Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Norethisterone 5mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Norethisterone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 2. What you need to know before you take Norethisterone Tablets 3. How to take Norethisterone Tablets 4. Possible side effects 5. How to store Norethisterone Tablets
What you need to know before you take it
e Norethisterone Tablets Norethisterone Tablets may not be suitable for all women. Please read the following list carefully to see if any of these apply to you. Consult your doctor if you are not sure. Do not take Norethisterone Tablets:
- if you are allergic to norethisterone, or other similar hormone medicines, or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant or think you might be pregnant. Your doctor
may give you a pregnancy test altered when they are taken at the same time: before starting treatment or if
- Medicines to treat epilepsy (e.g. you miss a period during phenytoin, carbamazepine) treatment
- Antibiotic medicines to treat an
- if you have now or have ever infection (e.g. tetracyclines, had any vaginal bleeding (not a rifampicin, co-trimoxazole) period) for which your doctor
- Antiviral medicines to treat HIV could not find a cause (e.g. ritonavir, nelfinavir)
- if you or a member of your family have ever had a problem • Anticancer medicines
- Herbal preparations containing with blood clots, including St John's wort (Hypericum deep vein thrombosis (DVT) perforatum)
- if you have now or have had in
- Aminoglutethimide, sometimes the past, a heart attack or used in Cushing's Syndrome angina
- Ciclosporin (for suppressing the
- if you have liver problems immune system)
- if you have ever had a
- Non-steroidal pregnancy where you had anti-inflammatory drugs jaundice, or an itchy rash (NSAIDs) for treating pain and known as pemphigoid gestationis. This rash appears as inflammation small blisters on your abdomen • Medicines for high blood pressure.
- if you have severe generalised itching all over your body Norethisterone Tablets can also (pruritis) interfere with some laboratory
- if you have a condition known tests, so tell your doctor if you are as porphyria (a rare inherited having any blood tests or hospital blood disease). investigations. Warnings and precautions Tell your doctor or pharmacist if Talk to your doctor or pharmacist you are taking any other before taking Norethisterone medicines not listed above, Tablets if you have any of the including those bought without a following conditions. This will prescription. help them decide if Pregnancy, breast-feeding and Norethisterone Tablets are fertility suitable for you: If you are pregnant or
- Epilepsy breast-feeding, think you may be
- Migraine headaches pregnant or are planning to have
- Asthma a baby, ask your doctor for advice
- Heart problems before taking this medicine.
- Kidney problems. Pregnancy Psychiatric disorders Norethisterone Tablets must not Some women using hormonal be taken if you are pregnant as contraceptives including hormonal medicines can affect Norethisterone Tablets have the developing baby. It is reported depression or depressed mood. Depression can important you use some form of contraception (e.g. a condom) be serious and may sometimes while taking Norethisterone lead to suicidal thoughts. If you Tablets, as it is not a experience mood changes and contraceptive. depressive symptoms contact Breast-feeding your doctor for further medical If you are breast-feeding, ask your advice as soon as possible. doctor for advice before taking Risk of Venous this medicine, so they can advise Thromboembolism (VTE) All women have a small chance of whether you should use an having a blood clot in the veins of alternative method of feeding the leg, in the lung or other part your baby. Driving and using machines of the body. The chances of No effect on the ability to drive or getting a clot are very slightly use machinery has been seen higher if you are taking a with Norethisterone Tablets. hormone medicine like Norethisterone Tablets. You are Norethisterone Tablets contain more likely to get a clot whether lactose or not you are taking Lactose is a type of sugar. If you Norethisterone Tablets if you: have been told by your doctor
- are very overweight that you have an intolerance to
- have systemic lupus some sugars, contact your doctor erythematosus. (This is a before taking this medicine. condition where the immune
How to take it
system attacks healthy tissues, Norethisterone Tablets typically causing symptoms such as painful joints and Always take this medicine exactly muscles, tiredness, fever and as your doctor has told you. rashes) Check with your doctor or
