Mifegyne

PACKAGE LEAFLET: INFORMATION FOR THE USER

MIFEGYNE® 200 mg tablets
Mifepristone
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet:

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

1. What MIFEGYNE is and what it is used for

MIFEGYNE tablets contain mifepristone, an antihormone that acts by blocking the effects of progesterone, a hormone necessary for the continuation of pregnancy. Therefore, MIFEGYNE can cause termination of pregnancy. It may also be used to soften and dilate the opening (cervix) to the uterus.
MIFEGYNE is recommended for the following uses:

1. For the medical termination of an ongoing intrauterine pregnancy:
   • up to 63 days after the first day of the last menstrual period,
   • in combination with a second medicine, a prostaglandin (a substance that induces uterine contractions and softens the cervix), to be taken 36–48 hours after taking MIFEGYNE.
2. To soften and dilate the cervix prior to surgical termination of pregnancy during the first trimester.
3. As pre-treatment before administration of prostaglandins for therapeutic termination of pregnancy beyond the third month of gestation.
4. To induce labour in cases where the fetus has died inside the uterus and in cases where other medical treatments (prostaglandin or oxytocin) cannot be used.

2. What you should know before taking Mifegyne

Do not take Mifegyne:

• In all cases,
  • if you are allergic to mifepristone or to any of the other ingredients of this medicine (listed in section 6),
  • if you have adrenal failure,
  • if you suffer from severe asthma that cannot be adequately treated with medication,

Page 1 of 15

• if you have hereditary porphyria.
  • Additionally, For termination of pregnancy up to the 63rd day after the last menstrual period:
• if pregnancy has not been confirmed by laboratory test or ultrasound examination,
• if the first day of your last menstrual period was more than 63 days ago,
• if your doctor suspects an ectopic pregnancy (the egg has implanted outside the uterus),
• if you cannot take the selected prostaglandin analogue.

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

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

For termination of pregnancy beyond the 3rd month of pregnancy:
If you cannot take the selected prostaglandin analogue.
Warnings and precautions
Talk to your doctor before taking Mifegyne:

• if you have liver or kidney disease,
• if you are anaemic or malnourished,
• if you have cardiovascular disease (heart or circulatory disease),
• if you are at increased risk of cardiovascular disease. Risk factors include being over 35 years of age, being a smoker, or having high blood pressure, high cholesterol levels in the blood, or diabetes,
• if you suffer from a disease affecting blood clotting,
• if you suffer from asthma.

If you use an intrauterine contraceptive device (IUD), it must be removed before taking Mifegyne.
Before taking Mifegyne, your Rh blood factor must be determined. If you are Rh negative, your
doctor will advise you on the routine treatment required.
Severe skin adverse reactions have been reported in association with treatment with Mifegyne,
including toxic epidermal necrolysis and acute generalised exanthematous pustulosis.
Discontinue use of Mifegyne and contact your doctor immediately if you notice the appearance of
any symptoms described in section 4. If you experience a severe skin reaction, do not take
mifepristone again in the future.
Other medicines and Mifegyne
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those obtained without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:

• corticosteroids (used to treat asthma or other inflammatory conditions)
• ketoconazole, itraconazole (used to treat fungal infections)
• erythromycin, rifampicin (antibiotics)
• St John’s wort (a herbal remedy used for mild depression)
• phenytoin, phenobarbital, carbamazepine (used to treat seizures; epilepsy)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid or diclofenac.

Mifegyne with food and drink
Page 2 of 15
Do not consume grapefruit juice during treatment with Mifegyne.
Pregnancy, breastfeeding and fertility
Pregnancy
Failed termination of pregnancy (continuation of pregnancy) followed by live birth after taking Mifegyne alone or in combination with prostaglandin has been associated with congenital malformations.
The risk of failure increases:

• if the prostaglandin is not administered in accordance with the respective prescribing information (see section 3)
• with the duration of pregnancy
• with the number of previous pregnancies

If termination of pregnancy is unsuccessful after taking this medicine or combination of medicines, there is an unknown risk to the fetus. If you decide to continue the pregnancy, you should undergo careful prenatal monitoring and repeated ultrasound examinations, with particular attention to the limbs, at a specialized clinic. Your doctor will provide you with further information.
If you decide to proceed with termination of pregnancy, another method will be used. Your doctor will advise you on the available options.
Breastfeeding
If you are breastfeeding, inform your doctor before using this medicine. Do not breastfeed during treatment with Mifegyne, as the medicine passes into breast milk.
Fertility
This medicine does not affect fertility. A new pregnancy can occur immediately after completion of termination of pregnancy. Contraception should therefore be started immediately after the doctor has confirmed that the pregnancy has been terminated.
Driving and using machines
Dizziness may occur as an adverse effect related to the abortion procedure. Exercise particular caution when driving or using machines after taking this medicine until you know how Mifegyne affects you.

