IMODIUM INSTANT MELTS
Active substance: LOPERAMIDE HYDROCHLORIDE
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Transcript
1 What the medicine is for
Extra warnings for IBS patients
Use only if your doctor has previously diagnosed IBS. Check the following:
2 Before taking this medicine
Do not take this medicine
If you are aged under 18.
Imodium Instant Melts are used to treat two types of diarrhoea. The two types have different age limits.
Warnings for everyone
TOP
loperamide
Talk to your doctor rst
Short-term diarrhoea For adults and children aged 12 and over.
This medicine is suitable for most people, but a few people should not use it:
To treat attacks that last up to 48 hours.
Do not take this medicine
If your attack lasts longer than 48 hours, talk to your doctor.
oral desmopressin (used to treat excessive urination). itraconazole or ketoconazole (used to treat fungal infections). gembrozil (used to treat high cholesterol). If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these applies to you (now or in the past), talk to a doctor or pharmacist.
This medicine is used for two different types of diarrhoea. They have different age limits. See Section 1 c
IBS diarrhoea For adults and young people aged 18 and over who have been diagnosed with IBS (Irritable Bowel Syndrome).
Pregnancy or breast-feeding
Do not take this medicine: There are some people who should not use this medicine. To nd out if you are one of them, see Section 2 c If you have ever had a bad reaction to any of the ingredients. For the list of ingredients, see Section 6 c
To treat attacks that last up to 48 hours.
You can use this medicine for up to 2 weeks for repeated attacks, but if any one attack lasts continuously for longer than 48 hours, talk to your doctor.
If you are pregnant, think you are pregnant or planning a pregnancy: ask your doctor or pharmacist for advice before taking this medicine. If you are breast-feeding do not take this medicine. Small amounts may get into your milk. Talk to your doctor about a suitable treatment.
Speak to your doctor: If you suffer from any of the conditions mentioned in Section 2 c If you are taking any other medicines. See Section 2 c
If you have ever had a bad reaction to any of the ingredients. If it is for a child aged under 12 (or under 18 for an IBS patient). If you have severe diarrhoea after taking antibiotics. If you are having a flare-up of an inammatory bowel condition like ulcerative colitis. If you are constipated, or your stomach appears swollen (especially in children with severe dehydration). If you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature. If any of these applies to you, talk to a doctor or pharmacist and do not take Imodium.
Special warnings about this medicine
If you have Irritable Bowel Syndrome (IBS) see also Section 2 Extra warnings for IBS patients c
The tablets contain loperamide hydrochloride, a substance that helps reduce diarrhoea by slowing down an overactive bowel. This allows water and salts that are usually lost in diarrhoea to be absorbed by the body.
Talk to your doctor rst
Follow the dosage instructions carefully. See Section 3 c
This medicine may make you feel dizzy, tired or sleepy. You may feel less alert, feel faint or pass out. If youre affected do not drive or use machines. Your body can lose large amounts of fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about rehydration therapy to replace lost salts. This is especially important for children, and frail or older people.
If you are aged 40 or over and it is some time since your last IBS attack. If you are aged 40 or over and your IBS symptoms are different this time. If you have recently passed blood from the bowel. If you suffer from severe constipation. If you are feeling sick or vomiting. If you have lost your appetite or lost weight. If you have difculty or pain passing urine. If you have a fever. If you have recently travelled abroad. If any of these applies to you, talk to your doctor before taking Imodium.
Now read this whole leaet carefully before you use this medicine. Keep the leaflet: you might need it again.
Some of the ingredients can cause problems
If you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and contact your doctor. If you suffer from liver disease. If you have diarrhoea that lasts for more than 48 hours. If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal. If you are taking any other medicines, including: ritonavir (used to treat HIV). quinidine (used to treat abnormal heart rhythms or malaria).
