Mifegyne 200 mg. 3 tablets

What Mifegyne is and what it is used for
Mifegyne tablets contain mifepristone, which is an antihormone that works by blocking the effects of progesterone, the hormone needed to continue pregnancy. Therefore, Mifegin can cause pregnancy interruption. It can also be used to soften and open the entrance (cervix) of the womb (uterus).

Mifegyne is recommended for use:
1) For medical termination of pregnancy:
- no later than 63 days from the first day of your last menstrual period,
- in combination with another medicine, prostaglandin (a substance that unlocks uterine contractions and softens the cervix), which is administered from 36 to 48 hours after administration of Mifegin.
2) To soften and open the cervix before surgically terminating the pregnancy during the first three months.
3) As a preparatory treatment before the administration of prostaglandins for termination of pregnancy for medical reasons after the 3rd month of pregnancy.
4) To induce birth activity in cases where the fetus has died inside the uterus and when treatment with other drugs (prostaglandin or oxytocin) is not possible.

2. What you need to know before you take Mifegyne

Do not take Mifegyne:
• In any case,
- 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 that cannot be adequately treated with medication,
- if you have hereditary porphyria.

• Also,
For abortion up to 63 days after last menstruation:
- if your pregnancy is not confirmed by a bioassay or ultrasound,
- if the first day of your last menstruation was more than 63 days ago,
- if your doctor suspects an ectopic pregnancy (the egg has implanted outside the uterus),
- if you cannot accept the selected prostaglandin analogue.

To soften and open the cervix before surgical termination of pregnancy:
- if the pregnancy is not confirmed by a bioassay or ultrasound scan,
- if your doctor suspects an ectopic pregnancy,
- if the first day of your last menstrual period was 84 or more days ago.

To terminate pregnancy after the 3rd month of pregnancy:
- if you cannot accept the selected prostaglandin analogue,

Warnings and precautions
Talk to your doctor before using Mifegyne
- if you have liver or kidney disease,
- if you suffer from anemia or malnutrition,
- if you have heart disease (heart disease and circulatory disorders),
- if you are at increased risk for cardiovascular disease. Risk factors include age over 35 and smoking or high blood pressure, high blood cholesterol or diabetes,
- if you have a condition that affects your blood clotting,
- if you suffer from asthma.

If you are using a birth control spiral, it must be removed before you take Mifegin.

You will be given a blood test for Rhesus before you take Mifegin. If you are Rh-negative, your doctor will advise you on routinely needed treatment.

Other medicines and Mifegyne
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines, including medicines obtained without a prescription:

corticosteroids (used in the treatment of asthma or other inflammatory diseases),
ketoconazole, itraconazole (used in the treatment of fungal infections), erythromycin, rifampicin (antibiotics),
St. John's wort (a 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.
Mifegin with food and drink
You should not take grapefruit juice when you are being treated with Mifegin.

Pregnancy, breastfeeding and fertility
Pregnancy
Unsuccessful termination of pregnancy (continued pregnancy) after administration of Mifegin alone or in combination with prostaglandin and worn to term, is associated with birth defects. The risk of failure increases:
- If prostaglandins are not administered according to the prescribing instructions (see section 3).
- With the advancement of pregnancy.
- With the number of your previous pregnancies.

If pregnancy termination is unsuccessful after taking this medicine or combination of medicines, there is an unspecified risk to the fetus. If you decide to continue with pregnancy, careful prenatal monitoring and multiple ultrasounds should be performed, with special attention to the limbs, in a specialist clinic. Your doctor will advise you further. If you do decide to terminate your pregnancy, another method will be used.
Driving and using machines
Dizziness may occur as a side effect associated with the abortion process. Be especially careful when driving or using machines after taking this medicine 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, ask your doctor or pharmacist.

