MISOONE 400 micrograms tablets

Introduction

Leaflet: information for the user

MisoOne 400 micrograms tablets

Misoprostol

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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. Storage of MisoOne

1. Contents of the pack and additional information

1. What is MisoOne and what is it used for

MisoOne tablets contain misoprostol, which is similar to a chemical substance called "prostaglandin" that the body produces naturally. Misoprostol stimulates uterine contractions and softens the cervix.

For medical termination of pregnancy: MisoOne is used after administration of another medication called mifepristone. It should be taken no later than 49 days after the first day of your last menstrual period.

For surgical termination of pregnancy: MisoOne is taken only before surgical termination of pregnancy during the first trimester of pregnancy (in the 12 weeks following 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 another prostaglandin, or to any of the other components of this medication (listed in section 6),
• if pregnancy has not been confirmed by a biological test or ultrasound,
• if your doctor suspects that you may have an ectopic pregnancy (the egg is 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 period was more than 49 days ago (7 weeks).

Warnings and precautions

Consult your doctor before starting to take MisoOne:

• if you have liver or kidney disease,
• if you have anemia or malnutrition,
• if you have any cardiovascular disease (heart or circulatory disease),
• if you have a higher risk of cardiovascular disease. Risk factors include being over 35 years old and smoking cigarettes, or having high blood pressure, high cholesterol levels, or diabetes,
• if you have any disease that may affect your blood clotting,
• if you have had a cesarean section or have undergone uterine surgery.

Before taking mifepristone and MisoOne, your blood Rh factor will be tested. If your Rh factor is negative, your doctor will recommend the necessary routine treatment.

Healthcare professionals must ensure that, due to the risk of method failure and birth defects observed in ongoing pregnancies, patients are informed about the risk of teratogenicity and a follow-up visit is scheduled to verify that the expulsion has been completed (see section Pregnancy, breastfeeding, and fertility).

For medical termination of pregnancy:

If you use an intrauterine device, it must be removed before taking the first medication, mifepristone.

For surgical termination of pregnancy:

Since there is no data on cervical preparation with misoprostol before surgical termination of pregnancy after the first trimester, MisoOne should not be taken beyond 12 weeks after the first day of your menstruation.

Due to the possible occurrence of vaginal bleeding after taking this medication, you should take MisoOne, preferably, at the treatment center before the surgical procedure.

Other medications and MisoOne

Tell your doctor that you are taking, have recently taken, or may need to take any other medication, including over-the-counter medications.

In particular, tell your doctor if you are taking any of the following:

• Non-steroidal anti-inflammatory medications (NSAIDs) such as aspirin or diclofenac.
• Antacids or antacids containing magnesium (used to treat stomach acid and heartburn).

Pregnancy, breastfeeding, and fertility

Pregnancy

Failure of pregnancy termination (continuation of pregnancy) after administration of MisoOne has been associated with a 3-fold increased risk of congenital defects, particularly facial paralysis, head, and limb malformations. Defects in newborns have also been observed when this medication is taken alone. For medical termination of pregnancy, you musttake the other medication, mifepristone, between 36 and 48 hours before taking MisoOne.

The risk of MisoOne failure increases:

• if it is not administered orally,
• as pregnancy progresses,
• with the number of previous pregnancies.

For medical termination of pregnancy, if taken more than 49 days after the first day of your last menstrual period.

In case of failure of pregnancy termination after taking this medication, the risk to the fetus is unknown. If you decide to continue the pregnancy, a thorough prenatal check-up with ultrasound should be performed at a specialized clinic, with special attention to the limbs and head. Your doctor will provide further recommendations.

If you decide to continue with the termination of pregnancy, a new procedure will be used. Your doctor will inform you about the possible options.

You should avoid becoming pregnant again before your next menstrual cycle after taking this medication. You should take contraceptive precautions immediately after your doctor confirms the termination of pregnancy.

Breastfeeding

If you are breastfeeding, consult your doctor before taking this medication. Since this medication passes into breast milk, you should interrupt breastfeeding while being treated with it.

Fertility

This medication does not affect fertility. You can become pregnant after the termination of pregnancy is complete. You should take contraceptive precautions immediately after your doctor confirms the termination of pregnancy.

Driving and using machines

This medication may cause dizziness. Be careful when driving or using machines after taking this medication until you know how MisoOne affects you.

MisoOne contains hydrogenated castor oil

This medication may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take MisoOne

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adult dosage

• One tablet administered orally.

Tablet administration

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

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

• if you experience vaginal bleeding for more than 12 days and/or if it is very heavy (e.g., you need more than 2 pads per hour for 2 hours)
• if you have severe abdominal pain
• if you have a fever or if you feel cold and are shivering.

• For medical termination of pregnancy.

The steps to follow to take MisoOne for medical termination of pregnancy are as follows:

1. At the Health Center, you will be given the first medication, mifepristone, which you must take orally.
2. 36-48 hours later, you will take MisoOne orally. You should rest for at least 3 hours after taking this medication.
3. It is possible that you will expel the embryo a few hours after taking MisoOne or during the following days. You may experience vaginal bleeding for about 12 days after taking the first medication, mifepristone, and the flow will be lighter as time passes.
4. You must return to the center 14-21 days after taking the first medication, mifepristone, for a follow-up visit to verify that the expulsion has been completed.

Important aspects to remember when taking this medication:

This tablet should be taken orally.

For medical termination of pregnancy, MisoOne should be taken between 36 and 48 hours after taking 600 mg of mifepristone.

If you do not follow these instructions, the risks associated with this medication will increase.

• For surgical termination of pregnancy.

The tablet should be taken 3-4 hours before the surgical procedure for termination of pregnancy.

