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NORETHISTERONE is a brand name for Norethindrone (also known as Norethisterone). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's MHRA label. Tap a section to expand.
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
, anaphylaxis & anaphylactoid reactions, angioedema) Miscellaneous oedema/fluid retention, bloating, weight gain, pyrexia, change in appetite, change in libido, hypercalcaemia, malaise Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
If menstrual bleeding should fail to follow a course of Utovlan, the possibility of pregnancy must be excluded before a further course is given. Therapy should be discontinued if the following occur: - Jaundice or deterioration in liver function - Significant increase in blood pressure - New onset of migraine-type headache Progestogens may cause fluid retention.
Special care should be taken when prescribing norethisterone in patients with conditions which might be aggravated by this factor: - Epilepsy - Migraine - Asthma - Cardiac dysfunction - Renal dysfunction Risk of venous thromboembolism (VTE) Long term use of low dose progestogens as part of combined oral contraception or combined hormone replacement therapy has been associated with an increased risk of venous thromboembolism, although the role of progestogens in this aetiology is uncertain.
A patient who develops symptoms suggestive of thromboembolic complications should have her status and need for treatment carefully assessed before continuing therapy. Any patient who develops an acute impairment of vision, proptosis, diplopia or migraine headache should be carefully evaluated ophthalmologically to exclude papilloedema or retinal vascular lesions before continuing medication.
Generally recognised risk factors for VTE include a personal history or family history, severe obesity (BMI >30 kg/m2) and systemic lupus erythematosus (SLE). There is no consensus about the possible role of varicose veins in VTE. Treatment with steroid hormones may add to these risk factors.
Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophillic predisposition. Until a thorough evaluation of thrombophillic factors has been made or anticoagulant treatment initiated, use of progestogens in these patients should be viewed as contraindicated.
Where a patient is already taking anticoagulants, the risks and benefits of progestogen therapy should be carefully considered. The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery.
g. angina, myocardial infarction) Disturbance of liver function History during pregnancy of idiopathic jaundice Severe pruritus or pemphigoid gestationis Undiagnosed irregular vaginal bleeding Porphyria
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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As in all post-operative patients, scrupulous attention should be given to prophylactic measures to prevent VTE. Where prolonged immobilisation is likely to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to stopping progestogen therapy 4-6 weeks pre-operatively.
Treatment should not be restarted until the patient is fully remobilised. If VTE develops after initiating therapy the drug should be withdrawn. , painful swelling in the leg, sudden pain in the chest, dyspnoea). Hepatic adenoma - In very rare cases, hepatic adenomas may be associated with progesterone-only pill (POP) use.
In some cases the hepatic adenoma may decrease in size or become undetectable after discontinuation of norethisterone. Rupture of hepatic adenomas may cause death through intra-abdominal haemorrhage. In extremely rare cases, hepatocellular carcinoma may be associated with combined oral contraceptives use.
8). Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
Utovlan contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.