200 mg tablets
mifepristone
What Mifegyne is and what it is used for
Mifegyne tablets contain mifepristone, an anti-hormone that inhibits the effect of progesterone, a hormone that is necessary for pregnancy to continue. Mifegyne can therefore cause miscarriage. It can also be used to soften and dilate the cervix.
Mifegyne is recommended for use:
1) For medical termination of pregnancy:
- no later than 63 days after the first day of your last menstrual cycle,
- in combination with another medicine, prostaglandin (a substance that triggers uterine contractions and softens the cervix) that you take 36 to 48 hours after taking Mifegyne.
2) To soften and dilate (dilate) the cervix before surgical abortion during the first trimester.
3) As a pre-treatment before prostaglandin is administered when pregnancy lasting longer than 3 months is terminated for medical reasons.
4) To induce (induce) labor in cases where the fetus has died in utero and where it is not possible to use other medical treatments ( prostaglandin or oxytocin ).
Mifepristone contained in Mifegyne may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Mifegyne
Do not use Mifegyne:
• In all cases,
- if you are allergic to mifepristone or any of the other ingredients of this medicine (listed in section 6),
- if you suffer from adrenal insufficiency,
- if you suffer from severe asthma , which can not be treated with adequate medication,
- if you have hereditary porphyria .
• In addition,
For termination of pregnancy 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 extrauterine pregnancy (ectopic pregnancy, the fertilized egg has attached outside the uterus),
- if you can not take the selected prostaglandin .
To soften and widen the cervix (cervix) before surgical abortion:
- if the pregnancy has not been confirmed by a biological test or ultrasound,
- if your doctor suspects an extrauterine pregnancy (ectopic pregnancy),
- if the first day of your last menstrual cycle was 84 days ago or more.
For termination of pregnancy after the third month of pregnancy:
- if you can not take the selected prostaglandin
Warnings and cautions
Talk to your doctor before taking Mifegyne
- if you have any liver or kidney disease
- if you have anemia ( anemia ) or are malnourished
- if you have any cardiovascular disease
- if you are at increased risk of developing cardiovascular disease. Some risk factors are that you are over 35 years old, a smoker, have high blood pressure , high blood cholesterol levels or diabetes
- if you have any disease that affects coagulation one of the blood
- if you suffer from asthma .
If you have an IUD, it must be removed before using Mifegyne.
Before taking Mifegyne, the blood will be tested for the Rh factor. If you are Rh-negative, your doctor will provide information on what routine treatment is required.
Severe skin reactions, including toxic epidermal necrolysis and acute generalized
exanthematous pustulosis, have been reported in association with treatment with Mifegyne.
Stop using Mifegyne and seek medical attention immediately if you get any of the symptoms described in section 4. If you get 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 taking, have recently taken, or might take any other medicines.
In particular, you should tell your doctor if you take the following:
- corticosteroids (used to treat asthma or to treat certain inflammations )
- ketoconazole , itraconazole (used to treat fungal infections)
- erythromycin, rifampicin ( antibiotics )
- St. John’s wort (natural medicine used to treat 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
Grapefruit juice should not be taken while you are being treated with Mifegyne.
Pregnancy, breastfeeding and fertility
Pregnancy
If the abortion fails (continued pregnancy) after the woman has taken Mifegyne alone or in combination with prostaglandin, malformations have been seen in the full-term pregnancy in the child. The risk of abortion failing increases:
- If prostaglandin is not taken as prescribed by your doctor ( see section 3)
- Depending on how far along the pregnancy is
- Depending on the number of previous pregnancies
If the abortion fails after the woman has taken this drug or this combination of drugs, it is not known what risk this entails for the fetus. If you decide to allow the pregnancy to continue, until the birth, careful checks and repeated ultrasound examinations (especially of the arms and legs) must be performed at a specialist clinic. Your doctor can provide additional information.
If you decide you still want to terminate your pregnancy, another method will be used. Your doctor will provide information on the various options.
