MIFEGYNE 200 mg TABLETS

Introduction

Package Leaflet: Information for the User

Mifegyne 200 mg tablets

Mifepristone

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet

1. What is Mifegyne and what is it used for
2. What you need to know before taking Mifegyne
3. How to take Mifegyne
4. Possible side effects
5. Storage of Mifegyne
6. Contents of the pack and further information

1. What is Mifegyne and what is it used for

Mifegyne tablets contain mifepristone, which is an anti-hormone 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 period,
• in combination with a second medication, a prostaglandin (a substance that increases uterine contractions and softens the cervix), which is taken 36 to 48 hours after taking Mifegyne.

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

1. As pre-treatment with prostaglandins for termination of pregnancy for medical reasons after the third month of gestation.

1. To induce labor in cases where fetal death has occurred in the uterus and when other medical treatments (prostaglandins or oxytocin) are not possible.

2. What you need to know before taking Mifegyne

Do not take Mifegyne

• Under any circumstances,
• 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 termination of pregnancy up to 63 days after your last menstrual period:

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

• if the first day of your last menstrual period 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 analog.

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

• 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 period was 84 days or more ago.

For termination of pregnancy after the third month of pregnancy:

• if you cannot take the selected prostaglandin analog.

Warnings and precautions

Consult your doctor before starting to take Mifegyne

• if you have liver or kidney disease,
• if you suffer from anemia or malnutrition,
• if you have a cardiovascular disease (heart or circulatory disease).
• if you have a higher risk of cardiovascular disease. Risk factors 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 are using an intrauterine contraceptive device, it must be removed before taking Mifegyne.

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

Severe skin reactions, such as toxic epidermal necrolysis and acute generalized exanthematous pustulosis, have been reported 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

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

In particular, inform your doctor if you are taking:

• corticosteroids (used to treat asthma and other inflammatory conditions)
• ketoconazole, itraconazole (used to treat fungal infections)
• erythromycin, rifampicin (antibiotics)
• St. John's Wort (a natural remedy used to treat mild depression)
• phenytoin, phenobarbital, carbamazepine (used to treat epilepsy)

• non-steroidal anti-inflammatory medications (NSAIDs) such as aspirin or diclofenac.

Taking Mifegyne with food and drinks

Do not drink grapefruit juice while being treated with Mifegyne.

Pregnancy, breastfeeding, and fertility

Pregnancy

Failure of pregnancy termination (continuation of pregnancy) after taking Mifegyne alone or in combination with prostaglandin and carrying the pregnancy to term has been associated with congenital defects.

The risk of failure increases:

• If the prostaglandin is not administered according to the medication's prescription information (see section 3).
• With the duration of pregnancy.
• With the number of previous pregnancies.

If pregnancy termination fails after taking this medication or the combination of medications, there is an unknown risk to the fetus. If you decide to continue with this pregnancy, you will need to have close prenatal monitoring with repeated ultrasounds, paying special attention to the limbs, in a specialized clinic. Your doctor will provide more information.

If you decide to continue with pregnancy termination, another method will need to 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 may pass into breast milk.

Fertility

This medication does not affect fertility. You can become pregnant again as soon as the termination is complete. You should start using a contraceptive method immediately after your doctor confirms the termination of pregnancy.

Driving and using machines

Dizziness may occur as a side effect related to the abortion process. Be careful when driving or using machines after taking this medication until you know how Mifegyne affects you.

3. How to take Mifegyne

Follow the administration instructions indicated by your doctor exactly.

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

1. Medical termination of ongoing intrauterine pregnancy (MTOP)

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

Adult dosage

• 3 tablets orally.

Tablet intake

• Swallow the tablet whole with a glass of water in the presence of a doctor or a member of their staff.
• Take the prostaglandin analog between 36 and 48 hours after Mifegyne. The prostaglandin is administered either in tablets, which should 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 need to take another tablet.

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

Adult dosage

You should take 3 tablets orally.