- have had a blood clot in the pharmacist if you are not sure. veins or lungs before The recommended dose will
- have relatives who have had depend on the condition you are blood clots being treated for. This
- are unable to move for long information can also be found on periods of time (for example the label on the box the tablets after an operation) come in. The following
- have a serious injury or have information will help you see major surgery what the usual dose is for a
- have a history of repeated particular problem. miscarriage. Taking Norethisterone Tablets Tell your doctor if you have just for heavy bleeding and other had an operation or if you are going to have an operation while period problems – You will usually take 1 tablet 3 times a day taking Norethisterone Tablets. Section 4 of this leaflet ('Possible (15 mg) for 10 days. A few days after you stop taking the tablets side effects') also has more information on the warning signs you will usually have bleeding like a period. To stop your periods of blood clots. causing problems again, your Other medicines and doctor may tell you to take Norethisterone Tablets Norethisterone Tablets for a few Tell your doctor or pharmacist if days after your next two periods. you are taking, have recently You will probably take 1 tablet taken or might take any other twice a day (10 mg) for 8 days. medicines. You will need to start taking This includes the following these tablets 19 days after your medicines, as the effect of last period began. Norethisterone Tablets may be
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Norethisterone 5mg – 30 tablets Wockhardt UK FP2060 / FP4410 Daman (Kadiaya) (w)148 x (h)384mm 2853 228631 (PREVIOUS VERSION SAP CODE No. : 227510) 9 pt. Norethisterone 5mg_Leaflet_104373-9.ai Adobe Illustrator CS6 Myriad Pro Regular / Bold 30th September & 3rd October, 2024
R 1st PDF sent on – 3RD OCT. 2024 R 2nd PDF sent on – 7TH NOV. 2024 CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Updated sections, 4.4 and 4.8,of SmPC/sections 1, 2, 3 and 4 of the PIL in line with the reference product
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becomes red and warm to search for MHRA Yellow Card in touch. the Google Play or Apple App If you get any of these symptoms, Store. you should stop taking the By reporting side effects you can tablets and see your doctor help provide more information immediately. on the safety of this medicine. Reasons for seeking medical advice during treatment It is important to see your doctor straightaway if you get:
- Yellowing of the skin or whites of the eyes (jaundice)
- Migraine headache for the very first time. Your doctor may also decide to stop treatment if your blood pressure gets too high. Other side effects
Possible side effects
weak or numb. If you get any side effects, talk to Symptoms of a deep-vein your doctor, pharmacist or nurse. thrombosis (DVT): This includes any possible side
- You have severe pain, effects not listed in this leaflet. tenderness or swelling in your You can also report side effects calf, ankle or foot directly via the Yellow Card
- You have purple discolouration Scheme Website: of the skin of the leg or the skin www.mhra.gov.uk/yellowcard or 104373/9 228631
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Taking Norethisterone Tablets for premenstrual tension – You will usually take one 5 mg tablet a day for 10 days, starting 16 days after your last period began. Taking Norethisterone Tablets for endometriosis – You will usually take 1 tablet 3 times (15 mg) a day for at least 6 months. If you have any irregular bleeding or spotting, your doctor may increase the dose to 4 or 5 tablets (20-25 mg) a day until this bleeding stops. Taking Norethisterone Tablets for breast cancer – You will usually take 8 tablets (40 mg) a day. Your doctor may increase this to 12 tablets (60 mg). Taking Norethisterone Tablets to delay your periods – You will usually take 1 tablet 3 times (15 mg) a day. You need to start taking the tablets 3 days before your period is due to start. Your period will usually start within 3 days of finishing the tablets. If you do not have a period after you finish a course of Norethisterone Tablets, check with your doctor in case you are pregnant. If you take more Norethisterone Tablets than you should If you take more Norethisterone Tablets than you should, contact your doctor straight away. If you forget to take Norethisterone Tablets Take the tablet as soon as you remember, and carry on taking the tablets at the normal times. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
How to store it
You can also get the following Norethisterone Tablets side effects with medicines like Norethisterone Tablets: Keep this medicine out of the Effects on the reproductive sight and reach of children. system and breasts: bleeding
