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Medabon Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets
Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets
Mifepristone and Misoprostol
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
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.
Health care professionals should ensure that due to the risk of the failure of the method and the birth defects observed in these ongoing pregnancies, patients are being informed about the risk of teratogenicity and that a follow-up visit must be scheduled in order to check that the expulsion is completed (see section 2. ‘Pregnancy, breast-feeding and fertility’).
Serious skin reactions including toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been reported in association with mifepristone treatment. Seek medical attention immediately if you notice any of the symptoms described in section 4. If you get a serious skin reaction you should not use mifepristone again in the future.
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.
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.
You should not drink grapefruit juice when you are treated with Medabon.
There is little information on the risks to the unborn baby. Failure of pregnancy termination (continuing pregnancy) after taking Medabon after the first medicine (mifepristone) has been associated with a 3-fold increased risk of birth defects, in particular facial paralysis, head and limb malformations. If you decide to continue with the, careful pre-natal monitoring and ultrasound examinations, with a special attention to the limbs and head, in a specialised clinic must be carried out.
Medabon may pass into breast milk and be taken in by your baby. You should stop breast-feeding once you have used the treatment.
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’).
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.
The use of Medabon requires your active participation as follows:
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.
The doctor will give you the exact amount of Medabon; it is therefore unlikely that you will use more than you should.
If you take too many tablets, contact your doctor immediately or go to the nearest hospital/clinic.
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 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
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 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.
Each tablet of mifepristone contains 200 mg mifepristone.
Each vaginal tablet of misoprostol contains 0.2 mg misoprostol.
The other ingredients are:
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.
This medicinal product is authorised in the Member States of the EEA under the following name:
The Netherlands: Sunmedabon
United Kingdom: Medabon
This leaflet was last revised in August 2021.