1) Medicinal interruption of an intrauterine developing pregnancy

Breastfeeding up to 49 days after your last menstrual cycle

Dosage in adults
- You must take 3 tablets by mouth

Taking the tablet
- Swallow the tablet whole with a glass of water, in the presence of a doctor or a member of his / her team.
- Take the prostaglandin analogue 36-48 hours after Mifegin. Prostaglandin is also taken in the form of tablets that are swallowed with water (misoprostol 400 micrograms) or in the form of vaginal pessaries (hemoprost 1 mg).
- If you vomit within 45 minutes of taking mifepristone tablets, talk to your doctor immediately. You will need to take the tablets once more.
Breastfeeding 50 - 63 days after your last menstrual cycle

Dosage in adults
- You must take 3 tablets by mouth.

Taking tablets
Swallow the tablets whole with a glass of water in the presence of a doctor or a member of his / her team.
Take the prostaglandin analogue 36-48 hours after Mifegin. Prostaglandin is in the form of a vaginal pesar (hemeprost 1 mg).
- If you vomit within 45 minutes of taking mifepristone tablets,
talk to your doctor immediately. You will need to take the tablets once more.

This method requires your active involvement and you should be informed of: You must take the second medicine (which contains prostaglandin) to be sure of the effectiveness of the treatment.
- You should go for a checkup (3rd visit) between 14-21 days after taking Mifegin to check if your pregnancy is terminated, your fetal bag is discarded and you are well.

The scheme for medical termination of pregnancy is:
1) At the hospital where you are prescribed the medicine, you will be given Mifegin, which you should take orally.
2) You will be given a prostaglandin analogue 36 to 48 hours later. You should stay at least 3 hours after taking a prostaglandin analogue.
3) The embryo may be discarded within a few hours after administration of the prostaglandin analogue or within the next few days. You will have vaginal bleeding, which will last an average of 12 days after taking Mifegin, and will gradually weaken over time.
4) You must return to the center within 14 - 21 days after receiving Mifegin for a checkup to check that the expulsion is complete.

Contact the healthcare facility where you are prescribed the medicine:
- if you have vaginal bleeding for more than 12 days and / or if it is very severe (eg if you use more than 2 dressings per hour for 2 hours)
- if you have acute abdominal pain,
- if you have a fever or if you are cold and shaking.

Other important things to remember:
- The presence of vaginal bleeding does not mean that the expulsion is complete.
Uterine bleeding usually begins 1 to 2 days after taking Mifegin.
In rare cases, expulsion may occur before the administration of prostaglandin. It is very important to have a check-up to confirm that a full expulsion has occurred and therefore you must go to the hospital again.

If the pregnancy is ongoing or the expulsion is incomplete, your doctor will advise you on the options to complete the termination of pregnancy.

It is recommended that you carry out the follow-up examination not to travel far from the hospital where you are prescribed the medicine,

In case of emergency, or if you have any questions, call or visit the hospital where you are prescribed the medicine. You do not have to wait for the date of your inspection.

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

Dosage in adults
- You must take 1 tablet by mouth.

Taking the tablet
- Swallow the tablet whole with a glass of water.
- If you vomit within 45 minutes of taking the mifepristone tablet, talk to your doctor immediately. You will need to take another tablet.

The scheme for medical termination of pregnancy is:
1) At the hospital where you are prescribed the medicine, you will be given Mifegin, which you should take orally.
2) 36 to 48 hours after that, you will return to the hospital where you are prescribed the medicine for the surgical procedure.

Your doctor will explain to you what the procedure is. After taking Mifegin, you may have bleeding prior to the surgical procedure.

In rare cases, expulsion may also occur before the surgical procedure. It is very important to come back
How to store Mifegyne

Keep out of the reach and sight of children.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if the box or blisters show signs of damage.
Do not dispose of medicines in the sewer. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information

What Mifegyne  contains
The active substance is mifepristone.
One tablet of Mifegin contains 200 mg of mifepristone.

The other ingredients are: anhydrous colloidal silicon, corn starch, povidone, magnesium stearate (E572), microcrystalline cellulose (E460).

What Mifegyne looks like and contents of the pack.
Mifegyne is available in the form of a yellow biconvex tablet with a diameter of 11 mm and embossed on one side with "167 V".

Mifegyne is available in packs of 1, 3x1, 15x1 or 30x1 tablets in perforated unit dose blisters of PVC / aluminum.
Not all pack sizes may be marketed.

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