Imodium Classic 2mg Capsules
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AW_112568.pdf - Page 1 of 5 - March 16, 2016 - 12:34:43
I
Imodium
CLASSIC 2 mg CAPSULES
loperamide hydrochloride
■ This medicine is used for two different types of diarrhoea. They have different age limits.
See Section 1 ►
■ Do not take this medicine:
■ There are some people who should not use
this medicine. To find out if you are one of them, see Section 2 ►
■ If you have ever had a bad reaction to any of the ingredients. For the list of ingredients, see Section 6 ►
■ Speak to your doctor:
■ If you suffer from any of the conditions mentioned in Section 2 ►
■ If you are taking any other medicines.
See Section 2 ►
■ If you have Irritable Bowel Syndrome (IBS)
see also Section 2 Extra warnings for IBS patients ►
■ Follow the dosage instructions carefully.
See Section 3 ►
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.
1 What the medicine is for
Imodium Classic is used to treat two types of diarrhoea. The two types have different age limits.
O Short-term diarrhoea
■ For adults and children aged 12 and over.
■ To treat attacks that last up to 48 hours.
■ If your attack lasts longer than 48 hours, talk to your doctor.
o IBS diarrhoea
■ For adults and young people aged 18 and over who have been diagnosed with IBS (Irritable Bowel Syndrome).
■ 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.
The capsules 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.
2 Before taking this medicine O Warnings for everyone
This medicine is suitable for most people,
but a few people should not use it:
□ Do not take this medicine...
■ 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 inflammatory 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.
This section is continued over the page.
FACE 1
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AW_112568.pdf - Page 2 of 5 - March 16, 2016 - 12:34:43
O Warnings for everyone (continued)
A Talk to your doctor first...
■ If you have AIDS and your stomach becomes swollen, stop taking the capsules 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 been told by your doctor that you have an intolerance to some sugars.
■ 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).
■ oral desmopressin (used to treat excessive urination).
■ itraconazole or ketoconazole (used to treat fungal infections).
■ gemfibrozil (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.
Pregnancy or breast-feeding
■ 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.
Driving and using machines
■ This medicine may make you feel dizzy, tired or sleepy. You may feel less alert, feel faint or pass out. If you’re affected do not drive, cycle or use machines.
Special warnings about this medicine
■ 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.
Some of the ingredients can cause problems
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.
O Extra warnings for IBS patients
Use only if your doctor has previously diagnosed IBS.
Check the following:
□ Do not take this medicine.
■ If you are aged under 18.
A Talk to your doctor first.
■ 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 difficulty 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.
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AW_112568.pdf - Page 3 of 5 - March 16, 2016 - 12:34:44
3 How to take this medicine
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Check the tables below to see how much medicine to take.
■ Swallow the correct number of capsules whole with a drink of water. For oral use only.
■ Do not use more than the dose shown in the tables.
■ The capsules are not for long-term treatment.
Short-term diarrhoea
Age Dose
Adults and Take two capsules to start
children aged treatment.
12 and over Take one capsule after each loose bowel movement.
■ Do not take for attacks lasting longer than 48 hours.
■ Do not take more than six capsules in a 24-hour period.
■ Replace lost fluid by drinking more liquid than usual.
■ Not for children aged under 12.
O 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.
IBS diarrhoea
Age Dose
Adults aged Take two capsules to start
18 and over treatment.
Take one capsule after each loose bowel movement (or as advised by your doctor).
■ 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 capsules in a 24-hour period.
■ Replace lost fluid by drinking more liquid than usual.
■ Not for children and young people aged under 18.
Talk to your doctor and stop taking this medicine:
■ If you have been using this medicine continuously for 48 hours.
■ If you develop new IBS symptoms.
■ If your IBS symptoms get worse.
■ If your IBS symptoms have not improved after 2 weeks.
O 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.
