Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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.
Do not use Medabon • if your pregnancy has not been confirmed by gynecological examination, ultrasound-scan or biological tests
• if the first day of your last period was more than 63 days ago (if there is any doubt, the doctor can check the age of your pregnancy with a scanner)
• if your doctor suspects an extra-uterine pregnancy (the egg is implanted outside the womb)
• if you are allergic to mifepristone, misoprostol (or any other prostaglandins) or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from severe asthma which cannot be adequately treated with medication
• if you have hereditary porphyria (an inherited disorder of the blood)
• if you suffer from chronic adrenal failure.
Warnings and precautions 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:
• you have undergone genital cutting or circumcision
• you cannot return for a follow up visit to assess that the pregnancy is completely terminated (see section 3)
• you cannot easily get emergency medical help in the 2 weeks after you take Medabon
• you have a heart complaint
• your heart has been fitted with an artificial valve
• you have a risk factors for heart diseases, such as high blood pressure or high blood cholesterol levels (increased fat content in your blood)
• you suffer from asthma
• you suffer from an illness that may affect the clotting of your blood
• you have liver or kidney disease
• you are anaemic or otherwise malnourished
• you are at increased risk of cardiovascular disease. Risk factors include being aged over 35 years and a cigarette smoker or having h igh blood pressure, high blood cholesterol levels or diabetes.
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:
• corticosteroids, such as dexamethasone (used to treat asthma or inflammation)
• ketoconazole, itraconazole (used in antifungal treatment)
• erythromycin, rifampicin (antibiotics)
• St John's Wort (natural remedy used to treat mild depression)
• phenytoin, phenobarbital, carbamazepine (used to treat seizures or epilepsy).
Caution should be exercised when Medabon is used with medicines containing the following active substances:
• immunospressants such as cyclosporine, tacrolimus, sirolimus, everolimus (used to prevent the body from rejecting a transplanted organ)
• alfentanil, fentanyl (used to relieve pain)
• ergotamine, diergotamine (used to treat migraines)
• quinidine (used to help keep the heart beating normally)
• some agents used during general anesthesia.
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. 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.
Breast-feeding
Medabon may pass into breast milk and be taken in by your baby. You should stop breastfeeding once you have taken 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.
• For pregnancies that have occurred with an intrautrine contraceptive device (coil) in place, this must be removed prior to administering Medabon.
• It is recommended that you do not travel too far away from the prescribing hospital/clinic until the follow-up (see 'Third step below'), in case in an emergency you need to return to the hospital/clinic. In an emergency or if you are worried for any reason, you can contact or return to the hospital/clinic before the appointment time. You will be given the telephone number to call for emergencies or any problems.
The use of Medabon requires your active participation as follows:
First step
• Take one tablet of mifepristone 200 mg to swallow with some water.
• If you vomit shortly after administration of mifepristone, please inform the doctor. You may need to take a mifepristone tablet again.
• If you experience symptoms such as severe abdominal pain, fainting, fast heartbeat, fever lasting more than 4 hours after taking the tablet, please tell your doctor.
• In rare cases, the pregnancy may be expelled before you use the misoprostol tablets. It is essential that you still have a follow-up consultation to confirm that a complete pregnancy termination has occurred (see 'Third step' below).
Second step
• 36 to 48 hours after taking mifepristone, the four misoprostol vaginal tablets are inserted into the vagina.
• If you receive misoprostol in a clinic, you may be asked to stay for 3 hours after the misoprostol vaginal tablets are inserted or until you feel comfortable and able to return home.
• If you use the misoprostol vaginal tablets at home, follow the same insertion instructions as given above. Please make sure that you empty your bladder and clean your hands thoroughly before inserting the misoprostol vaginal tablets. Push the four vaginal tablets one at a time up into the vagina as far as you can using your finger.
• After the misoprostol vaginal tablets have been inserted into the vagina, remain lying down for 30 minutes.
• The pregnancy may be expelled within a few hours or during the next few days after misoprostol treatment.
Third step
• To confirm you are no longer pregnant, a follow-up is required 14 – 21 days after the mifepristone tablet was swallowed.
• A special type of pregnancy test after about 2 weeks is required, to confirm the pregnancy has ended. Some women may need to have a scan to confirm the pregnancy has ended.
• A follow-up consultation can take place remotely by phone, video call, text messaging or other form of communication with your healthcare professional.
