Citotec

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Cytotec, 200 µg, tablets

Misoprostol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

Table of contents of the leaflet:

• 1. What is Cytotec and what is it used for
• 2. Important information before taking Cytotec
• 3. How to take Cytotec
• 4. Possible side effects
• 5. How to store Cytotec
• 6. Contents of the packaging and other information

1. WHAT IS CYTOTEC AND WHAT IS IT USED FOR

Cytotec contains the active substance misoprostol. Misoprostol is similar to substances naturally produced in the body, called prostaglandins (in particular prostaglandin E1), which are produced, among others, in the stomach, duodenum, and intestines. Cytotec is indicated for the prevention of gastric and duodenal ulcers that occur during treatment with non-steroidal anti-inflammatory drugs (NSAIDs).

2. IMPORTANT INFORMATION BEFORE TAKING CYTOTEC

When not to take Cytotec

• if the patient is allergic to misoprostol, other prostaglandins, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is of childbearing age and does not use effective contraception to prevent pregnancy (for more information, see the "Pregnancy" section);
• if the patient is pregnant, trying to become pregnant, or has not had a negative pregnancy test result, as taking this medicine may cause miscarriage (for more information, see the "Pregnancy" section);
• during breastfeeding.

The patient should inform their doctor if they have heart or blood vessel diseases, including coronary artery disease, hypertension, or cerebrovascular diseases.

Warnings and precautions

Before starting to take Cytotec, the patient should discuss it with their doctor or pharmacist if:

• the patient is pregnant or plans to become pregnant (see the "Pregnancy" section below); due to the risk to the fetus, Cytotec should be stopped immediately;
• the patient is of childbearing age (see the "Pregnancy" section below); due to the risk to the fetus, it is essential to use effective contraception while taking Cytotec.

When to exercise special caution when taking Cytotec

• in women before menopause, unless the patient requires non-steroidal anti-inflammatory drugs (NSAIDs) and is at high risk of complications from ulcers caused by these drugs. In such cases, effective methods of preventing pregnancy should be used,
• in patients with conditions predisposing to diarrhea, such as non-specific inflammatory bowel diseases. To reduce the risk of diarrhea, misoprostol should be taken with food and antacids containing magnesium should be avoided,
• in patients in whom dehydration may be dangerous. These patients should be closely monitored.

In patients treated with NSAIDs and taking Cytotec, ulcers, perforations, and gastrointestinal bleeding may occur. The doctor may decide to perform an endoscopy or biopsy before starting treatment to rule out cancer of the upper gastrointestinal tract. Relief of symptoms after taking Cytotec does not rule out the presence of a gastric tumor.

Using Cytotec in elderly patients (over 65 years old)

No dose adjustment is necessary.

Using Cytotec in patients with renal impairment

No dose adjustment is necessary.

Using Cytotec in patients with hepatic impairment

The effect of hepatic impairment on the metabolism of the medicine and its concentration in the blood is minimal.

Cytotec and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. Studies have not shown any effect of Cytotec on the use of other medicines. During treatment with Cytotec, the patient should avoid taking antacids containing magnesium, as they may exacerbate diarrhea caused by misoprostol. In rare cases, concurrent administration of NSAIDs and Cytotec may increase the activity of aminotransferases and cause peripheral edema.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Pregnancy If the patient is pregnant or plans to have a child, they should not take Cytotec. If the patient becomes pregnant while taking Cytotec, the doctor will inform them about the risks associated with the treatment, as Cytotec may cause miscarriage, premature birth, or birth defects in the fetus. Pregnancies exposed to misoprostol in the first trimester were associated with an approximately 3-fold increased risk of birth defects in the fetus, particularly facial paralysis, limb defects, and developmental brain and skull defects. If the patient is exposed to Cytotec during pregnancy, they should discuss this with their doctor. If the patient decides to continue the pregnancy, they should be closely monitored until birth and undergo repeated ultrasound examinations, with particular attention to the fetus's limbs and head. Cytotec should not be used during breastfeeding. Cytotec should not be used during breastfeeding, as its metabolites pass into human milk, which may cause side effects in breastfed infants (e.g., diarrhea).

Driving and using machines

Cytotec may cause dizziness, so it may affect the ability to drive and use machines.

Cytotec contains hydrogenated castor oil

The medicine may cause indigestion and diarrhea.

Cytotec contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. HOW TO TAKE CYTOTEC

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose is 400 micrograms to 800 micrograms per day, divided into two or four doses. During treatment with Cytotec, the patient should continue to take NSAIDs as prescribed by the doctor. If necessary, Cytotec should be taken at the same time as NSAIDs, until the end of NSAID therapy. Individual doses of Cytotec should be taken during breakfast and (or) main meals and before bedtime.

Taking a higher dose of Cytotec than recommended

If a higher dose of Cytotec is taken than recommended, the side effects listed below may occur, or existing side effects may worsen. If a higher dose of the medicine is taken than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Cytotec

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Cytotec

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cytotec can cause side effects, although not everybody gets them. If any of the side effects get serious, or if the patient notices any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Very common(may affect more than 1 in 10 people) diarrhea*, rash Common(may affect up to 1 in 10 people) dizziness of central origin, headaches, abdominal pain*, constipation, indigestion, bloating, nausea, vomiting, birth defects (fetal developmental abnormalities). If the patient becomes pregnant during treatment, they should stop taking Cytotec immediately and seek medical advice. Uncommon(may affect up to 1 in 100 people) vaginal bleeding (including bleeding in postmenopausal women), intermenstrual bleeding, menstrual disorders, uterine contractions, fever Rare(may affect up to 1 in 1,000 people) menstrual bleeding, painful menstruation, uterine rupture (uterine tear) after administration of prostaglandins in the second or third trimester of pregnancy (mainly in women who have given birth before or have cesarean section scars). The patient should seek immediate medical attention. Frequency not known(cannot be estimated from the available data) anaphylactic reactions, amniotic fluid embolism, abnormal uterine contractions, fetal death, incomplete miscarriage, premature birth, retained placenta, uterine rupture, uterine perforation, uterine bleeding, chills. * Diarrhea and abdominal pain were dose-related, usually occurred in the early stages of treatment, and were self-limiting. In rare cases, severe diarrhea was reported, leading to severe dehydration.Selected population groups No special differences in the safety profile of misoprostol were found in patients over 65 years old compared to younger patients. The use of misoprostol in children has not been evaluated.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE CYTOTEC

Do not store above 30°C. The medicine should be kept out of the sight and reach of children. Do not use Cytotec after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. OTHER INFORMATION

What Cytotec contains

• The active substance of Cytotec is misoprostol (Misoprostolum). One tablet contains 200 micrograms (µg) of misoprostol.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (see section 2 "Cytotec contains sodium"), hydrogenated castor oil, hypromellose.

What Cytotec looks like and contents of the pack

White or grayish hexagonal tablets with a score line on both sides, with the inscription "SEARLE 1461" embossed on one side. Aluminum foil blisters in a cardboard box, containing 42 tablets. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Pfizer Hellas A.E. 243, Messoghion Ave Neo Psychiko 154 51 Greece

Manufacturer:

Piramal Pharma Solutions (Dutch) B.V. Level, 7e verdieping, Bargelaan 200, 2333 CW, Leiden, Netherlands

Parallel importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warsaw Marketing authorization number in Greece, the country of export:40410/07/19-05-2008 Parallel import authorization number:564/13

Date of leaflet approval: 10.03.2025

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