Label:information for the user

MisoOne 400 micrograms tablets

Misoprostol

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

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

6. Contents of the pack and additional information

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 at most 49 days after the first day of your last menstrual period.

For surgical termination of pregnancy: MisoOne is taken alone before surgical termination of pregnancy during the first trimester of pregnancy (in the 12 weeks after the first day of your menstruation).

Do not take MisoOne

• if you are allergic to misoprostol, another prostaglandin, or any of the other components of this medication (listed in section 6),
• if the pregnancy has not been confirmed by a biological test or ultrasound,
• if your doctor suspects that there may be 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 abortion: if the first day of your last period was more than 49days 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 developing 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 previous cesarean section or if you have undergone any uterine surgery.

Before taking mifepristone and MisoOne, your blood type will be analyzed. If your blood type is Rh 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 continuing pregnancies, patients are informed of the risk of teratogenicity and a follow-up visit is scheduled to check that the expulsion has been completed (see section Pregnancy, breastfeeding, and fertility).

For medical abortion:

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

For surgical abortion:

Since there is no data on the preparation of the uterine cervix with misoprostol before surgical abortion 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 medication, you should take MisoOne, preferably, at the treatment center before the surgical procedure.

Other medications and MisoOne

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

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

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

Pregnancy, breastfeeding, and fertility

Pregnancy

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

The risk of MisoOne failure increases:

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

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

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

If you decide to continue with the abortion, 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 the doctor confirms the abortion.

Breastfeeding

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

Fertility

This medication does not affect fertility. You can become pregnant after completing the abortion. You should take contraceptive precautions immediately after the doctor confirms the abortion.

Driving and operating machinery

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

MisoOne contains hydrogenated ricin oil

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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, 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) of abortion interruption:

• if you experience vaginal bleeding for more than 12 days and/or if it is very intense (for example, 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 are shivering and have chills.

• For medical abortion interruption.

The steps to follow to take MisoOne for medical abortion interruption will be the following:

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 must rest for at least 3 hours after taking this medication.
3. You may expel the embryo a few hours after taking MisoOne or during the following days. You may experience vaginal bleeding for up to 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 check that the expulsion has been completed.

Important aspects to remember when taking this medication:

• For surgical abortion interruption.

The tablet must be taken 3 to 4 hours before the surgical abortion procedure.

The steps to follow to take MisoOne for surgical abortion interruption will be the following:

1) Take MisoOne orally

2) The surgical procedure will be performed 3 to 4 hours after this intake

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

3)You must return to the center 14 to 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 packaging 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 abortion interruption.

• The vaginal bleeding does not mean that the expulsion has been completed after the abortion interruption.
• 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 abortion interruption.

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

• For surgical abortion interruption.

• 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 nearest hospital emergency room.

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 that can bemortal.

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

If you forgot to take MisoOne

If you forget to take mifepristone or MisoOne, it is likely that the abortion interruption will not be completed effectively. Consult your doctor or the center that prescribed the medication if you forgot to take MisoOne.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

The following side effects may occur:

Severe side effects

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

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

Or

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

Severe side effects include:

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

Other severe side effects include:

• Severe or fatal cases of toxic or septic shock.Fever with muscle pain, acceleration of 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 from the first day of your last menstrual period for medical abortion.

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
• 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)
• Fetal malformations

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

• Fever
• Fetal death
• Headache, dizziness, and feeling tired or unwell in general
• Urticaria and skin disorders that can be severe
• Uterine rupture: uterine rupture after administration of prostaglandins in the second or third trimester of pregnancy, mainly in women with previous births 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 urticaria

Other side effects include:

• Feeling cold, chills
• Back pain

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears 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 observe signs of deterioration in the box or in the blisters.

All tablets stored outside the blister or not used immediately must be discarded.

Medications should not be thrown away through drains. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

Composition of MisoOne

The active ingredient is misoprostol.

One MisoOne tablet contains 400 micrograms of misoprostol.

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

Appearance of the product and contents of the package

White, round, flat tablets with a diameter of 11 mm and a thickness of 4.5 mm, with a groove 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 pre-cut single-dose blister of PVC-PCTFE/Aluminum or OPA-Alu-PVC/Aluminum.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

EXELGYN

216 boulevard Saint-Germain

75007 Paris, France

Responsible 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 with 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: Miso O ne
• Netherlands: MisoOne
• Norway: Topogyne
• Portugal: Topogyne
• Romania: Topogyne
• Sweden: Topogyne
• Slovenia: Topogyne
• United Kingdom (Northern Ireland): Topogyne

Last review date of this leaflet: 06/2024

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/