Cytotec

Warning! Keep the package leaflet. Information on the immediate packaging in a foreign language.
Cytotec
200 µg (200 mcg), tablets
Misoprostol
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Cytotec is and what it is 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 pack and other information

1. WHAT CYTOTEC IS AND WHAT IT IS USED FOR

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

2. IMPORTANT INFORMATION BEFORE USING CYTOTEC

When not to use 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 is not using an effective method of contraception to prevent pregnancy (for further information see section "Pregnancy");
• if the patient is pregnant, trying to become pregnant, or has not obtained a negative pregnancy test result, because taking this medicine may cause miscarriage (for further information see section "Pregnacy");
• during breastfeeding.

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

Warnings and precautions

Before starting treatment with Cytotec, discuss with your doctor or pharmacist if:

• the patient is pregnant or plans to become pregnant (see section "Pregnancy" below); due to the risk to the fetus, treatment with Cytotec must be discontinued immediately;
• the patient is of childbearing age (see section "Pregnancy" below); due to the risk to the fetus, it is important to use an effective method of contraception during treatment with Cytotec.

When to exercise particular caution when using Cytotec

• in premenopausal women, unless the patient requires treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) and is at high risk of NSAID-induced ulcer complications. In such cases, effective contraception methods should be used;
• in patients with conditions predisposing to diarrhea, such as inflammatory bowel disease. To reduce the risk of diarrhea, misoprostol should be taken with food and antacids containing magnesium (which neutralize gastric acid) should be avoided;
• in patients in whom dehydration may be dangerous. Such patients should be closely monitored.

Patients treated with NSAIDs who are also taking Cytotec may develop gastrointestinal ulcers, perforations, and bleeding.

The doctor may decide to perform endoscopy or biopsy before starting treatment to exclude malignancy of the upper gastrointestinal tract.

Symptom relief after using Cytotec does not rule out the presence of gastric malignancy.

Use of Cytotec in elderly patients (over 65 years of age)
No dose adjustment is necessary.

Use in patients with renal impairment
No dose adjustment is necessary.

Use in patients with hepatic impairment
The effect of hepatic impairment on the metabolism and plasma concentration of the drug is minimal.

Cytotec and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription. Studies have not shown any effect of Cytotec on the use of other medicines.

During treatment with Cytotec, avoid taking antacids that neutralize gastric acid (containing magnesium), as they may worsen misoprostol-induced diarrhea.

In rare cases, concomitant use of NSAIDs and Cytotec may lead to increased aminotransferase activity and peripheral edema.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

If the patient is pregnant or planning to become pregnant, she should not take Cytotec.

If pregnancy occurs during treatment with Cytotec, the doctor will inform the patient about the risks associated with the treatment, as Cytotec may cause miscarriage, premature delivery, or congenital malformations in the fetus. Pregnancies exposed to misoprostol during the first trimester have been associated with approximately a threefold increased risk of congenital malformations, particularly facial nerve palsy, limb malformations, and developmental abnormalities of the brain and skull.

If a patient is exposed to Cytotec during pregnancy, she should discuss this with her doctor. If the patient decides to continue the pregnancy, careful monitoring until delivery is required, including multiple ultrasound examinations focusing particularly on the fetus's limbs and head.

Breastfeeding

Cytotec should not be used during breastfeeding.

Cytotec should not be used during breastfeeding because its metabolites pass into human milk and may cause adverse effects in breastfed infants (e.g., diarrhea).

Driving and operating machinery

Cytotec may cause dizziness; therefore, Cytotec may affect the ability to drive vehicles and operate machinery.

Cytotec contains sodium

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

3. HOW TO USE CYTOTEC

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose is 400 to 800 micrograms per day, divided into two or four doses. During treatment with Cytotec, continue using nonsteroidal anti-inflammatory drugs (NSAIDs) as directed by your physician. If indicated, Cytotec should be taken concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs) until the end of NSAID therapy. Individual doses of Cytotec should be taken with breakfast and/or main meals and at bedtime.
Use of a higher than recommended dose of Cytotec
If a dose higher than recommended is taken, the adverse reactions listed below may occur or existing adverse reactions may worsen. If you take more than the recommended dose, contact your doctor or pharmacist immediately.
Missed dose of Cytotec
Do not take a double dose to make up for a missed dose.
Stopping Cytotec
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur,
the patient should inform 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)
central dizziness, headache, abdominal pain*, constipation, indigestion, bloating, nausea, vomiting, congenital abnormalities (fetal developmental defects). If pregnancy occurs during treatment, Cytotec must be discontinued immediately and medical advice should be sought.
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)
menorrhagia, dysmenorrhea, uterine rupture (uterine perforation) following administration of prostaglandins in the second or third trimester of pregnancy (occurs mainly in women who have previously given birth or who have scars from previous caesarean sections). Immediate medical attention is required.
Frequency not known (cannot be estimated from the available data)
anaphylactic reactions, amniotic fluid embolism, abnormal uterine contractions, fetal death, incomplete abortion, premature delivery, retained placenta, uterine rupture, uterine perforation, uterine hemorrhage, chills.
*Diarrhea and abdominal pain were dose-related, usually occurred early in treatment and tended to resolve spontaneously. In rare cases, severe diarrhea leading to serious dehydration has been reported.

Selected population groups
No specific differences in the safety profile of misoprostol have been observed in patients aged 65 years or older compared to younger patients.
The use of misoprostol in children has not been evaluated to date.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 4921301
Fax: +48 (22) 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE CYTOTEC

Store below 30°C.
Keep the medicine 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Cytotec contains

• The active substance is mizoprostol. One tablet contains 200 µg (200 mcg) of mizoprostol.
• The other components are: microcrystalline cellulose, sodium carboxymethyl starch, hydrogenated castor oil, hypromellose.

What Cytotec looks like and contents of the pack
White or greyish, hexagonal tablets, scored on both sides, with the imprint
"SEARLE 1461" on one side.
Aluminum foil blisters in a cardboard box containing 28 or 42 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Greece, country of export:
Pfizer Hellas A.E.
243, Messoghion Ave
Neo Psychiko 154 51
Greece

Manufacturer:
Piramal Healthcare UK Limited
Whalton Road, Morpeth, Northumberland
NE61 3YA
United Kingdom
Piramal Pharma Solutions (Dutch) B.V.
Level, 7e verdieping, Bargelaan 200
2333 CW, Leiden
The Netherlands

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Greece, country of export: 40410/07/19-05-2008
Parallel Import Licence Number: 357/19