Package Insert: Information for the User

Cytotec 200 microgram tablets

Misoprostol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Misoprostol is a prostaglandin that belongs to a group of medications known as antiulceratives. It is indicated in adults for the treatment of duodenal ulcers and for the prevention of gastrointestinal injuries induced by the administration of nonsteroidal anti-inflammatory drugs in long-term treatments.

Do not takeCytotec

• if you are a woman of childbearing age and are not using an effective contraceptive method to prevent pregnancy (see the section "Pregnancy" for more information).
• if you are pregnant, plan to become pregnant, or have a negative pregnancy test, as misoprostol increases uterine tone and contractions during pregnancy, which may cause a miscarriage.
• if you are allergic to misoprostol, other prostaglandins, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cytotec.

• if you are pregnant or plan to become pregnant (see the subsection "Pregnancy" below). Due to the risk to the fetus, Cytotec treatment should be stopped immediately,
• if you are a woman of childbearing age (see the subsection "Pregnancy" below). Due to the risk to the fetus, it is essential to use effective contraceptive methods while taking Cytotec,
• if you are a woman of childbearing age, as misoprostol treatment should not begin until a possible pregnancy has been ruled out. You should use an appropriate contraceptive method during treatment with this medication. If you suspect a pregnancy, you should stop misoprostol treatment and discuss it with your doctor,
• if you are being treated with nonsteroidal anti-inflammatory drugs (NSAIDs), there is a possibility of gastrointestinal bleeding, ulceration, or perforation despite misoprostol treatment. You should be aware of this possibility even in the absence of gastrointestinal symptoms. If you are a patient prone to diarrhea, for example, if you have irritable bowel syndrome,
• if you are dehydrated,
• if you have a heart or blood circulation disease, including high blood pressure.

Taking Cytotec with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Anti-acids containing magnesium should be avoided during misoprostol treatment, as they may worsen the possible diarrhea induced by it.

The concomitant administration of misoprostol with NSAIDs, in rare cases, produces peripheral edema and alteration of biochemical tests (elevation of transaminases).

Taking Cytotec with food and drinksand beverages

Cytotec should be taken during or after meals and before bedtime with a glass of water.

Pregnancy, lactation, and fertility

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

Pregnancy

Do not take Cytotec if you are pregnant or plan to become pregnant. Your doctor will inform you of the risks if you become pregnant, as Cytotec may cause a spontaneous abortion, premature birth, or birth defects. Pregnancies exposed to misoprostol during the first trimester have been associated with a risk approximately 3 times higher of birth defects, particularly facial paralysis, limb malformations, cerebral and cranial anomalies. If you are exposed to Cytotec during pregnancy, consult your doctor. If you decide to continue with the pregnancy, you will be closely monitored prenatally and undergo periodic ultrasound examinations, paying special attention to the limbs and head.

Cytotec is contraindicated in pregnant women as it induces uterine contractions associated with abortions, premature births, birth defects, and fetal death. Therefore, a pregnancy should be ruled out before starting to use this medication, and an appropriate contraceptive method should be used during treatment with it.

Misoprostol is excreted in breast milk and should not be administered to lactating mothers as it may have adverse effects on the infant.

Driving and operating machinery

Although no effects are expected, if you experience dizziness, you should not drive or operate hazardous machinery.

Cytotec contains castor oil and sodium

This medication may cause stomach discomfort and diarrhea because it contains castor oil.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

The recommended dose in adults and elderly patients is:

For the prevention of gastrointestinal lesions induced by nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with long-term treatment: 1 tablet (200 micrograms of misoprostol) 2 to 4 times a day, during or after meals and before bedtime. The maximum recommended daily dose is 2 to 4 tablets (400 micrograms to 800 micrograms of misoprostol).

For the treatment of duodenal ulcer:4 tablets (800 micrograms of misoprostol) per day divided into 4 doses, for a minimum period of 4 weeks, although symptoms may have disappeared before. Your doctor may indicate that you continue treatment until 8 weeks.

Use in children and adolescents

The safety and efficacy have not been established in children under 18 years.

Patients with kidney function impairment

If you have kidney problems (renal failure), your doctor may recommend a lower dose.

Cytotec is administered orally. The tablets should be swallowed whole with a sufficient amount of liquid during or after meals or before bedtime.

The notch should not be used to break the tablet

If you take more Cytotec than you should

You may experience the following symptoms: drowsiness, tremors, convulsions, difficulty breathing, abdominal pain, diarrhea, fever, palpitations, low blood pressure or slower heart rate.

If you have taken more misoprostol than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Cytotec

In case of forgotten dose, take the medication as soon as possible and continue treatment as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Cytotec

Do not stop treatment without consulting your doctor, as there is a risk of suffering a gastrointestinal lesion.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Diarhea is the most common side effect. It usually appears in the first few days of treatment and is temporary. To reduce the risk of diarrhea, it is recommended to take the medicine with food.

The reported side effects are classified according to their frequency order:

Very common(may affect more than 1 in 10 people):

• diarrhea,
• skin rash.

Common(may affect up to 1 in 10 people):

• dizziness, headache,
• abdominal pain, constipation, heavy digestion, gas, nausea, and vomiting,
• birth defects (fetal malformations). If you become pregnant during treatment, stop taking Cytotec immediately and seek medical attention.

Uncommon(may affect up to 1 in 100 people):

• vaginal bleeding (including bleeding after menopause), bleeding between periods, menstrual disorders, and uterine cramps,
• fever.

Rare(may affect up to 1 in 1,000 people):

• excessive or prolonged menstrual bleeding (menorrhagia), painful menstruation (dysmenorrhea),
• uterine rupture (uterine rupture) after administration of prostaglandins in the second or third trimester of pregnancy, mainly in women with previous births or with a cesarean scar. Seek urgent medical attention.

Frequency not known(cannot be estimated from available data):

• allergy,
• leakage of amniotic fluid into the mother's circulation, which may cause heart failure, abnormal uterine contractions, fetal death, incomplete abortion, premature birth, retention of the placenta in the uterus after delivery, uterine bleeding,
• chills.

Reporting of side effects

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

Store below 30°C. Store in the original packaging to protect it from light.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Cytotec

• The active ingredient is misoprostol. Each tablet contains 200 micrograms of misoprostol.
• The other components (excipients) are: hypromellose, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (potato starch), hydrogenated ricin oil. See section 2 “Cytotec contains ricin oil”.

Appearance of the product and contents of the packaging

Cytotec 200 mcg is presented in the form of white to off-white, hexagonal, scored tablets on both faces, and with the marks “SEARLE” and “1461” on one of them. Each package contains 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa, 20 B.Parque Empresarial La Moraleja. 28108 Alcobendas, Madrid.

Responsible for manufacturing

Piramal Pharma Solutions (Dutch) B.V.

Bargelaan 200

2333 CW

Leiden

Netherlands

Date of the last review of this leaflet:06/2018

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.es/