3. How to take Mifegyne

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

1) Medical termination of an ongoing intrauterine pregnancy (IUP)

Termination of pregnancy up to 49 days after the last menstrual period
Dosage in adults

• 3 tablets to be taken orally

Tablet intake
Page 3 of 15

• Swallow the tablet whole with a glass of water in the presence of a doctor or a member of their medical staff.
• Take the prostaglandin analogue 36–48 hours after Mifegyne. The prostaglandin may be administered as tablets to be swallowed with water (misoprostol 400 micrograms) or as a vaginal suppository (gemeprost 1 mg).
• If vomiting occurs within 45 minutes after taking the mifepristone tablet, contact your doctor immediately. You will need to take the tablets again.

Termination of pregnancy up to 50–63 days after the last menstrual period
Dosage in adults
3 tablets to be taken orally
Tablet intake

• Swallow the tablets whole with a glass of water in the presence of a doctor or a member of their medical staff.
• Take the prostaglandin analogue 36–48 hours after Mifegyne. The prostaglandin is administered as a vaginal suppository (gemeprost 1 mg).
• If vomiting occurs within 45 minutes after taking the mifepristone tablets, contact your doctor immediately. You will need to take the tablets again.

This method requires your active participation, and therefore you must be informed that:

• It is necessary to take the second medicine (containing the prostaglandin) for the treatment to be effective.
• You must attend a follow-up visit (3rd visit) within 14–21 days after taking Mifegyne to confirm that the pregnancy has been completely expelled and that you are well.

For medical termination of pregnancy, the following programme will be followed:

1. Mifegyne will be handed to you at the prescribing centre and must be taken orally.
2. 36–48 hours later, the prostaglandin analogue will be administered. You must rest for 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, you will experience vaginal bleeding lasting on average 12 days, with gradually decreasing intensity.
   4) You must return to the centre for a follow-up visit within 14–21 days after taking Mifegyne to confirm that expulsion is complete.
   Contact the prescribing centre immediately:

• if vaginal bleeding lasts longer than 12 days and/or is very heavy (e.g. more than 2 sanitary pads per hour for 2 hours)
• if you have severe abdominal pain
• if you have fever or feel cold and have chills.

Another important point to remember:

• Vaginal bleeding does not mean that 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 have a check-up to confirm complete evacuation. For this reason, you must return to the centre.
Page 4 of 15
If the pregnancy continues or expulsion is incomplete, your doctor will advise you on the available options to complete the termination of pregnancy.
It is recommended that you do not travel far from the prescribing centre until the follow-up visit has been completed.
In case of emergency, or if you have any questions, call or go to the prescribing centre. Do not wait until your scheduled follow-up appointment.

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

• 1 tablet to be taken orally

Tablet intake

• Swallow the tablet whole with a glass of water.
• If vomiting occurs within 45 minutes after taking the mifepristone tablet, contact your doctor. You will need to take another tablet.

For medical termination of pregnancy, the following programme will be followed:

1. Mifegyne will be handed to you at the prescribing centre and must be taken orally.
2. 36–48 hours later, you must return to the prescribing centre for the surgical procedure.
   Your doctor will explain the procedure to you. Vaginal bleeding may occur after taking Mifegyne, before the surgical procedure.
   In rare cases, expulsion may occur before the surgical procedure. It is essential that you return to the centre to confirm that expulsion has been complete.
   Therefore, you must return to the chosen centre to undergo the surgical procedure.
   In case of emergency, or if you have any questions, call or go to the prescribing centre. Do not wait until your scheduled follow-up appointment.

3) For termination of pregnancy beyond the first three months of pregnancy:
Dosage in adults

• 3 tablets to be taken orally

Tablet intake

• Swallow the tablets whole with a glass of water.
• 36–48 hours after taking this medicine, take the prostaglandin analogue, which may be repeated several times at regular intervals until expulsion is complete.
• If vomiting occurs within 45 minutes after taking the mifepristone tablets, contact your doctor immediately. You will need to take the tablets again.

4) For induction of labour when pregnancy has been terminated (intrauterine fetal death).
Dosage in adults

• 3 tablets to be taken orally every day for two days

Page 5 of 15
Tablet intake

• Swallow the tablets whole with a glass of water.
• If vomiting occurs within 45 minutes after taking the mifepristone tablets, contact your doctor immediately. You will need to take the tablets again.

