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MIFEPRISTONE LINEPHARMA 200 MG TABLET

Active substance(s): MIFEPRISTONE

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Dossier n° : 161849
PRODUIT

MIFEPRISTONE

CODE ARTICLE

LF1000A00A

TYPE

NOTICE

DOSAGE

200 mg

PRÉSENTATION

tablet

PAYS

UK - 1 LANGUE

FABRICANT

Leon Farma

FORMAT

222x340 mm

Ref. PLAN

-

COULEURS : 1

PANTONE 321 C
Plan technique

POLICE(S)

BANK GOTHIC
HELVETICA NEUE CONDENSED

CORPS minimum

10,5

LOGICIEL

Indesign CC

CODE BARRES

DATE

26/10/2015

VERSION

2

RECTO / FRONT

Package leaflet: Information for the user

mifepristone 200 mg tablet
Mifepristone

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.

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.

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

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.

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
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)
Tell your doctor if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription.
Taking Mifepristone with food and drink:
• grape fruit juice should not be taken when you are treated with Mifepristone.

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.

VERSO / BACK

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.
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
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Contact your doctor or go to the nearest hospital department
immediately if you experience any of the following symptoms:
• Heavy vaginal bleeding (frequency: common). Also see section 2
“Warnings and precaution”
• Infections: cases of fatal toxic shock caused by infection by Clostridium
sordellii endometritis.
It may cause symptoms such as fever with aching muscles, rapid heart rate,
dizziness, diarrhoea, vomiting or feeling weak. It can also occur without
fever or other obvious symptoms of infection (frequency: rare or very rare)
Serious allergic reactions (angioedema and anaphylaxis) with swelling
of the face, tongue or throat; difficulty swallowing; hives and breathing
difficulties (frequency: rare or very rare)
• Cardiovascular accidents: heart attack, heart rhythm disorder (frequency:
rare or very rare)
• Steep fall in blood pressure caused by loss of a large amount of blood
(hemorrhagic shock) (frequency: uncommon).
Other side effects that may occur:
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
Common side effects (may affect up to 1 in 10 people):
• prolonged bleeding after the abortion
• spotting
• severe bleeding
• endometritis (inflammation of the womb)
• breast tenderness
• fainting
• cramping
Uncommon side effects (may affect up to 1 in 100 people):
• 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:
• 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
• urticarial reaction, periorbital edema
• bronchospasm, asthma
• abnormal liver function tests
• hepatic failure
• gastric bleeding
• epilepsy
• tinnitus (ringing in the ear)
• mania
• superficial thrombophlebitis
• toxic epidermal necrolysis
• thrombotic thrombocytopenic purpura (coagulation disorder)
• thrombocytopenia
• induced systemic lupus erythematous
• renal failure
• muscular spasm
• ophtalmoplegia
• erythema nodosum
• vagal symptoms (hot flushes, skin rashes/itching)
• malaise
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.
By reporting side effects you can help provide more information on the
safety of this medicine.
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
What Mifepristone contains
• The active substance is mifepristone. Each tablet contains 200 milligrams
of mifepristone.
•
The other ingredients are maize starch, povidone, cellulose
microcrystalline, silica colloidal anhydrous, magnesium stearate.
What Mifepristone looks like and contents of the pack
White to off-white, round tablet, diameter 11 mm, with MF debossed on
one side of the tablet.
PVC/PVDC/Aluminum blister of 1 tablet and 30 tablets (hospital pack).
Marketing Authorisation Holder and Manufacturer
Linepharma International Limited
338 Regent’s Place, Euston Road
London NW1 3BT
UNITED KINGDOM
Manufacturer
Laboratorios León Farma, S.A.
Poligono Industrial Navatejera
C/ La Vallina, s/n
24008 Villaquilambre, León
SPAIN
and/or
Centre Spécialités Pharmaceutiques
76-78 avenue du Midi
63800 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
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 03/2016
Other sources of information
Detailed information on this medicine is available on the website of
Medicines and Healthcare Products Regulatory Agency (MHRA) of United
LF1000A00A
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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