PACKAGE LEAFLET: INFORMATION FOR THE USER

Mifegyne Combikit 600 mg / 400 microgram tablets Combikitk of Mifepristone 600 mg tablets and Misoprostol 400 microgram tablets

Mifepristone and Misoprostol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Mifegyne Combikit is and what it is used for

2.    What you need to know before you take Mifegyne Combikit

3.    How to take Mifegyne Combikit

4.    Possible side effects

5.    How to store Mifegyne Combikit

6.    Contents of the pack and other information

1.    What Mifegyne Combikit is and what it is used for

Mifegyne Combikit is a combination therapy containing two medicines called mifepristone and misoprostol.

Mifegyne Combikit is recommended for the medical termination of pregnancy no later than 49 days after the first day of your last menstrual cycle.

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 (uterus) 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 take Mifegyne Combikit Do not take Mifegyne Combikit

-    if you are allergic to mifepristone, misoprostol, any other prostaglandin or any of the other ingredients of this medicine (listed in section 6),

-    if you suffer from adrenal failure,

-    if you suffer from severe asthma, which cannot be adequately treated with medication,

-    if you have hereditary porphyria,

- if your pregnancy has not been confirmed by a biological test or an ultrasound scan,

- if the first day of your last menstrual cycle was more than 49 days (7 weeks) ago when the first medicine (mifepristone) is taken,

-    if your doctor suspects an ectopic pregnancy (the egg is implanted outside the womb).

Warnings and precautions

Talk to your doctor before taking Mifegyne Combikit

-    if you have liver or kidney disease,

-    if you suffer from anaemia or malnutrition,

-    if you have cardiovascular disease (heart or circulatory disease),

-    if you are at increased risk of cardiovascular disease. Risk factors include being aged over 35 years and a cigarette smoker or having high blood pressure, high blood cholesterol levels or diabetes,

-    if you have an illness that affects the clotting of your blood,

-    if you suffer from asthma,

-    if you have had a previous caesarean section or surgery of the womb.

If you use a contraceptive coil it must be removed before you take the first medicine, mifepristone.

Before taking mifepristone and misoprostol your blood will be tested for Rhesus factor. If you are Rhesus negative your doctor will advise you of the routine treatment required.

Other medicines and Mifegyne Combikit

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

In particular tell your doctor if you are taking any of the following:

-    corticosteroids (used in the treatment of asthma or other inflammation treatments)

-    ketoconazole, itraconazole (used in antifungal treatment)

-    erythromycin, rifampicin (antibiotics)

-    St John's Wort (natural remedy used in the treatment of mild depression)

-    phenytoin, phenobarbital, carbamazepine (used in the treatment of seizures; epilepsy)

-    non-steroidal anti-inflammatory drugs (NSAIDs) such as acetyl salicylic acid or diclofenac

-    Antacid medicines or an antacid medicine containing magnesium (used to treat heartburn and acid indigestion)

Mifegyne Combikit with food and drink

Grape fruit juice should not be taken when you are treated with Mifegyne Combikit.

Pregnancy, breast feeding and fertility

Pregnancy

Failure of pregnancy termination (continuing pregnancy) after taking mifepristone and misoprostol has been associated with birth defects.

The risk of failure of this medicine increases:

-    if mifepristone is taken later than 49 days after the first day of your last menstrual cycle

-    if misoprostol is not taken orally

-    With the duration of the pregnancy

-    With the number of pregnancies you have had before

If termination of pregnancy fails after taking mifepristone and misoprostol there is an unknown risk to the foetus. If you decide to continue with the pregnancy, careful pre-natal monitoring and repeated ultrasound examinations, with a special attention to the limbs, in a specialised clinic must be carried out. Your doctor will advise further.

If you decide to continue with the termination of the pregnancy another method will be used.

Your doctor will advise you of the options.

Breastfeeding

If you are breastfeeding, talk to your doctor before using this medicine. Do not breastfeed while taking mifepristone and misoprostol as these medicines are passed into breast milk.

