MIFEGYNE 600 MG TABLETS

2. What you need to know before you take Mifegyne

Do not take Mifegyne

• Under any circumstances,

• Nor

For interruption of pregnancy up to 63 days after your last menstrual period:

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

For interruption of pregnancy after the third month of pregnancy:

Warnings and precautions

Talk to your doctor before starting Mifegyne

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 are Rh negative, 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 medicines and Mifegyne

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained 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 medicines (NSAIDs) such as aspirin or diclofenac.

Taking Mifegyne with food and drinks

Do not drink grapefruit juice when taking Mifegyne.

Pregnancy, breast-feeding, and fertility

Pregnancy

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

The risk of failure increases:

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

If the interruption of pregnancy fails after taking this medicine or the combination of medicines, 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 give you more information.

If you decide to continue with the interruption of pregnancy, another method will need to be used. Your doctor will inform you of the options.

Breast-feeding

If you are breast-feeding, talk to your doctor before taking this medicine. You should stop breast-feeding while taking Mifegyne, as the medicine may pass into breast milk.

Fertility

This medicine does not affect fertility. You can become pregnant again as soon as the interruption is complete. You should start using a contraceptive method immediately after your doctor confirms the interruption 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 medicine until you know how Mifegyne affects you.

3. How to take Mifegyne

Follow the instructions for administration given by your doctor exactly. If you are unsure, talk to your doctor or pharmacist again.

1. Medical interruption of ongoing intrauterine pregnancy (IMdE)

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

Adult dose

• 1 tablet by mouth

Taking the tablet

• Swallow the tablet whole with a glass of water in the presence of a doctor or a member of their staff.
• Take the prostaglandin analogue, between 36 and 48 hours after Mifegyne. The prostaglandin is administered either as tablets, which should be swallowed with water (misoprostol 400 micrograms), or as 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.

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

Adult dose

• 1 tablet by mouth

Taking the tablet

• Swallow the tablet whole with a glass of water in the presence of a doctor or a member of their staff.
• Take the prostaglandin analogue, between 36 and 48 hours after Mifegyne. The prostaglandin is administered as 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 medicine (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 the medical interruption of pregnancy are as follows:

1. In the health center, you will receive Mifegyne, which you should take by mouth.
2. Between 36 and 48 hours later, the prostaglandin analogue will be administered. You should rest for at least 3 hours after taking the prostaglandin analogue.
3. The embryo may be expelled a few hours after taking the prostaglandin analogue or during the following days. After taking Mifegyne, you will experience vaginal bleeding that will last for an average of 12 days, and the flow will be lighter as time passes.
4. You should 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 medicine immediately:

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 a complete expulsion has occurred; 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 interruption of pregnancy.

It is recommended that you do not travel far from the center that prescribed the medicine 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 have to wait for your follow-up visit.

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

Adult dose

• 1 tablet by mouth

Taking the tablet

• Swallow the tablet whole with a glass of water.
• Between 36 and 48 hours after taking this medicine, take the prostaglandin analogue, which may be repeated several times at regular intervals until the interruption 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 dose

• 1 tablet by mouth every day for two days

Taking the tablet

• 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.

If you forget to take Mifegyne

If you forget to follow any part of the treatment, it is likely that the interruption 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects:

• allergic reaction, skin rash, and localized inflammation of the face and/or larynx that may be accompanied by urticaria.
• red patches on the trunk. These patches are target-like or circular red spots, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis; frequency: rare).
• generalized exfoliative red rash, 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 severe 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 medicine, the misoprostol tablet, by mouth.

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):

• low 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 administration of prostaglandin in the second and third trimester of pregnancy, especially in multiparous women or women with a cesarean scar.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Mifegyne

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

Store below 25°C. Store in the original package to protect from light.

Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date is the last day of the month shown.

Do not use this medicine if you notice signs of deterioration in the carton or blisters.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Mifegyne Composition

• The active ingredient is mifepristone.

A Mifegyne tablet contains 600 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, almond-shaped, biconvex tablets, 19 mm long and 11 mm wide, with γ engraved on one face and 600 on the other.

Mifegyne is available in package sizes of 1, 8, 16, or 20 tablets in 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

Nordic Pharma B.V.

Siriusdreef 41

2132 WT Hoofddorp

The Netherlands

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,

28232 Parque Empresarial Las Rozas,

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:May 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/