Misofar 200 micrograms vaginal tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MISOFAR 200 micrograms vaginal tablets

Misoprostol

Read the entire leaflet carefully before you start using 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, and you should not give it to other people, 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 200 is and what it is used for
2. What you need to know before using Misofar 200
3. How to use Misofar 200
4. Possible adverse effects
5. How to store Misofar 200
6. Contents of the pack and other information

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

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

Misofar 200 is indicated:

• for cervical dilation of the uterus in non-pregnant women prior to diagnostic and/or surgical hysteroscopy or other gynecological procedures requiring access to the uterine cavity.
• for the treatment of uncomplicated incomplete spontaneous or induced abortion, as monotherapy or in combination with mifepristone.

The decision regarding the treatment method for incomplete abortion should be based on the individual's clinical condition and treatment preference.

2. What you need to know before using Misofar 200

Do not use Misofar 200

• if you are allergic to misoprostol, to prostaglandins, or to any of the other ingredients of this medicine (listed in section 6);
• if oxytocic drugs are contraindicated or prolonged uterine contractions are considered inappropriate;
• for cervical dilation in non-pregnant women prior to hysteroscopy or other gynecological procedures requiring access to the uterine cavity: if you are pregnant or think you might be pregnant.
• for the treatment of incomplete spontaneous abortion and incomplete induced abortion: in known or suspected ectopic pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before using Misofar 200.

Inform your doctor:

• if you have blood clotting 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 epileptic episodes;

• if you suffer from kidney, liver, heart, or arterial disease;

• if you have low blood pressure (hypotension).

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

The administration of mifepristone and misoprostol should be spaced 1-2 days apart, according to available information. For further details, refer to the package leaflet of medicines containing mifepristone.

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

After treatment, uterine bleeding will occur, which may last up to 2-3 weeks (usually averaging 9 days), and may vary in intensity. Your doctor will advise you on how to manage the bleeding. If bleeding is very heavy and/or prolonged, consult your doctor.

Use of Misofar 200 with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Misofar 200, such as anticoagulants (acenocoumarol), antacids containing magnesium, non-steroidal anti-inflammatory drugs (NSAIDs), and laxatives.

Use of Misofar 200 with food and drink

No interactions between Misofar 200 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.

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

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

Driving and use of machines

No effects on driving or use of machines have been observed.

Misofar 200 contains hydrogenated castor oil, which may cause allergic reactions at the application site.

3. How to use Misofar 200

Follow exactly the instructions for administration of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment with Misofar 200, as well as the dose to start with and how to proceed.

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

• For medical treatment of incomplete abortion with uterine size less than 14 weeks: use 600 µg of misoprostol, either as monotherapy or 1–2 days after mifepristone administration. Depending on clinical assessment and local recommendations or protocols, 800 µg of misoprostol may also be used. Additional doses may be administered if necessary after 24 hours.

• For medical treatment of incomplete abortion with uterine size of 14 weeks or greater: use 400 µg of misoprostol every three hours, either as monotherapy or 1–2 days after mifepristone administration. Misoprostol may be repeated at the indicated intervals as needed to successfully complete the abortion process.

Your doctor will determine the maximum number of doses for gestational ages greater than 14 weeks if you have a prior uterine incision.

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 of Misofar 200 is vaginal.

Follow these usage instructions:

• Wash your hands thoroughly.

• Remove the vaginal tablet from the blister pack.

• Lie on your back with your knees drawn up toward your chest.

• Using the middle finger, insert the vaginal tablet into the vagina as deeply as possible without causing discomfort.

If you feel that the effect 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 of age.

If you use more Misofar 200 than you should

If you have used more tablets than your doctor prescribed, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone 91 562 04 20, stating the name of the medicine and the amount administered.

Overdose may present with 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).

In cases of massive overdose, supportive treatment will be symptomatic.

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

4. Possible adverse effects

Like all medicines, Misofar 200 may cause adverse effects, although not everyone experiences 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 the following:

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

Other adverse effects described occasionally are:

• Infections and infestations: Systemic infection (septicemia) and septic shock.
• Blood and lymphatic system disorders: anemia.
• 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), edema (swelling), thromboembolism (blood clot formation in blood vessels).
• Respiratory, thoracic and mediastinal disorders: cough, dyspnea (difficulty breathing), 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 hematuria (blood in urine) have been reported.
• Pregnancy, puerperium (weeks following childbirth), and perinatal conditions: 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 (amniotic fluid infection), pulmonary embolism due to amniotic fluid, vaginal hemorrhage (bleeding).
• Reproductive system and breast disorders: In rare cases, dysmenorrhea (painful menstruation) and vaginal hemorrhage (bleeding) may occur.
• General disorders and administration site conditions: transient fever (increased body temperature), chills, and general malaise.

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 not listed in this leaflet. You may also report them directly through 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 200

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 carton after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Misofar 200

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

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

Appearance of the medicinal product and contents of the pack

Misofar 200 are white vaginal tablets, oblong capsule-shaped with a score line. They are supplied in packs containing 4 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 revision of this leaflet: 09/2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/