Norethisterone should be used with caution in: patients who are obese or have a family member who has had a blood clot in their legs or lungs, fibroids of the womb, raised blood pressure (hypertension), raised blood sugar (diabetes), depression, water retention, migraine, fitting (epilepsy), asthma, heart, liver or kidney problems, varicose veins, smoking, multiple sclerosis, muscle spasm (tetany), gallstones, problems with contact lenses, amenorrhoea (lack of menstrual periods), previous ectopic pregnancy (where the foetus develops outside the womb) and the immune condition systemic lupus erythematosus (also known as SLE).
It should not be used in: the elderly, children, patients who are allergic to norethisterone or to any of the other ingredients contained in the medicine, pregnancy, patients who have problems with their circulation such as phlebitis or blood clots, patients who have had a heart attack, stroke or angina, patients with yellowing of the skin or whites of the eyes (jaundice) during pregnancy or while taking the pill, patients with severe liver problems, liver tumours, or tumours of the breast, womb or ovaries, patients with irregular or unusual vaginal bleeding of unknown cause, the rare inherited blood condition porphyria or the blood disordersickle cell anaemia, patients undergoing surgery or patients who have to take bed rest or remain immobile for a long time, patients who have had severe itching or rash caused by Herpes virus during pregnancy, patients with an intolerance to certain sugars.
Also see list of precautions and interactions
Store below 25ºC and protect from light.
What is it used for?
- Norethisterone is used to mimic the effects of female sex hormones produced naturally by the body.
- It is a synthetic progestogen hormone, sometimes known as a progestogen-only oral contraceptive or the mini pill.
- It is used to thicken the vaginal fluid so that sperm cannot get to the womb and to change the lining of the womb so that eggs cannot grow there, preventing pregnancy. Norethisterone also decreases the production of oestrogen and progestogen hormones produced naturally by the body and may also have a direct effect on the pituitary gland which is involved in the production of several hormones.
- In general this drug is used to treat irregular, painful or heavy periods, endometriosis (a painful condition caused by tissue that usually lines the womb growing outside the womb), premenstrual tension (also known as PMS or PMT) and to prevent pregnancy (oral contraceptive pill)
- Benefits of being on this drug can include prevention of pregnancy, return to a normal menstrual cycle, relief from the pain associated with endometriosis and relief from the symptoms of PMS or PMT.
Listed below are the typical uses of norethisterone.
- Prevention of pregnancy
- Relief from premenstrual (PMT) symptoms including headache, migraine, breast discomfort, water retention or changed behaviour before a period is due
- Abnormal, heavy or continuous bleeding from the womb (not related to a heavy period)
- Heavy bleeding during a period
- Painful periods
- Endometriosis (a painful condition caused by tissue that usually lines the womb growing outside the womb)
On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below.
HOW TO USE/TAKE
How often do I take it?
- Take this medication by mouth usually once a day, with or without food. Swallow the tablet whole with a glass of water. If you are taking norethisterone as an oral contraceptive and you have a stomach upset (sickness and/or diarrhoea) within 2 hours of taking the tablet, then another pill should be taken as soon as possible. If a replacement pill is not taken within 3 hours of the usual pill taking time or in case of persistent sickness or severe diarrhoea, then carry on taking your tablet as usual but also use extra contraception for as long as you are ill and for the next 2 days after that.
- Use this medication regularly in order to get the most benefit from it.
- Remember to use it at the same time each day - unless specifically told not to by your doctor.
- Certain medical conditions may require different dosage instructions as directed by your doctor.
- Dosage is based on your age, medical condition, response to therapy, and use of certain interacting medicines.
Do I need to avoid anything?
- Norethisterone is not known to affect ability to drive or operate machinery. Consult your doctor or pharmacist for more details.
When can I stop?
- It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.
NORETHISTERONE SIDE EFFECTS
- Headache (including migraine headache)
- Feeling sick
- Being sick
- Stomach ache
- Swollen or sore breasts
- Change in weight
- Changes in sex drive
- Patches of darkened skin
- Change in appetite
- Feeling dizzy
- Feeling tired
- Feeling depressed
- Breakthrough bleeding or spotting from the vagina
- Irregular menstrual periods
- High sugar levels in the blood
- Difficulty sleeping
- Feeling nervous
- Dry mouth
- Blood clots
- Eye problems
- Increase in body hair
- Worsening of migraine headaches
- Worsening of fitting (epilepsy)
- Liver tumours
If any of these persist or you consider them severe then inform your doctor or pharmacist. Further information on other side effects can be found in the patient information leaflet.