Use in adolescents
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 emergency department.
Your doctor will provide you with the exact amount of Mifegyne; therefore, it is unlikely that you will take an excessive number of tablets. Taking too many tablets may cause symptoms of adrenal insufficiency. Symptoms of acute intoxication may require specialist treatment, including administration of dexamethasone.

If you forget to take Mifegyne
If you forget to take any part of the treatment, the method may not be fully effective. Speak with your doctor if you have forgotten to take Mifegyne or the prescribed part of the treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• Allergic reaction. Skin rash, localized swelling of the face and/or larynx, sometimes accompanied by hives.
• Reddish patches on the trunk; the patches are target-shaped or circular macules, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis, frequency: rare).
• A widespread, red, scaly rash, with subcutaneous swellings and blisters accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption, acute, frequency: not known).

Other serious side effects:

• Cases of severe or fatal toxic or septic shock. Fever with muscle pain, tachycardia, dizziness, diarrhoea, vomiting, or feeling of weakness. This side effect may occur if you do not take the second medicine, the misoprostol tablet, by mouth.

If you experience any of these side effects, seek IMMEDIATE medical attention from your doctor or go to the nearest emergency department.
Page 6 of 15
Other side effects
Very common (may affect more than 1 in 10 people):

• uterine contractions or cramps
• diarrhoea
• feeling unwell (nausea) or vomiting

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

• heavy bleeding
• mild or moderate gastrointestinal cramps
• infection of the uterus (endometritis and pelvic inflammatory disease)

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

• drop in blood pressure

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

• fever
• headache
• general malaise or feeling of fatigue
• vaginal symptoms (hot flushes, dizziness, chills)
• hives and skin reactions, which may be severe
• uterine rupture following administration of prostaglandin during the second and third trimesters of pregnancy, particularly in multiparous women or women who have previously had a caesarean section

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mifegyne

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the carton or blister show signs of deterioration.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mifegyne contains
Page 7 of 15
The active substance is mifepristone.
One tablet of Mifegyne contains 200 mg of mifepristone.
The other components are anhydrous colloidal silica, maize starch, povidone, magnesium stearate, microcrystalline cellulose.
Description of the appearance of Mifegyne and package contents
Mifegyne is available as yellow, biconvex tablets, 11 mm in diameter, with the inscription "167 B" engraved on one side.
Mifegyne is available in packs of 1, 3 x 1, 15 x 1 or 30 x 1 tablets in PVC/aluminum blisters divided into single-dose units.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
EXELGYN
216 boulevard Saint-Germain
75007 Paris
France
Manufacturer:
Laboratoires Macors
Rue des Caillotes
ZI Plaine des Isles
89000 Auxerre, France.
This medicinal product is authorized in the European Economic Area Member States under the
following names: MIFEGYNE;
Page 8 of 15

PATIENT LEAFLET: INFORMATION FOR THE USER

MIFEGYNE® 600 mg tablets
Mifepristone
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

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

1. What Mifegyne is and what it is used for

Mifegyne tablets contain mifepristone, an antihormone that works by blocking the effects of progesterone, a hormone necessary for the continuation of pregnancy. Mifegyne can therefore cause termination of pregnancy. It may also be used to soften and dilate the opening (cervix) to the uterus.

Mifegyne is recommended for the following uses:

1. For the medical termination of an ongoing intrauterine pregnancy:

• no later than the 63rd day following the first day of the last menstrual period,
• in combination with a second medicine, a prostaglandin (a substance that induces uterine contractions and softens the cervix), to be taken 36–48 hours after taking Mifegyne.

2. As a pretreatment prior to administration of prostaglandins for therapeutic termination of pregnancy beyond the third month of gestation.

3. To induce labour in cases where the fetus has died inside the uterus and in cases where other medical treatments (prostaglandin or oxytocin) cannot be used.

2. What you need to know before taking Mifegyne

Do not take Mifegyne:

• In all cases,
  • if you are allergic to mifepristone or to any of the other ingredients of this medicine (listed in section 6),
  • if you have adrenal failure,
  • if you suffer from severe asthma that cannot be adequately treated with medication,
  • if you have hereditary porphyria.

Page 9 of 15

• Additionally, for termination of pregnancy up to the 63rd day after the last menstrual period:
  • if pregnancy has not been confirmed by laboratory test or ultrasound examination,
  • if the first day of your last menstrual period was more than 63 days ago,
  • if your doctor suspects an ectopic pregnancy (the egg has implanted outside the uterus),
  • if you cannot take the selected prostaglandin analogue.

