Label: Information for the User

Mifegyne 200 mg Tablets

Mifepristone

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.

1.Whatis Mifegyne and how it is used

2. What you need to know before starting to take Mifegyne

3. How to take Mifegyne

4. Possible adverse effects

5. Storage of Mifegyne

6. Contents of the package and additional information

The Mifegyne tablets contain mifepristone, which is an antihormone that acts by blocking the effects of progesterone, a hormone necessary for the continuation of pregnancy. Mifegyne can therefore cause the interruption of pregnancy. It can also be used to soften and dilate the entrance to the uterus (cervix).

Mifegyne is recommended for use:

1) For medical termination of pregnancy:

• up to a maximum of 63 days after the first day of your last menstrual cycle,
• in combination with a second medication, a prostaglandin (a substance that increases the contraction of the uterus and softens the cervix), which is taken36 to48 hours after taking Mifegyne.

2) To soften and dilate the cervix before surgical termination of pregnancy during the first trimester.

3) As a pre-treatment before the administration of prostaglandins for medical termination of pregnancy after the third month of gestation.

4) To induce labor in cases where fetal death in the uterus has occurred and other medical treatments (prostaglandins or oxytocin) cannot be used.

Do not take Mifegyne

· In no case,

• if you are allergic to mifepristone or any of the other components of this medication (listed in section 6),
• if you have adrenal insufficiency,
• if you have severe asthma that cannot be adequately treated with medication,
• if you have hereditary porphyria.

· Nor,

For abortion up to 63 days after your last menstrual cycle:

• if your pregnancy has not been confirmed by a biological test or ultrasound,

• if the first day of your last menstrual cycle was more than 63 days ago,
• if your doctor suspects an ectopic pregnancy (the egg is implanted outside the uterus),
• if you cannot take the selected prostaglandin analogue.

For softening and opening the cervix before surgical abortion:

• if your pregnancy has not been confirmed by a biological test or ultrasound,
• if your doctor suspects an ectopic pregnancy,
• if the first day of your last menstrual cycle was 84 days or more ago.

For abortion after the third month of pregnancy:

• if you cannot take the selected prostaglandin analogue.

Warnings and precautions

Consult your doctor beforestartingto take Mifegyne

• if you have liver or kidney disease,
• if you suffer from anemia or malnutrition,
• if you have cardiovascular disease (heart or circulatory disease).
• if you have a higher risk of cardiovascular disease. Factors that increase the risk include being over 35 years old and a smoker or having high blood pressure, high cholesterol levels, or diabetes,
• if you have a disease that affects your blood clotting,
• if you have asthma.

If you use an intrauterine contraceptive device, you must remove it before taking Mifegyne.

Before taking Mifegyne, you will have a blood test to determine your Rh factor. If you are Rh negative, your doctor will inform you of the usual treatment required.

Severe skin reactions, such as toxic epidermal necrolysis and acute generalized pustular psoriasis, have been associated with Mifegyne treatment. Stop using Mifegyne and seek medical attention immediately if you experience any of the symptoms described in section 4. If you experience a severe skin reaction, you should not use mifepristone again in the future.

Other medications and Mifegyne

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Specifically, inform your doctor if you are taking the following:

• corticosteroids (used in the treatment of asthma and other inflammatory treatments)
• ketoconazole, itraconazole (used as treatment for fungi)
• erythromycin, rifampicin (antibiotics)
• St. John's Wort (natural remedy used in the treatment of mild depression)
• phenytoin, phenobarbital, carbamazepine (used in the treatment of epilepsy)

• nonsteroidal anti-inflammatory drugs (NSAIDs) such asaspirinor diclofenac.

Taking Mifegyne with food and drinks

You should not take grapefruit juice while taking Mifegyne.

Pregnancy, breastfeeding, and fertility

Pregnancy

The failure of abortion (continuation of pregnancy)after taking Mifegyne alone or in combination with prostaglandin and carried to term has been associated with congenital defects.

The risk offailure increases:

• if theprostaglandin is not administered according to the informationin the medication's prescribing information(see section 3).
• with the duration of pregnancy.
• with the number of previous pregnancies.

If the abortionfails after taking this medication or the combination of medications,there is anunknownrisk for thefetus.If you decide to continue with this pregnancy, you should have an exhaustive prenatal check-upwith repeated ultrasounds, paying special attention to the limbs, in a specialized clinic. Your doctor will provide you with more information.