Breast-feeding
If you are breastfeeding, talk to your doctor before using this medicine. Do not breastfeed while taking Mifegyne as the medicine passes into breast milk.
Fertility
This medicine does not affect fertility. You can get pregnant again as soon as the abortion is complete. You must start using a contraceptive method immediately as soon as your doctor has confirmed that your pregnancy has been terminated.
Driving and using machines
You may experience dizziness as a side effect of the abortion process itself. Be careful if you drive or use machines after taking Mifegyne until you know how the medicine affects you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Mifegyne
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
1) Medical termination of intrauterine pregnancy (medical abortion)
Termination of pregnancy up to 49 days after the last menstrual cycle
Dosage for adults
- 3 tablets taken by mouth
Take the tablet like this - Swallow the tablets whole with a glass of water in the presence of a doctor or other healthcare professional
- Take prostaglandin 36-48 hours after Mifegyne. Prostaglandin et is given either as tablets (misoprostol 400 micrograms) to be swallowed with water or as a vagitorium (gemeprost 1 mg).
- If you vomit within 45 minutes of taking Mifegyne, you must contact your doctor immediately. You will need to take additional tablets.
Termination of pregnancy 50‑63 days after the last menstrual cycle
Dosage for adults
- 3 tablets taken by mouth
Take the tablet like this - Swallow the tablets whole with a glass of water in the presence of a doctor or other healthcare professional
- Take prostaglandin 36-48 hours after Mifegyne. Prostaglandin et is a vagitorium (gemeprost 1 mg).
- If you vomit within 45 minutes of taking Mifegyne, you must contact your doctor immediately. You will need to take additional tablets.
This method requires your participation and you must therefore be aware of the following:
- You will need to take another medicine (which contains prostaglandin ) to ensure effective treatment.
- You must make a follow-up visit (third visit) 14-21 days after taking Mifegyne to determine that a complete abortion has taken place and that you are well.
The schedule for medical termination of pregnancy looks like this:
1) At the treatment clinic you will receive Mifegyne, which you must take by mouth.
2) 36-48 hours later you get prostaglandin et. You must rest for 3 hours after receiving prostaglandin.
3) The abortion can take place within a few hours after you have taken the prostaglandin or in the following days. You will bleed from the vagina for an average of 12 days after taking Mifegyne – over time the bleeding will decrease.
4) You must make a follow-up visit to the treatment clinic 14-21 days after taking Mifegyne to check that the abortion is complete.
Contact the treating clinic immediately:
– if you have vaginal bleeding for more than 12 days and/or if the bleeding is very heavy (eg if you need to use more than 2 bandages per hour for 2 hours)
– if you have severe abdominal pain
– if you have a fever or feel frozen and shivering.
Another important thing to remember:
- Vaginal bleeding does not mean that the abortion is complete.
Uterine bleeding generally begins 1-2 days after you take Mifegyne.
In rare cases, the abortion may take place before you take prostaglandin. It is of utmost importance that an examination is performed to confirm that the uterus is empty, and therefore a new visit to the clinic is needed.
If the pregnancy continues or the abortion is not complete, the doctor will inform you about the options available to terminate the pregnancy completely.
We recommend that you do not make any trips which means that you are far away from the treatment clinic before the follow-up visit.
If something happens urgently or if you have any questions, call the treatment clinic or go there. You do not have to wait for the follow-up visit.
2) To soften and widen the cervix before surgical abortion
Dosage for adults
- 1 tablet taken by mouth
Take the tablet like this - Swallow the tablet whole with a glass of water
- If you vomit within 45 minutes of taking Mifegyne, you must contact your doctor immediately. You will need to take another tablet.
The schedule looks like this:1) At the treatment clinic you will receive Mifegyne, and you will need to take the medicine by mouth2) 36-48 hours later you will return to the treatment clinic for the surgical abortion.
Your doctor will explain the procedure to you. You may start bleeding after taking Mifegyne, before the procedure.