If anyone takes too much of this medicine
If anyone takes too many Imodium capsules, contact your doctor or nearest Accident and Emergency department taking this leaflet with you.
If you forget to take the medicine
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.
4 Possible side-effects
Imodium can have side-effects, like all medicines, although these don’t affect everyone and most are usually mild.
This section is continued over the page.
FACE 3
AW_112568.pdf - Page 4 of 5 - March 16, 2016 - 12:34:44
4 Possible side-effects (continued)
Get medical help at once
Rare: (may affect up to 1 in 1,000 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.
Talk to a doctor as soon as possible Uncommon: (may affect up to 1 in 100 people)
■ Itchiness or hives.
■ Stomach pain or swollen stomach.
Rare: (may affect up to 1 in 1,000 people)
■ Difficulties passing water.
■ Severe constipation.
■ Miosis (narrowing of the pupils of the eye).
If you notice any of the above, stop using the medicine and talk to a doctor.
Other effects that may occur Common: (may affect up to 1 in 10 people)
■ Feeling sick, constipation or wind.
■ Headache.
Uncommon: (may affect up to 1 in 100 people)
■ Dizziness or drowsiness.
■ Vomiting, indigestion.
■ Dry mouth.
Rare: (may affect up to 1 in 1,000 people)
■ Tiredness.
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 Storing this medicine
Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use your medicine after the date shown as the expiry date on the packaging.
Do not throw away any medicines 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’s in this medicine
The active ingredient in Imodium Capsules is:
Loperamide hydrochloride 2 mg per capsule.
Other ingredients are: Lactose, maize starch, talc and magnesium stearate (E572). The capsule itself is made up of titanium dioxide (E171), black ferrous oxide (E172), yellow ferric oxide (E172), indigo carmine (E132), erythrosine (E127) and gelatin.
What the medicine looks like
Imodium Capsules are green / grey capsules marked ‘Imodium’ and JANSSEN’. They are available in packs of 8, 12 or 18 capsules.
Not all pack sizes may be marketed.
Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Janssen-Cilag, Domaine de Maigremont, 27100 Val de Reuil, France.
This leaflet was revised March 2016.
Imodium is a registered trade mark.
GB - AW_112568 16-0056
■ This medicine is used for two different types of diarrhoea.
They have different age limits. See Section 1 ►
■ Do not take this medicine:
■ There are some people who should not use this medicine.
To find out if you are one of them, see Section 2 ►
■ If you have ever had a bad reaction to any of the ingredients. For the list of ingredients, see Section 6 ►
■ Speak to your doctor:
■ If you suffer from any of the conditions mentioned in Section 2 ►
■ If you are taking any other medicines. See Section 2 ►
■ If you have Irritable Bowel Syndrome (IBS) see also Section 2 Extra warnings for IBS patients ►
■ Follow the dosage instructions carefully. See Section 3 ►
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.
1 What the medicine is for
Imodium Classic is used to treat two types of diarrhoea.
The two types have different age limits.
Short-term diarrhoea
■ For adults and children aged 12 and over.
■ To treat attacks that last up to 48 hours.
■ If your attack lasts longer than 48 hours, talk to your doctor.
IBS diarrhoea
■ For adults and young people aged 18 and over who have been diagnosed with IBS (Irritable Bowel Syndrome).
■ 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.
The capsules 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.
2 Before taking this medicine
Warnings for everyone
This medicine is suitable for most people, but a few people should not use it:
□ Do not take this medicine...
■ 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 inflammatory 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.
A Talk to your doctor first.
■ If you have AIDS and your stomach becomes swollen,
stop taking the capsules 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 been told by your doctor that you have an intolerance to some sugars.
■ 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).
■ oral desmopressin (used to treat excessive urination).
■ itraconazole or ketoconazole (used to treat fungal infections).
■ gemfibrozil (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.
Pregnancy or breast-feeding
■ 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.
Driving and using machines
■ This medicine may make you feel dizzy, tired or sleepy.