If you decide to continue with the abortion, another method should be used. Your doctor will inform you of the options.

Breastfeeding

If you are breastfeeding, consult your doctor before taking this medication. You should stop breastfeeding while taking Mifegyne, as the medication can pass into breast milk.

Fertility

This medication does not affect fertility. You canbecome pregnant againas soon as the abortion is completed. You should start using a contraceptive method immediately after your doctor confirms the abortion.

Driving and operating machinery

You may experience dizziness as a side effect related to the abortion process. Be extra careful when driving or operating machinery after taking this medication until you know how Mifegyne affects you.

Follow exactly the administration instructions indicated by your doctor.

In case of doubt, consult again with your doctor or pharmacist.

1) Medical termination of ongoing intrauterine pregnancy (IMdE)(IMdE)

Termination of pregnancy up to 49 days after your last menstrual cycle

Dosage in adults

• 3 tablets orally.

Tablet intake

• Swallow the tablet whole with a glass of water in the presence of a doctor or a member of your staff.
• Take the prostaglandin analogue, between 36 and 48 hours after Mifegyne. The prostaglandin is administered either in tablets, which must be swallowed with water (misoprostol 400 micrograms), or in vaginal pessaries (gemeprost 1 mg).
• If you vomit within 45 minutes after taking the mifepristone tablet, inform your doctor immediately. You will have to take another tablet.

Termination of pregnancy between 50 and 63 days after your last menstrual cycle

Dosage in adults

3 tablets must be taken orally.

Tablet intake

• Swallow the tablet whole with a glass of water in the presence of a doctor or a member of your staff.
• Take the prostaglandin analogue, between 36 and 48 hours after Mifegyne. The prostaglandin is a vaginal pessary (gemeprost 1 mg).
• If you vomit within 45 minutes after taking the mifepristone tablet, inform your doctor immediately. You will have to take another tablet.

This method involves your active participation and therefore, you must be aware of:

• You must take the second medication (which contains prostaglandin) to ensure the effectiveness of the treatment.

-You must attend the follow-up visit (third visit) within 14 to 21 days after taking Mifegyne to check that the expulsion has been completed and that you are well.

The steps to follow for medical termination of pregnancy are as follows:

1. In the Health Centre, you will receive Mifegyne, which must be taken orally.
2. Between 36 and 48 hours later, the prostaglandin analogue will be administered. You must rest for at least 3 hours after taking the prostaglandin analogue.
3. The embryo may be expelled within a few hours after taking the prostaglandin analogue or in the following days. After taking Mifegyne, a vaginal bleeding will occur, lasting an average of 12 days, and the flow will be lighter as time passes.
4. You must return to the centre 14-21 days after taking Mifegyne for a follow-up consultation and to ensure that the expulsion has been completed.

Contact the centre that prescribed the medication immediately:

• if you experience vaginal bleeding for more than 12 days and/or is very heavy (e.g., you need more than 2 pads in an hour for 2 hours).
• If you have severe abdominal pain.
• If you have a fever or feel cold or shivering.

Another important aspect to remember:

• The vaginal bleeding does not mean that the expulsion has been completed.

Uterine bleeding usually begins 1-2 days after taking Mifegyne.

In rare cases, expulsion may occur before taking the prostaglandin. It is essential that you undergo a check-up to confirm that a complete expulsion has occurred; for this, you must return to the centre where you were treated.

If the pregnancy continues or the expulsion has not been completed, your doctor will inform you of the options to complete the termination of pregnancy.

It is recommended that you do not travel far from the centre that prescribed the medication until the follow-up visit is completed.

In case of emergency or if you have any questions, you can contact your centre by phone or visit it. You do not have to wait for your follow-up visit.

2) To soften and open the cervix before surgical termination of pregnancy:

Dosage in adults

• 1 tablet orally.

Tablet intake

• Swallow the tablet whole with a glass of water.

• If you vomit within 45 minutes after taking the mifepristone tablet, inform your doctor immediately. You will have to take another tablet.

The steps to follow for medical termination of pregnancy are as follows:

1)In the Health Centre, you will receive Mifegyne, which must be taken orally.

2)Between 36 and 48 hours later, you must return to the centre that prescribed the medication for a surgical intervention.

Your doctor will explain the procedure. You may experience bleeding after taking Mifegyne, before the operation.

In rare cases, expulsion may occur before surgery. It is essential that you return to the centre to confirm that a complete expulsion has occurred.