• It is important that you keep this follow-up appointment to check that your pregnancy has been completely expelled and you are well.
After treatment you should be aware that • Uterine bleeding usually starts 1 to 2 days after taking the mifepristone tablet. The bleeding lasts 2 or 3 weeks (on average 13 days). If the bleeding is heavy and prolonged, contact the doctor immediately.
• The presence of these bleedings is not related to the success of the method. If pregnancy continues or expulsion is incomplete, you will be offered a surgical method for terminating the pregnancy.
• 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.
• Important : It is possible for you to become pregnant again very soon after the pregnancy termination is complete. It is recommended that you avoid getting pregnant again soon after the termination. You should therefore start using a method of contraception within 3 to 9 days of taking the mifepristone tablet. Discuss contraceptive options with your doctor.
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 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 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects Contact the hospital/clinic if you have:
• tearing of the womb (uterine rupture):
tearing of the womb after administration of prostaglandins in the second or third trimester of pregnancy, mainly in women with previous deliveries of a child or with a scar of a caesarian section
• persistent heavy bleeding, for example soaking two sanitary pads per hour, for more than two hours
• persistent fever with a temperature of 38C or higher, for more than four hours
• reddish patches on the trunk, the patches are target-like macules or circular, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (toxic epidermal necrolysis, frequency: rare or very rare)
• a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis, frequency: not known)
• an unpleasant smelling discharge
• persistent pain unrelieved by medication.
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)
• uterine contractions or lower abdominal cramps in the hours following misoprostol.
Common side effects (may affect up to 1 in 10 people)
• birth defects (foetal malformations)
• heavy bleeding
• gastrointestinal cramping, light or moderate
• nausea, vomiting or diarrhoea. These side effects are related to misoprostol use.
Uncommon side effects (may affect up to 1 in 100 people)
• infection following abortion
• hypersensitivity: skin rashes.
Rare side effects (may affect up to 1 in 1,000 people)
• headaches
• malaise (feeling unwell)
• hot flushes, dizziness, chills
• fever
• low blood pressure
• hives and skin disorders, which can be serious
• uterine rupture.
Very rare side effects (may affect up to 1 in 10,000 people)
• fatal toxic shock caused by infection by Clostridium sordellii endometritis, presenting without fever or other obvious symptoms of infection.
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.
Keep this medicine 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.
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:
• mifepristone tablet; silica, colloidal anhydrous, maize starch, microcrystalline cellulose (E460), povidone K30, and magnesium stearate (E470b).
• misoprostol vaginal tablet; hypromellose (E464), microcrystalline cellulose (E460), sodium starch glycolate (type A), and castor oil, hydrogenated.
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 Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
124 Fabricii Street
400632
Cluj-Napoca
Cluj County
Romania
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 April 2024.
V029
Ranbaxy (UK) Limited a Sun Pharmaceutical Company
Address
6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, UK
Telephone
+44 (0) 208 848 8688
Medical Information Direct Line
+44 (0) 208 848 5052
WWW
http://www.sunpharma.com
Medical Information e-mail
[email protected]
Out of Hours contact
[email protected]
E-mail
[email protected]
• Contact us
• Links
• Accessibility
• Legal and privacy notice
• Cookie notice
• Cookie Settings
• Glossary
• Site Maps
Delivered to you by
Medabon – Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets comes as tablet containing 200mg / 0.2mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Medabon – Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets is mifepristone, misoprostol.
Medicines with the same active substance, strength and form include: Medabon Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Medabon – Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Medabon is indicated for medical termination of developing intra-uterine pregnancy of up to 63 days of amenorrhoea.
Posology
200mg of mifepristone (one tablet) is taken in a single oral dose, followed 36 to 48 hours later, by the administration of misoprostol 800 micrograms (i.e. 4 vaginal tablets of 0.2mg each) vaginally in a single dose. If the patient vomits shortly after administration of mifepristone, she should inform the doctor.
Medabon has only been studied in women over age 18.
Paediatric population
The product is not evaluated for use in children and adolescents.