For termination of pregnancy beyond the 3rd month of pregnancy:
If you cannot take the selected prostaglandin analogue.
Warnings and precautions
Talk to your doctor before taking Mifegyne:

• if you have liver or kidney disease,
• if you are anaemic or malnourished,
• if you have cardiovascular disease (heart or circulatory disease),
• if you are at increased risk of cardiovascular diseases. Risk factors include being over 35 years of age, being a smoker, or having high blood pressure, high cholesterol levels in the blood, or diabetes,
• if you suffer from a disease that may affect blood clotting,
• if you suffer from asthma.

If you use an intrauterine contraceptive device (IUD), it must be removed before taking Mifegyne.
Before taking Mifegyne, your Rh blood factor must be determined. If you are Rh negative, your
doctor will advise you on the routine treatment required.
Serious skin adverse reactions have been reported in association with treatment with Mifegyne,
including toxic epidermal necrolysis and acute generalized exanthematous pustulosis.
Stop using Mifegyne and contact your doctor immediately if you notice the appearance of any
symptom described in section 4. If you experience a serious skin reaction, do not take mifepristone again in the future.
Other medicines and Mifegyne
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:

• corticosteroids (used to treat asthma or other inflammatory conditions)
• ketoconazole, itraconazole (used to treat fungal infections)
• erythromycin, rifampicin (antibiotics)
• St John’s wort (a herbal remedy used for the treatment of mild depression)
• phenytoin, phenobarbital, carbamazepine (used to treat seizures; epilepsy)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid or diclofenac.

Mifegyne with food and drink
Do not consume grapefruit juice during treatment with Mifegyne.
Pregnancy, breastfeeding and fertility
Pregnancy
Page 10 of 15
Failure of pregnancy termination (continuation of pregnancy) following administration of Mifegyne alone or in combination with prostaglandin has been associated with congenital malformations.
The risk of failure increases:

• if the prostaglandin is not administered in accordance with medical instructions (see section 3)
• with the duration of pregnancy
• with the number of previous pregnancies

If termination of pregnancy is unsuccessful after taking this medicine or combination of medicines, there is an unknown risk to the fetus. If you decide to continue the pregnancy, you should undergo careful prenatal monitoring and repeated ultrasound examinations, with particular attention to the limbs, at a specialized clinic. Your doctor will provide you with further information.
If you decide to proceed with termination of pregnancy, another method will be used. Your doctor will advise you of the available options.
Breastfeeding
If you are breastfeeding, inform your doctor before using this medicine. Do not breastfeed during treatment with Mifegyne, as the medicine passes into breast milk.
Fertility
This medicine does not affect fertility. A new pregnancy is possible immediately after completion of the termination of pregnancy. Contraception should therefore be started immediately after the doctor confirms that the pregnancy has been terminated.
Driving and use of machines
Dizziness may occur as a side effect related to the abortion procedure. Exercise particular caution when driving or operating machinery until you know how Mifegyne affects you.

3. How to take Mifegyne

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
5) Medical termination of an ongoing intrauterine pregnancy (IUP)
Termination of pregnancy up to 49 days after the last menstrual period
Dosage in adults

• 1 tablet to be taken orally

Taking the tablet

• Swallow the tablet whole with a glass of water in the presence of a doctor or a member of the medical team.
• Take the prostaglandin analogue 36–48 hours after Mifegyne. The prostaglandin is administered either as tablets to be swallowed with water (misoprostol 400 micrograms) or as a vaginal pessary (gemeprost 1 mg).

Page 11 of 15

• If vomiting occurs within 45 minutes after taking the mifepristone tablet, contact your doctor immediately. You will need to take another tablet.

Termination of pregnancy 50–63 days after the last menstrual period
Dosage in adults

• 1 tablet to be taken orally

Taking the tablet

• Swallow the tablet whole with a glass of water in the presence of a doctor or a member of the medical team.
• Take the prostaglandin analogue 36–48 hours after Mifegyne. The prostaglandin is a vaginal pessary (gemeprost 1 mg).
• If vomiting occurs within 45 minutes after taking the mifepristone tablet, contact your doctor immediately. You will need to take another tablet.

This method requires your active participation, and you must be informed that:

• You will need to take the second medication (containing prostaglandin) to ensure the effectiveness of the treatment.
• You must attend a follow-up visit (3rd visit) within 14–21 days after taking Mifegyne to confirm termination of pregnancy, complete expulsion, and to assess your health status.

