Skip to Content

UK Edition. Click here for US version.

CYTOTEC 200MICROGRAM TABLETS

Active substance(s): MISOPROSTOL

View full screen / Print PDF » Download PDF ⇩
Transcript
CYTOTEC 200 microgram TABLETS
(misoprostol)
Your medicine is known by the above name, but will be referred to as Cytotec
throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start using this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Cytotec is and what it is used for
2) Before you take Cytotec
3) How to take Cytotec
4) Possible side effects
5) How to store Cytotec
6) Further information

1) What Cytotec is and what it is used for
Cytotec tablets contain misoprostol which is similar to a chemical substance
called 'prostaglandin' which your body produces naturally. Prostaglandins are
produced in the stomach and intestine and help to protect the lining. Cytotec
belongs to a group of medicines known as 'anti-ulcer agents'.
The Cytotec tablets may help prevent you getting ulcers in your stomach or
the part it empties into, called the duodenum. These ulcers could be caused
by taking non-steroidal anti inflammatory drugs (NSAIDs) like diclofenac and
naproxen. The way NSAIDs work means they reduce the amount of
prostaglandins in your stomach and intestine. This can cause
indigestion and lead to ulcers forming. The Cytotec tablets will replace these
prostaglandins and help to protect your stomach and intestine, so you can
continue getting benefit from your NSAID. Cytotec also reduces acid and
increases bicarbonate in your stomach secretions.
Cytotec can also be used to heal existing ulcers.

2) Before you take Cytotec
Cytotec may not be suitable for everyone. Please read the following list
carefully to see if any of these apply to you. Consult your doctor if you are not
sure.
Do not take Cytotec if you:
 are pregnant or trying to become pregnant because it may cause a
miscarriage (see Section ‘Pregnancy’ for further information);
 are breastfeeding;
 have ever had an allergic reaction to Cytotec or any of the other ingredients
in it, or other prostaglandin medicines in the past.
Take special care with Cytotec
Tell your doctor if you have any of the following conditions to help him or her
decide if Cytotec is suitable for you:
 heart disease;
 low or high blood pressure, or any disease of the blood vessels.
 Inflammatory bowel disease
If you are a younger woman who has not yet gone through the menopause,
your doctor will have only prescribed Cytotec if he is satisfied you are at high
risk of developing ulcers from your NSAID medicine
Taking other medicines
You can take Cytotec with most medicines without any problems. If you use
an antacid (something to reduce acid in the stomach) you should avoid
antacids with magnesium in them as these may make diarrhoea worse.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription
Taking Cytotec with food and drink
You should take your Cytotec tablet with food.
Pregnancy
If you are a younger woman who has not yet gone through the menopause,
your doctor will have only prescribed Cytotec if he is satisfied you are at high
risk of developing ulcers from your NSAID medicine. Your doctor will make
you aware of the risks if you do become pregnant.
Cytotec can cause a miscarriage or damage to your womb, so it is very
important to use reliable contraception while taking this medicine. The risk of
damage to your womb is greater in the later stages of pregnancy, and if you
have had a previous Caesarean delivery or have given birth to five or more
children. If you want to try for a baby, tell your doctor as you will have to stop
taking Cytotec and use a different treatment.
Cytotec should not be taken by pregnant women and in women planning a
pregnancy.
Breastfeeding
Do not breastfeed while taking Cytotec.
Driving and using machinery
Dizziness has been reported after taking Cytotec. Be cautious when driving or
operating machinery until you know how the medicine affects you.
Important information about some of the ingredients of Cytotec
Cytotec contains hydrogenated castor oil which may cause stomach upset
and diarrhoea.

3) How to take Cytotec
Always take your medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Cytotec is suitable only for adults aged 18 years and over.
To heal ulcers in your stomach or duodenum
You should normally take two 200 microgram Cytotec tablets twice a day with
food.
Alternatively you can take one Cytotec tablet four times a day, at regular
intervals with food.
Treatment will usually last for 4 weeks, but may be extended up to 8 weeks. If
your ulcers are not completely healed after this period, further treatment may
be given.
To prevent ulcers when taking NSAID medicines
You should usually take one 200 microgram tablet, two, three or four times a
day. Your doctor will adjust your dose to suit you.
You will need to continue to take Cytotec as long as is needed to protect your
stomach or gut, and must keep taking the tablets until your doctor advises you
to stop.
If you take more Cytotec than you should
If you take too many tablets, contact your doctor or accident and emergency
department straight away.
If you forget to take Cytotec
If you forget to take a dose of your tablets, take them as soon as you
remember. But if it is almost time for your next dose, do not take the tablet(s)
you have missed.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4) Possible side effects
Like all medicines Cytotec can cause side effects although not everybody
gets them. Most of these don't happen very often, are not serious and will
often wear off after a while. If you are worried about any side effects, then talk
to your doctor.
The following side effects have been reported with Cytotec:
Effects on the stomach and intestines: wind, indigestion, stomach pain,
constipation, feeling or being sick. Diarrhoea is the most common problem
and is occasionally severe. You have less chance of getting diarrhoea if you
take Cytotec with food. If you use an antacid (something to reduce acid in the
stomach) you should avoid antacids with magnesium in them as these may
make diarrhoea worse. Your pharmacist can help you choose a suitable
antacid.
Effects on the reproductive system: Some women can get period problems
including cramp, prolonged heavy bleeding, bleeding between periods,
irregular periods and severe uterine pain. Some older women may have
vaginal bleeding even though they have gone through the menopause.
Other effects: Chills, High temperature, Skin rashes and dizziness can occur.
Sometimes Cytotec can be prescribed for uses other than the approved ones
of healing or prevention of ulcers (this also called ‘off label’ use). When used
in this way the following side effects have been reported:
 abnormal contractions of the womb
 bleeding from the womb
 tearing of the tissues in the womb,
 placenta remaining in the womb after birth, termination or miscarriage
 amniotic fluid (the fluid which surrounds the baby when pregnant) entering
the mother’s bloodstream causing allergic reaction
 incomplete miscarriage and premature birth
 foetal death and birth defects.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor

5) How to store Cytotec
 Keep your tablets in a dry place below 30 ° C.
 Keep all medicines out of the sight and reach of children.
 Do not take your tablets after the expiry date printed on the box or tablet
strip. Take any out-of-date or unused tablets to your pharmacist who will
dispose of them safely.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
 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) Further information
What Cytotec contains:
Each Cytotec tablet contains: 200 micrograms of misoprostol (this is the
active ingredient); and microcrystalline cellulose, sodium starch glycolate,
hydrogenated castor oil and hydroxypropylmethylcellulose (these are known
as inactive ingredients).
What Cytotec looks like and contents of the pack
The tablets are white, hexagonal with breakline on both sides and marked
‘SEARLE 1461’ on one side.
Each pack contains 42 tablets.
PL 10383/0684

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Pharmacia Ltd, England UK. Procured
from within the EU and repackaged by Product Licence Holder: Primecrown
Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 01.05.2013

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide