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CYTOTEC 200MCG TABLETS

Active substance: MISOPROSTOL

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FPO
PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

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.
f you
• Idoctorhave any further questions, ask your
or pharmacist.
 his medicine has been prescribed for you.
T
• Do not pass it on to others. It may harm them,

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.

even if their symptoms are the same as yours.

Do not take Cytotec if you :

• you notice any side effects not listed in this
f any of the side effects gets serious, or if
I

• 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.

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

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

1.  hat Cytotec is and
W
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,

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

08/01/2014

Supplier N° 2013-1104/3
Perigord N° 221330
Barcode N° N/A
Pages 1 of 2

Proof No 02
Component Leaflet
Colour Bar Positions N/A
Drawing No N/A
Pharma Code FPO

Dimensions 176 x 240 mm - Image Prints @ 100%
Notes N/A
Colours 02
Supplier Piramal
Smallest Font Used Body Text - 8.5pt / Part No - 7 pt
PAR Number PAR-2013-0016276

PMS 2727

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

15:24

REASON FOR REVISION:
Change of ownership mock ups required for submission by
11th November 2013. production PAR will be raised
once we get approval - estimated January

Description CYTOTEC
Market United Kingdom

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.

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3. How to take Cytotec

often wear off after a while. If you are worried
about any side effects, then talk to your doctor.

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.

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.

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

08/01/2014

Supplier N° 2013-1104/3
Perigord N° 221330
Barcode N° N/A
Pages 2 of 2

Proof No 02
Component Leaflet
Colour Bar Positions N/A
Drawing No N/A
Pharma Code FPO

Dimensions 176 x 240 mm - Image Prints @ 100%
Notes N/A
Colours 02
Supplier Piramal
Smallest Font Used Body Text - 8.5pt / Part No - 7 pt
PAR Number PAR-2013-0016276

PMS 2727

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 30°C. 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.

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):

Pfizer 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 revised in 03/2014.
Ref: CZ 7_0
2013-1104/3

15:24

REASON FOR REVISION:
Change of ownership mock ups required for submission by
11th November 2013. production PAR will be raised
once we get approval - estimated January

Description CYTOTEC
Market United Kingdom

5. How to store Cytotec

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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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