The steps to follow to take MisoOne for surgical termination of pregnancy are as follows.

1. Take MisoOne orally

1. The surgical procedure will be performed 3-4 hours after this intake

You will experience vaginal bleeding that will last for an average of 12 days after the surgical procedure, and the flow will be lighter as time passes.

1. You should return to the center 14-21 days after this surgical procedure for a follow-up visit.

Other important points to remember:

• In all cases

• Do not take this medication if the aluminum blister is broken or if the tablet has been stored outside its packaging.

In case of emergency or if you have any questions, call or visit the center that prescribed the medication. You do not have to wait for your follow-up appointment.

• For medical termination of pregnancy.

• Vaginal bleeding does not mean that the expulsion has been completed after termination of pregnancy.
• The risk of side effects increases if you take this medication 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 incomplete, your doctor will recommend other options for termination of pregnancy.

It is recommended that you do not travel far from the center that prescribed the medication until the follow-up visit is performed.

• For surgical termination of pregnancy.

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

Use in children and adolescents

Only 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, inform your doctor immediately or go to the emergency department of the nearest hospital.

Your doctor will give you the exact amount of MisoOne; therefore, it is unlikely that you will take too many tablets. Taking too many tablets can cause symptoms such as drowsiness, tremors, seizures, difficulty breathing, abdominal pain, diarrhea, fever, chest pain, low blood pressure, and slow heart rate, which can be fatal.

In case of overdose or accidental ingestion, call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to take MisoOne

If you forget to take mifepristone or MisoOne, it is likely that the termination of pregnancy will not be effective. Consult your doctor or the center that prescribed the medication if you forget to take MisoOne.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

The following side effects may occur:

Severe side effects

The risk of severe side effects increases if you take the medication after:

• 49 days after the first day of your last menstrual period for medical termination of pregnancy.

Or

• 12 weeks after the first day of your last menstrual period for surgical termination of pregnancy

Severe side effects include:

• Allergic reaction. Severe skin rash, such as red spots accompanied by itching, blisters, or sores.
• Cardiovascular accidents. Chest pain, difficulty breathing, confusion, or irregular heartbeat. This can lead to cardiac arrest.

Other severe side effects include:

• Severe or fatal cases of toxic or septic shock. Fever with muscle pain, accelerated heart rate, dizziness, diarrhea, vomiting, or feeling of weakness. These side effects can occur if you do not take this medication orally or if you take it after 49 days from the first day of your last menstrual period for medical termination of pregnancy.

If you experience any of these side effects, contact your doctor or go to the emergency department of the nearest hospital IMMEDIATELY.

Other side effects

Very common (may affect more than 1 in 10 people):

• Uterine contractions or spasms
• Diarrhea
• Nausea or vomiting
• Uterine bleeding

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

• Heavy vaginal bleeding
• Abdominal pain
• Mild or moderate gastrointestinal spasms
• Uterine infection (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 of tiredness or not feeling well in general
• Hives and skin disorders that can be severe
• Uterine rupture (uterine tear): uterine tear after administration of prostaglandins in the second or third trimester of pregnancy, mainly in women with previous deliveries or with a cesarean scar

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

• Localized inflammation of the face and/or larynx that may be accompanied by hives

Other side effects include:

• Feeling of cold, chills
• Back pain

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of MisoOne

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the box after "EXP". The expiration date is the last day of the month indicated.

Store below 25°C.

Do not use this medication if you notice signs of deterioration in the box or blisters.

Any unused tablet should be discarded immediately.

Medications should not be disposed of through wastewater. Ask your pharmacist how to dispose of medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

MisoOne Composition

The active ingredient is misoprostol.

One MisoOne tablet contains 400 micrograms of misoprostol.

The other components are microcrystalline cellulose, hypromellose, sodium carboxymethyl starch (type A) (derived from potato starch), hydrogenated castor oil.

Product Appearance and Package Contents

White, round, flat tablets with a diameter of 11 mm and a thickness of 4.5 mm, with a notch on each side and the double code "M" engraved on one side. The tablet can be divided into equal doses.

MisoOne is available in packages of 1, 4, 16, or 40 tablets.

The tablets are packaged in a precut, single-dose PVC-PCTFE/Aluminum or OPA-Alu-PVC/Aluminum blister pack.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

EXELGYN

216 boulevard Saint-Germain

75007 Paris, France

Manufacturer

Nordic Pharma B.V.

Siriusdreef 41

2132 WT Hoofddorp, Netherlands

Or

Delpharm Lille SAS

Parc D’Activités Roubaix Est

22 Rue de Toufflers, Cs 50070

59452 Lys-Lez-Lannoy Cedex

France

Or

Laboratoires MACORS

22 Rue des Caillottes

89000 Auxerre

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Nordic Pharma S.A.U.

Adolfo Perez Esquivel 3, 2nd floor, Office 17,

Edificio Las Americas III,

28232 Parque Empresarial Las Rozas,

Madrid (Spain)

+34 916 404 041

[email protected]

This medication is authorized 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
• Germany: MisoOne
• Denmark: Topogyne
• Estonia: Topogyne
• Spain: MisoOne
• Finland: Topogyne
• France: MisoOne
• Greece: MisoOne
• Italy: Misoone
• Ireland: MisoOne
• Luxembourg: Topogyne
• Latvia: Misoone
• Lithuania: MisoOne
• Netherlands: MisoOne
• Norway: Topogyne
• Portugal: Topogyne
• Romania: Topogyne
• Sweden: Topogyne
• Slovenia: Topogyne
• United Kingdom (Northern Ireland): Topogyne

Date of the last revision of this prospectus:06/2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/