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MIFEPRISTONE LINEPHARMA 200 MG TABLET

Active substance(s): MIFEPRISTONE

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RECTO / FRONT

VERSO / BACK

260

260

CODE ARTICLE

MOCK-UP

TYPE

NOTICE

DOSAGE

200 mg

PRÉSENTATION

tablet

PAYS

UK - 1 LANGUE

FABRICANT

-

FORMAT

260 x 372 mm

Ref. PLAN

P016

COULEURS : 1

PANTONE 321

PACKAGE LEAFLET: INFORMATION FOR THE USER

mifepristone 200 mg tablet

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.

Mifepristone

BANK GOTHIC
HELVETICA NEUE CONDENSED

CORPS minimum

10,5

What is in this leaflet:

LOGICIEL

Indesign CS5.5

1. What Mifepristone is and what it is used for

CODE BARRES
10

2. What you need to know before you use Mifepristone
3. How to use Mifepristone

DATE

08/09/2014

4. Possible side effects

VERSION

1

5. How to store Mifepristone
6. Contents of the pack and other information
1. WHAT MIFEPRISTONE 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIFEPRISTONE
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:
• 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; epilepsia)
Please tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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372

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.

Taking Mifepristone with food and drink:
• grape fruit juice should not be taken when you are treated with Mifepristone.
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.

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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.

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 Mifepristone exactly as your doctor has told you.
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.

Use in children
No 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.

By reporting side effects you can help provide more information on the safety of this
medicine.

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.

5. HOW TO STORE MIFEPRISTONE

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

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

4. POSSIBLE SIDE EFFECTS

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.

Like all medicines, Mifepristone can cause side effects, although not everybody gets
them.

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

Common side effects (may affect up to 1 in 10 people):
• heavy vaginal bleeding
• prolonged bleeding after the abortion
• spotting
• severe bleeding
• endometritis (inflammation of the womb)
• breast tenderness
• fainting
• cramping

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

In a very small number of women, especially those who have had an operation on
the womb or have had a baby by cesarean delivery, there is a risk that the uterus or
womb may rupture during a further pregnancy.
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.gov.uk/yellowcard.

The following side effects have been observed:
Very common side effects (may affect more than 1 in 10 people):
• headache
• vaginal bleeding
• effects related to prostaglandin use such nausea, vomiting, diarrhoea, dizziness,
abdominal discomfort, abdominal pain, uterine spasm, fatigue and chill/fever
• uterine contractions or cramping in the hours following prostaglandin intake

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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. Do not pass it on to others. It may harm
them, even if their signs 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.

Plan technique

POLICE(S)

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

Uncommon side effects (may affect up to 1 in 100 people):
• hemorrhagic shock
• salpingitis (infection in the fallopian tubes)
• infection
• hypotension
Rare (may affect up to 1  in 1,000  people) and very rare (may affect up to 1  in
10,000 people) side effects:
• cases of fatal toxic shock caused by infection by Clostridium sordellii endometritis,
without fever or other obvious symptoms of infection
• ectopic pregnancy
• bilateral adnexal mass (increase size in fallopian tubes)
• intrauterine adhesion, uterine rupture, hematosalpynx (bleeding in the fallopian tubes)
• ovarian cyst rupture
• breast abcess
• hydatiform mole, trophoblastic tumor, elevated alpha fetoprotein, elevated
carcinoembryogenic antigen, amniotic band syndrome, uteroplacental apoplexia
• anaphylaxis, urticarial reaction, periorbital edema
• bronchospasm, asthma
• abnormal liver function tests
• hepatic failure
• gastric bleeding
• epilepsy
• tinnitus (ringing in the ear)
• mania
• superficial thrombophlebitis
• myocardial infarction
• cardiac rhythm disorder
• toxic epidermal necrolysis
• thrombotic thrombocytopenic purpura (coagulation disorder)
• thrombocytopenia
• induced systemic lupus erythematous
• renal failure
• muscular spasm
• ophtalmoplegia
• erythema nodosum
• angioedema
• vagal symptoms (hot flushes, skin rashes/itching)
• malaise

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.
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MIFEPRISTONE
8

PRODUIT

8

Dossier n° : 141035

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Mifepristone contains
• The active substance is mifepristone.
• The other ingredients are maize starch, povidone, cellulose microcrystalline, silica
colloidal anhydrous, magnesium stearate.
What Mifepristone looks like and contents of the pack
PVC/PVDC/Aluminum blister of 1 tablet and 30 tablets (hospital pack).
Marketing Authorisation Holder
Linepharma International Limited
338 Regent’s Place, Euston Road
London NW1 3BT
UNITED KINGDOM
Manufacturer
Laboratorios León Farma, S.A.
Poligono Industrial Navatejera
La Vallina, S/N
24008 Villaquilambre, León
SPAIN

or

Delpharm Lille S.A.S.
Z.I. de Roubaix-Est
Rue de Toufflers
59452 Lys-Lez-Lannoy
FRANCE

and/or
Centre Spécialités Pharmaceutiques
76-78 avenue du Midi
CS 30077
63808 Cournon d’Auvergne Cedex
FRANCE
This medicinal product is authorised in the Member States of the EEA under
the following names:
Austria : Mifepriston Linepharma 200 mg tabletten
Belgium, France, Luxembourg, The Netherlands: MIFFEE® 200 mg comprimé/tablet/
tablette/tabletten
Bulgaria : Мифепристон Линефарма 200 mg таблетка
Denmark : Mifepriston Linepharma 200 mg tablet
Estonia : Mifepristone Linepharma 200 mg, tabletid
Finland : Mifepristone Linepharma 200 mg tabletti
United Kingdom : Mifepristone 200 mg tablet
Island : Mifepristone Linepharma 200 mg tafla
Latvia : Mifepristone Linepharma 200 mg, tabletes
Lithuania : Mifepristone Linepharma 200 mg, tablet
Norway, Sweden : Mifepristone Linepharma 200 mg tablett
Portugal : Mifepristona Linepharma 200 mg comprimidos
Romania : Mifepristona Linepharma 200 mg comprimate
Slovenia : Mifepristone Linepharma 200 mg tableta
Spain : Mifepristona Linepharma 200 mg comprimidos
This leaflet was last approved in 10/2012
Detailed information on this medicine is available on the website of Medicines and
Healthcare Products Regulatory Agency (MHRA) of United kingdom: www.mhra.gov.uk

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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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