Misoprostol 400 micrograms tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MisoOne 400 micrograms tablets

Misoprostol

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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, which is similar to a chemical substance called "prostaglandin" that the body produces naturally. Misoprostol induces contractions of the uterus and softens the cervix.

For medical termination of pregnancy: MisoOne is used after administration of another medicine 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 alone prior to surgical termination of pregnancy during the first trimester of pregnancy (within 12 weeks after the first day of your last menstrual period).

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 ingredients of this medicine (listed in section 6),
• if pregnancy has not been confirmed by a biological test or an ultrasound,
• if your doctor suspects 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 more than 49 days (7 weeks) have passed since the first day of your last menstrual period.

Warnings and precautions

Consult your doctor before taking MisoOne:

• if you have liver or kidney disease,
• if you have anaemia or malnutrition,
• if you have cardiovascular disease (heart or circulatory disease),
• if you have an increased risk of cardiovascular disease. Risk factors include being over 35 years old and smoking cigarettes, or having high blood pressure, high blood cholesterol levels, or diabetes,
• if you have a disease affecting blood clotting,
• if you have previously had a caesarean section or have undergone any surgical procedure on the uterus.

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

Healthcare professionals must ensure that, due to the risk of treatment failure and birth defects observed in pregnancies that continue, patients are informed about the risk of teratogenicity and that a follow-up visit is scheduled to confirm that expulsion is complete (see section Pregnancy, breastfeeding and fertility).

For medical termination of pregnancy:

If you have an intrauterine device (IUD), it must be removed before taking the first medication, mifepristone.

For surgical termination of pregnancy:

As there are no data on cervical preparation with misoprostol prior to surgical termination of pregnancy after the first trimester, MisoOne should not be taken beyond 12 weeks after the first day of your 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

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including medicines without a prescription.

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

• Non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid or diclofenac,
• Antacids or antacids containing magnesium (used to treat stomach acidity and acid indigestion).

Pregnancy, breastfeeding and fertility

Pregnancy

Failure of pregnancy termination (continuation of pregnancy) following administration of MisoOne has been associated with a threefold increased risk of congenital malformations, particularly facial paralysis and malformations of the head and limbs. Birth defects have also been observed when this medicine is taken alone. For medical termination of pregnancy, you must take the other medicine, mifepristone, between 36 and 48 hours before taking MisoOne.

The risk of failure of MisoOne 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 medicine, the risk to the fetus is unknown. If you decide to continue the pregnancy, thorough prenatal monitoring with ultrasounds should be performed at a specialized clinic, with special attention to limbs and head. Your doctor will provide further recommendations.

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

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

Breastfeeding

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

Fertility

This medicine does not affect fertility. You can become pregnant after completion of the termination of pregnancy. You should use contraceptive precautions immediately after completion of the termination of pregnancy is confirmed.

Driving and use of machines

This medicine may cause dizziness. Exercise particular caution when driving or using machines after taking this medicine until you know how MisoOne affects you.

MisoOne contains hydrogenated castor oil

This medicine may cause gastrointestinal discomfort and diarrhoea because it contains hydrogenated castor oil.

3. How to take MisoOne

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

Dosage in adults

• One tablet administered orally.

Administration of the tablet

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

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

• if you have vaginal bleeding lasting longer than 12 days and/or if it is very heavy (for example, you need more than 2 sanitary pads per hour for 2 hours)

• if you have severe abdominal pain

• if you have fever or feel cold and are shivering.

• For medical termination of pregnancy.

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

1. At the healthcare center, you will be given the first medicine, mifepristone, which you must take orally.
2. 36–48 hours later, you will take MisoOne orally. You must rest for at least 3 hours after taking this medicine.
3. You may expel the embryo several hours after taking MisoOne or during the following days. You may experience vaginal bleeding for about 12 days after taking the first medicine, mifepristone, and the flow will gradually become lighter 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 that expulsion is complete.

Important points to remember when taking this medicine:

This tablet must be taken orally.

For medical termination of pregnancy, MisoOne must 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 medicine will increase.

• For surgical termination of pregnancy.

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

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

1. Take MisoOne orally.
2. The surgical procedure will be performed 3 to 4 hours after this dose.

You will have vaginal bleeding lasting an average of 12 days after the surgical procedure, and the flow will gradually decrease over time.

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

Other important points to remember:

• In all cases

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

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

• For medical termination of pregnancy.

• Vaginal bleeding does not necessarily mean that expulsion is complete after termination of pregnancy.

• 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 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 medicine 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 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 nearest hospital emergency department.

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

In case of overdose or accidental ingestion, call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to take MisoOne

If you forget to take mifepristone or MisoOne, the termination of pregnancy may not be completed effectively. Consult your doctor or the center that prescribed the medicine if you forget to take MisoOne.

If you have any other 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 everyone gets them.

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

The following side effects may occur:

Serious side effects

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

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

Or

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

Serious side effects include:

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

Other serious side effects include:

• Severe or fatal cases of toxic or septic shock. Fever with muscle pain, rapid heartbeat, dizziness, diarrhoea, vomiting, or feeling weak. These side effects may occur if you do not take this medicine orally or if you take it more than 49 days after the first day of your last menstrual period for medical termination of pregnancy.

If you experience any of these side effects, contact your 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 spasms
• Diarrhoea
• 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 tired or generally unwell
• Urticaria and skin disorders which may be severe
• Uterine rupture: tearing of the uterus following administration of prostaglandins in the second or third trimester of pregnancy, primarily in women with previous deliveries or a history of caesarean section

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

• Localised swelling of the face and/or larynx which may be accompanied by urticaria

Other side effects include:

• Feeling cold, chills
• Back pain

Reporting of side effects

If you experience any type of side effect, talk to your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of MisoOne

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Do not use this medicine if you notice any signs of deterioration in the carton or blisters.

Any tablet stored outside the blister or not used immediately should be discarded.

Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of MisoOne

The active substance is misoprostol.

One tablet of MisoOne contains 400 micrograms of misoprostol.

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

Appearance of the product and contents of the pack

White, round, flat tablets 11 mm in diameter and 4.5 mm thick, with a score line on each side and the double code "M" imprinted on one side. The tablet can be divided into equal doses.

MisoOne is available in packs containing 1, 4, 16 or 40 tablets.

The tablets are packaged in single-dose cut blister packs made of PVC-PCTFE/Aluminum or OPA-Alu-PVC/Aluminum.

Only certain pack sizes may be marketed.

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, The 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Nordic Pharma S.A.U.
Juan Esplandiú 15, 13th floor, AB
28007 Madrid
Spain
+34 916 404 041
[email protected]

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

Date of most recent revision of this leaflet: 06/2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/