The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0152.
Norethisterone 5mg Tablets
Norethisterone 5mg Tablets
The name of your medicine is Norethisterone 5mg Tablets. In the rest of this leaflet it is called Norethisterone Tablets.
1. What Norethisterone Tablets are and what they are used 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
6. Contents of the pack and other information
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:
Your doctor may also prescribe Norethisterone Tablets if you want to delay your next period.
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.
Talk to your doctor or pharmacist before taking Norethisterone Tablets if you have any of the following conditions. This will help them decide if Norethisterone Tablets is suitable for you:
All women have a small chance of having a blood clot in the veins of the leg, in the lung or other part of the body. The chances of getting a clot are very slightly higher if you are taking a hormone medicine like Norethisterone Tablets. You are more likely to get a clot whether or not you are taking Norethisterone Tablets if you:
Tell your doctor if you have just had an operation or if you are going to have an operation while taking Norethisterone Tablets.
Section 4 of this leaflet (‘Possible side effects’) also has more information on the warning signs of blood clots.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This includes the following medicines, as the effect of Norethisterone Tablets may be altered when they are taken at the same time:
Norethisterone Tablets can also interfere with some laboratory tests, so tell your doctor if you are having any blood tests or hospital investigations.
Tell your doctor or pharmacist if you are taking any other medicines not listed above, including those bought without a prescription.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Norethisterone Tablets must not be taken if you are pregnant as hormonal medicines can affect the developing baby. It is important you use some form of contraception (e.g. a condom) while taking Norethisterone Tablets, as it is not a contraceptive.
If you are breast-feeding, ask your doctor for advice before taking this medicine, so they can advise whether you should use an alternative method of feeding your baby.
No effect on the ability to drive or use machinery has been seen with Norethisterone Tablets.
Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
The recommended dose will depend on the condition you are being treated for.
This information can also be found on the label on the box the tablets come in. The following information will help you see what the usual dose is for a particular problem.
Taking Norethisterone Tablets for heavy bleeding and other period problems - You will usually take 1 tablet 3 times a day (15 mg) for 10 days. A few days after you stop taking the tablets you will usually have bleeding like a period. To stop your periods causing problems again, your doctor may tell you to take Norethisterone Tablets for a few days after your next two periods. You will probably take 1 tablet twice a day (10 mg) for 8 days.
You will need to start taking these tablets 19 days after your last period began.
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, contact your doctor straight away.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rarely, Norethisterone Tablets may cause a severe allergic reaction which can be life-threatening in some cases.
You can get some or all of the following symptoms:
If you think you are reacting badly to the medicine, get emergency medical help immediately.
The following symptoms could be warning signs of thrombosis (a blood clot) which will need urgent treatment:
If you get any of these symptoms, you should stop taking the tablets and see your doctor immediately.
It is important to see your doctor straightaway if you get:
Your doctor may also decide to stop treatment if your blood pressure gets too high.
You can also get the following side effects with medicines like Norethisterone Tablets:
Effects on the reproductive system and breasts: bleeding and spotting between periods, lack of periods (amenorrhoea), unexpected or unusual vaginal bleeding, changes in discharge from the cervix, cervical erosions (this may be seen when you have a smear test), cycles where you don’t ovulate (anovulation), breast pain and tenderness, a milky discharge from the breast when not pregnant or breastfeeding (galactorrhoea).
Effects on the nervous system: headache, depression, dizziness, fatigue, difficulty sleeping, confusion, nervousness, a feeling of intense happiness (euphoria), feeling sleepy, loss of concentration, vision problems.
Effects on the stomach and intestines: feeling or being sick, constipation, diarrhoea, dry mouth.
Effects on the liver: disturbed liver function, yellowing of the skin or whites of the eyes.
Effects on your metabolism: altered fat levels in the blood, alteration of blood sugar levels, increased levels of insulin between meals and existing diabetes getting worse, decreased tolerance to some sugars like glucose, adrenergic-like effects (e.g. fine hand tremors, sweating, cramps in the calves at night), effects on the adrenal glands (e.g. Cushingoid syndrome), cloudy vision, sugar in your urine.
Effects on your heart and circulation: blood clots, including clots in the lung, and swelling in the veins due to blood clots, stroke, heart attacks, congestive heart failure, increased blood pressure, feeling your heartbeat, clots in the blood vessels of the retina (this causes visual problems), heart beating faster (tachycardia).
Effects on your skin and hair: acne, increase in body or facial hair, hair loss, itching, rash, hives.
Miscellaneous: fluid retention and swelling of hands and ankles, bloating, weight gain, raised temperature, change in appetite, changes in sex drive, fatigue, increase in calcium (seen in blood tests).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the .Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
The active substance is norethisterone. Each tablet contains 5mg.
The other ingredients are lactose, maize starch and magnesium stearate.
Norethisterone Tablets are round, white, uncoated tablets with “NE 5” on one side and a break line on the other.
Norethisterone Tablets are available in blister packs of 30, 72 and 180 tablets in aluminium foil.
Not all pack sizes may be marketed.
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Product Name Reference Number
Norethisterone 5mg Tablets 29831/0152
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This leaflet was revised in 10/2022.