Tell your doctor immediately and stop taking norethisterone if you develop any of the following symptoms:
- Swelling of the face, hands or feet, wheezing, difficulty breathing, or an intense itchy skin rash which may be caused by a severe allergic reaction
- Signs and symptoms of a blood clot which may include severe pain or tenderness or swelling in the calf of one or both legs, unexpected chest pain, shortness of breath or coughing up blood, unexpected numbness, tingling, weakness, severe headache, dizziness, fainting, fitting, problems with eyesight or speech or unexpected stomach pain
- Painful or inflamed leg veins
- Changes in your sense of taste, smell or touch
- A crushing type of chest pain or heaviness in your chest
- Migraine or your existing migraine worsens
- Persistent headaches
- Swelling or tenderness in the upper part of your tummy
- Yellowing of the skin or whites of your eyes (this may be a sign of jaundice)
- Large increase in blood pressure
- Recurrence of earlier depression
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.
Before taking norethisterone tell your doctor or pharmacist if you are allergic to it; or to other progestogens; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of: an allergy to norethisterone or to any of the other ingredients contained in the medicine, pregnancy, high levels of fat in your blood, problems with your circulation such as phlebitis or blood clots, heart attack, stroke or angina, yellowing of the skin or whites of the eyes (jaundice) during pregnancy or while taking the pill, severe liver problems, liver tumours, or tumours of the breast, womb or ovaries, irregular or unusual vaginal bleeding of unknown cause, the rare inherited blood condition porphyria or the blood disorder sickle cell anaemia, undergoing surgery or have to take bed rest or remain immobile for a long time, severe itching or rash caused by Herpes virus during pregnancy, or an intolerance to certain sugars.
Before using this medication tell your doctor or pharmacist your medical history, especially any of the following: you have a family member who has had a blood clot in their legs or lungs, fibroids of the womb, raised blood pressure (hypertension), raised blood sugar (diabetes), depression, water retention, migraine, fitting (epilepsy), asthma, heart, liver or kidney problems, varicose veins, smoking, multiple sclerosis, muscle spasm (tetany), gallstones, problems with contact lenses, amenorrhoea (lack of menstrual periods), previous ectopic pregnancy (where the foetus develops outside the womb) or the immune condition systemic lupus erythematosus (also known as SLE).
Before having surgery, tell your doctor or dentist that you are taking this medication.
Does alcohol intake affect this drug?
- Alcohol intake is not known to affect norethisterone.
The elderly: norethisterone is not indicated for use in the elderly.
Pregnancy and breastfeeding - please ensure you read the detailed information below
Norethisterone is not safe to take if you are, or are planning to become, pregnant.
It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Speak to your prescriber about taking norethisterone whilst breastfeeding.
It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Before using this medicine, tell your prescriber of all the medicines you are taking including prescription medicines and medicines you have bought over the counter without a prescription. Tell your prescriber if you are taking vitamins or complementary remedies such as herbal products, as these can also interact with medicines.
If you are taking more than one medicine, these may interact with each other. Your prescriber may decide to use medicines which interact with each other if the benefit outweighs the risks. In these cases, the dose of your medicines may need to be adjusted or you may be monitored more closely.
The following medicines may interact with norethisterone:
- St John's Wort
- Medicines for high blood pressure
- Medicines for cancer
- Other female sex hormones
This information does not contain all possible interactions. Therefore, tell your prescriber of all the products you are using before taking this medicine.
If you have a question or want to discuss anything about your medicine, speak to your local pharmacist.
An overdose of norethisterone may cause nausea (feeling sick) and being sick, enlargement of the breasts and withdrawal bleeding. If you take more norethisterone tablets than you should, then contact your doctor, pharmacist or nearest hospital casualty department immediately. Take any remaining tablets with you.
If you think you, or someone you care for, might have accidentally taken more than the recommended dose of norethisterone or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
If you are taking norethisterone to prevent pregnancy (as an oral contraceptive pill) and you are not more than 3 hours late taking your tablet, then the missed tablet should be taken as soon as possible. If you are more than 3 hours late taking your tablet then you should take the last missed tablet as soon as possible and continue to take the rest of your tablets as usual. However, you should then also use an extra method of (non-hormonal) contraception such as a condom for the next 2 days.