Active ingredient
- norethisterone enantate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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: PL00010/0548.
Noristerat 200mg solution for intramuscular injection
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Package leaflet: Information for the user
Noristerat®
Norethisterone enantate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Three important things to know about this medicine.
What is in this leaflet:
1. What Noristerat is and what it is used for
2. Make sure Noristerat is OK for you
3. How to use Noristerat
4. Possible side effects
5. How to store Noristerat
6. What is in Noristerat and who makes it
1. What Noristerat is and what it is used for
Noristerat is an injectable (depot) contraceptive. It is intended as a short-term method of contraception, for example in women whose partners are undergoing vasectomy, until the vasectomy is effective. It is also for use in women immunised against rubella, to prevent pregnancy while the virus is active.
You use it to stop you getting pregnant.
Noristerat contains a type of female sex hormone, called a progestogen.
This hormone stops you getting pregnant by working in three ways: by preventing an egg being released from your ovaries; by making the fluid (mucus) in your cervix thicker, which makes it more difficult for sperm to enter the womb; and by preventing the lining of your womb thickening enough for an egg to grow in it.
The benefits of using Noristerat include:
Noristerat will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this.
2. Make sure Noristerat is OK for you
It’s important that you understand the benefits and risks of using Noristerat before you are given it, or when deciding whether to have a second injection. Although Noristerat is suitable for most healthy women it isn’t suitable for everyone.
Before you are given Noristerat
While you’re on Noristerat
2.1 Noristerat and blood clots
Noristerat may slightly increase your risk of having a blood clot (called a thrombosis), especially in the first year of using it.
A clot in a leg vein – a deep vein thrombosis (or DVT) – is not always serious. However, if it moves up the veins and blocks an artery in the lungs, it can cause chest pain, breathlessness, collapse or even death. This is called a pulmonary embolism and is very rare.
Very rarely, blood clots can also form in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). In healthy young women the chance of having a heart attack or stroke is extremely small.
You are more at risk of having a blood clot:
Signs of a blood clot include:
2.2 Noristerat and cancer
Noristerat has also been linked to liver diseases, such as jaundice and non-cancer liver tumours, but this is rare. Very rarely, Noristerat has also been linked with some forms of liver cancer in women who have used it for a long time.
2.3 Noristerat should not be used by some women
Do not use Noristerat if you have any of the problems listed below. Using Noristerat would put your health at risk.
2.4 Noristerat can make some illnesses worse
Some of the conditions listed below can be made worse by using Noristerat. Or they may mean it is less suitable for you. You may still be able to be given Noristerat but you need to take special care.
The main ingredient of Noristerat (the progestogen, norethisterone enantate) is partly converted into the oestrogen, ethinylestradiol. The expected concentration of ethinylestradiol in your body is relatively low compared to taking combined hormonal contraceptives containing ethinylestradiol. This means that although effects similar to those after taking combined hormonal contraceptives containing ethinylestradiol cannot be completely ruled out, experience to date suggests that this may not be the case.
2.5 Psychiatric disorders
Some women using hormonal contraceptives including Noristerat have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
2.6 Taking other medicines
If you ever need to take another medicine or herbal products at the same time, always tell your doctor, pharmacist or dentist that you’ve been given Noristerat. Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives.
Some medicines can stop Noristerat from working properly – for example:
If you do need to take one of these medicines, you may need to use extra contraception (for example condoms) for a while. Your doctor, pharmacist or dentist can tell you if this is necessary and for how long.
Noristerat can also affect how well other medicines work. For example, if you have diabetes, you may need to take more insulin or other anti-diabetic drugs after being given Noristerat. Your doctor will tell you if this is necessary.
2.7 Using Noristerat with food and drink
There are no special instructions about food and drink while on Noristerat
2.8 Pregnancy and breast-feeding
Pregnancy
You should not be given Noristerat if you are pregnant. If you think you might be pregnant, do a pregnancy test to confirm that you are and do not have your second injection.
Breast-feeding
Noristerat has not been shown to reduce the amount of milk you produce which is an advantage if you wish to breastfeed your baby. Very small amounts of the hormone are found in breast milk. There is no evidence to suggest that the small amounts of the hormone that appear in the milk are harmful to a healthy baby. However, if your baby has severe or long-lasting jaundice that requires medical treatment you should not breast-feed your baby after having your injection.
2.9 Driving and using machines
Noristerat has no known effect on the ability to drive or use machines.
2.10 Noristerat contains benzyl benzoate
This medicine contains 333.8 mg benzyl benzoate in each 1 ml ampoule.
Benzyl benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
3. How to use Noristerat
3.1 How to start
Your doctor or family planning clinic will give you the first injection of Noristerat within the first five days of your period (unless you start just after a pregnancy or an abortion). The injection is given into the muscle.
By starting in this way you will have contraceptive protection at once.
3.2 Further injections of Noristerat
One injection will give you contraception for 8 weeks. After 8 weeks a second injection can be given. You must make sure that you leave no longer than 8 weeks between injections or contraceptive protection will be lost.
3.3 Starting Noristerat after having a baby
Noristerat can normally be used straight after having a baby. Your doctor will advise you on when to start.
3.4 Starting Noristerat after having a miscarriage or an abortion
You may be able to have an injection immediately. Your doctor will advise you.
3.5 Missed a period – could you be pregnant?
If, when the second injection is due, you have not had a further period since the first injection, it is unlikely that you are pregnant, but the second injection should not be given until pregnancy has been ruled out.
3.6 Being given more Noristerat than you should
Overdosage is unlikely but if it does occur no serious ill-effects are expected.
4. Possible side effects
Like all medicines, Noristerat can cause side effects, although not everybody gets them.
4.1 Serious side effects – see a doctor straight away
Signs of a blood clot:
Signs of a severe allergic reaction to Noristerat:
Signs of severe liver problems include:
4.2 Less serious side effects
Reporting of side effects
If you get any side effects, talk to your doctor, family planning nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.
5. How to store Noristerat
Keep this medicine out of the sight and reach of children.
Noristerat should not be used after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store below 25°C. Protect from light.
6. What is in Noristerat and who makes it
What is in Noristerat
The active substance is norethisterone enantate.
Each ampoule of Noristerat contains 200mg of the progestogen norethisterone enantate in 1ml of oily solution for injection into a muscle.
The other ingredients are benzyl benzoate and castor oil for injection.
What Noristerat looks like and contents of the pack
Noristerat is a solution for intramuscular injection; the injection is given into the muscle.
Noristerat is supplied in single packs of 1 ampoule.
The company that holds the product licence for Noristerat is:
Noristerat is made by:
This leaflet was last updated in June 2019.
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