Aspartame (E951) contains a source of phenylalanine. This may be harmful for people with phenylketonuria. Turn Over c
3 How to take this medicine
Check the tables below to see how much medicine to take. Peel back the lid and tip the tablet out. Do not push the tablets through the lid. Place the correct number of tablets on the tongue. The tablets dissolve quickly in your mouth, so you dont need water to swallow them. Do not chew. For oral use only. Do not use more than the dose shown in the tables. The tablets are not for long-term treatment. Age
IBS diarrhoea
Adults aged 18 and over
If anyone takes too much of this medicine
Talk to a doctor as soon as possible
Dose
Take two tablets to start treatment. Take one tablet after each loose bowel movement (or as advised by your doctor).
If anyone takes too many Imodium tablets, contact your doctor or nearest Accident and Emergency department taking this leaflet with you.
Uncommon: (affects less than 1 in 100 but 1 or more in 1,000 people) Itchiness or hives. Stomach pain or swollen stomach.
5 Storing this medicine
If you forget to take the medicine
Keep the product out of the reach and sight of children. Store in the original package. Do not use your medicine after the date shown as the expiry date on the packaging.
Short-term diarrhoea
Age Adults and children aged 12 and over Dose Take two tablets to start treatment. Take one tablet after each loose bowel movement.
You can use this medicine for up to 2 weeks for repeated attacks, but do not take for any one attack lasting longer than 48 hours. Do not take more than six tablets in a 24-hour period.
You should only take this medicine as you need it, following the dosage instructions above carefully. If you forget to take a dose, take a dose after the next loose stool (bowel movement). Do not take a double dose.
Replace lost uid by drinking more liquid than usual. Not for children and young people aged under 18.
4 Possible side-effects
Imodium can have side-effects, like all medicines, although these dont affect everyone and most are usually mild.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people) Difficulties passing water. Severe constipation. Burning or prickling sensation of the tongue. Miosis (narrowing of the pupils of the eye). If you notice any of the above, stop using the medicine and talk to a doctor.
6 Further information
Whats in this medicine
The active ingredient in Imodium Instant Melts is: Loperamide hydrochloride 2 mg per tablet. Other ingredients are: Gelatin, mannitol, aspartame, mint flavour and sodium hydrogen carbonate.
Other effects that may occur
Talk to your doctor and stop taking this medicine:
Get medical help at once
Do not take for attacks lasting longer than 48 hours. Do not take more than six tablets in a 24-hour period. Replace lost uid by drinking more liquid than usual. Not for children aged under 12.
If you have been using this medicine continuously for 48hours. If you develop new IBS symptoms. If your IBS symptoms get worse. If your IBS symptoms have not improved after 2 weeks.
How long to take Imodium for short-term diarrhoea
You can use this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Imodium and talk to your doctor.
TOP
How long to take Imodium for IBS diarrhoea
You can use this medicine for up to 2 weeks for repeated attacks of IBS diarrhoea. But if any one attack lasts for longer than 48 hours, stop taking Imodium and talk to your doctor.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people) Allergic reactions including unexplained wheezing, shortness of breath, passing out or swelling of face and throat. Skin rashes, which may be severe and include blistering or peeling skin. Loss of consciousness or reduced level of consciousness (passing out, feeling faint or less alert), uncoordinated movements. If you get any of these, stop using the medicine and get medical help at once.
Common: (affects less than 1 in 10 but 1 or more in 100 people) Feeling sick, constipation or wind. Headache.
What the medicine looks like
Uncommon: (affects less than 1 in 100 but 1 or more in 1,000 people) Dizziness or drowsiness. Vomiting, indigestion. Dry mouth.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people) Tiredness. If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.
Imodium Instant Melts come in the form of white, orodispersible (dissolve in the mouth) tablets available in packs of 12 and 18 (not all pack sizes may be marketed). Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. Manufacturer: Janssen-Cilag SpA, Via Constant Janssen, Borgo San Michele, Latina, Italy. This leaet was revised October 2011. Imodium is a registered trade mark.