Method of administration
Misoprostol vaginal tablets can be administered by a health care provider (place two tablets on each side of the cervix in vaginal vault) or by the woman herself. The woman should be instructed to clean her hands thoroughly before inserting the misoprostol vaginal tablets as high as possible into the vagina, and remain recumbent for at least 30 minutes
This product SHOULD NEVER be prescribed in the following situations:
- pregnancy not confirmed by gynaecological examination, ultrasound scan or biological tests,
- pregnancy beyond 63 days of amenorrhoea,
- confirmed or suspected extra-uterine pregnancy,
- previous known allergy to prostaglandins,
- severe asthma uncontrolled by therapy,
- inherited porphyria,
- chronic adrenal failure,
- hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Warnings
In the absence of specific studies, caution is advised when Medabon use is considered in patients with:
- renal failure
- hepatic failure
- malnutrition.
Patients with prosthetic heart valves or who have had one previous episode of infective endocarditis should receive appropriate prophylactic antibiotic treatment.
This method requires an active involvement of the woman who should be informed of the requirements of the method:
- the necessity to take the two drugs sequentially, i.e. to first take mifepristone and then follow with misoprostol to be administered 36-48 hours later,
- the need for a follow-up visit within 14-21 days after intake of mifepristone in order to check that abortion is complete,
- the possibility of failure of the method which may require pregnancy termination by a surgical method.
In the case of a pregnancy occurring with an intra-uterine device in situ, this device must be removed before administration of mifepristone.
The expulsion of the product of conception may take place before misoprostol administration (in 1 to 2% of cases). This does not preclude the follow-up visit in order to check that abortion is complete.
Before Medabon is given to a woman who has undergone genital mutilation (FGM) a physical examination must be performed by a qualified trained medical professional to exclude any anatomical obstacles to medical abortion.
Exposure of the foetus to misoprostol or mifeprostone increases the risk of developing Moebius syndrome and/or an amniotic band syndrome and/or central nervous system anomalies (see section 4.6). A second termination of pregnancy procedure shall be considered. In case of continuation of the pregnancy close monitoring by ultrasound scan must be performed in specialised centres.
Severe cutaneous adverse reactions, including toxic epidermal necrolysis and acute generalised exanthematous pustulosis, have been reported in association with mifepristone (see section 4.8). In patients who experience severe cutaneous adverse reactions, retreatment with mifepristone is not recommended.
Because it is important to have access to appropriate medical care if an emergency develops, the treatment procedure should only be performed where the patient has access to medical facilities equipped to provide surgical treatment for incomplete abortion, or emergency blood transfusion or resuscitation during the period from the first visit until discharged by the administering qualified medical professional.
• Risks related to the method
- Failures
The non-negligible risk of failure, which occurs in 4.5 to 7.8% of the cases, makes the follow-up visit mandatory in order to check that abortion is complete.
The patient should be informed that surgical treatment may be required to achieve complete abortion.
- Bleeding
The patient must be informed of the occurrence of prolonged vaginal bleeding (an average of about 13 days after mifepristone intake, up to three weeks in some women). In a few cases, heavy bleeding may require surgical evacuation of the uterus. Bleeding is not in any way a proof of termination of pregnancy as it occurs also in most cases of failure.
The patient should be informed not to travel far away from the prescribing centre as long as complete expulsion has not been confirmed. She should receive precise instructions as to whom she should contact and where to go, in the event of any problems or emergency, particularly in the case of very heavy vaginal bleeding.
A follow-up visit must take place within a period of 14-21 days after administration of mifepristone to verify by the appropriate means (clinical examination, ultrasound scan, or beta-hCG measurement) that expulsion the abortion has been completed and that vaginal bleeding has stopped or substantially reduced. In case of persistent bleeding (even light) beyond the follow-up visit, its disappearance should be checked a few weeks later. If an ongoing pregnancy is suspected, a further ultrasound scan may be required to evaluate its viability.
Persistence of vaginal bleeding at this point could signify incomplete abortion, or an unnoticed extra-uterine pregnancy, and appropriate investigation/treatment should be considered.
In the event of an ongoing pregnancy diagnosed at the follow-up visit, termination by another method should be proposed to the woman.
Since heavy bleeding requiring haemostatic curettage occurs in 0.2 to 1.8% of the cases during the medical method of pregnancy termination, special care should be given to patients with haemostatic disorders with hypocoagulability, or with anaemia. The decision to use the medical or the surgical method should be decided with specialised consultants according to the type of haemostatic disorder and the level of anaemia.
