Misoone

PACKAGE LEAFLET: INFORMATION FOR THE USER

Misoone 400 micrograms, tablets

Misoprostol
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor.

The use of this medicinal product must comply strictly with the legal provisions set forth in Law No. 194 of 22 May 1978. Hospitalization must be ensured in one of the healthcare facilities designated under Article 8 of the aforementioned Law 194/78, from the moment of drug administration until confirmation of expulsion of the products of conception. Administration of the drug must occur 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 taking 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 Misoone is and what it is used for

Misoone tablets contain misoprostol, a compound similar to a chemical substance called "prostaglandin" naturally produced by the human body. Misoprostol stimulates uterine contractions and causes cervical ripening.
For medical termination of pregnancy, Misoone must be used following the administration 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 prior to surgical termination of pregnancy during the first trimester of pregnancy (within 12 weeks from the first day of the last menstrual period).

2. What you should 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 your doctor suspects an ectopic pregnancy (a 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 more than 49 days (7 weeks) have passed since the first day of your last menstrual period.

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

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

Healthcare providers must ensure that, due to the risk of treatment failure and congenital defects observed in ongoing pregnancies, patients are informed of the risk of teratogenicity and that a follow-up visit must be scheduled to confirm complete expulsion (see section Pregnancy, breast-feeding and fertility).
Before taking mifepristone and Misoone, you will undergo a blood test to determine your Rh factor. If the test shows that your blood is Rh-negative, your doctor will advise you on the necessary routine treatment.
For medical termination of pregnancy:
If you use an intrauterine contraceptive device (IUD), it must be removed before taking the first medicine, mifepristone.
For surgical termination of pregnancy:

• Since there are no data available on cervical ripening with misoprostol before surgical termination of pregnancy in the first trimester, Misoone must not be taken after 12 weeks from the first day of the last menstrual period.
• Due to the possible occurrence of vaginal bleeding after taking this medicine, Misoone should preferably be taken at the treatment centre before the surgical procedure.

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

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

Pregnancy, breast-feeding and fertility
Pregnancy
Failure to terminate pregnancy (continuation of pregnancy) following administration of Misoone has been associated with a threefold increased risk of congenital malformations, particularly facial palsy and malformations of the head and limbs. Neonatal defects have also been observed when this medicine was taken alone. For medical termination of pregnancy, it is mandatory that you take the other medicine, mifepristone, 36–48 hours before taking Misoone.
The risk of failure associated with Misoone increases:

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

If termination of pregnancy is unsuccessful after taking this medicine, there is an unknown risk to the fetus. If you decide to continue the pregnancy, careful prenatal monitoring and repeated ultrasound examinations, with particular attention to limbs and head, must be performed at a specialized clinic. Your doctor will be able to provide further advice.
If you decide to proceed with termination of pregnancy, a different procedure will be used. Your doctor will inform you about the available options.
After taking these medicines, you must avoid becoming pregnant again before your next menstrual cycle. Immediately after confirmation of pregnancy termination by your doctor, you should start using contraception.
Breast-feeding
If you are breast-feeding, consult your doctor before using this medicine. Avoid breast-feeding, as this medicine passes into breast milk.
Fertility
This medicine has no effect on fertility. You may become pregnant again as soon as the termination of pregnancy is complete. Immediately after confirmation of pregnancy termination, you should start using contraception.
Driving and using machines
This medicine may cause dizziness. After taking this medicine, take particular care when driving or using machines until you know how Misoone affects you.

3. How to take Misoone

Take this medicine exactly as directed by 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 after taking the tablet, contact your doctor immediately. You will need to take another tablet.

Contact the prescribing center immediately after the procedure for termination of pregnancy
(medical or surgical):

• if you experience vaginal bleeding lasting longer than 12 days and/or if the bleeding is very heavy (e.g., if you need to change more than 2 sanitary pads per hour over a 2-hour period)

• if you experience severe abdominal pain

• if you have a fever or feel cold with chills

• For medical termination of pregnancy

The recommended schedule for taking Misoone for medical termination of pregnancy is as follows:

1. At the prescribing center, you will be given the first medicine (mifepristone), which you must take orally.
2. 36–48 hours later, you must take Misoone orally. You should remain at 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, which will last on average 12 days after taking the first medicine (mifepristone), and the intensity will gradually decrease over time.
4. You must return to the center 14–21 days after taking the first medicine (mifepristone) for a follow-up visit to confirm complete expulsion of the embryo.

