MISOONE 400 МКГ Коированная таблетка

Содержание инструкции

1. Misoone 400 micrograms, tablets
   1. What is Misoone and what is it used for
   2. What you need to know before taking Misoone
   3. How to take Misoone
   4. Possible side effects
   5. How to store Misoone
   6. Contents of the pack and other information

Misoone 400 micrograms, tablets

Misoprostol
Read this leaflet carefully before you take this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor.

The use of the drug must be applied in strict compliance with the regulatory provisions provided by
Law 22 May 1978, No. 194. Hospitalization must be guaranteed in one of the healthcare facilities identified
by Article 8 of the aforementioned Law 194/78 from the time of taking the drug until verification
of the expulsion of the products of conception. The drug must be taken within the seventh
week of amenorrhea.

Contents of this leaflet:

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

1. What is Misoone and what is it used for

Misoone tablets contain misoprostol, a compound similar to a chemical substance called
“prostaglandin” produced naturally by the human body. Misoprostol stimulates uterine
contractions and causes cervical relaxation.
For medical termination of pregnancy, Misoone must be used following the intake of another
medicine called mifepristone. It must be taken no later than 49 days from the first
day of the last menstrual period.
For surgical termination of pregnancy: Misoone is taken alone before surgical termination
of pregnancy during the first trimester of pregnancy (within 12 weeks from the first day of your
menstruation).

2. What you need to know before taking Misoone

Do not take Misoone:

• if you are allergic to misoprostol, to any other prostaglandin or to any of the other ingredients of this medicine (listed in section 6)
• if pregnancy has not been confirmed by ultrasound or biological tests
• -if the doctor suspects an ectopic pregnancy (pregnancy in which the embryo has implanted outside the uterus)
• if you cannot take mifepristone (when mifepristone is used in combination with Misoone)
• for medical termination of pregnancy, if the first day of your last menstrual period was more than 49 days (7 weeks) ago.

Warnings and precautions
Before taking Misoone, talk to your doctor:

• if you have liver or kidney problems
• if you suffer from anaemia or malnutrition
• if you have cardiovascular diseases (heart or circulatory diseases)
• if you have an increased risk of cardiovascular diseases. Risk factors include: age over 35 years and being a smoker or having high blood pressure, high cholesterol levels or diabetes
• if you have a condition that affects blood clotting
• if you have previously had a caesarean section or uterine surgery

Healthcare professionals must ensure that, due to the risk of method failure and congenital defects observed in ongoing pregnancies, patients must be informed of the risk of teratogenicity and that a follow-up visit must be scheduled to check that the expulsion has been completed (see section Pregnancy, breastfeeding and fertility).
Before taking mifepristone and Misoone, you will undergo a blood test to determine your Rh factor. If the analysis shows that your blood is Rh-negative, your doctor will be able to tell you the necessary routine treatment.
For medical termination of pregnancy:
If you are using an intrauterine device (IUD), it must be removed before taking the first medicine, mifepristone.
For surgical termination of pregnancy:

• Because there is no data available on cervical preparation with misoprostol before surgical termination of pregnancy before the first trimester, Misoone should not be taken after 12 weeks after the first day of the menstrual cycle.
• Due to the possible onset of vaginal bleeding after taking this medicine, you should preferably take Misoone at the treatment centre before the surgical procedure.

Other medicines and Misoone
Tell your doctor if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
In particular, tell your doctor if you are taking any of the following medicines:

• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid or diclofenac
• Antacids or antacid medicines containing magnesium (used to treat heartburn and acid reflux)

Pregnancy, breastfeeding and fertility
Pregnancy
Failure to interrupt the pregnancy (continuation of the pregnancy) following the intake of Misoone has been associated with a three times higher risk of congenital malformations, in particular facial paralysis, head and limb malformations. Neonatal defects have also been observed when this medicine has been taken alone. For medical termination of pregnancy, it is necessarythat you take the other medicine, mifepristone, 36-48 hours before taking Misoone.
The risk of failure related to Misoone increases:

• if it is not taken orally
• with increasing gestational duration
• with the number of previous pregnancies
• for medical termination of pregnancy, if it is taken more than 49 days after the first day of the last menstrual period