GB-IE - 983911 11-0291
Extra warnings for IBS patients
Use only if your doctor has previously diagnosed IBS. Check the following:
2 Before taking this medicine
Do not take this medicine
If you are aged under 18.
Imodium Instant Melts are used to treat two types of diarrhoea. The two types have different age limits.
Warnings for everyone
TOP
loperamide
Talk to your doctor rst
Short-term diarrhoea For adults and children aged 12 and over.
This medicine is suitable for most people, but a few people should not use it:
To treat attacks that last up to 48 hours.
Do not take this medicine
If your attack lasts longer than 48 hours, talk to your doctor.
oral desmopressin (used to treat excessive urination). itraconazole or ketoconazole (used to treat fungal infections). gembrozil (used to treat high cholesterol). If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these applies to you (now or in the past), talk to a doctor or pharmacist.
This medicine is used for two different types of diarrhoea. They have different age limits. See Section 1 c
IBS diarrhoea For adults and young people aged 18 and over who have been diagnosed with IBS (Irritable Bowel Syndrome).
Pregnancy or breast-feeding
Do not take this medicine: There are some people who should not use this medicine. To nd out if you are one of them, see Section 2 c If you have ever had a bad reaction to any of the ingredients. For the list of ingredients, see Section 6 c
To treat attacks that last up to 48 hours.
You can use this medicine for up to 2 weeks for repeated attacks, but if any one attack lasts continuously for longer than 48 hours, talk to your doctor.
If you are pregnant, think you are pregnant or planning a pregnancy: ask your doctor or pharmacist for advice before taking this medicine. If you are breast-feeding do not take this medicine. Small amounts may get into your milk. Talk to your doctor about a suitable treatment.
Speak to your doctor: If you suffer from any of the conditions mentioned in Section 2 c If you are taking any other medicines. See Section 2 c
If you have ever had a bad reaction to any of the ingredients. If it is for a child aged under 12 (or under 18 for an IBS patient). If you have severe diarrhoea after taking antibiotics. If you are having a flare-up of an inammatory bowel condition like ulcerative colitis. If you are constipated, or your stomach appears swollen (especially in children with severe dehydration). If you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature. If any of these applies to you, talk to a doctor or pharmacist and do not take Imodium.
Special warnings about this medicine
If you have Irritable Bowel Syndrome (IBS) see also Section 2 Extra warnings for IBS patients c
The tablets contain loperamide hydrochloride, a substance that helps reduce diarrhoea by slowing down an overactive bowel. This allows water and salts that are usually lost in diarrhoea to be absorbed by the body.
Talk to your doctor rst
Follow the dosage instructions carefully. See Section 3 c
This medicine may make you feel dizzy, tired or sleepy. You may feel less alert, feel faint or pass out. If youre affected do not drive or use machines. Your body can lose large amounts of fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about rehydration therapy to replace lost salts. This is especially important for children, and frail or older people.
If you are aged 40 or over and it is some time since your last IBS attack. If you are aged 40 or over and your IBS symptoms are different this time. If you have recently passed blood from the bowel. If you suffer from severe constipation. If you are feeling sick or vomiting. If you have lost your appetite or lost weight. If you have difculty or pain passing urine. If you have a fever. If you have recently travelled abroad. If any of these applies to you, talk to your doctor before taking Imodium.
Now read this whole leaet carefully before you use this medicine. Keep the leaflet: you might need it again.
Some of the ingredients can cause problems
If you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and contact your doctor. If you suffer from liver disease. If you have diarrhoea that lasts for more than 48 hours. If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal. If you are taking any other medicines, including: ritonavir (used to treat HIV). quinidine (used to treat abnormal heart rhythms or malaria).
