Citotec
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How to use Citotec
PATIENT INFORMATION LEAFLET: USER INFORMATION
Warning! Keep the leaflet, the information on the immediate packaging is 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.
- You should keep this leaflet, so that you can read it again if you need to.
- If you have any doubts, you should consult a doctor or pharmacist.
- This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
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 pack and other information
1. What is Cytotec and what is it used for
Cytotec contains the active substance misoprostol. Misoprostol is similar to substances produced naturally 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, which occur during treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
2. Important information before taking Cytotec
When not to take Cytotec
- during breastfeeding.
The patient should inform their doctor if they have heart or blood vessel diseases, including coronary artery disease, hypertension, and cerebral vascular 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 be particularly careful when taking Cytotec
- in premenopausal women, 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 that predispose 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 for whom dehydration may be hazardous. 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 exclude the presence of a gastric tumor.
Taking Cytotec in elderly patients (over 65 years)
No dose adjustment is necessary.
Taking Cytotec in patients with renal impairment
No dose adjustment is necessary.
Taking Cytotec in patients with hepatic impairment
The effect of hepatic impairment on the metabolism of the medicine and its concentration in the blood is small.
Taking 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. While taking Cytotec, the patient should avoid taking antacids containing magnesium, as they may exacerbate diarrhea caused by misoprostol. In rare cases, concomitant administration of NSAIDs and Cytotec may cause increased aminotransferase activity and 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 approximately a 3-fold increased risk of birth defects in the fetus, particularly facial paralysis, limb defects, and brain and skull developmental abnormalities. If the patient is exposed to Cytotec during pregnancy, they should discuss it 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 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. If in 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. While taking Cytotec, the patient should continue to take NSAIDs as prescribed by their doctor. If indicated, 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, side effects may occur, or existing side effects may worsen. If a higher dose of Cytotec 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 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 worse, or if the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Very common(more than 1 in 10 people) diarrhea*, rash Common(more than 1 in 100, but less than 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(more than 1 in 1,000, but less than 1 in 100 people) vaginal bleeding (including bleeding in postmenopausal women), intermenstrual bleeding, menstrual disorders, uterine contractions, fever Rare(more than 1 in 10,000, but less than 1 in 1,000 people) menstrual bleeding, painful menstruation, uterine rupture (uterine rupture) after administration of prostaglandins in the second or third trimester of pregnancy; this occurs mainly in women who have given birth before or have scars from a cesarean section. Medical help should be sought immediately. Unknown(frequency 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. Selected population groups No special differences in the safety profile of misoprostol have been found in patients over 65 years of age 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Al. Jerozolimskie 181C 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
Store at room temperature (15°C-25°C). The medicine should be stored out of sight and reach of children. Do not use this medicine 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 containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
6. Contents of the pack and other information
What Cytotec contains
- The active substance of Cytotec is misoprostol. One tablet contains 200 micrograms (µg) of misoprostol.
- The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, hydrogenated castor oil, hypromellose 2910.
What Cytotec looks like and contents of the pack
Aluminum foil blisters in a cardboard box, containing 28 or 42 tablets. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.
Marketing authorization holder in Belgium, the country of export:
Pfizer NV/SA, boulevard de la Plaine 17, B-1050 Brussels, Belgium
Manufacturer:
Piramal Pharma Solutions (Dutch) B.V., Level, 7e verdieping, Bargelaan 200, 2333 CW Leiden, Netherlands
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź Belgian marketing authorization number: BE134093
Parallel import authorization number: 40/22 Date of approval of the leaflet: 18.01.2022
[Information about the trademark]
- Country of registration
- Active substance
- Prescription requiredYes
- Marketing authorisation holder (MAH)Pfizer NV/SA
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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