Misofar 25 micrograms vaginal tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MISOFAR 25 micrograms vaginal tablets

Misoprostol

Read the entire leaflet carefully before you start using this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could 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 Misofar 25 is and what it is used for
2. What you need to know before using Misofar 25
3. How to use Misofar 25
4. Possible side effects
5. How to store Misofar 25
6. Contents of the pack and other information

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

Misofar 25 are vaginal tablets belonging 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 labour at term, particularly in cases of an immature cervix, provided there are no fetal or maternal contraindications.

2. What you need to know before using Misofar 25

Do not use Misofar 25

• if you are allergic to misoprostol, prostaglandins, or any of the other ingredients of this medicine (listed in section 6);

• if oxytocic drugs cannot be administered to you or prolonged uterine contractions are considered inappropriate;

• if you have any of the following conditions:

• History of caesarean section or major uterine surgery

• Cephalopelvic disproportion

• Transverse fetal position

• Suspicion or clinical evidence of pre-existing fetal distress

• History of difficult and/or traumatic delivery

• Multiparous women with six or more previous term pregnancies

• Obstetric emergencies when the benefit-risk ratio for both fetus and mother indicates surgical intervention

• Multiple pregnancy

• Unexplained vaginal discharge and/or irregular uterine bleeding during the current pregnancy

• if 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 simultaneously receiving oxytocin or other stimulants of uterine contractions.

Warnings and precautions

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

Inform your doctor:

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

Before using Misofar 25:

• Cephalopelvic proportions should be carefully assessed.

Before and during the use of Misofar 25:

• The cervix should be evaluated using standard gynecological procedures, such as vaginal-abdominal palpation.
• Uterine activity and fetal status must be closely monitored to detect possible adverse reactions such as hypertonia, sustained uterine contractility, or fetal distress.

If patients develop uterine hypercontractility or hypertonia (increased contractions or uterine tone), or if the fetal heart rate becomes abnormal, appropriate measures must be taken to ensure no risk to either the mother or the fetus.

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

An increased risk of disseminated intravascular coagulation (severe bleeding) after delivery has been reported in patients whose labor was induced by any method.

Use of Misofar 25 with other medicines

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

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

Misoprostol may enhance the effect of oxytocin (a medicine that promotes the onset and progress of labor by stimulating contractions). The simultaneous administration of oxytocin and other medicines that stimulate uterine contractions is contraindicated. If, in the physician’s judgment, it is necessary to administer misoprostol and oxytocin consecutively, careful monitoring of uterine activity is required.

Use of Misofar 25 with food and drink

No interactions between Misofar 25 and food or drink 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 medicine.

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

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

Driving and using machines

No effects on driving or using machines have been observed.

Misofar 25 contains hydrogenated castor oil, which may cause skin reactions. Although the amount present in the formulation is unlikely to trigger such a reaction, this should be taken into account.

3. How to use Misofar 25

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

The recommended dose is one tablet containing 25 micrograms of misoprostol every 4–6 hours, up to a maximum of 4 to 6 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 route of administration for Misofar 25 is vaginal.

You will lie down 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 feel that the effect 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 of age.

If you use more Misofar 25 than you should

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

If uterine activity or side effects become excessive in intensity, the dose should be reduced or administration discontinued, and symptomatic treatment should be considered.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or midwife.

4. Possible adverse effects

Like all medicines, Misofar 25 may cause adverse effects, although not everyone will experience them.

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

The most frequent adverse effects are:

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

Other adverse effects described occasionally are:

• Immune system disorders: hypersensitivity reactions (allergies).
• Psychiatric disorders: syncope (fainting), neurosis.
• Nervous system disorders: dizziness, confusion, somnolence (drowsiness), headache, tremors, anxiety.
• Eye disorders: visual disturbances and conjunctivitis (eye infection).
• Cardiac disorders: hypertension (high blood pressure), hypotension (low blood pressure), cardiac arrhythmia (abnormal heart rhythm).
• Vascular disorders: phlebitis (vein inflammation), oedema (swelling), thromboembolism (blood clot formation in blood vessels).
• Respiratory, thoracic and mediastinal disorders: cough, dyspnoea (breathing difficulties), bronchitis, pneumonia, epistaxis (nosebleed).
• Skin and subcutaneous tissue disorders: skin rash (redness), exanthematous rash (skin allergy), dermatitis (skin inflammation), alopecia (hair loss).
• Musculoskeletal 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 haematuria (blood in urine) have been reported.
• Pregnancy, puerperium (weeks following childbirth), 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, premature placental abruption, amnionitis (infection of amniotic fluid), pulmonary embolism due to amniotic fluid, vaginal haemorrhage (bleeding).
• Reproductive system and breast disorders: dysmenorrhoea (painful menstruation) and vaginal haemorrhage (bleeding) may rarely occur.
• General disorders and administration site conditions: transient hyperthermia (increased body temperature), chills.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Misofar 25

No special storage conditions are required.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Misofar 25

• The active substance is misoprostol. Each vaginal tablet contains 25 micrograms of misoprostol.

• The other components (excipients) are: hypromellose, microcrystalline cellulose, sodium carboxymethylstarch type A (from potato), and hydrogenated castor oil.

Appearance of the product and contents of the pack

Misofar 25 are white, round vaginal tablets with a cross-shaped notch on one side. They are supplied in packs containing 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 most recent review of this leaflet: May 2019

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