MIFEPRISTONE LINEPHARMA 200 MG TABLET

Active substance: MIFEPRISTONE

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RECTO / FRONT

VERSO / BACK

260

260

Dossier n° : 140317

MOCK-UP

TYPE

NOTICE

DOSAGE

200 mg

PRÉSENTATION

tablet

PAYS

UK

FABRICANT

CHEMO

FORMAT

260 x 372 mm

Ref. PLAN

P016

COULEURS : 1

PANTONE 321

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.
•  eep this leaflet. You may need to read it again.
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• f you have any further questions, ask your doctor or pharmacist.
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•  his 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.
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• f you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
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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


Plan technique

BANK GOTHIC
HELVETICA NEUE CONDENSED
9 pts

LOGICIEL

Indesign CS5.5

1. WHAT MIFEPRISTONE AND WHAT IT IS USED FOR


CODE BARRES
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VERSION

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:
•  o later than 63 days after the first day of your last period,
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• n combination with another treatment called prostaglandin (a substance that increases contraction of the womb) which you take 36 to 48 hours after taking Mifepristone.
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIFEPRISTONE


04/03/2014
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372

DATE

4.  OSSIBLE SIDE EFFECTS
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Do not take Mifepristone
• f you are allergic (hypersensitive) to mifepristone or any of the other ingredients of this medicine (listed in section 6)
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• f you suffer from chronic adrenal failure,
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• f you suffer from asthma uncontrolled by treatment,
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• f you have hereditary porphyria,
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• f your pregnancy has not been confirmed by a biological test or an ultrasound scan,
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• f the first day of your last period was more than 63 days (9 weeks) ago,
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• f your doctor suspects an ectopic pregnancy (the egg is implanted outside the womb),
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•  ecause of the need to prescribe a prostaglandin in association with Mifepristone, you must not take this treatment if you are allergic to prostaglandins.
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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)

•  etoconazole, itraconazole (used in antifungal treatment)
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•  rythromycin, rifampicin (antibiotics)
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•  t John’s Wort (natural remedy used in the treatment of mild depression)
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•  henytoin, phenobarbital, carbamazepine (used in the treatment of seizures; epilepsia)
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Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription
Taking Mifepristone with food and drink:
•  rape fruit juice should not be taken when you are treated with Mifepristone.
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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:
•  he necessity to combine treatment with prostaglandin to be administered at a second visit.
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• The need for a follow up visit within 14 to 21days 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.

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CORPS minimum

Like all medicines, Mifepristone can cause side effects, although not everybody gets them.
The following side effects have been observed:
Very common side effects (may affect more than 1 in 10 people):
•  eadache
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•  aginal bleeding
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•  ffects related to prostaglandin use such nausea, vomiting, diarrhoea, dizziness, abdominal discomfort, abdominal pain, uterine spasm, fatigue and chill/fever
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•  terine contractions or cramping in the hours following prostaglandin intake
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Common side effects (may affect up to 1 in 10 people):
•  eavy vaginal bleeding
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•  rolonged bleeding after the abortion
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•  potting
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•  evere bleeding
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•  ndometritis (inflammation of the womb)
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•  reast tenderness
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• ainting
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•  ramping
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Uncommon side effects (may affect up to 1 in 100 people):
•  emorrhagic shock
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•  alpingitis (infection in the fallopian tubes)
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• nfection
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•  ypotension
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Rare (may affect up to 1 in 1,000 people) and very rare (may affect up to 1 in 10,000 people) side effects:
•  ases of fatal toxic shock caused by infection by Clostridium sordellii endometritis, without fever or other obvious symptoms of infection
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•  ctopic pregnancy
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•  ilateral adnexal mass (increase size in fallopian tubes)
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• ntrauterine adhesion, uterine rupture, hematosalpynx (bleeding in the fallopian tubes)
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•  varian cyst rupture
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•  reast abcess
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•  ydatiform mole, trophoblastic tumor, elevated alpha fetoprotein, elevated carcinoembryogenic antigen, amniotic band syndrome, uteroplacental apoplexia
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•  naphylaxis, urticarial reaction, periorbital edema
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•  ronchospasm, asthma
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•  bnormal liver function tests
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•  epatic failure
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•  astric bleeding
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•  pilepsy
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• innitus (ringing in the ear)
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•  ania
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•  uperficial thrombophlebitis
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•  yocardial infarction
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•  ardiac rhythm disorder
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• oxic epidermal necrolysis
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• hrombotic thrombocytopenic purpura (coagulation disorder)
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• hrombocytopenia
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• nduced systemic lupus erythematous
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•  enal failure
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•  uscular spasm
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•  phtalmoplegia
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•  rythema nodosum
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•  ngioedema
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•  agal symptoms (hot flushes, skin rashes/itching)
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•  alaise
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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


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.
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.
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POLICE(S)

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.

What Mifepristone contains
•  he active substance is mifepristone.
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•  he other ingredients are maize starch, povidone, cellulose microcrystalline, silica colloidal anhydrous, magnesium stearate.
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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 France - 55 rue de Turbigo - 75003 Paris - FRANCE
Manufacturer
Laboratorios León Farma, or Delpharm Lille S.A.S.
S.A.
Z.I. de Roubaix-Est
Poligono
Industrial
Rue de Toufflers
Navatejera
59452 Lys-Lez-Lannoy
La Vallina, S/N
FRANCE
24008 Villaquilambre, León
SPAIN
and/or
Centre Spécialités Pharmaceutiques
76-78 avenue du Midi
CS 30077
63808 Cournon d’Auvergne Cedex
FRANCE
This leaflet was last approved in 03/2014
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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CODE ARTICLE

8

MIFEPRISTONE
8

PRODUIT

10

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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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