Fertility

Mifepristone and misoprostol do not affect fertility. You can become pregnant again as soon as your termination is completed. You should start contraception immediately after the termination of the pregnancy is confirmed by your doctor.

Driving and using machines

Dizziness can occur as a side effect related to the abortion process. Take special care when driving or using machines after taking mifepristone and misoprostol until you know how those medicines affects you.

3. How to take Mifegyne Combikit

Always take mifepristone and misoprostol exactly as your doctor has told you. Check with your

doctor or pharmacist if you are not sure.

Dosage in adults

Mifepristone tablets

•    1 tablet to be taken orally

Misoprostol tablets

•    1 tablet to be taken orally

Taking the tablet

•    Swallow the tablets whole with a glass of water in the presence of a doctor or a member of his/her medical staff

•    Take the mifepristone tablet (light yellow, almond shaped tablet, with y engraved in one side and 600 on the other side) first

•    Take the misoprostol tablet (white, round, flat tablets, with "M400" engraved on one side) 36 - 48 hours after the mifepristone tablet

•    You need to rest for at least 3 hours after taking the misoprostol tablet

•    If you vomit within 45 minutes after taking the mifepristone tablet, talk to your doctor immediately. You will need to take another tablet.

•    If you vomit within 30 minutes after taking the misoprostol tablet, talk to your doctor immediately. You will need to take another tablet.

Important things to remember when taking mifepristone and misoprostol:

This method involves your active participation and you should therefore be aware that:

-    You need to take the second medicament (which contains prostaglandin) to ensure the treatment is effective.

-    You need to attend a check-up consultation (3rd consultation) within 14 - 21 days of taking Mifegyne in order to check that your pregnancy has been completely expelled and you are well.

The schedule for the medical termination of pregnancy will be as follows:

1)    At the prescribing centre you will be given the first drug mifepristone, which must be taken orally.

2)    36 - 48 hours after this, misoprostol will be administered orally. You should stay at rest for 3 hours after having misoprostol.

3)    The embryo may be expelled within a few hours of taking the misoprostol or during the next few days. You will have vaginal bleeding which will last for an average of 12 days after taking the first drug, mifepristone, and the flow will become lighter as time continues.

4)    You must return to the centre within 14 - 21 days of taking the first medicine, mifepristone, for a follow-up consultation to make sure the expulsion is complete.

Contact your prescribing centre immediately:

-    if you have vaginal bleeding for longer than 12 days and/or if it is very heavy (e.g. you need more than 2 sanitary pads per hour for 2 hours)

-    if you have severe abdominal pain

-    if you have fever or if you are feeling cold and shivering.

Other important point to remember:

•    Vaginal bleeding does not mean the expulsion has been completed.

•    Do no take the second medicine, the misoprostol tablet, if the blister foil is damaged or if the tablet has been stored outside the packaging

•    The risk of side effects increases if you take the first medicine, the mifepristone tablet, later than 49 days after the first day of your last menstrual cycle of if you do not take the, second medicine, the misoprostol tablet, orally.

Uterine bleeding usually starts 1 to 2 days after taking mifepristone.

In rare cases, an expulsion can occur before you take misoprostol. It is essential that you are checked to confirm that a complete evacuation has occurred and you must return to the centre for this.

If pregnancy continues or expulsion is incomplete, your doctor will advise you of the options for completion of the pregnancy termination.

It is recommended that you do not travel too far away from your prescribing centre until the follow-up consultation is done.

In case of emergency or if you have any questions, telephone or visit your prescribing centre. You do not have to wait for your follow-up appointment.

Use in adolescents

Only limited data are available on the use of mifepristone and misoprostol in adolescents.

If you take more Mifegyne Combikit than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital casualty department.