- Infection
The genital tract is more susceptible to ascending infection when the cervix is dilated after abortion or childbirth. There are few data on the incidence of clinically significant pelvic infection after medical abortion, but it seems to be rare and probably occurs less often than after vacuum aspiration. Many of the symptoms of pelvic infection, such as pain, are often non-specific and hence precise diagnosis is difficult. In women with clinical signs such as pelvic pain, abdominal or adnexal tenderness, vaginal discharge and fever, a pelvic infection should be suspected and appropriate treatment should be given.
Very rare cases of fatal or serious toxic shock caused by pathogens like Clostridium sordellii endometritis, Escherichia coli presenting with or without fever or other obvious symptoms of infection, have been reported after medical abortion with the use of 200mg mifepristone followed by non authorised vaginal administration of misoprostol tablets for oral use. It cannot be excluded that this infection may occur also with vaginal misoprostol as in Medabon. Clinicians should be aware of this potentially fatal complication.
• Other risks
Pregnancy-related symptoms such as nausea and vomiting may increase after mifepristone and increase further after misoprostol administration, and they will weaken and disappear during the abortion process. Lower abdominal pain and cramping are the most common symptoms and they are related to misoprostol administration and the abortion process. If pain persists after expulsion of the products of conception, its origin should be investigated. Diarrhoea is the most common dose-related side-effect related to misoprostol use which normally does not require treatment. Some women also report chills, shivering and/or temperature rise after misoprostol administration.
Regarding rhesus determination and prevention of rhesus allo-immunisation, the same general measures apply to the use of medical abortion as during any termination of pregnancy.
Any reproductive tract infections should be treated before the medical abortion regimen is administered.
During clinical trials, pregnancies have occurred between abortion and the resumption of menses. To avoid potential exposure of a subsequent pregnancy to mifepristone, it is recommended that unprotected sexual intercourse be avoided until the appearance of the first menses after the abortion. Reliable contraceptive methods should therefore be started as early as possible after misoprostol administration.
Precautions for use
In case of suspected acute adrenal failure, dexamethasone administration is recommended. 1mg of dexamethasone antagonises a dose of 400mg of mifepristone.
Due to the antiglucocorticoid activity of mifepristone, the efficacy of long-term corticosteroid therapy, including inhaled corticosteroids in asthmatic patients, may be decreased during the 3 to 4 days following intake of mifepristone. Therapy should be adjusted.
A decrease of the efficacy of the method can theoretically occur due to the antiprostaglandin properties of non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin (acetyl salicylic acid). Limited evidence suggests that co-administration of NSAIDs on the day of misoprostol administration does not adversely influence the effects of mifepristone or misoprostol and does not reduce the clinical efficacy of medical termination of pregnancy.
Rare but serious cardiovascular accidents (cardiac arrest, myocardial infarction and/or spasm of the coronary arteries and severe hypotension) have been reported following use of misoprostol. For this reason, women with risk factors for cardiovascular disease e.g. age over 35 years with chronic smoking, hyperlipidemia, or established cardiovascular disease should be treated with caution.
Method of misoprostol administration
During intake and for three hours following the intake, the patient should be monitored in the treatment centre, in order not to miss possible acute effects of misoprostol administration.
On discharge from the treatment centre the woman should be provided with appropriate medications as necessary and be fully counselled regarding the likely signs and symptoms she may experience and have direct access to the treatment centre by telephone or local access.
No interaction studies have been performed in view of the single dose administration. On the basis of mifepristone's metabolism by CYP3A4, it is possible that ketoconazole, itraconazole, erythromycin, and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Furthermore, rifampicin, dexamethasone, St. John's Wort and certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) may induce mifepristone metabolism (lowering serum levels of mifepristone).
Based on in vitro inhibition information, co-administration of mifepristone may lead to an increase in serum levels of drugs that are CYP3A4 substrates. Due to the slow elimination of mifepristone from the body, such interaction may be observed for a prolonged period after its administration. Therefore, caution should be exercised when mifepristone is administered with drugs that are CYP3A4 substrates and have narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine, or some agents used during general anesthesia.
Antacids containing magnesium may worsen misoprostol induced diarrhoea.
In animals (see section 5.3 Pre-clinical safety data), the abortifacient effect of mifepristone precludes the proper assessment of any teratogenic effect of the molecule.
