Active ingredient
- norethisterone
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: PL00010/0553.
Primolut N
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
Primolut® N
Norethisterone
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Primolut N is and what it is used for
2. What you need to know before you take Primolut N
3. How to take Primolut N
4. Possible side effects
5. How to store Primolut N
6. Contents of the pack and other information
1. What Primolut N is and what it is used for
Primolut N contains norethisterone, which belongs to a group of medicines called progestogens, which are female hormones.
Primolut N can be used in several different circumstances:
2. What you need to know before you take Primolut N
Do not take Primolut N:
or:
Do not use Primolut N if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section “Other medicines and Primolut N”).
In addition, do not take Primolut N if you have had any of the following conditions when you were pregnant:
Warnings and precautions
Talk to your doctor or pharmacist before taking Primolut N
Primolut N and blood clots:
The main ingredient in Primolut N (progestogen) is partly converted into oestrogen so you should also consider the general warnings given for combined oral contraceptive pills (“the Pill”).
Do not take Primolut N if you have a blood clot or have any medical condition which makes you more at risk of developing clots.
The risk of blood clots occurring in the veins and arteries is slightly greater in women who take the combined oral contraceptive pill than in women who don’t. People do not always fully recover from such blood clots, which can cause strokes, heart attacks and bleeding into the brain (subarachnoid haemorrhage). In very rare cases these blood clots can be fatal.
You are more at risk of having a blood clot:
To reduce the risk of blood clots, treatment with Primolut N must be stopped:
Signs of a blood clot include:
Primolut N and cancer
If you have breast cancer, or have had it in the past, you should not take combined oral contraceptives (the Pill). The Pill slightly increases your risk of breast cancer. This risk goes up the longer you’re on it, but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40, the extra cases of breast cancer in current and recent Pill users is small. For example:
Your risk of breast cancer is higher if:
Very rarely, the Pill has been linked with some forms of liver cancer in women who take it for a long time. These may lead to bleeding in the abdomen.
Taking the Pill has also been linked to liver diseases, such as jaundice and non-cancerous liver tumours, but this is rare.
Other medicines and Primolut N
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Some medicines
These include:
Primolut N may influence the effect of other medicines, e.g.:
Do not use Primolut N if you have Hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Primolut N can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Primolut N”.
Taking Primolut N can affect the results of some blood and urine tests. Tell your doctor that you are taking Primolut N if you are asked to provide a blood or urine sample.
Other things you should know:
Once you have finished taking a course of Primolut N, you will usually have a menstrual bleed (period) 2-3 days after taking your last tablet. If you do not have a period, you must make sure that you are not pregnant before taking any more tablets.
Pregnancy and breast-feeding
Do not take Primolut N if you are pregnant or breast-feeding. If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Primolut N is unlikely to affect your ability to drive or use machines.
Primolut N contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Primolut N
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The number of tablets that you need to take and the number of days per month when you need to take them will depend on why the doctor has prescribed Primolut N. A common dosage would be 2-3 tablets each day. For some conditions Primolut N has to be taken every day, but this is not always the case.
Ask your doctor or pharmacist, if you are not sure about the number of tablets that you need to take, when they should be taken or how long you should take them for.
Swallow the tablets whole with a drink of water.
If you take more Primolut N than you should
Taking too many tablets is unlikely to cause serious problems. If you take too many, contact your doctor who will tell you what to do.
If you forget to take Primolut N
If you forget a dose, wait until it is time to take the next prescribed dose. Do not take the missed dose. If you are worried, contact your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reasons for stopping Primolut N immediately:
Stop taking Primolut N and speak to your doctor immediately if you experience any of the following:
Primolut N must also be stopped immediately if:
General side effects:
Side effects that have been reported with Primolut N are listed below according to the frequency with which they occur.
Very common side effects
(These may affect more than 1 in 10 people)
Common side effects
(These may affect up to 1 in 10 people)
Uncommon side effects
(These may affect up to 1 in 100 people)
Rare side effects
(These may affect up to 1 in 1,000 people)
Very rare side effects
(These may affect up to 1 in 10,000 people)
Other side effects
(Frequency not known: frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Malta
5. How to store Primolut N
Keep this medicine out of the sight and reach of children.
Store in the original carton.
Do not use this medicine after the expiry date which is stated on both the outer carton and on each blister strip of tablets after EXP. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information
What Primolut N contains
Each tablet contains 5 mg of the active ingredient, norethisterone. The other ingredients are lactose, maize starch and magnesium stearate (E572).
What Primolut N looks like and contents of the pack
Each pack contains 30 tablets. Each white tablet has ‘AN’ embossed in a regular hexagon on one side.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Manufacturers:
or
This leaflet was last revised in December 2018.
Product licence number:
PL 00010/0553
v014_0
400 South Oak Way, Reading, Berkshire, RG2 6AD
+44 (0)118 206 3000