhoea and metropathia haemorrhagia: 1 tablet three times daily for 10 days; bleeding usually stops within 48 hours. Withdrawal bleeding resembling true menstruation occurs a few days after the end of treatment. One tablet twice daily, from days 19 to 26 of the two subsequent cycles, should be given to prevent recurrence of the condition.

Endometriosis: 1 tablet three times daily for a minimum treatment period of six months. The dosage should be increased to 4 or 5 tablets a day if spotting occurs. The initial dosage should be resumed when bleeding or spotting stops.

Postponement of menstruation: 1 tablet three times daily, starting three days before the expected onset of menstruation. Menstruation usually follows within three days of finishing the treatment.

Pre-menstrual syndrome: 1 tablet daily from days 16 to 25 of the menstrual cycle.

High dose

For disseminated breast carcinoma the starting dose is 8 tablets (40mg) per day increasing to 12 tablets (60mg) if no regression is noted.

Method of administration

Oral administration.

Overdose

Overdosage may be manifested by nausea, vomiting, breast enlargement and later vaginal bleeding. There is no specific antidote and treatment should be symptomatic.

Gastric lavage may be employed if the overdosage is large and the patient is seen sufficiently early (within four hours).

Shelf life

3 years.

Special precautions for storage

Store below 25°C.

Store in the original package to protect from light and moisture.

Nature and contents of container

Pvc/foil blister packs of 30 and 90 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.