Tablet intake

• Swallow the tablet whole with a glass of water in the presence of a doctor or a member of their staff.
• Take the prostaglandin analog 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 need 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 center, you will receive Mifegyne, which you should take orally.
2. Between 36 and 48 hours later, the prostaglandin analog will be administered. You should rest for at least 3 hours after taking the prostaglandin analog.
3. The embryo may be expelled a few hours after taking the prostaglandin analog or during the following days. After taking Mifegyne, you will experience vaginal bleeding, which will last for an average of 12 days, and the flow will be lighter as time passes.
4. You must return to the center 14 to 21 days after taking Mifegyne for a follow-up consultation to ensure that the expulsion has been completed.

Contact the center that prescribed the medication immediately:

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

Another important aspect to remember:

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

Uterine bleeding usually starts 1 to 2 days after taking Mifegyne.

In rare cases, expulsion may occur before taking the prostaglandin. It is essential to have a check-up to confirm that the expulsion has been completed; for this, you will need to return to the center where you were treated.

If the pregnancy continues or the expulsion has not been complete, 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 center that prescribed the medication until the follow-up visit.

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

1. To soften and open the cervix before surgical termination of pregnancy:

Adult dosage

• 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 need to take another tablet.

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

1. In the health center, you will receive Mifegyne, which you should take orally.
2. Between 36 and 48 hours later, you should return to the center 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 to return to the center to confirm that the expulsion has been completed.

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

1. For termination of pregnancy after the third month of pregnancy:

Adult dosage

• 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 analog, which may be repeated several times at regular intervals until the termination of pregnancy is complete.
• If you vomit within 45 minutes after taking the mifepristone tablet, inform your doctor immediately. You will need to take another tablet.

1. To induce labor when pregnancy is interrupted (intrauterine fetal death).

Adult dosage

• 3 tablets orally every 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 need 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 emergency department of the nearest hospital.

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

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious side effects:

• Allergic reaction, skin rash, and localized inflammation in the face and/or larynx that may be accompanied by urticaria.
• Red patches on the trunk. These patches are target-shaped or circular red spots, 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 exfoliative red eruption, with bumps under the skin and blisters accompanied by fever. These symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis; frequency: unknown).

Other serious side effects:

• Cases of toxic shock or severe septic shock. Fever with muscle pain, rapid heart rate, dizziness, diarrhea, vomiting, or feeling of weakness. These side effects may occur if you do not take the second medication, the misoprostol tablet, orally.

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

Other side effects

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

• uterine contractions or spasms
• diarrhea

• feeling sick (nausea) or being sick (vomiting)

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

• heavy bleeding
• mild or 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 sick or tired
• vagal symptoms (hot flashes, dizziness, and chills)
• urticaria and skin disorders that can be severe
• uterine rupture after prostaglandin administration in the second and third trimester of pregnancy, especially in multiparous women or women with a cesarean scar.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Mifegyne

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 stated on the box after "EXP". The expiration date is the last day of the month indicated.

Do not use this medication if you notice signs of deterioration in the box or blisters.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Mifegyne Composition

• The active ingredient is mifepristone.

A Mifegyne tablet contains 200 mg of mifepristone.

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

Product Appearance and Package Contents

Mifegyne is presented in the form of light yellow, biconvex tablets, with a diameter of 11 mm and "167 B" engraved on one face.

Mifegyne is available in package sizes of 1, 3 x 1, 15 x 1, or 30 x 1 tablets in precut unit-dose PVC/aluminum blisters.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

EXELGYN

216 boulevard Saint-Germain

75007 Paris

France

Manufacturer:

Laboratoires MACORS

22 rue des Caillotes

89000 Auxerre

France

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

Nordic Pharma S.A.U.

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

Las Americas III Building,

Parque Empresarial Las Rozas,

28232 Madrid, Spain

+34 916 404 041

[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following name: MIFEGYNE

Date of the last revision of this leaflet:05/2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/