You may feel less alert, feel faint or pass out. If you’re affected do not drive, cycle or use machines.
Special warnings about this medicine
■ 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.
Some of the ingredients can cause problems
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.
Extra warnings for IBS patients
Use only if your doctor has previously diagnosed IBS.
Check the following:
□ Do not take this medicine.
■ If you are aged under 18.
A Talk to your doctor first.
■ 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 difficulty 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.
Imodium Classic 2 mg Capsules Job bag: 16-0057 Version: 1
Size: 150x520 mm main body text: 8.5 pts
3 How to take this medicine
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Check the tables below to see how much medicine to take.
■ Swallow the correct number of capsules whole with a drink of water. For oral use only.
■ Do not use more than the dose shown in the tables
■ The capsules are not for long-term treatment.
Short-term diarrhoea Age Dose
Adults and children Take two capsules to start treatment.
aged 12 and over Take one capsule after each loose
bowel movement.
■ Do not take for attacks lasting longer than 48 hours.
■ Do not take more than six capsules in a 24-hour period.
■ Replace lost fluid by drinking more liquid than usual.
■ Not for children aged under 12._
a 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.
IBS diarrhoea
Age Dose
Adults aged 18 Take two capsules to start treatment.
and over Take one capsule after each loose
bowel movement (or as advised by your doctor).
■ 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 capsules in a 24-hour period.
■ Replace lost fluid by drinking more liquid than usual.
■ Not for children and young people aged under 18.
Talk to your doctor and stop taking this medicine:
If you have been using this medicine continuously for 48 hours.
■ If you develop new IBS symptoms.
■ If your IBS symptoms get worse.
■ If your IBS symptoms have not improved after 2 weeks.
a 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.
If anyone takes too much of this medicine
If anyone takes too many Imodium capsules, contact your doctor or nearest Accident and Emergency department taking this leaflet with you.
If you forget to take the medicine
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.
4 Possible side-effects
Imodium can have side-effects, like all medicines, although these don’t affect everyone and most are usually mild.
Get medical help at once
Rare: (may affect up to 1 in 1,000 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.
Talk to a doctor as soon as possible Uncommon: (may affect up to 1 in 100 people)
■ Itchiness or hives.
■ Stomach pain or swollen stomach.
Rare: (may affect up to 1 in 1,000 people)
■ Difficulties passing water.
■ Severe constipation.
■ Miosis (narrowing of the pupils of the eye).
If you notice any of the above, stop using the medicine and talk to a doctor.
Other effects that may occur Common: (may affect up to 1 in 10 people)
■ Feeling sick, constipation or wind.
■ Headache.
Uncommon: (may affect up to 1 in 100 people)
■ Dizziness or drowsiness.
■ Vomiting, indigestion.
■ Dry mouth.
Rare: (may affect up to 1 in 1,000 people)
■ Tiredness.
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 Storing this medicine
Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use your medicine after the date shown as the expiry date on the packaging.
Do not throw away any medicines 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’s in this medicine
The active ingredient in Imodium Capsules is: Loperamide hydrochloride 2 mg per capsule.
Other ingredients are: Lactose, maize starch, talc and magnesium stearate (E572). The capsule itself is made up of titanium dioxide (E171), black ferrous oxide (E172), yellow ferric oxide (E172), indigo carmine (E132), erythrosine (E127) and gelatin.
What the medicine looks like
Imodium Capsules are green / grey capsules marked ‘Imodium’ and ‘JANSSEN’, available in packs of 8, 12 or 18 capsules (not all pack sizes may be marketed).
Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Janssen-Cilag, Domaine de Maigremont,
27100 Val de Reuil, France.
This leaflet was revised March 2016.
Imodium is a registered trade mark. 16-0057
Imodium Classic 2 mg Capsules Job bag: 16-0057 Version: 1
Size: 150x520 mm Mainbody text: 8.5 pts