Leaflet: information for the user

MISOFAR 25 microgram vaginal tablets

Misoprostol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What is Misofar 25 and what it is used for

2. What you need to know before you start taking Misofar 25

3. How to use Misofar 25

4. Possible side effects

5. Storage of Misofar 25

6. Contents of the pack and additional information

Misofar 25are vaginal tablets that belong to a group of medicines called prostaglandins. Specifically, it is a synthetic analogue of prostaglandin E1.

Misofar 25 is a uterotonic agent indicated for cervical ripening and induction of labor at term, especially in cases of immature cervix, provided there are no fetal or maternal contraindications.

No use Misofar 25

• If you are allergic to misoprostol, prostaglandins, or any of the other components of this medication (listed in section 6);
• If you cannot be given oxytocic drugs or prolonged uterine contractions are considered inappropriate;
• If you have any of the following characteristics:

• History of cesarean section or major uterine surgery
• Cephalopelvic disproportion
• Fetal transverse positions
• Suspected or existing pre-existing fetal distress
• History of difficult delivery and/or traumatic delivery
• Multiparous women, with six or more previous pregnancies at term
• Emergency obstetric situations when the benefit-risk ratio for both the fetus and the mother advises surgical intervention
• Multiple pregnancy
• Unexplained vaginal discharge and/or irregular uterine bleeding during the current pregnancy

• If a vaginal delivery is contraindicated, such as in cases of placenta previa or active genital herpes;
• If you have risk factors for amniotic fluid embolism, preeclampsia, or eclampsia;
• If you are being given oxytocin or other uterine stimulants simultaneously.

Warnings and precautions

Consult your doctor, pharmacist, or midwife before starting to use Misofar 25.

Inform your doctor:

• If you have bleeding disorders or anemia;
• If you have malnutrition;
• 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);
• If you experience a rupture of the membranes;
• If you have any cases of placental and amniotic fluid infection (chorioamnionitis), molar pregnancy, and/or intrauterine fetal death.

Before using Misofar 25:

• Cephalopelvic indices must be carefully measured.

Before and during the use of Misofar 25:

• The uterine cervix should be evaluated using standard gynecological procedures, such as vaginal-abdominal palpation.
• Uterine activity and fetal status should be closely monitored to detect any unwanted responses such as hypertension, sustained uterine contractility, or fetal distress.

In the event that patients develop hypercontractility or hypertension (increased contractions or uterine tone), or if the fetal heart rate is not adequate, proceed in a manner that does not pose a risk to either the mother or the fetus.

As with other uterotonic agents, the risk of uterine rupture should be considered, especially if there is a previous uterine scar.

An increased risk of disseminated intravascular coagulation (severe bleeding) has been described after delivery in patients induced with any method.

Use of Misofar 25 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 25, such as anticoagulants (acenocoumarol), antacids containing magnesium, anti-inflammatory drugs (NSAIDs), and laxatives.

Misoprostol may potentiate the effect of oxytocin (a medication that promotes the onset and progression of labor by stimulating contractions). The simultaneous administration of oxytocin and other medications that stimulate uterine contractions is contraindicated. If, in the doctor's opinion, it is necessary to administer misoprostol and oxytocin consecutively, the patient should be closely monitored for uterine activity.

Use of Misofar 25 with food and beverages

No interactions of Misofar 25 with food and beverages are known.

Pregnancy and lactation

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

Misofar 25 is used to help initiate labor from week 37 of pregnancy. When used at this time, there is no risk of birth defects for the baby. However, do not use Misofar 25 at any other time during pregnancy because misoprostol may then cause birth defects.

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

Driving and operating machinery

No effects on driving or operating machinery have been observed.

Misofar 25 containshydrogenated ricin oil, which may cause skin reactions. Although the amount present in the preparation is probably insufficient to trigger this effect, it should be taken into account.

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

Your doctor will inform you of the duration of your treatment with Misofar 25, as well as the starting dose and how to continue.

The recommended dose is one 25 microgram misoprostol tablet every 4-6 hours, up to a maximum of4 to6 tablets.

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

The administration route for Misofar 25 is vaginal.

You will lie on a gynecological examination table and the doctor or midwife will administer the tablets by inserting them into the vagina, after a careful hand wash.

If you estimate that the action of Misofar 25 is too strong or too weak, inform your doctor.

Use in children and adolescents

Misofar 25 has not been studied in women under 18 years old.

If you use more Misofar 25 than you should

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

If uterine activity or side effects become too intense, the dose will be reduced or administration will be suspended, and symptomatic treatment will be evaluated.

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

Like all medications, Misofar 25 may cause adverse 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 adverse effects are as follows:

• Gastrointestinal disorders: nausea, vomiting, diarrhea, and abdominal pain (abdominal cramps).

Other adverse effects described occasionally are:

Reporting of adverse effects

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

This product does not require special conservation conditions.

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 disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Misofar 25

• The active principle is misoprostol. Each vaginal tablet contains 25 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 25 are white, round vaginal tablets with a cross-scored face. They are presented in packs of 8 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: May 2019

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/