MISOFAR 25 micrograms VAGINAL TABLETS

2. What you need to know before starting to use Misofar 25

Do not 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 administered 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
• Suspicion or clinical evidence of pre-existing fetal distress
• History of difficult and/or traumatic delivery
• Grand multiparity, with six or more previous term pregnancies
• In obstetric emergencies 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 you have a contraindication for vaginal delivery, such as placenta previa or active genital herpes;
• if you have risk factors for amniotic fluid embolism, preeclampsia, or eclampsia;
• if you are simultaneously administered oxytocin or other uterine contraction stimulants.

Warnings and precautions

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

Inform your doctor:

• if you have blood coagulation problems or anemia;
• if you have malnutrition;
• if you have epilepsy or a history of epileptic episodes;
• if you have kidney, liver, heart, or arterial disease;
• if you have low blood pressure (hypotension);
• if you have rupture of membranes;
• if you have any case of infection of the placental membranes and amniotic fluid (chorioamnionitis), a disorder of pregnancy called hydatidiform mole, and/or intrauterine fetal death.

Before using Misofar 25:

• The cephalopelvic indices should be carefully measured.

Before and during the use of Misofar 25:

• The cervical os should be evaluated through usual gynecological procedures, such as the vagino-abdominal examination.
• Uterine activity and fetal status should be closely monitored to detect possible undesirable responses, such as hypertonus, sustained uterine contractility, or fetal distress.

In case patients develop uterine hypercontractility or hypertonus (increased contractions or uterine tone), or if the fetal heart rate is not adequate, action should be taken in a way 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) after delivery has been described in patients who have been induced into labor by any method.

Use of Misofar 25 with other medications

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

Certain medications may interact with Misofar 25, such as anticoagulants (acenocoumarol), antacids containing magnesium, non-steroidal anti-inflammatory drugs (NSAIDs), and laxatives.

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

Use of Misofar 25 with food and beverages

No interactions between Misofar 25 and food or beverages are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 the 37th week of pregnancy. When used at this time in pregnancy, there is no risk of birth defects for the baby. However, you should not use Misofar 25 at any other time during pregnancy, as misoprostol may cause birth defects.

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

Driving and using machines

No effects on driving or using machines have been observed.

Misofar 25 containshydrogenated ricin oil, which may cause skin reactions. Although the amount present in the preparation is probably not sufficient to trigger this effect, it should be taken into account.

3. How to use Misofar 25

Follow your doctor's or pharmacist's instructions for administering this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

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

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

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

The route of administration of 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 carefully washing their hands.

If you think the effect of Misofar 25 is too strong or too weak, tell your doctor.

Use in children and adolescents

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

If you use more Misofar 25 than you should

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

If uterine activity or side effects reach excessive intensity, the dose will be reduced or administration will be suspended, and symptomatic treatment will be assessed.

If you have any other doubts about using this medication, ask your doctor, pharmacist, or midwife.

4. Possible side effects

Like all medications, Misofar 25 can cause side effects, although not everyone will experience them.

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

The most frequent side effects are:

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

Other side effects that have been occasionally reported are:

• Immune system disorders: hypersensitivity reactions (allergies).
• Psychiatric disorders: syncope (fainting), neurosis.
• Nervous system disorders: dizziness, confusion, somnolence (sleepiness), headache, tremors, anxiety.
• Eye disorders: vision disturbances and conjunctivitis (eye infection).
• Cardiac disorders: hypertension (high blood pressure), hypotension (low blood pressure), cardiac arrhythmia (alteration of heart rate).
• Vascular disorders: phlebitis (inflammation of the veins), edema (swelling), thromboembolism (formation of blood clots in the blood vessels).
• Respiratory, thoracic, and mediastinal disorders: cough, dyspnea (breathing difficulties), bronchitis, pneumonia, epistaxis (nasal bleeding).
• Skin and subcutaneous tissue disorders: rash (redness), exanthematous rash (skin allergy), dermatitis (skin inflammation), alopecia (hair loss).
• Musculoskeletal and connective tissue disorders: arthralgia (joint pain), myalgia (muscle pain), muscle cramps and stiffness, back pain.
• Renal and urinary disorders: cases of polyuria (increased frequency of urination) and hematuria (blood in urine) have been reported.
• In pregnancy, puerperium (weeks following delivery), and perinatal disorders: abnormal uterine contractility (increased frequency, tone, or duration) with or without fetal bradycardia (slower heart rate), uterine rupture, premature rupture of membranes, placental abruption, amnionitis (infection of the amniotic fluid), pulmonary embolism by amniotic fluid, vaginal bleeding.
• Reproductive system and breast disorders: dysmenorrhea (painful menstruation) and vaginal bleeding have been occasionally reported.
• General disorders and administration site conditions: transient hyperthermia (increased body temperature), chills.

Reporting of side effects

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

5. Storage of Misofar 25

No special storage conditions are required.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Misofar 25

• The active ingredient 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 package contents

Misofar 25 are white, round vaginal tablets with a cross-shaped groove on one face. They are available in packages of 8 vaginal tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid

Spain

Manufacturer:

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

Date of the last revision of this leaflet: May 2019

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