With sub-abortive doses, isolated cases of malformations are observed in rabbits, but not in rats or mice, and are too few to be considered significant, or attributable to mifepristone.
In humans, the few reported cases of malformations do not allow a causality assessment for mifepristone alone or associated to prostaglandin. Therefore, data are too limited to determine whether the molecule is a human teratogen.
Animal studies have not evidenced teratogenicity of misoprostol but have shown its foetotoxicity at high doses.
Failure of pregnancy termination (continuing pregnancy) has been associated with a 3-fold increased risk of birth defects/malformations for ongoing pregnancies exposed to mifepristone and misoprostol or misoprostol alone, compared to control group (about 2%). In particular, prenatal exposure to misoprostol has been associated with Moebius syndrome (congenital facial paralysis leading to hypomimia, troubles of sucking and deglutition, and eye movements, with or without limb defects) and with amniotic band syndrome (limb deformities/amputations, especially clubfoot, acheiria, olygodactyly, cleft palate inter alia), and central nervous system anomalies (cerebral and cranial anomalies such as anencephaly, hydrocephaly, cerebellar hypoplasia, neural tube defects).
Consequently:
- Women considering medical termination of pregnancy should be precisely counselled on the risks to their foetus if an abortion failure occurs and a second termination of pregnancy procedure is not desirable.
- Women should be informed, that due to the risk of failure of the medical method of pregnancy termination and due to the unknown risk to the foetus, the follow-up visit is mandatory (see section 4.4 Special warnings and precautions for use).
- Should a failure of the method be diagnosed at the control visit (viable ongoing pregnancy), and should the patient still agree, pregnancy termination should be completed by another method.
- Should the patient wish to continue with her pregnancy, a careful ultrasound scan monitoring of the pregnancy with a special attention to the limbs and head, must be established in a specialised centre.
Lactation
Mifepristone is a lipophilic compound and may theoretically be excreted in the mother's breast milk. However, no data is available. Consequently, Medabon use should be avoided during breast-feeding.
No studies on the effects on the ability to drive and use machines have been performed.
Mifepristone and misoprostol may cause dizziness, which could have an effect on the ability to drive and use machines.
Undesirable effects are ranked under headings of frequency. Within each frequency grouping, the effects are presented in order of decreasing seriousness.
Very common (≥1/10)
Common (≥1/100, <1/10)
Uncommon (≥1/1,000, ≤1/100)
Rare (≥1/10,000 ≤1/1,000)
Very rare (<1/10,000), not known (cannot be estimated from the available data).
Vascular Disorders
Rare:
Hypotension.
Gastrointestinal System
Common:
Cramping, light or moderate.
Nausea, vomiting, diarrhoea (these gastrointestinal effects are related to misoprostol use).
Skin and subcutaneous tissue disorders
Uncommon:
Hypersensitivity: skin rashes.
Rare:
Urticaria, erythroderma, erythema nodosum, epidermal necrolysis.
Not known
Acute generalised exanthematous pustulosis
Reproductive system and breast disorders
Very common:
Uterine contractions or cramping (up to 70 to 80%) in the hours following misoprostol intake.
Common:
Foetal malformations
Heavy bleeding occurs in up to 5% of the cases and may require haemostatic curettage and blood transfusion in up to 1.8% of the cases.
Uncommon:
Infection following abortion: Suspected or confirmed infections (endometritis, pelvic inflammatory disease) have been reported in less than 1% of women.
General disorders and administration site conditions
Rare:
Headaches, malaise, vagal symptoms (hot flushes, dizziness, chills have been reported) and fever.
Injury, poisoning and procedural complications
Rare:
Uterine rupture *
* Uterine rupture has been uncommonly reported after prostaglandin intake for induction of termination of second trimester pregnancy or labour induction for foetal death in utero in the third trimester. Uterine ruptures occurred particularly in multiparous women or in women with a caesarean section scar.
Very rare cases of fatal toxic shock caused by Clostridium sordellii endometritis, presenting without fever or other obvious symptoms of infection, have been reported. Clinicians should be aware of this potentially fatal complication (see section 4.4. Special warnings and precautions for use).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
No case of overdose has been reported.
In the event of accidental massive ingestion, signs of adrenal failure might occur. Signs of acute intoxication may require specialist treatment including the administration of dexamethasone.
Ask anything about Medabon – Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.