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MEDABON :COMBIPACK OF MIFEPRISTONE 200 MG TABLET AND MISOPROSTOL 4 X 0.2 MG VAGINAL TABLETS

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. In particular,
medicines containing the following active substances may interfere with the
action of Medabon:
- corticosteroids (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)

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.
- 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.

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.
Taking Medabon with food and drink
You should not drink grapefruit juice when you are treated with Medabon.

In this leaflet:
1. What Medabon is and what it is used for
2. Before you take Medabon
3. How to take Medabon
4. Possible side effects
5. How to store Medabon
6. Further information

Pregnancy and breast feeding
Medabon may pass into breast milk and be taken in by your baby. You should
stop breast feeding once you have taken the treatment.
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.
It is recommended that you avoid becoming pregnant again before your next
menstrual period after taking Medabon.

1. WHAT MEDABON IS AND WHAT IS IT USED FOR

Driving and using machines

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

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.

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.
Medabon is recommended for the medical termination of a pregnancy no later
than 63 days after the first day of your last period.

2. BEFORE YOU TAKE MEDABON
DO NOT TAKE MEDABON IF:
- your pregnancy has not been confirmed by gynecological examination,
ultrasound scan or biological tests,
- 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),
- your doctor suspects an extra-uterine pregnancy (the egg is implanted
outside the womb),
- 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 know that you are allergic (hypersensitive) to mifepristone, misoprostol
(or any other prostaglandins) or to any other of the components of Medabon,
- you suffer from severe asthma which cannot be adequately treated with
medication,
- you have hereditary porphyria (an inherited disorder of the blood),
- you suffer from chronic adrenal failure,
Take special care with Medabon
In some circumstances the treatment may not be suitable for you, so please
tell your doctor if:
- 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.

3. HOW TO TAKE MEDABON
The use of Medabon requires your active participation as follows:
- 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 visit date. 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.
First visit to the hospital/clinic
- You will be given one tablet of mifepristone 200 mg to swallow with some
water in the presence of a doctor or a member of his/her medical staff.
- You will be able to go home after taking the tablet of mifepristone once the
doctor is sure that you will not be sick. 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 take the
misoprostol tablets. It is essential that you return to the hospital/clinic to
confirm that a complete pregnancy termination has occurred.
Follow-up visit
- You must return to the hospital/clinic 36 to 48 hours after taking
mifepristone.
- You will be given 4 vaginal tablets of misoprostol to ensure the treatment is
effective. The doctor or nurse will place the tablets into your vagina or you
may do this yourself. In this case, 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. It is recommended that you lie down for
about 30 minutes after the misoprostol vaginal tablets have been inserted.
- You should stay in the hospital/clinic for a few hours or until you and the
doctor are happy that you are well enough to go home. The pregnancy may
be expelled within a few hours or during the next few days after misoprostol
treatment.

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Third visit
- You must return to the hospital/clinic for a check up within 14 – 21 days of
taking the mifepristone tablet.
- It is important that you keep this appointment to check that your pregnancy
has been completely expelled and you are well, as you will not be able to
judge for yourself if the treatment has been successful.

Other side effects:
- single cases of hives and skin disorders, which can be serious.
Other side effects are gastrointestinal cramping, light or moderate.

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 for an earlier
appointment.
- 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.

If you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE MEDABON
Keep out of reach and out of sight of children.
Do not use 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 if the box or the blisters show signs of damage.
Store below 25°C.

6. FURTHER INFORMATION
What Medabon contains

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.

Each tablet of mifepristone contains 200 mg mifepristone.

If you take more Medabon than you should
As you will be supervised during administration of the treatment, it is unlikely
that you will take more than you should.

The other ingredients are:
- mifepristone tablet; silica, colloidal anhydrous, corn starch, microcrystalline
cellulose (E460), povidone K30, and magnesium stearate (E470b).
- misoprostol vaginal tablet; hypromellose (E464), microcrystalline cellulose
(E460), sodium starch glycolate type A, and hydrogenated castor oil.

If you forget to take Medabon
If you forget to take any part of the treatment, it may not be fully effective. Talk
with your doctor if you forgot to take the treatment.

Each vaginal tablet of misoprostol contains 0.2 mg misoprostol.

What Medabon looks like and contents of the pack

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

Medabon contains 1 tablet of mifepristone and 4 vaginal tablets of misoprostol
supplied in an aluminium blister pack.
Mifepristone tablet is light yellow coloured and round-shaped.
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Medabon can cause side effects, although not everybody
gets them.

Marketing authorisation holder and manufacturer
Serious side effects
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Contact the hospital/clinic if you have:
- persistent heavy bleeding, for example soaking two sanitary pads per hour,
for more than two hours
- persistent fever with a temperature of 38°C or higher, for more than four
hours
- an unpleasant smelling discharge
- persistent pain unrelieved by medication.

This medicinal product is authorised in the Member States of the EEA under
the following name: MEDABON.
This leaflet was last approved on 22 March 2012

Contact your doctor if any of the following side effects gets serious or you
are worried.
Very common side effects (occur among more than 1 in 10 patients):
- heavy bleeding
- uterine contractions or lower abdominal cramps in the hours following
misoprostol.
Common side effects (occur among more than 1 in 100 patients but less
than 1 in 10 patients):
- infection following abortion
- nausea, vomiting or diarrhoea.
Uncommon side effects (occur among more than 1 in 1000 patients but less
than 1 in 100 patients):
- skin rashes
- headaches
- malaise (feeling unwell)
- hot flushes, dizziness, chills
- fever
- fall in blood pressure.
Very rare side effects (occur among less than 1 in 10000 patients):
- fatal toxic shock caused by infection by Clostridium sordellii endometritis,
presenting without fever or other obvious symptoms of infection.

Folding
188--1--94mm
288--3 Zigzag--48mm

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EUUK- UNITED KINGDOM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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