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PRIMOLUT N 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: Metropathia haemorrhagica. Premenstrual syndrome. Postponement of menstruation. Endometriosis. Menorrhagia. Dysmenorrhoea.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Not intended for use in children. Metropathia haemorrhagica (dysfunctional uterine bleeding): 1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment.
One tablet twice daily from the 19th to the 26th day of the two subsequent cycles should be given to prevent recurrence of the condition. To ensure treatment success, Primolut N must be taken for the full 10 days. Occasionally, slight bleeding may occur after the initial suspension of bleeding.
Treatment should not be interrupted or suspended in these cases. g. polyps, carcinoma of the cervix uteri or endometrium, myoma, residua of abortion, extra-uterine pregnancy, or coagulation disorders) must be considered so that other measures are then mostly required.
This also applies to cases where after an initial suspension of bleeding, fairly heavy bleeding reoccurs during tablet intake.
Premenstrual syndrome (including premenstrual mastalgia):
Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological disturbances may be relieved by the administration of 1-3 tablets daily from the 19th to the 26th day of the cycle.
Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom-free for a number of months. g. operations, travel, sports) the postponement of menstruation is possible. The dosage is 1 tablet of Primolut N three times daily, starting 3 days before the expected onset of menstruation and continuing for not longer than 10 to 14 days.
A normal period should occur 2-3 days after the patient has stopped taking tablets. This method should be restricted to users who are not at risk of pregnancy during the treatment cycle.
Endometriosis (pseudo-pregnancy therapy):
Treatment should begin between the first and 5th day of the cycle with 1 of tablet Primolut N twice daily. In the event of spotting, the dose can be increased to 2 tablets twice daily. If bleeding ceases, dose reduction to the initial dose should be considered.
Undesirable effects are more common during the first months after start of intake of Primolut preparations, and subside with duration of treatment. The frequencies are based on reporting rates from postmarketing experience and literature.
System Organ Class (MeDRA) Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommo n (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1000) Very rare (< 1/10,000) Frequency (not known) Immune system disorders Hyper- sensitivit y reactions Nervous system disorders Headache Migraine Dizziness Psychiatric disorders Depression aggravated Eye disorders Visual disturbances Respiratory, thoracic and mediastinal disorders Dyspnoea Gastro- intestinal disorders Nausea Abdominal pain Hepato- biliary disorders Cholestasis Jaundice Skin and subcutaneou s tissue disorders Urticaria Rash Reproductiv e system and breast disorders Uterine/ Vaginal bleeding including Spotting* Hypo- Amenorrhoea * System Organ Class (MeDRA) Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommo n (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1000) Very rare (< 1/10,000) Frequency (not known) menorrhoea * General disorders and administrati on site conditions Oedema * in the indication Endometriosis 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.
Medical Examination A complete personal and family medical history should be taken for each woman. 4) for this product. The frequency and nature of these assessments should be based upon relevant guidelines which should be adapted to the individual woman and should include measurement of blood pressure, and if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.
g. g. after accidents) • Onset of jaundice or deterioration in liver function, anicteric hepatitis, general pruritus • Significant increase in blood pressure • Pregnancy. If any of the conditions/risk factors mentioned below is present or deteriorates while using Primolut N, an individual risk-benefit analysis should be done before Primolut N is started or continued.
• Circulatory disorders It has been concluded from epidemiological surveys that the use of oral oestrogen/progestogen containing ovulation inhibitors is associated by an increased incidence of thromboembolic diseases. Therefore, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic diseases.
A patient who develops symptoms suggestive of thromboembolic complications should stop treatment immediately. The need for treatment should be reassessed before continuing therapy. Generally recognised risk factors for venous thromboembolism (VTE) include: 1.
Positive personal or family history (VTE in a sibling or a parent at a relatively early age) 2. Age 3. Obesity 4. Systemic lupus erythematous (SLE) 5. Prolonged immobilisation 6. Major surgery 7. Major trauma. Patients with a history of VTE or known thrombophilic states have an increased risk of VTE.
The treatment with steroid hormone may add to this risk. Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thromboembolic predisposition. Until a thorough evaluation of thrombophilic factors has been made or anticoagulant treatment initiated, use of progestogens in these patients should be viewed as contraindicated.
Primolut N should not be used in the presence of any of the conditions listed below. Should any of the conditions appear during the use of Primolut N, the use of the product should be stopped immediately. 1. 1. 2. Known or suspected pregnancy.
3. Lactation. 4. Previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism). 5. g. angina, myocardial infarction). 6. g. transient ischaemic attack, angina pectoris). 7. 4) 8. History of migraine with focal neurological symptoms.
9. Diabetes mellitus with vascular involvement. 10. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. 11. Previous or existing liver tumours (benign or malignant). 12. g of the genital organs or the breasts) 13.
History during pregnancy of idiopathic jaundice or severe pruritus. 14. Undiagnosed genital bleeding. 15. Untreated endometrial hyperplasia. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment is to be continued for at least 4 to 6 months. With uninterrupted daily intake, ovulation and menstruation do not usually occur. Menorrhagia (hypermenorrhoea): 1 tablet 2-3 times a day from the 19th to the 26th day of the cycle (counting the first day of menstruation as day 1).
Dysmenorrhoea:
Functional or primary dysmenorrhoea is almost invariably relieved by the suppression of ovulation. 1 tablet three times daily for 20 days, starting on the fifth day of the cycle (the first day of menstruation counting as day 1). Treatment should be maintained for three to four cycles followed by treatment-free cycles.
A further course of therapy may be employed if symptoms return. Method of administration Oral use. The tablets are to be swallowed whole with some liquid.
Where a patient is already taking anticoagulants, the risk 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.
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. There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism. • Known Hyperlipidaemias Women with hypertriglyceridemia, or a family history thereof, may be at increased risk of pancreatitis when using COCs.
4 “Circulatory disorders”). However, routine screening of women on COCs is not appropriate. • Tumours In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of hormonal substances such as the one contained in Primolut N.
In isolated cases, these tumours have led to life-threatening intra- abdominal haemorrhages. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn.
• Other Primolut-N can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum.
Women with a tendency to chloasma should minimise exposure to the sun or ultraviolet radiation when taking Primolut N. Patients who have a history of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Any patient who develops an acute impairment of vision, proptosis, diplopia or migraine headache should be carefully evaluated ophthalmologically to exclude papilloedema or retinal lesions before continuing medication.
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.
If menstrual bleeding should fail to follow a course of Primolut N, or if the patient wishes to postpone menstruation in special circumstances, the possibility of pregnancy must be excluded before a further course is given. 2). Due to the partial conversion of […]