IMODIUM CAPSULES 2MG
Active substance: LOPERAMIDE HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
1
capsules
Loperamide hydrochloride
Imodium is a registered trademark
Read all of this leaet carefully before you start using this medicine.
Keep this leaet. 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 you get side eects and they become serious or if you notice any side eects not listed in this leaet, please tell your doctor or pharmacist
In this leaet
1 What Imodium capsules are and what they are used for 2 Before you use Imodium capsules 3 How to use Imodium capsules 4 Possible side eects 5 How to store Imodium capsules 6 Further information
1 What Imodium capsules are and what they are used for
The name of your medicine is Imodium capsules.
How Imodium capsules work
What Imodium capsules are used for
Imodium capsules are used: To treat sudden short-lived (acute) attacks of diarrhoea in adults and children aged 9 years and above To treat long-lasting (chronic) diarrhoea in adults If your child is aged 9 years and above the you stated everywhere below should be read as your child.
Imodium capsules contain a medicine called loperamide hydrochloride. It belongs to a group of medicines which helps reduce diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel.
2 Before you use Imodium capsules
Do not use Imodium capsules :
If you are allergic to anything in Imodium capsules (listed in section 6 below) If you have severe diarrhoea after taking antibiotics If you are having a are up of ulcerative colitis If you are constipated or your stomach appears swollen For a child less than 9 years old Imodium syrup can be used for children over 4 years old Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Imodium capsules.
2
2 Before you use Imodium capsules (continued)
Take special care with Imodium capsules Taking other medicines
Check with your doctor before using Imodium capsules if: You have acute dysentery, the symptoms of which may include blood in your stools and a high temperature. You will also need to be given other medicines to treat this You suer from liver problems You have AIDS and your stomach becomes swollen. Stop taking the capsules immediately and contact your doctor You may still be able to use Imodium capsules, but you should discuss this with your doctor rst. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines. In particular, tell your doctor or pharmacist if you are taking any of the following: ritonavir (used to treat HIV) quinidine (used to treat abnormal heart rhythms or malaria) itraconazole, ketoconazole (used to treat fungal infections) gembrozil (used to reduce levels of cholesterol) oral desmopressin (used to treat excessive urination) other drugs that slow down or speed up movement in the gut
Replacing uid and salts
Imodium capsules only treat the symptoms of diarrhoea. When you have diarrhoea, your body loses large amounts of uid and salts. You should therefore replace this lost uid by drinking more than normal. This is especially important for children. Your doctor may also give you a special powder containing sugar and salts (known as oral rehydration therapy) to help your body replace the uid and salts lost during diarrhoea.
Pregnancy and breast-feeding
Tell your doctor before taking Imodium capsules if you are pregnant, think you may be pregnant or might become pregnant. Do not take this medicine if you are breastfeeding as small amounts may get into your milk. Talk to your doctor about a suitable treatment. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving or using machines
This medicine may make you feel dizzy, tired or sleepy. You may also lose consciousness, feel faint or less alert. If aected do not drive or operate machinery.
Important information about some of the ingredients of Imodium capsules
Imodium capsules contain lactose. If your doctor has told you that you are intolerant of some sugars, discuss it with them before taking this medicine.
3 How to use Imodium capsules
Always use Imodium capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much to take
Taking this medicine
Take this medicine by mouth Swallow the correct number of capsules whole with a drink of water
The dose of Imodium capsules that you will need will depend on whether your diarrhoea is a sudden attack (acute) or a long-lasting condition (chronic).
3
3 How to use Imodium capsules (continued)
Short-lived (acute) diarrhoea
Adults Take 2 capsules straight away From then on take 1 capsule after each episode of diarrhoea You can take this medicine for up to 5 days Never take more than 8 capsules in any 24 hour period Children aged 9-12 years old Take 1 capsule 4 times a day until diarrhoea is controlled You can take this medicine for up to 5 days Children under 9 years old Imodium capsules are not recommended for children under 9 years old Imodium syrup can be used for children over 4 years old If you are not getting better within 2 days of taking your rst dose of Imodium capsules, go back to your doctor. He or she may want to examine you to check on why you have diarrhoea. Children Imodium capsules are not recommended for long-lasting (chronic) diarrhoea.