For medical termination of pregnancy, the following programme will be followed:

1. Mifegyne will be handed to you at the prescribing centre and must be taken orally.
2. 36–48 hours later, the prostaglandin analogue will be administered. You must rest for 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, you will experience vaginal bleeding, lasting on average 12 days, with gradually decreasing intensity.
   4) You must return to the centre for a follow-up visit within 14–21 days after taking
   Mifegyne to confirm that expulsion is complete.
   Contact the prescribing centre immediately:

• if vaginal bleeding lasts longer than 12 days and/or is very heavy (e.g. more than 2 sanitary pads per hour for 2 hours)
• if you have severe abdominal pain
• if you have fever or feel cold with shivering.

Another important point to remember:

• Vaginal bleeding does not necessarily mean that expulsion is complete.

Uterine bleeding usually starts 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 complete evacuation. For this reason, you must return to the centre.
If the pregnancy continues or expulsion is incomplete, your doctor will advise you on the available options to complete the termination of pregnancy.
It is recommended that you do not travel far from the prescribing centre until the follow-up visit has been completed.
Page 12 of 15
In case of emergency, or if you have any questions, call or go to the prescribing centre. Do not wait until the scheduled follow-up appointment.
6) For termination of pregnancy beyond the first trimester:
Dosage in adults

• 1 tablet to be taken orally

Taking the tablet

• Swallow the tablet whole with a glass of water.
• 36–48 hours after taking this medicine, take the prostaglandin analogue, which may be repeated several times at regular intervals until expulsion is complete.
• If vomiting occurs within 45 minutes after taking the mifepristone tablet, contact your doctor immediately. You will need to take another tablet.

7) For induction of labour when the pregnancy has been terminated (intrauterine fetal death).
Dosage in adults

• 1 tablet to be taken orally for two consecutive days

Taking the tablet

• Swallow the tablet whole with a glass of water.
• If vomiting occurs within 45 minutes after taking the mifepristone tablet, contact your doctor immediately. You will need to take another tablet.

Use in adolescents
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 emergency department.
Your doctor will provide you with the exact amount of Mifegyne; therefore, it is unlikely that you will take an excessive number of tablets. Taking too many tablets may cause symptoms of adrenal insufficiency. Symptoms of acute intoxication may require specialist treatment, including administration of dexamethasone.
If you forget to take Mifegyne
If you forget to take any part of the treatment, the method may not be fully effective. Speak to your doctor if you have forgotten to take Mifegyne or the prescribed part of the treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Severe side effects:
Page 13 of 15

• Allergic reaction. Skin rash, localized swelling of the face and/or larynx, sometimes accompanied by hives.
• Reddish patches on the trunk; the patches are target-shaped or circular macules, often with central blisters, skin peeling, mouth, throat, nasal, genital, and ocular ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis, frequency: rare).
• A widespread, red, scaly rash, with subcutaneous swellings and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption, acute generalized exanthematous pustulosis, frequency: not known).

Other serious side effects:

• Cases of severe or fatal toxic or septic shock. Fever with muscle pain, tachycardia, dizziness, diarrhea, vomiting, or feeling of weakness. This side effect may occur if you do not take the second medicine, the misoprostol tablet, orally.

If you experience any of these side effects, seek IMMEDIATE medical attention from your doctor or go to the nearest emergency room.
Other side effects
Very common (may affect more than 1 in 10 people):

• uterine contractions or cramps
• diarrhea
• nausea or vomiting

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

• heavy bleeding
• mild to moderate gastrointestinal cramps
• uterine infection (endometritis and 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
• general malaise or feeling of fatigue
• vaginal symptoms (hot flashes, dizziness, chills)
• hives and skin reactions, which may be severe
• Uterine rupture following administration of prostaglandin during the second and third trimesters of pregnancy, particularly in multiparous women or women who have previously undergone cesarean section.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mifegyne

Page 14 of 15
Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the carton or blister pack show signs of deterioration.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Mifegyne contains
The active substance is mifepristone.
One tablet of Mifegyne contains 600 mg of mifepristone.
The other components are: anhydrous colloidal silica, maize starch, povidone, magnesium stearate,
microcrystalline cellulose.

Description of the appearance of Mifegyne and the contents of the pack
Mifegyne is available as biconvex, light yellow, almond-shaped tablets, 19 mm long and 11 mm wide, with the symbol "γ" engraved on one side and "600" on the other.
Mifegyne is available in packs containing 1, 8, 16 or 20 tablets in PVC/aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
EXELGYN
216 boulevard Saint-Germain
75007 Paris
France

Manufacturer:
Laboratoires MACORS
ZI Plaine des Isles
89000 Auxerre
France.
Nordic Pharma B.V.
Siriusdreef 41
2132 WT Hoofddorp
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names: MIFEGYNE;
Page 15 of 15