CYTOTEC 200MCG TABLETS

Active substance: 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.

• Keep this leaflet. You may need to read
it again.
If you have any further questions, ask your
• doctor or pharmacist.
has
for
• This medicine on tobeen prescribedharmyou.
Do not pass it
others. It may
them, even if their symptoms are the same
as yours.
side effects gets serious, or if
• If any of theany side effects not listed in this
you notice
leaflet, please tell your doctor or pharmacist.

In this leaflet
1.
2.
3.
4.
5.
6.

What Cytotec is and what it is used for
Before you take Cytotec
How to take Cytotec
Possible side effects
How to store Cytotec
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.

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 so it’s very
important to use reliable contraception while
taking this medicine. 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

Take special care with Cytotec

Do not breastfeed while 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
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

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

4. Possible Side Effects

5. How to store 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.

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.

To heal ulcers in your stomach
or duodenum

The following side effects have been
reported with Cytotec:

Keep out of the reach and sight of children.
Do not use Cytotec after the expiry date which is
stated on the carton or blister strip.
Do not store above 30ºC. Store in the original
package.
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.

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.

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,
• 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.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor

6. Further Information
What Cytotec contains
Cytotec tablets contain 200 micrograms (mcg)
of the active substance, 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 boxes
containing 56, 60, 112, 120 or 140 tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder (UK):
Pharmacia Limited, Ramsgate Road, Sandwich,
Kent, CT13 9NJ, United Kingdom

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

Company Contact Address:
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 approved in February 2010 Ref: CZ 4_1
20714866

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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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