If you forget to take Imodium capsules
You should only take this medicine as required 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 to make up for a forgotten dose
If you use more Imodium capsules than you should
If you take more Imodium capsules than you were told to or if someone else has taken any, talk to a doctor or go to the nearest hospital casualty department straight away. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Long-lasting (chronic) diarrhoea
Adults Your doctor will tell you how many Imodium capsules to take. This will depend on how serious your condition is You will probably start with a dose of between 2 and 4 capsules spread out over a day Your doctor will nd the dose that suits you best. He or she may then suggest you take the capsules twice a day Never take more than 8 capsules in any 24 hour period
4 Possible side eects
Like all medicines, Imodium capsules can cause side eects, although not everybody gets them. Stop using Imodium capsules and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment. Sudden swelling of the face, lips or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction Blistering of your skin, mouth, eyes and genitals Stomach pain or severe swollen stomach Severe constipation Loss of consciousness or reduced level of consciousness (feeling faint or less alert)
4
4 Possible side eects (continued)
Tell your doctor if you notice any of the following side eects while using Imodium capsules: Common side eects (aects more than 1 in 100 patients) Headache Feeling dizzy Feeling sick (nausea) Constipation Wind Uncommon side eects (aects fewer than 1 in 100 patients) Feeling sleepy or drowsy Dry mouth Being sick (vomiting), indigestion (dyspepsia) Rash Rare side eects (aects fewer than 1 in 1000 patients) Tiny pupils Itchy skin Diculty passing water Feeling tired Problems with co-ordination Unusually sti muscles causing poor control of movement Some of the listed side eects may be due to the diarrhoea, such as discomfort around the middle, feeling sick or being sick, dry mouth, feeling tired, drowsy or dizzy and wind. If any of the side eects gets serious, or if you notice any other side eects not listed in this leaet, please tell your doctor or pharmacist.
5 How to store Imodium capsules
Keep out of the reach and sight of children. Do not use Imodium capsules after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. These measures will help protect the environment. Return any leftover Imodium capsules to your pharmacist.
6 Further information
The active substance in Imodium capsules is loperamide hydrochloride. Each Imodium capsule contains 2 mg of loperamide hydrochloride. The other ingredients are lactose, maize starch, talc and magnesium stearate. The capsule itself is made up of titanium dioxide (E171), iron oxides (E172), indigo carmine (E132), erythrosine (E127) and gelatin. The product licence is held by: JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK Imodium capsules are made by: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium OR Janssen-Cilag SA, Campus de Maigremont, 27100 Val de Reuil, France OR McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX 16 4RS, UK
What Imodium capsules look like and contents of the pack
Imodium capsules are green/grey capsules marked 'Imodium' and 'JANSSEN'. They are available in blister packs of 30 capsules or tubs of 250 capsules (for the pharmacist).
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last approved in 01/2012.
1
capsules
Loperamide hydrochloride
Imodium is a registered trademark
Read all of this leaet carefully before you start using this medicine.
Keep this leaet. 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 you get side eects and they become serious or if you notice any side eects not listed in this leaet, please tell your doctor or pharmacist
In this leaet
1 What Imodium capsules are and what they are used for 2 Before you use Imodium capsules 3 How to use Imodium capsules 4 Possible side eects 5 How to store Imodium capsules 6 Further information
1 What Imodium capsules are and what they are used for
The name of your medicine is Imodium capsules.
How Imodium capsules work
What Imodium capsules are used for
Imodium capsules are used: To treat sudden short-lived (acute) attacks of diarrhoea in adults and children aged 9 years and above To treat long-lasting (chronic) diarrhoea in adults If your child is aged 9 years and above the you stated everywhere below should be read as your child.
Imodium capsules contain a medicine called loperamide hydrochloride. It belongs to a group of medicines which helps reduce diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel.
2 Before you use Imodium capsules
Do not use Imodium capsules :
If you are allergic to anything in Imodium capsules (listed in section 6 below) If you have severe diarrhoea after taking antibiotics If you are having a are up of ulcerative colitis If you are constipated or your stomach appears swollen For a child less than 9 years old Imodium syrup can be used for children over 4 years old Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Imodium capsules.
2
2 Before you use Imodium capsules (continued)
Take special care with Imodium capsules Taking other medicines
Check with your doctor before using Imodium capsules if: You have acute dysentery, the symptoms of which may include blood in your stools and a high temperature. You will also need to be given other medicines to treat this You suer from liver problems You have AIDS and your stomach becomes swollen. Stop taking the capsules immediately and contact your doctor You may still be able to use Imodium capsules, but you should discuss this with your doctor rst. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines. In particular, tell your doctor or pharmacist if you are taking any of the following: ritonavir (used to treat HIV) quinidine (used to treat abnormal heart rhythms or malaria) itraconazole, ketoconazole (used to treat fungal infections) gembrozil (used to reduce levels of cholesterol) oral desmopressin (used to treat excessive urination) other drugs that slow down or speed up movement in the gut
Replacing uid and salts
Imodium capsules only treat the symptoms of diarrhoea. When you have diarrhoea, your body loses large amounts of uid and salts. You should therefore replace this lost uid by drinking more than normal. This is especially important for children. Your doctor may also give you a special powder containing sugar and salts (known as oral rehydration therapy) to help your body replace the uid and salts lost during diarrhoea.