You must return to the selected centre for the surgery. In case of emergency or if you have any questions, you can contact your centre by phone or visit it. You do not have to wait for your follow-up visit.

3) For termination of pregnancy after the third month of pregnancy:

Dosage in adults

• 3 tablets orally.

Tablet intake

• Swallow the tablet whole with a glass of water.
• Between 36 and 48 hours after taking this medication, take the prostaglandin analogue, an action that can be repeated several times at regular intervals until the termination of pregnancy is completed.
• If you vomit within 45 minutes after taking the mifepristone tablet, inform your doctor immediately. You will have to take another tablet.

4) To induce labour when pregnancy is interrupted (fetal death intrauterine)

Dosage in adults

• 3 tablets orally each day for two days.

Tablet intake

• Swallow the tablet whole with a glass of water.
• If you vomit within 45 minutes after taking the mifepristone tablet, inform your doctor immediately. You will have to take another tablet.

Use in adolescents

Only limited data are available on the use of Mifegyne in adolescents.

If you take more Mifegyne than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.

Your doctor will administer the exact amount of Mifegyne; therefore, it is unlikely that you will take too many tablets. Taking too many tablets can cause symptoms of adrenal insufficiency. Signs of acute poisoning may require specialist treatment, including administration of dexamethasone.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you forgot to take Mifegyne

If you forgot to follow any part of the treatment, it is likely that the method will not be fully effective.Inform your doctor if you forgot to take Mifegyne or the part of the treatment prescribed.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects:

• Allergic reaction, skin rash, and localized inflammation on the face and/or larynx that may be accompanied by urticaria.
• Red patches on the trunk. These patches are macules in the shape of a target or circular spots of red color, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis; frequency: rare).
• Generalized red exfoliative rash, with bumps under the skin and blisters accompanied by fever. These symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis; frequency: unknown).

Other severe side effects:

• Cases of toxic shock or severe septic shock. Fever with muscle pain, rapid heart rate, dizziness, diarrhea, vomiting, or feeling weak. These side effects may occur if the second medicine, the misoprostol tablet, is not taken orally.

If you experience any of these side effects, contact your doctor IMMEDIATELY or go to the nearest hospital emergency department.

Other side effects

Very common (may affect more than 1 in 10 people):

• Uterine contractions or spasms
• Diarrhea

-Feeling unwell (nausea) or sick (vomiting)

Common (may affect up to 1 in 10 people):

• Heavy bleeding
• Mild to moderate gastrointestinal spasms
• Uterine infection(endometritis or pelvic inflammatory disease).

Uncommon (may affect up to 1 in 100 people):

• Decreased blood pressure

Rare (may affect up to 1 in 1,000 people):

• Fever
• Headache
• Feeling unwell or tired
• Flu-like symptoms (chills, dizziness, and shivering)
• Urticaria and skin disorders that may be severe
• Uterine rupture after administration of prostaglandin in the second and third trimesters of pregnancy, especially in multiparous women or women with a cesarean scar.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require any special storage temperature.Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears inthe box after "EXP". The expiration date is the last day of the month indicated.

Do not use this medication if you observe signs of deterioration in the box or blister packs.

Medications should not be disposed of through drains or trash.Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Mifegyne

• The active principle is mifepristone.

Mifegyne tablet contains 200mg of mifepristone.

• The other components are anhydrous colloidal silica(E551), cornstarch, povidone(E1201), magnesium stearate(E572), microcrystalline cellulose(E460).

Appearance of the product and contents of the packaging

Mifegyne is presented in the form of yellowish clear, biconvex tablets, with a diameter of 11mm with "167 B" engraved on one side.

Mifegyne is presented in packaging sizes of1, 3 x 1, 15 x 1 or 30 x 1tabletsin pre-cut, single-dose PVC/aluminum blisters.

It is possible that not all packaging sizes will be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

EXELGYN

216 boulevard Saint-Germain

75007 Paris

France

Manufacturer responsible:

LaboratoiresMACORS

89000 Auxerre

France

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Nordic Pharma S.A.U.

Adolfo Perez Esquivel 3, 2nd floor, Office 17,

Edificio Las Americas III,

28232 Parque Empresarial Las Rozas,

Madrid, Spain

+34 916 404 041

[email protected]

This medicine is authorized in the Member States of the European Economic Area with the following denomination: MIFEGYNE

Last review date of this leaflet:05/2021

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/