If the termination of the pregnancy is unsuccessful after taking this medicine, there is a risk of unknown magnitude to the fetus. If you decide to continue the pregnancy, careful prenatal monitoring and repeated ultrasound examinations should be performed, with particular attention to the limbs and head, at a specialized clinic. Your doctor will be able to give you further advice.
If you decide to continue with the termination of the pregnancy, a different procedure will be used. Your doctor will tell you the possible options.
After taking these medicines, you should avoid becoming pregnant again before your next menstrual period. Immediately after confirmation of the termination of the pregnancy by your doctor, you should start using a contraceptive method.
Breastfeeding
If you are breastfeeding, ask your doctor before using this medicine. Avoid breastfeeding as this medicine passes into breast milk.
Fertility
This medicine has no effect on fertility. You can become pregnant again as soon as the termination of pregnancy is complete. Immediately after confirmation of the termination of the pregnancy, you should start using a contraceptive method.

Driving and operating machinery
This medicine can cause dizziness. After taking this medicine, pay particular attention while driving vehicles or operating machinery until you know how Misoone affects you.

3. How to take Misoone

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Dosage in adults

• One tablet to be taken orally.

How to take the tablet

• In all cases:
• Swallow the tablets whole with water,
• If you vomit within 30 minutes of taking the tablet, contact your doctor immediately. You will need to take another tablet.

Contact the prescribing center immediately after the abortion procedure
(medical or surgical):

• if you experience vaginal bleeding for more than 12 days and/or if this bleeding isvery heavy (e.g., if you need to change more than 2 pads per hour for 2 hours)
• if you experience severe abdominal pain
• if you have a fever or chills
• For medical abortion

The planned schedule for taking Misoone for a medical abortion is as
follows.

• 1) At the prescribing center, you will be given the first medicine (mifepristone) which must be taken orally.
• 2) 36-48 hours later, you must take Misoone orally. You must rest for at least 3 hours after taking this medicine.
• 3) The embryo may be expelled within a few hours of taking Misoone or in the following days. You will experience vaginal bleeding that will last an average of 12 days after taking the first medicine (mifepristone) and its intensity will decrease over time.
• 4) You must return to the center within 14-21 days of taking the first medicine,mifepristone, for a check-up visit to confirm complete expulsion of theembryo.

Important things to remember when taking this medicine:
This tablet must be taken orally
For medical abortion, Misoone must be taken 36 to 48 hours after
taking 600 mg of mifepristone
If you do not follow these instructions, the risks associated with this medicine will increase

• For surgical abortion

The tablet must be taken 3 to 4 hours before the surgical abortion
procedure.
The planned schedule for taking Misoone for a surgical abortion is as
follows:

• 1) Take Misoone orally
• 2) The surgical procedure will be performed 3 to 4 hours after taking it

You will experience vaginal bleeding that will last an average of 12 days after the surgical procedure and its intensity
will decrease over time.

• 3) You must return to the center within 14-21 days after this surgical procedure for a check-upvisit.

Other important things to remember:

• In all cases, do not take this medicine if the blister is damaged or if the tablet has been stored outside of the packaging

In case of emergency or for any questions, call or present yourself to the prescribing center. In
these cases, do not wait until the check-up visit.

• For medical abortion, the presence of vaginal bleeding does not imply that the expulsion has been completed after an abortion. The risk of side effects increases if you take this medicine more than 49 days after the first day of your last menstrual period or if you do not take it orally.

If the pregnancy continues or the expulsion is not complete, your doctor will be able to indicate the available options for
abortion.

It is recommended not to travel to places too far from the prescribing center until
the check-up visit is performed.

• For surgical abortionAfter taking Misoone, there is a risk of abortion before the start of the surgical procedure, although this risk is low. The risk of side effects increases if you take this medicine more than 12 weeks after the first day of your last menstrual period (first trimester of pregnancy).

Use in children and adolescents
Limited data are available on the use of misoprostol in adolescents.

