Read all of this leaflet carefully before you start using 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 or pharmacist.

•    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 Mifepristone is and what it is used for

2.    What you need to know before you use Mifepristone

3.    How to use Mifepristone

4.    Possible side effects

5.    How to store Mifepristone

6.    Contents of the pack and other information

1. What Mifepristone is and what it is used for

Mifepristone is an anti-hormone that acts by blocking the effects of progesterone, a hormone which is needed for pregnancy to continue. Mifepristone can therefore cause termination of pregnancy.

Mifepristone is recommended for the medical termination of a pregnancy:

•    no later than 63 days after the first day of your last period,

•    in combination with another treatment called prostaglandin (a substance that increases contraction of the womb) which you take 36 to 48 hours after taking Mifepristone.

2. What you need to know before you take Mifepristone ^{1 2}

This method requires the involvement of the woman who should be informed of the requirements of the method and you should therefore be aware of:

•    The necessity to combine treatment with prostaglandin to be administered at a second visit.

•    The need for a follow up visit within 14 to 21 days after intake of Mifepristone to check that abortion is complete.

•    The non-negligible risk of failure of the method which may require termination by another method, in rare cases surgery may be necessary.

Pregnancy, breast-feeding and fertility If you are pregnant:

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.

If you are breast-feeding:

Because Mifepristone may pass into breast milk and be taken in by your baby, you should stop breast feeding once you have taken the treatment.

Fertility:

Animal studies with mifepristone do not indicate direct or indirect harmful effects with respect to fertility.

It is recommended that you avoid getting pregnant again during your next menstrual period after taking Mifepristone.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

No studies on the effect on the ability to drive and use machines have been reported.

3. How to use Mifepristone

Always take this medicine exactly as your doctor has told you.

Check with your doctor if you are not sure.

Mifepristone is for oral use.

The method of administration is 200 mg of mifepristone (1 tablet) should be taken, followed 36 to 48 hours later by the administration of a prostaglandin analogue (1 pessary containing 1 mg of gemeprost placed in the vagina).

The dose of 200 mg should not be exceeded.

The Mifepristone tablet should be swallowed with some water in the presence of a doctor or a member of his/her medical staff.

In the case of a pregnancy occurring with an intra-uterine device in place, this device must be removed.

The expulsion may take place before prostaglandin administration (in about 3% of cases). This does not preclude the follow up visit to check that the abortion is complete.

After Mifepristone has been administered, you will return home. Uterine bleeding usually starts 1 to 2 days after taking Mifepristone.

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

Two days later the prostaglandin will be administered. You should stay and rest for 3 hours after having the prostaglandin. The pregnancy may be expelled within a few hours of prostaglandin administration or during the next few days. The bleeding lasts in average 12 days or more. In case of heavy or prolonged bleeding, you should contact your doctor immediately in order to re-schedule an earlier appointment.

You must return to the center for a check-up consultation within 14 to 21 days after taking Mifepristone. If pregnancy continues or expulsion is incomplete, you will be offered another method for terminating the pregnancy.

It is recommended that you do not travel too far away from your prescribing center until this date.

In an emergency or if you are worried for any reason, you can telephone your center or go back to it before the date fixed for the next consultation. You will be given the telephone number to call for emergencies or for any problem.

The use of Mifepristone 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.

It is possible for you to become pregnant again immediately after the pregnancy termination is complete.

As some effects of Mifepristone may still be present, it is recommended that you avoid getting pregnant again before your next menstrual period after taking Mifepristone.________________________J

VERSO / BACK

Use in children

iNo data are available for women under 18 years.

If you take more Mifepristone than you should

[As you will be supervised during administration of the treatment it is unlikely that you will take more that you should.

If you forget to take Mifepristone

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

[If you have any further questions on the use of this product, ask your doctor.

[4. Possible side effects

Reporting of side effects    )

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to Yellow Card Scheme,Website: www.mhra.aov.uk/vellowcard.'

By reporting side effects you can help provide more information on th^ safety of this medicine.    i 5. How to store Mifepristone

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

Keep the blister in the outer carton in order to protect from light. [

Do not use Mifepristone 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 throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment    ' 6. Contents of the pack and other information

1

Do not take Mifepristone

•    if you are allergic (hypersensitive) to mifepristone or any of the other ingredients of this medicine (listed in section 6)

•    if you suffer from chronic adrenal failure,

•    if you suffer from asthma uncontrolled by treatment,

•    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 period was more than 63 days (9 weeks) ago,

•    if your doctor suspects an ectopic pregnancy (the egg is implanted outside the womb),

•    because of the need to prescribe a prostaglandin in association with Mifepristone, you must not take this treatment if you are allergic to prostaglandins.

Take special care with Mifepristone

In some other circumstances the treatment may also be unsuitable to you so please tell your doctor if:

•    you have a heart complaint,

•    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 have an infection.

The doctor will then be able to discuss with you if you are able to have the treatment.

You can have prolonged and/or heavy vaginal bleeding (an average of about 12 days or more after Mifepristone intake). The presence of those bleedings is not related to the success of the method.

Other medicines and Mifepristone

Medicines containing the following active substances may interfere with the action of Mifepristone:

2

What Mifepristone contains    ,

•    The active substance is mifepristone. Each tablet contains 200 milligrams

of mifepristone.    ,