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CYTOTEC 200MCG TABLETS

Active substance(s): MISOPROSTOL

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Package leaflet: Information for the user

Cytotec®

200 microgram Tablets
Misoprostol
Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
-

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 only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Cytotec is and what it is used for
What you need to know before you take Cytotec
How to take Cytotec
Possible side effects
How to store Cytotec
Contents of the pack and other 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.

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

2. What you need to know
before you take Cytotec

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.
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.
Do not breast-feed while taking 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 allergic to misoprostol or any of the other ingredients
of this medicine (listed in section 6), or other prostaglandin
medicines.
• if you are pregnant or trying to become pregnant because
it may cause a miscarriage, premature birth or birth defects
(see section ‘Pregnancy’ for further information).
• if you are breastfeeding (as this may give your baby
diarrhoea).

Warnings and precautions

Talk to your doctor or pharmacist before taking 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
• prone to dehydration
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.

Other medicines and Cytotec

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any 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.
Use with NSAIDs in rare cases can result in swelling of feet or
hands and an increase in liver enzymes.

Cytotec with food, drink and alcohol
Please refer to section 3.

Pregnancy, breast-feeding and fertility

Driving and using machines

Dizziness has been reported after taking Cytotec. Be cautious
when driving or operating machinery until you know how the
medicine affects you.

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

You will find more about CYTOTEC on the
back of this leaflet

FPO
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 medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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.
Stop taking the tablets and get emergency medical help
immediately if you have any of the symptoms below which could
represent an allergic reaction:
• swelling of the face, lips, tongue or throat (angioedema)
• difficulty in breathing
• swelling of the extremities (hands and feet)
If you get any of the following symptoms, tell your doctor
immediately:
• prolonged heavy or painful bleeding
• abnormal contractions of the womb

The following side effects have been reported
with Cytotec:

Very common: may affect more than 1 in 10 people
• skin rashes
• diarrhoea
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.
Common: may affect up to 1 in 10 people
• dizziness
• headache
• stomach pain

• constipation
• wind
• indigestion
• feeling or being sick
Uncommon: may affect up to 1 in 100 people
• fever
• irregular periods
• periods problems
• severe uterine pain
• some older women may have vaginal bleeding even
though they have gone through the menopause
Rare: may affect up to 1 in 1,000 people
• cramping
Not known: frequency cannot be estimated from the available
data
• allergic reactions, including swelling of the hands and
feet, face, lips, tongue or throat and which may cause
great difficulty in breathing
• prolonged heavy or painful bleeding
• chills
• high temperature
• 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 an
allergic reaction
• incomplete miscarriage and premature birth
• foetal death and birth defects

6. Contents of the pack and
other information

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of this
medicine.

Company Contact Address

Reporting of side effects

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 and blister strip after EXP. The expiry date refers to the
last day of that month.
Do not store above 30ºC. Keep the blister in the outer carton.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

What Cytotec contains

- The active substance is misoprostol. Each Cytotec tablet
contains 200 micrograms (mcg) of misoprostol.
- The other ingredients are microcrystalline cellulose, sodium
starch glycolate, hydrogenated castor oil, and hypromellose
(E464).

What Cytotec looks like and contents of the
pack

Cytotec 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 cartons containing 56, 60,
112, 120 or 140 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom

Manufacturer

Piramal Healthcare UK Limited
Whalton Road, Morpeth
Northumberland
NE61 3YA
United Kingdom

For further information on your medicine please contact Medical
Information at the following address: Pfizer Limited, Walton Oaks,
Dorking Road, Tadworth, Surrey, KT20 7NS;
Tel 01304 616161.
This leaflet was last revised in 01/2016.
Ref: CZ 8_1

150917

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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