Aspartame (E951) contains a source of phenylalanine. This may be harmful for people with phenylketonuria. Turn Over c
3 How to take this medicine
Check the tables below to see how much medicine to take. Peel back the lid and tip the tablet out. Do not push the tablets through the lid. Place the correct number of tablets on the tongue. The tablets dissolve quickly in your mouth, so you dont need water to swallow them. Do not chew. For oral use only. Do not use more than the dose shown in the tables. The tablets are not for long-term treatment. Age
IBS diarrhoea
Adults aged 18 and over
If anyone takes too much of this medicine
Talk to a doctor as soon as possible
Dose
Take two tablets to start treatment. Take one tablet after each loose bowel movement (or as advised by your doctor).
If anyone takes too many Imodium tablets, contact your doctor or nearest Accident and Emergency department taking this leaflet with you.
Uncommon: (affects less than 1 in 100 but 1 or more in 1,000 people) Itchiness or hives. Stomach pain or swollen stomach.
5 Storing this medicine
If you forget to take the medicine
Keep the product out of the reach and sight of children. Store in the original package. Do not use your medicine after the date shown as the expiry date on the packaging.
Short-term diarrhoea
Age Adults and children aged 12 and over Dose Take two tablets to start treatment. Take one tablet after each loose bowel movement.
You can use this medicine for up to 2 weeks for repeated attacks, but do not take for any one attack lasting longer than 48 hours. Do not take more than six tablets in a 24-hour period.
You should only take this medicine as you need it, following the dosage instructions above carefully. If you forget to take a dose, take a dose after the next loose stool (bowel movement). Do not take a double dose.
Replace lost uid by drinking more liquid than usual. Not for children and young people aged under 18.
4 Possible side-effects
Imodium can have side-effects, like all medicines, although these dont affect everyone and most are usually mild.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people) Difficulties passing water. Severe constipation. Burning or prickling sensation of the tongue. Miosis (narrowing of the pupils of the eye). If you notice any of the above, stop using the medicine and talk to a doctor.
6 Further information
Whats in this medicine
The active ingredient in Imodium Instant Melts is: Loperamide hydrochloride 2 mg per tablet. Other ingredients are: Gelatin, mannitol, aspartame, mint flavour and sodium hydrogen carbonate.
Other effects that may occur
Talk to your doctor and stop taking this medicine:
Get medical help at once
Do not take for attacks lasting longer than 48 hours. Do not take more than six tablets in a 24-hour period. Replace lost uid by drinking more liquid than usual. Not for children aged under 12.
If you have been using this medicine continuously for 48hours. If you develop new IBS symptoms. If your IBS symptoms get worse. If your IBS symptoms have not improved after 2 weeks.
How long to take Imodium for short-term diarrhoea
You can use this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Imodium and talk to your doctor.
TOP
How long to take Imodium for IBS diarrhoea
You can use this medicine for up to 2 weeks for repeated attacks of IBS diarrhoea. But if any one attack lasts for longer than 48 hours, stop taking Imodium and talk to your doctor.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people) Allergic reactions including unexplained wheezing, shortness of breath, passing out or swelling of face and throat. Skin rashes, which may be severe and include blistering or peeling skin. Loss of consciousness or reduced level of consciousness (passing out, feeling faint or less alert), uncoordinated movements. If you get any of these, stop using the medicine and get medical help at once.
Common: (affects less than 1 in 10 but 1 or more in 100 people) Feeling sick, constipation or wind. Headache.
What the medicine looks like
Uncommon: (affects less than 1 in 100 but 1 or more in 1,000 people) Dizziness or drowsiness. Vomiting, indigestion. Dry mouth.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people) Tiredness. If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.
Imodium Instant Melts come in the form of white, orodispersible (dissolve in the mouth) tablets available in packs of 12 and 18 (not all pack sizes may be marketed). Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. Manufacturer: Janssen-Cilag SpA, Via Constant Janssen, Borgo San Michele, Latina, Italy. This leaet was revised October 2011. Imodium is a registered trade mark.
GB-IE - 983911 11-0291
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.
