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CYTOTEC 200MICROGRAM TABLETS

Active substance(s): MISOPROSTOL / MISOPROSTOL / MISOPROSTOL

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Ref: 0209/230115/1/F

®

Cytotec 200 microgram Tablets
(misoprostel)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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.
Your medicine is called Cytotec 200 microgram Tablets and will be referred
to as Cytotec throughout this Leaflet.
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

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 previuos Casearean 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 differnt treatment.

What is Cytotec and what is it 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.

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.
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 breast-feeding;
* 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

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.

Ref: 0209/230115/B

®

Cytotec 200 microgram Tablets
(misoprostel)
Patient Information Leaflet (continued)
6
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5

How to store Cytotec

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist (chemist) who will tell you what to do.
Storing your medicine
* Keep this medicine out of the sight and reach of children.
* Do not store above 30°C. Store in a dry place.
* Do not take your tablets out of the blister strip until it is time to take your
dose.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours.
This leaflet does not tell you everything about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist
(chemist). He/she will have additional information about this medicine and
will be able to advise you.

Further information

What this medicine contains:
Each tablet contains 200 micrograms misoprostol as the active ingredient.
Your medicine also contains the following: microcrystalline cellulose, sodium
starch glycolate, hydrogenated castor oil and hypromellose.
What this medicine looks like and contents of the pack
The tablets are white, hexagonal, scored on both sides, and marked
'SEARLE / 1461' on one side.
The blister packs contains 42 (3 blisters of 14) or 56 (4 blisters of 14)
tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pharmacia Ltd, Morpeth, Northumberland
and are procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0209

.

Cytotec is a registered trademark of G.D. Searle LLC.
Revision date: 23/01/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help

Expand Transcript

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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