- Do not use this medicine after and spotting between periods, the expiry date which is stated lack of periods (amenorrhoea), on the carton. The expiry date unexpected or unusual vaginal refers to the last day of that bleeding, changes in discharge month from the cervix, cervical erosions • Do not use this medicine if you (this may be seen when you have notice any signs of a smear test), cycles where you deterioration such as don't ovulate (anovulation), discolouration (they should be breast pain and tenderness, a white) milky discharge from the breast
- Norethisterone Tablets should when not pregnant or not be stored above 25°C. The breastfeeding (galactorrhoea). tablets should be kept in their original container, in order to Effects on the nervous system: protect from light. headache, depression, dizziness, fatigue, difficulty sleeping, Do not throw away any confusion, nervousness, a feeling medicines via wastewater or of intense happiness (euphoria), household waste. Ask your feeling sleepy, loss of pharmacist how to throw away concentration, vision problems. medicines you no longer use. These measures will help protect Effects on the stomach and intestines: feeling or being sick, the environment. constipation, diarrhoea, dry 6. Contents of the pack and mouth. other information Effects on the liver: disturbed What Norethisterone Tablets liver function, yellowing of the contain skin or whites of the eyes. 4. Possible side effects The active substance is Cysts and tumours: a liver norethisterone. Each tablet Like all medicines, this medicine disorder, such as a benign liver contains 5mg. can cause side effects, although tumour. These mostly do not The other ingredients are lactose, not everybody gets them. cause any symptoms but can maize starch and magnesium Reasons for stopping sometimes be felt. Benign liver stearate. Norethisterone Tablets tumours can sometimes cause What Norethisterone Tablets treatment immediately severe abdominal pain. look like and contents of the Very rarely, Norethisterone Effects on your metabolism: pack Tablets may cause a severe altered fat levels in the blood, Norethisterone Tablets are round, allergic reaction which can be alteration of blood sugar levels, white, uncoated tablets with "NE life-threatening in some cases. increased levels of insulin 5" on one side and a break line on You can get some or all of the between meals and existing the other. following symptoms: diabetes getting worse, Norethisterone Tablets are
- wheezing decreased tolerance to some available in blister packs of 30, 72
- difficulty breathing sugars like glucose, and 180 tablets in aluminium foil.
- feeling faint adrenergic-like effects (e.g. fine Not all pack sizes may be
- swelling of the face or tongue hand tremors, sweating, cramps marketed.
- swelling of the hands and feet in the calves at night), effects on
- intense itchy skin rash. Other formats the adrenal glands (e.g. To listen to or request a copy of If you think you are reacting Cushingoid syndrome), cloudy this leaflet in Braille, large print or badly to the medicine, get vision, sugar in your urine. audio please call, free of charge: emergency medical help Effects on your heart and 0800 198 5000 (UK Only) immediately. circulation: blood clots, Please be ready to give the The following symptoms could including clots in the lung, and be warning signs of thrombosis (a swelling in the veins due to blood following information: blood clot) which will need clots, stroke, heart attacks, Product Name Reference urgent treatment: congestive heart failure, Number Symptoms of a blood clot in the increased blood pressure, feeling Norethisterone lungs: your heartbeat, clots in the blood 5mg Tablets 29831/0152
- Sudden, severe, sharp pain in vessels of the retina (this causes This is a service provided by the your chest visual problems), heart beating Royal National Institute of Blind
- Coughing up blood faster (tachycardia). People.
- You suddenly become short of Effects on your skin and hair: breath Marketing Authorisation acne, increase in body or facial
- Your heart beats more rapidly. hair, hair loss, itching, rash, hives. Holder and Manufacturer Marketing Authorisation Holder: Symptoms of a blood clot in the Miscellaneous: fluid retention brain ('a stroke'): and swelling of hands and ankles, Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
- You have an unusually severe or bloating, weight gain, raised long headache temperature, change in appetite, Manufacturer: CP
- Your sight is affected in any way changes in sex drive, fatigue, Pharmaceuticals Ltd, Ash Road
- You find it difficult to speak increase in calcium (seen in blood North, Wrexham, LL13 9UF, UK.
