Active ingredient
- misoprostol
- mifepristone
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: PL 31750/0042.
Medabon Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets
Package leaflet: Information for the user
Medabon
Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets Mifepristone and Misoprostol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
In this leaflet
1. What Medabon is and what it is used for
2. What you need to know before you use Medabon
3. How to use Medabon
4. Possible side effects
5. How to store Medabon
6. Contents of the pack and other information
1. What Medabon is and what it is used for
Medabon is a combination therapy containing two medicines called mifepristone and misoprostol.
Medabon is recommended for the medical termination of a pregnancy no later than 63 days after the first day of your last menstrual period.
Mifepristone is an anti-hormone that acts by blocking the effects of progesterone, a hormone which is needed for pregnancy to continue. Misoprostol is a prostaglandin, which is a substance that increases contraction of the womb that will help expel the pregnancy. The two drugs can therefore cause termination of pregnancy and must be used one after the other to give the best possible chance for the treatment to work.
2. What you need to know before you use Medabon
Do not use Medabon
Warnings and precautions
In some circumstances the treatment may not be suitable for you or you may need extra care, so please tell your doctor if
Before taking Medabon your blood will be tested for Rhesus factor. If you are Rhesus negative your doctor will advise you of the routine treatment required (see also in section 3. ‘After treatment you should be aware that’).
The doctor will then be able to discuss with you if you are able to have the treatment.
Other medicines and Medabon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, medicines containing the following active substances may interfere with the action of Medabon:
Caution should be exercised when Medabon is used with medicines containing the following active substances:
The incidence of diarrhea may be reduced by avoiding antacids that contain magnesium. If an antacid is needed, one that contains aluminum or calcium may be a more appropriate choice.
Ask your doctor about which medicines you can take for pain.
Talk to your doctor if you need to take any other medicines during the treatment.
Medabon with food and drink
You should not drink grapefruit juice when you are treated with Medabon.
Pregnancy, breast-feeding and fertility
Pregnancy
There is little information on the risks to the unborn baby. If the pregnancy continues and you decide to keep it, discuss this with your doctor who will arrange careful pre-natal monitoring and ultrasound examinations.
Breast-feeding
Medabon may pass into breast milk and be taken in by your baby. You should stop breast-feeding once you have used the treatment.
Fertility
Important: It is possible for you to become pregnant again very soon after the pregnancy termination is complete. It is recommended that you avoid becoming pregnant again before your next menstrual period after taking Medabon, and use a method of contraception within 3 to 9 days of using the mifepristone tablet (see also in section 3. ‘After treatment you should be aware that’).
Driving and using machines
You should know that mifepristone and misoprostol may make you dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
3. How to use Medabon
The use of Medabon requires your active participation as follows:
First step
Second step
Third step
After treatment you should be aware that
The use of Medabon requires that measures are taken to prevent Rhesus factor sensitisation (if you are Rhesus negative) along with the general measures taken during any pregnancy termination.
If you use more Medabon than you should
If you take too many tablets, contact your doctor immediately or go to the nearest hospital/clinic.
The doctor will give you the exact amount of Medabon; it is therefore unlikely that you will use more than you should.
In the event of accidental massive ingestion, contact your doctor immediately or go to the nearest hospital casualty department. You may require specialist treatment including the administration of dexamethasone.
If you forget to use Medabon
If you forget to use any part of the treatment, it may not be fully effective. This means that your pregnancy may not have been completely expelled. Talk with your doctor if you forgot to use any part of the treatment, as you may need further treatment to end the pregnancy. Also if you change your mind and choose to continue with your pregnancy, talk to your doctor (see also section 2. Pregnancy, breast-feeding and fertility; Pregnancy).
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Contact the hospital/clinic if you have:
Contact your doctor if any of the following side effects gets serious or you are worried.
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Reporting of side effects
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.
5. How to store Medabon
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if the box or the blisters show signs of damage.
Store below 25°C.
6. Contents of the pack and other information
What Medabon contains
Each tablet of mifepristone contains 200 mg mifepristone.
Each vaginal tablet of misoprostol contains 0.2 mg misoprostol.
The other ingredients are:
What Medabon looks like and contents of the pack
Medabon contains 1 tablet of mifepristone and 4 vaginal tablets of misoprostol supplied in an aluminium blister. Each blister is packed in an aluminium pouch along with a silica gel desiccant sachet.
Mifepristone tablet is light yellow coloured and round-shaped, one side is marked with “S” and the other side is plain. Diameter: 11.0 mm.
Misoprostol vaginal tablets are white to off-white and rectangular-shaped, one side is marked with a square on each side of the score and the other side is plain. Diameter: 11.6 x 6.3 mm.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following name:
The Netherlands: Sunmedabon
Romania: Medabon
United Kingdom: Medabon
This leaflet was last revised in October 2020.
Art 61(3): P4
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