CYTOTEC 200MCG TABLETS
Active substance: MISOPROSTOL
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PACKAGE LEAFLET: INFORMATION FOR THE USER
The Cytotec tablets may help prevent you
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.
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.
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 its 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.
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 :
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
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.
Breastfeeding
Do not breastfeed while taking Cytotec.
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
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.
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.
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
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.
4. Possible Side Effects
Like all medicines Cytotec can cause side effects although not everybody gets them. Most of these dont 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.
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 30C. 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.
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.
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, placenta remaining in the womb after birth, termination or miscarriage, amniotic fluid (the fluid which surrounds the baby when pregnant) entering the mothers 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).
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.
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
If you take more Cytotec than you should
If you take too many tablets, contact your doctor or accident and emergency department straight away.
Marketing Authorisation Holder (UK):
Pharmacia Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
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.
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
Back
PMS 2727
The Cytotec tablets may help prevent you
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.
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.
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 its 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.
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 :
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
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.
Breastfeeding
Do not breastfeed while taking Cytotec.
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
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.
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.
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
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.
4. Possible Side Effects
Like all medicines Cytotec can cause side effects although not everybody gets them. Most of these dont 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.
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 30C. 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.
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.
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, placenta remaining in the womb after birth, termination or miscarriage, amniotic fluid (the fluid which surrounds the baby when pregnant) entering the mothers 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).
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.
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
If you take more Cytotec than you should
If you take too many tablets, contact your doctor or accident and emergency department straight away.
Marketing Authorisation Holder (UK):
Pharmacia Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
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.
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
Back
PMS 2727
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