Important points to remember when taking this medicine:
This tablet must be taken orally.
For medical termination of pregnancy, 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 termination of pregnancy

The tablet must be taken 3 to 4 hours before the surgical termination of pregnancy procedure.
The recommended schedule for taking Misoone for surgical termination of pregnancy is as follows:

1. Take Misoone orally.
2. The surgical procedure will be performed 3 to 4 hours after this dose.
   You will experience vaginal bleeding lasting on average 12 days after the surgical procedure, with decreasing intensity over time.
3. You must return to the center 14–21 days after the surgical procedure for a follow-up visit.

Other important points to remember:

• In all cases: Do not take this medicine if the blister pack is damaged or if the tablet has been stored outside the original packaging.

In case of emergency or if you have any questions, call or go to the prescribing center. In these cases, do not wait until your follow-up visit.

• For medical termination of pregnancy:
  • Vaginal bleeding does not necessarily mean that the expulsion has been completed after termination of pregnancy.
  • The risk of adverse effects increases if you take this medicine more than 49 days after the first day of the last menstrual period or if you do not take it orally.

If the pregnancy continues or expulsion is incomplete, your doctor will advise you on the available options for terminating the pregnancy.
It is recommended not to travel far from the prescribing center until after the follow-up visit.

• For surgical termination of pregnancy:
  • After taking Misoone, there is a risk of abortion occurring before the surgical procedure begins, although this risk is low.
  • The risk of adverse effects increases if you take this medicine more than 12 weeks after the first day of the 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 department.
Your doctor will provide you with the exact dose of Misoone; therefore, it is unlikely that you will take too many tablets.
Taking an excessive number of tablets may cause symptoms such as lethargy, tremors, seizures, breathing difficulties, abdominal pain, diarrhea, fever, chest pain, low blood pressure, and reduced heart rate, which may be fatal.

If you forget to take Misoone
If you forget to take mifepristone or Misoone, the termination of pregnancy may not be completely effective. If you forget to take Misoone, contact your doctor or the prescribing center.

If you have any doubts about using 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. If you experience any side effect, including those not listed in this leaflet, please consult 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 the last menstrual period for a medical termination of pregnancy, or
• 12 weeks have passed since the first day of the 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. These may lead to cardiac arrest.

Other serious side effects include:

• Cases of severe or fatal toxic or septic shock. Fever accompanied by muscle aches, increased heart rate, dizziness, diarrhoea, vomiting, or a feeling of weakness. 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 the last menstrual period for a medical termination of pregnancy.

If you experience any of these side effects, consult a doctor IMMEDIATELY or go to the nearest hospital emergency department.
Other side effects
Very common (may affect more than 1 in 10 people):

• Uterine contractions or cramps
• Diarrhoea
  • Feeling of nausea or presence of vomiting
• Uterine bleeding

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

• Severe vaginal bleeding
• Abdominal pain
• Mild to moderate gastrointestinal cramps
• Uterine infection (endometritis and pelvic inflammatory disease)
• Congenital malformations (fetal abnormalities)

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

• Fever
• Fetal death
• Headache, dizziness, and general malaise or fatigue
• Urticaria and skin disorders which may be severe
• Uterine rupture: following administration of prostaglandins during the second or third trimester of pregnancy, particularly in women who have previously given birth or who have a caesarean section scar.

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

• Localised 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 experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton after the word “EXP.”. The expiry date refers to the last day of that month.
Store below 25 °C.
Do not use this medicine if the outer packaging or blisters show any signs of damage.
Do not use this medicine if the tablet has been stored outside the blister.
Do not dispose of any medicine via wastewater or household waste. 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 Misoone contains
The active substance is misoprostol.
One tablet of Misoone 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
White, flat, round tablet with a diameter of 11 mm and a thickness of 4.5 mm, with a break line on each side and 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 unit-dose divisible blisters made of PVC-PCTFE/aluminum or aluminum/aluminum.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
EXELGYN - 216 boulevard Saint-Germain - 75007 Paris – France

Manufacturers
Nordic Pharma B.V.
Siriusdreef 41
2132 WT Hoofddorp
The 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 authorized in the European Economic Area member states 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
The Netherlands: MisoOne
United Kingdom (Northern Ireland): Topogyne

This Patient Information Leaflet was last approved in July 2024