MISOFAR 200 micrograms VAGINAL TABLETS

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

Do not use Misofar 200

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

Warnings and precautions

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

Tell your doctor:

• if you have problems with blood clotting or have 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 seizures;
• if you have kidney, liver, heart or arterial disease;
• if you have low blood pressure (hypotension).

An increased risk of disseminated intravascular coagulation (severe bleeding) has been described after delivery in patients who have been induced into labor by some method.

The administration between mifepristone and misoprostol should be spaced 1-2 days apart, according to available information. For more information, consult the package leaflet of the medicines that contain mifepristone.

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

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

Using Misofar 200 with other medicines

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

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

Using Misofar 200 with food and drinks

No interactions with Misofar 200 and food or drinks 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 according to the recommended indications, no clinical effect is expected, as Misofar 200 should only be administered to women of childbearing age who are not pregnant and/or postmenopausal women.

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

Driving and using machines

No effects on driving or using machines have been observed.

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

3. How to use Misofar 200

Follow exactly the administration instructions of this medicine 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 cervix in non-pregnant women prior to a hysteroscopy or other 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 history of previous cesarean section or uterine scars, and 2 to 4 hours before in uteri with a history of previous cesarean section or uterine scars.

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

• For the medical treatment of incomplete abortion with a uterine size of 14 weeks or more: use 400 µg of misoprostol every three hours, as monotherapy or 1-2 days after the administration of mifepristone. The use of misoprostol can be repeated at the indicated interval, as necessary to successfully complete the abortion process.

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 maintained at the lowest levels that produce a satisfactory uterine response.

The route of administration of Misofar 200 is vaginal.

Follow these recommendations for use:

• Wash your hands carefully.

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

If you think the action of Misofar 200 is too strong or too weak, tell 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 a larger number of tablets than your doctor has indicated, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount administered.

Overdose can manifest with uterine contractions (with risk of intrauterine fetal 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Misofar 200 can cause side effects, although not everybody gets them.

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

The most frequent adverse effects are:

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

Other adverse effects described occasionally are:

• Infections and infestations: generalized 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 (sleep), headache, tremors, anxiety.
• Eye disorders: vision disorders 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), exanthematic rash (allergy on the skin), dermatitis (inflammation of the skin), alopecia (hair loss).
• Musculoskeletal and connective tissue disorders: arthralgia (joint pain), myalgia (muscle pain), muscle cramps and spasms, back pain.
• Renal and urinary disorders: cases of polyuria (increased frequency of urination) and hematuria (blood in urine) have been described.
• In pregnancy, puerperium (weeks following delivery), and perinatal disorders: abnormal uterine contractility (increased frequency, tone, or duration) with or without fetal bradycardia (slower heartbeats), uterine rupture, premature rupture of membranes, placental abruption, amnionitis (infection of amniotic fluid), pulmonary embolism by amniotic fluid, vaginal hemorrhage (bleeding).
• Reproductive system and breast disorders: dysmenorrhea (painful menstruation) and vaginal hemorrhage (bleeding) have been reported occasionally.
• General disorders and administration site conditions: transient fever (increased body temperature), chills, and general malaise.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients (excipients) are: hydroxypropylmethylcellulose, microcrystalline cellulose, sodium starch glycolate type A (from potato), and hydrogenated ricin oil.

Appearance of the product and pack contents

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

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