0.2 mg tablets 
misoprostol

1. What Cytotec is and what it is used for

Cytotec is used to heal ulcers in the stomach and for preventive purposes to prevent the appearance of ulcers in the stomach and duodenum in patients with an increased risk of ulcers when treated with drugs for inflammation and pain. Cytotec protects the gastric mucosa by increasing the production of mucus in the stomach and the excretion of bicarbonate in the duodenum. Cytotec also inhibits gastric juice secretion and reduces nocturnal gastric acid secretion.

2. What you need to know before using Cytotec

Do not use Cytotec if you

  • is allergic to misoprostol, other prostaglandins, or any of the other ingredients of this medicine (listed in section 6).
  • is a fertile woman and does not use effective contraception to avoid pregnancy (see section “Pregnancy” for more information).
  • is pregnant or trying to conceive, or does not have a negative pregnancy test, as this medicine may cause miscarriage. Women who have not reached menopause should use adequate contraception before starting treatment with Cytotec.

Warnings and cautions

Talk to your doctor or pharmacist before using Cytotec if you

  • are pregnant or planning to become pregnant (see section “Pregnancy” below). Due to the risk to the fetus, treatment with Cytotec must be stopped immediately.
  • is a fertile woman (see section “Pregnancy” below). Due to the risk to the fetus, you must use an effective contraceptive while taking Cytotec.
  • have a disease that makes you more prone to diarrhea, such as inflammatory bowel diseases such as ulcerative colitis or Crohn’s disease.
  • suffers from angina or narrowing of the blood vessels to the heart or brain, has severe problems with blood circulation ( peripheral vascular disease or if you have high blood pressure ).
  • concomitantly treated with anti-inflammatory and analgesic drugs of the NSAIDtype.
  • is sensitive to dehydration.

Other medicines and Cytotec

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Cytotec may affect the effectiveness of certain other medicines if they are taken at the same time, such as medicines containing ketoconazole (for fungal infections). Concomitant treatment with antacids (anti-heartburn agents) containing magnesium should be avoided as it may worsen misoprostol-induced diarrhea. Concomitant use of anti-inflammatory and analgesic drugs of the NSAID type can in rare cases cause an increase in certain blood levels, as well as fluid accumulation in the body (swelling in the ankles, legs, and/or hands).

Blood pressure-lowering drugs containing propranolol may, after repeated dosing of Cytotec, lead to a moderate increase in the concentration of propranolol in the blood.

Cytotec with food, drink, and alcohol

Cytotec should be taken immediately after a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Cytotec if you are pregnant or planning to become pregnant. Your doctor will inform you about the risks if you become pregnant as Cytotec can cause miscarriages, premature births, and fetal malformations. In pregnancies where the woman has taken misoprostol during the first three months (the first trimester), there has been an approximately three times as large increase in fetal malformations, especially facial paralysis, and malformation in the arms, legs, and head. If you are exposed to Cytotec during pregnancy, talk to your doctor. If you decide not to terminate the pregnancy, you must be closely monitored and repeated ultrasound examinations must be performed, paying special attention to the baby’s legs, arms, and head.

Cytotec must not be used during pregnancy. Women of childbearing potential using Cytotec should use effective contraception. Should you nevertheless become pregnant during treatment with Cytotec, you should stop taking Cytotec and contact your doctor. 

The risk of rupture of the uterus increases with the length of the pregnancy and with previous surgery in the uterus, including a cesarean section. The number of births a woman has undergone also seems to be a risk factor for rupture of the uterus.

Breast-feeding

Cytotec should not be used by breastfeeding women as misoprostol passes into breast milk and may cause side effects such as diarrhea in breastfeeding babies.

Driving and using machines

Cytotec may cause dizziness. If you feel dizzy or drowsy after taking Cytotec, do not drive or use machines until these symptoms have subsided.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cytotec contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium free’.

3. How to use Cytotec

Always use Cytotec exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The usual dose for adults is 1 tablet 2-4 times daily. Cytotec should be taken immediately after a meal, to reduce the risk of diarrhea, as well as the last dose at bedtime. Cytotec and medicines for pain/inflammation should be taken at the same time if possible.

Use for children and adolescents

The use of misoprostol in children has not been evaluated.

If you use more Cytotec then you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice.

If you forget to use Cytotec

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 user in 10): Skin rash, diarrhea

Common (may affect up to 1 in 10 people): Birth defects (fetal malformations). If you become pregnant during treatment, you must stop taking Cytotec immediately and seek medical advice.

Headache, dizziness, abdominal pain, nausea, flatulence, acid regurgitation, vomiting, and constipation.

Uncommon (may affect up to 1 in 100 people): Uterine cramps, menstrual disorders, hemorrhages, fever.

Rare (may affect up to 1 in 1,000 people): Uterine rupture (uterine rupture) after ingestion of prostaglandins during the second or third trimester of pregnancy, mainly in women who have previously had children or undergone a cesarean section. Seek medical attention immediately.

Abundant menstruation, painful menstruation.

Has been reported (occurs in an unknown number of users): Anaphylactic reaction ( hypersensitivity reaction with fever, rash, swelling, and sometimes drop in blood pressure), amniotic fluid embolism (means that amniotic fluid is forced into the mother’s blood vessels and causes a blood clot), Abnormal contractions of the uterus, fetal death abortion, premature birth, retained placenta after childbirth, perforation of the uterus, uterine bleeding, and goosebumps.

The side effects usually occur at the beginning of treatment and are usually transient.

To reduce the risk of diarrhea, the tablets should be taken immediately after a meal.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

5. How to store Cytotec

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 expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is misoprostol 0.2 mg per tablet.
  • The other ingredients are hypromellose, microcrystalline cellulose, sodium starch glycolate, hydrogenated castor oil.

What the medicine looks like and the contents of the pack

Tablet 0.2 mg, white, hexagonal, 8.4 × 8.4 mm, partially cut, marked SEARLE 1461

Pressure pack containing 56, 60, or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Manufacturer

Piramal Healthcare UK Limited

Whalton Road

Morpeth

Northumberland

NE61 3YA

UK

or

Piramal Pharma Solutions (Dutch) BV

Level, 7th floor

Bargelaan 200

2333 CW

Leiden

Netherlands

Muhammad Nadeem

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