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MISOPROSTOL 200MICROGRAM TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTOTEC® 200 microgram TABLETS/ MISOPROSTOL 200 microgram TABLETS
(misoprostol)
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 gets 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 nonsteroidal 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.
If you are taking any medicines for a heart condition, please consult your doctor.
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.
You will find more about CYTOTEC on the back of this leaflet

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 out of the sight and reach of children.
• Do not use Cytotec 200 microgram Tablets after the expiry date which is stated on
the carton or blister strip.
• Store in a dry place below 30ºC.
• 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.
• 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.
6. FURTHER INFORMATION
What Cytotec 200 microgram Tablets contains
Cytotec 200 microgram Tablets contain 200 micrograms (mcg) of the active substance,
misoprostol. The other ingredients are: microcrystalline cellulose, sodium starch
glycolate, hydrogenated castor oil, and hypromellose.
What Cytotec 200 microgram Tablets looks like and contents of the pack
Cytotec 200 microgram Tablets are white to off white hexagonal tablets scored on both
sides and engraved ‘SEARLE 1461’ on one side. The tablets are packed in aluminium
foil blisters in boxes containing 42 tablets.
PL No: 15814/0175

POM

Manufactured by Pharmacia Limited, Morpeth, Northumberland and procured from the
EU and repackaged by the Product Licence holder OPD Laboratories Ltd, Unit 6
Colonial Way, Watford, Herts WD24 4PR
Leaflet revision and issue date (Ref.) 07.05.2013.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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.

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