In rare cases, the abortion can take place before the procedure. You must return to the clinic to establish that a complete abortion has taken place.
You must return to the clinic of your choice for the procedure.
If something happens urgently or if you have any questions, call the treatment clinic or go there. You do not have to wait for the follow-up visit.
3) For termination of pregnancy after the third month of pregnancy
Dosage for adults
- 3 tablets taken by mouth
Take the tablet like this - Swallow the tablets whole with a glass of water
- 36 – 48 hours later you take the prostaglandin , this can be repeated several times at regular intervals until the abortion is complete.
- If you vomit within 45 minutes of taking Mifegyne, you must contact your doctor immediately. You will need to take additional tablets.
4) To induce labor after the termination of pregnancy (in case of intrauterine fetal death)
Dosage for adults
- 3 tablets taken by mouth every day for two days
Take the tablet like this - Swallow the tablets whole with a glass of water
- If you vomit within 45 minutes of taking Mifegyne, you must contact your doctor immediately. You will need to take additional tablets.
Use for young people
There are only limited data on the use of Mifegyne in adolescents.
If you use more Mifegyne than you should
Your doctor will give you exactly the amount of Mifegyne tablets to take, so you are unlikely to take too many tablets. If you take too many tablets, you may experience symptoms of adrenal insufficiency. Signs of acute poisoning may require specialist treatment, including treatment with dexamethasone.
If you forget to take Mifegyne
If you forget to take any part of the treatment, likely, the method will not be completely effective. Talk to your doctor or midwife if you forget to take Mifegyne or any of the prescribed treatments.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
- Allergic reaction . Skin rash, local swelling of the face and / or larynx, possibly with hives
- Reddish; target-like or round spots on the torso, often with blisters in the middle, flaky skin, sores 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 red, scaly, widespread rash with bumps under the skin and blisters along with fever. Symptoms usually appear at the beginning of treatment ( acute generalized exanthematous pustulosis , frequency: no known frequency).
Other serious side effects:
- Cases of severe or fatal toxic or septic shock . Fever with muscle aches, fast heart rate, dizziness, diarrhea, vomiting or feeling weak. You can get this side effect one if you do not take the other medicine, the misoprostol tablet, by mouth.
If you get any of these side effects, you must contact your doctor IMMEDIATELY or go to the emergency department of the nearest hospital.
Other side effects are
Very common (may affect more than 1 user in 10):
- contractions or cramps in the uterus
- diarrhea
- nausea or vomiting
Common (may affect up to 1 in 10 people):
- profuse bleeding
- mild to moderate cramps in the gastrointestinal tract
- uterine infection (uterine inflammation and pelvic inflammatory disease (PID))
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 fatigue
- hot flashes, dizziness, chills (vagal symptoms)
- hives and skin reactions, which can be serious
- ruptured uterus after treatment with prostaglandin during the second and third trimesters of pregnancy, especially in women who have given birth to several children or women with a caesarean section scar
How to store Mifegyne
Keep this medicine out of the sight and reach of children.
No special temperature instructions.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after “EXP” and on the blister after “EXP”. The expiration date is the last day of the specified month.
Do not use this medicine if the package or blister shows signs of damage.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is mifepristone.
One tablet of Mifegyne contains 200 mg of mifepristone.
The other ingredients are anhydrous colloidal silica, corn starch, povidone, magnesium stearate, microcrystalline cellulose.
What the medicine looks like and contents of the pack
Light yellow, cylindrical, biconvex tablets, with a diameter of 11 mm and “167 B” embossed on one side.
Mifegyne is available in pack sizes of 1, 3 x 1, 15 x 1, or 30 x 1 tablets in PVC / aluminum perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
EXELON
216 boulevard Saint-Germain
75007 Paris
France
Manufacturer:
Macors Laboratories
89000 Auxerre
France
Agent :
Nordic Drugs AB
Box 300 35
200 61 Limhamn