Label: information for the user

MISOFAR 200 microgram vaginal tablets

Misoprostol

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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.

1. What Misofar 200 is and for what it is used

2. What you need to know before starting to use Misofar 200

3. How to use Misofar 200

4. Possible adverse effects

5. Storage of Misofar 200

6. Contents of the package and additional information

Misofar 200 are vaginal tablets that belong to a group of medications called prostaglandins. Specifically, it is a synthetic analogue of prostaglandin E1.

Misofar 200 is indicated for:

- dilation of the cervix of the uterus in non-pregnant women prior to a diagnostic and/or surgical hysteroscopy and/or other gynecological procedures that require access to the uterine cavity.

-for the treatment of spontaneous or induced incomplete abortion without complications, in monotherapy or associated with mifepristone.

The decision on the form of treatment for incomplete abortion should be based on the clinical condition of the person and the preference for treatment.

No use Misofar 200

• If you are allergic to misoprostol, prostaglandins, or any of the other components of this medication (listed in section 6);
• If you cannot be administered oxytocic drugs or prolonged uterine contractions are considered inappropriate;
• For uterine cervix dilation prior to a hysteroscopy or other gynecological procedures that require access to the uterine cavity: If you are pregnant or think you may be.
• For the treatment of incomplete spontaneous abortion and incomplete induced abortion: In known or suspected ectopic pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Misofar 200.

Inform your doctor:

• If you have bleeding disorders or anemia.

• If you have malnutrition;
• If you have a history of cesarean section or major uterine surgery;
• If you have epilepsy or a history of seizures;
• If you have kidney, liver, heart, or artery disease;
• If you have low blood pressure (hypotension).

A higher risk of disseminated intravascular coagulation (severe bleeding) has been described after delivery in patients who have induced labor by any method.

The administration of mifepristone and misoprostol should be spaced 1-2 days apart, according to the available information. For more information, consult the prospectus of the medications containing mifepristone.

The risk of uterine rupture increases with gestational age.Uterine rupture is a rare complication; in cases of advanced gestational age, this should be considered in clinical judgment as well as the availability of the healthcare system for urgent treatment of a uterine rupture.

After treatment, uterine bleeding will appear, which can last up to 2-3 weeks (usually 9 days), and can be more or less intense. Your doctor will inform you how to manage the bleeding. If the bleeding is very abundant and/or prolonged, consult your doctor.

Use of Misofar 200 with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with Misofar 200, such as anticoagulants (acenocoumarol), anti-acids containing magnesium, anti-inflammatory drugs (NSAIDs), and laxatives.

Use of Misofar 200 with food and drinks

No interactions of Misofar 200 with food and drinks are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Since Misofar 200 should only be administered to women of childbearing age who are not pregnant and/or to postmenopausal women, no clinical effects are expected if used as recommended.

Misoprostol is excreted in breast milk, but its concentration is insignificant 5 hours after administration.

Driving and operating machines

No effects on driving or operating machines have been observed.

Misofar 200 containshydrogenated ricin oil, which may cause allergic reactions at the application site.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Misofar 200, as well as the dose with which you should start and how you should continue.

• For the dilation of the non-pregnant uterus cervix prior to a hysteroscopy orother gynecological procedures that require access to the uterine cavity,the recommended dose is 400 micrograms of misoprostol administered 2 to 8 hours before in uteri without a previous history of cesarean section or uterine scars, and 2 to 4 hours before, in uteri with a previous history of cesarean section or uterine scars.

- For medical treatment of incomplete abortion with a uterine size less than 14 weeks: use 600 µg of misoprostol,in monotherapy or 1-2 days after administration of mifepristone. Depending on clinical evaluation and different local recommendations or protocols, it may also be used 800 µg of misoprostol. If necessary, additional doses can be administered after 24 hours.

- For medical treatment of incomplete abortion with a uterine size of 14 weeks or greater: use 400 µg of misoprostol every three hours,in monotherapy or 1-2 days after administration of mifepristone. Misoprostol can be repeated, at the indicated interval, as needed to achieve successful abortion.

Your doctor will decide, in gestational ages greater than 14 weeks, the maximum number of doses if you have a previous uterine incision.

The dose should be adapted to the patient's response and should always be kept at the lowest levels that produce a satisfactory uterine response.

The administration route of Misofar 200 is vaginal.

Follow the following use recommendations:

• Wash your hands carefully.

• Remove the vaginal tablet from the blister.
• Recline on your back with your knees touching your chest.
• With the tip of your index finger, insert the vaginal tablet as deeply as possible into the vagina without causing discomfort.

If you estimate that the action of Misofar 200 is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

Misofar 200 has not been studied in women under 18 years old.

If you use more Misofar 200 than you should

If you have used a number of tablets greater than what your doctor has indicated, consult your doctor or pharmacist immediately, go to the nearest hospital or call the Toxicological Information Service, phone 91562 04 20, indicating the medication and the amount administered.

Overdose may manifest with uterine contractions (with risk of fetal intrauterine death), hyperthermia (increased temperature), tachypnea (increased respiratory rate), hypotension (low blood pressure), convulsions with chills, agitation, and emesis (vomiting).

In the case of massive overdose, supportive treatment will be symptomatic.

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

Like all medicines, Misofar 200 may cause side effects, although not everyone will experience them.

The most serious adverse reactions that may occur are as follows: hypersensitivity to the drug, uterine rupture, and cardiac arrest.

The most frequent side effects are as follows:

• Infections and infestations: uterine infection (endometritis and pelvic inflammatory disease).
• Gastrointestinal disorders: nausea, vomiting, diarrhea, and abdominal pain (abdominal cramps).

Other side effects described occasionally are:

Reporting of adverse reactions

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

No requires special conditions for conservation.

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

Do not use this medication afterthe expiration datethat appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Misofar 200

• The active principle is misoprostol. Each vaginal tablet contains 200 micrograms of misoprostol.

-The other components (excipients) are: hydroxypropylmethylcellulose, microcrystalline cellulose, sodium carboxymethylcellulose type A (from potato) and hydrogenated ricin oil.

Appearance of the product and contents of the packaging

Misofar 200 are white vaginal tablets, oblong capsule shape with a groove. They are presented in packs of 4 vaginal tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid

Spain

Responsible for manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A:

C/ Laguna 66-68-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid) – Spain

Local representative:

Exeltis Healthcare, S.L.

Avda. de Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares

(Guadalajara), Spain

Last review date of this leaflet: 09/2022

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