- You collapse or faint tests). This leaflet was revised in
- Any part of your body feels 09/2024. Reporting of
Contents of the pack and other information
1. What Norethisterone Tablets are and what they are used for Norethisterone Tablets is one of a group of medicines called 'Progestogens'. Progestogens are similar to the natural female hormone progesterone. Norethisterone Tablets contains the progestogen called norethisterone as the active ingredient. Norethisterone Tablets has many uses. You can take Norethisterone Tablets to treat or manage:
- Heavy periods
- Painful periods
- Irregular periods or periods that are more frequent than normal
- Premenstrual tension (PMT)
- Endometriosis (where tissue from your womb is found outside your womb)
- Breast cancer. Your doctor may also prescribe Norethisterone Tablets if you want to delay your next period.
Frequently asked questions about Norethisterone 5mg Tablets
How do I take Norethisterone 5mg Tablets?
Norethisterone 5mg Tablets comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Norethisterone 5mg Tablets?
The active substance in Norethisterone 5mg Tablets is norethisterone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Norethisterone 5mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Norethisterone 5mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: norethisterone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
At low dose:
Dysfuntional uterine bleeding
Polymenorrhoea
Menorrhagia
Metropathia
Haemorrhagia
Pre-menstrual syndrome
Postponement of menstruation
At high dose:
Disseminated carcinoma of the breast.
4.2. 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
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1
Pregnancy
Previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism)
Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
Disturbance of liver function
History during pregnancy of idiopathic jaundice
Severe pruritus or pemphigoid gestationis
Undiagnosed irregular vaginal bleeding
Porphyria
4.4. Special warnings and precautions for use
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. 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. Patients should be advised to contact their doctor immediately if they become aware of a potential thromboembolic symptom (e.g., 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.
4.5. Interaction with other medicinal products and other forms of interaction
Interaction with other medicines
The metabolism of progestogens may be increased by concomitant administration of compounds known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes. These compounds include anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz, tetracyclines, ampicillin, oxacillin and cotrimoxazole)
Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John's wort (Hypericum perforatum) may induce the metabolism of progestogens. Progestogen levels may therefore be reduced.
Aminoglutethimide has been reported to decrease plasma levels of some progestogens.
Concurrent administration of cyclosporin and norethisterone has been reported to lead to increased plasma cyclosporin levels and/or decreased plasma norethisterone levels.
When used in combination with cytotoxic drugs, it is possible that progestogens may reduce the haematological toxicity of chemotherapy.
Special care should be taken when progestogens are administered with other drugs which also cause fluid retention, such as NSAIDs and vasodilators.
Other forms of interaction
Progestogens can influence certain laboratory tests (e.g., tests for hepatic function, thyroid function and coagulation).
4.6. Fertility, pregnancy and lactation
Norethisterone is contraindicated in pregnancy
4.7. Effects on ability to drive and use machines
Norethisterone has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Progestogens given alone at low doses have been associated with the following undesirable effects:
Genitourinary
breakthrough bleeding, spotting, amenorrhoea, abnormal uterine bleeding, (irregular, increase, decrease), alterations of cervical secretions, cervical erosions, prolonged anovulation
Breast
galactorrhoea, mastodynia, tenderness
Central Nervous System
depression, headache, dizziness, fatigue, insomnia, nervousness, somnolence, confusion, euphoria, loss of concentration, vision disorders
Gastrointestinal/Hepatobiliary
nausea, vomiting, cholestatic icterus/jaundice, constipation, diarrhoea, dry mouth, disturbed liver function
Neoplasms benign, malignant andunspecified (incl cysts and polyps)
hepatic adenoma
Metabolic & Nutritional
altered serum lipid and lipoprotein profiles, increased fasting glucose levels, increased fasting insulin levels, decreased glucose tolerance, adrenergic-like effects (e.g., fine hand tremors, sweating, cramps in calves at night), corticoid-like effects (e.g., Cushingoid syndrome), diabetic cataract, exacerbation of diabetes mellitus, glycosuria
Cardiovascular
thrombo-embolic disorders, cerebral and myocardial infarction, congestive heart failure, increased blood pressure, palpitations, pulmonary embolism, retinal thrombosis, tachycardia, thrombophlebitis
Skin & Mucous Membranes
acne, hirsutism, alopecia, pruritis, rash, urticaria
Allergy
hypersensitivity reactions (e.g., 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. 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).
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Primolut-NorNorethisteroni acetas · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Norethisterone 5mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.