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Document: leaflet MAH BRAND_PL 00057-0956 change

• leaflet MAH BRAND_PL 00057-0956
• leaflet PHARMACIA_PL 00057-0956

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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.

•    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 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.

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.

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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 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

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PAR Number PAR-2013-0016276