If you take more Misoone than you should
If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency
room.
The doctor will give you the exact amount of Misoone; it is therefore unlikely that you will take too many tablets.
Taking an excessive number of tablets can cause symptoms such as lethargy, tremors, convulsions,
difficulty breathing, abdominal pain, diarrhea, fever, chest pain, low blood pressure and a slowed heart rate that can be fatal.

If you forget to take Misoone
If you forget to take mifepristone or Misoone, it is likely that the abortion will not be
completely effective. If you forget to take Misoone, contact your doctor or the prescribing center.
If you have any 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.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
The following side effects may occur:

Serious side effects
The risk of serious side effects increases if you take this medicine after:

• 49 days have passed since the first day of your last menstrual period for a medical termination of pregnancy, or
• 12 weeks have passed since the first day of your last menstrual period for a surgical termination of pregnancy.

Serious side effects include:

• allergic reaction. Severe skin rashes, such as itchy red spots, blisters or lesions.
• cardiovascular events. Chest pain, difficulty breathing, confusion or irregular heartbeat. This can lead to cardiac arrest.

Other serious side effects include:

• Cases of severe or fatal toxic shock or septic shock. Fever accompanied by muscle soreness, increased heart rate, dizziness, diarrhea, vomiting or feeling weak. These side effects may occur if you do not take this medicine orally or if you take it after 49 days have passed since the first day of your last menstrual period for a medical termination of pregnancy.

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

• uterine contractions or cramps
• diarrhea
• feeling sick (nausea) or being sick (vomiting)
• uterine bleeding

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

• heavy vaginal bleeding
• abdominal pain
• mild to moderate gastrointestinal cramps
• infection of the uterus (endometritis and pelvic inflammatory disease)
• birth defects (fetal malformations)

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

• fever
• fetal death
• headache, dizziness and feeling unwell or tired
• urticaria and skin conditions that may be severe
• uterine rupture: following the administration of prostaglandins in the second or third trimester of pregnancy, particularly in women who have previously given birth or who have a scar from a caesarean section.

Very rare (may affect up to 1 in 10,000 people)

• localized swelling of the face and/or larynx, which may occur with urticaria

Other side effects include:

• feeling cold, chills
• back pain

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Misoone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after the wording “EXP.”. The
expiry date refers to the last day of that month.
Store at a temperature below 25 °C.
Do not use this medicine if the outer packaging or blisters show signs of damage.
Do not use this medicine if the tablet has been stored outside of the blister.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Misoone contains
The active ingredient is misoprostol.
One Misoone tablet contains 400 micrograms of misoprostol.
The other excipients are: microcrystalline cellulose, hypromellose, sodium starch glycolate (type A), hydrogenated castor oil

Description of the appearance of Misoone and contents of the pack
Flat, round tablet, white in colour, with a diameter of 11 mm and a thickness of 4.5 mm, with a fracture line on each side and with a double “M” engraved on one side. The tablet can be divided into two equal doses.
Misoone is available in packs of 1, 4, 16 or 40 tablets in divisible blisters for single doses made of PVC-PCTFE/aluminium or aluminium/aluminium.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
EXELGYN - 216 boulevard Saint-Germain - 75007 Paris – France
Manufacturer
Nordic Pharma B.V.
Siriusdreef 41
2132 WT Hoofddorp
Netherlands
Delpharm Lille SAS
Rue de Toufflers 59390
Lys-lez- Lannoy, France
Laboratoires MACORS
Rue des Caillottes Z.I. Plaine des Isles
89000 Auxerre, France

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Austria: Topogyne
Belgium: Topogyne
Bulgaria: Topogyne
Croatia: Mispregnol
Cyprus: MisoOne
Czech Republic: Mispregnol
Denmark: Topogyne
Estonia: Topogyne
Finland: Topogyne
France: MisoOne
Germany: MisoOne
Greece: MisoOne
Ireland: MisoOne
Italy: Misoone
Latvia: Misoone
Lithuania: MisoOne
Luxembourg: Topogyne
Norway: Topogyne
Portugal: Topogyne
Romania: Topogyne
Slovenia: Topogyne
Sweden: Topogyne
Spain: MisoOne
Netherlands: MisoOne
United Kingdom (Northern Ireland): Topogyne