The doctor will give you the exact amount of Mifegyne Combikit; it is therefore unlikely that you will take too many tablets. Taking too many mifepristone tablets may cause symptoms of adrenal failure. Signs of acute intoxication may require specialist treatment including the administration of dexamethasone. Taking too many misoprostol tablets may cause symptoms such as drowsiness, shaking, fits, difficulty in breathing, abdominal pain, diarrhoea, fever, chest pain, low blood pressure and a slow heartbeat that can be fatal.

If you forget to take Mifegyne Combikit

If you forget to take any part of the treatment, it is likely that the termination will not be fully effective. Talk with your doctor if you forgot to take mifepristone or misoprostol.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mifegyne Combikit can cause side effects, although not everybody gets them. Serious side effects:

•    allergic reaction. Skin rash, localised swelling of face and/or larynx which can be with urticaria Other serious side effects:

•    Cardiovasvular accidents. Chest pain, difficulty breading, confusion, or an irregular heartbeat.

•    cases of serious or fatal toxic or septic shock. Fever with aching muscles, rapid heart rate, dizziness, diarrhoea, vomiting or feeling weak.

These side effects may occur if the second medicine, the misoprostol tablet is taken at a dose different to the one mentioned in this leaflet and/or if you do not take the misoprostol tablet orally.

If you experience any of these side effects contact your doctor IMMEDIATELY or go to your nearest hospital casualty department.

Other side effects

Very common (may affect more than 1 in 10 people):

-    uterine contractions or cramping

-    diarrhoea

-    feeling sick (nausea), or being sick (vomiting)

Common (may affect up to 1 in 10 people):

-    heavy vaginal bleeding

-    abdominal pain

-    gastro intestinal cramping light or moderate

-    infection of the uterus (endometritis and pelvic inflammatory disease)

Uncommon (may affect up to 1 in 100 people):

-    blood pressure fall

Rare (may affect up to 1 in 1,000 people):

-    fever

-    foetal death

-    birth defects

-    headaches

-    dizziness

-    generally feeling unwell or tired

-    vagal symptoms (hot flushes, dizziness, chills)

-    hives and skin disorders which can be serious

-    Uterine rupture following prostaglandin administration within the second and third trimester of pregnancy, particularly in multiparous women or in women with a caesarean section scar

Very rare (may affect up to 1 in 10,000 people)

-    localised swelling of face and/or larynx which can be with urticaria

Other side effects include

-    feeling cold, shivering

-    back pain

Tell your doctor if any of the side effects get serious or if you notice any other unwanted or unexpected effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mifegyne Combikit

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiry date, which is stated on the carton 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.

Do not use the tablet if it is stored outside the blister.

Store in the original package in order to protect from moisture and light.

Do not throw away any medicines via wastewater. 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 Mifegyne Combikit contains

The active ingredients are mifepristone and misoprostol.

One Mifepristone tablet contains 600 mg mifepristone.

The other ingredients are: anhydrous colloidal silica, maize starch, povidone, magnesium stearate, microcrystalline cellulose.

One Misoprostol tablet contains 400 microgram misoprostol.

The other ingredients are: microcrystalline cellulose, hypromellose, sodium starch glycolate (type A), hydrogenated castor oil.

What Mifegyne Combikit looks like and contents of the pack

Mifegyne Combikit contains 1 tablet of mifepristone supplied in a blister strip (PVC/Al) and 1 tablet of misoprostol supplied a blister strip (OPA-Al-PVC/Al or PVC-PCTFE/Al).

Mifepristone tablet is available as biconvex, light yellow, almond shaped tablet with a length of 19 mm and a width of 11 mm, with y engraved on one side and 600 on the other side.

Misoprostol tablet is available as white, round, flat tablets, with a diameter of 11 mm, with "M400" engraved on one side.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

EXELGYN

216 Boulevard Saint Germain

75007 Paris

France

Manufacturer:

Nordic Pharma BV Tolweg 15 3741 LM Baarn The Netherlands

QPharma AB Agneslundsvagen 27 20125, Malmo Sweden

This medicinal product is authorised in the Member States of the EEA under the following name: Mifegyne Combikit.

This leaflet was last revised in

06/2014

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