Pregnancy and breast-feeding
Tell your doctor before taking Imodium capsules if you are pregnant, think you may be pregnant or might become pregnant. Do not take this medicine if you are breastfeeding as small amounts may get into your milk. Talk to your doctor about a suitable treatment. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving or using machines
This medicine may make you feel dizzy, tired or sleepy. You may also lose consciousness, feel faint or less alert. If aected do not drive or operate machinery.
Important information about some of the ingredients of Imodium capsules
Imodium capsules contain lactose. If your doctor has told you that you are intolerant of some sugars, discuss it with them before taking this medicine.
3 How to use Imodium capsules
Always use Imodium capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much to take
Taking this medicine
Take this medicine by mouth Swallow the correct number of capsules whole with a drink of water
The dose of Imodium capsules that you will need will depend on whether your diarrhoea is a sudden attack (acute) or a long-lasting condition (chronic).
3
3 How to use Imodium capsules (continued)
Short-lived (acute) diarrhoea
Adults Take 2 capsules straight away From then on take 1 capsule after each episode of diarrhoea You can take this medicine for up to 5 days Never take more than 8 capsules in any 24 hour period Children aged 9-12 years old Take 1 capsule 4 times a day until diarrhoea is controlled You can take this medicine for up to 5 days Children under 9 years old Imodium capsules are not recommended for children under 9 years old Imodium syrup can be used for children over 4 years old If you are not getting better within 2 days of taking your rst dose of Imodium capsules, go back to your doctor. He or she may want to examine you to check on why you have diarrhoea. Children Imodium capsules are not recommended for long-lasting (chronic) diarrhoea.
If you forget to take Imodium capsules
You should only take this medicine as required 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 to make up for a forgotten dose
If you use more Imodium capsules than you should
If you take more Imodium capsules than you were told to or if someone else has taken any, talk to a doctor or go to the nearest hospital casualty department straight away. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Long-lasting (chronic) diarrhoea
Adults Your doctor will tell you how many Imodium capsules to take. This will depend on how serious your condition is You will probably start with a dose of between 2 and 4 capsules spread out over a day Your doctor will nd the dose that suits you best. He or she may then suggest you take the capsules twice a day Never take more than 8 capsules in any 24 hour period
4 Possible side eects
Like all medicines, Imodium capsules can cause side eects, although not everybody gets them. Stop using Imodium capsules and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment. Sudden swelling of the face, lips or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction Blistering of your skin, mouth, eyes and genitals Stomach pain or severe swollen stomach Severe constipation Loss of consciousness or reduced level of consciousness (feeling faint or less alert)
4
4 Possible side eects (continued)
Tell your doctor if you notice any of the following side eects while using Imodium capsules: Common side eects (aects more than 1 in 100 patients) Headache Feeling dizzy Feeling sick (nausea) Constipation Wind Uncommon side eects (aects fewer than 1 in 100 patients) Feeling sleepy or drowsy Dry mouth Being sick (vomiting), indigestion (dyspepsia) Rash Rare side eects (aects fewer than 1 in 1000 patients) Tiny pupils Itchy skin Diculty passing water Feeling tired Problems with co-ordination Unusually sti muscles causing poor control of movement Some of the listed side eects may be due to the diarrhoea, such as discomfort around the middle, feeling sick or being sick, dry mouth, feeling tired, drowsy or dizzy and wind. If any of the side eects gets serious, or if you notice any other side eects not listed in this leaet, please tell your doctor or pharmacist.
5 How to store Imodium capsules
Keep out of the reach and sight of children. Do not use Imodium capsules after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. These measures will help protect the environment. Return any leftover Imodium capsules to your pharmacist.
6 Further information
The active substance in Imodium capsules is loperamide hydrochloride. Each Imodium capsule contains 2 mg of loperamide hydrochloride. The other ingredients are lactose, maize starch, talc and magnesium stearate. The capsule itself is made up of titanium dioxide (E171), iron oxides (E172), indigo carmine (E132), erythrosine (E127) and gelatin. The product licence is held by: JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK Imodium capsules are made by: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium OR Janssen-Cilag SA, Campus de Maigremont, 27100 Val de Reuil, France OR McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX 16 4RS, UK
What Imodium capsules look like and contents of the pack
Imodium capsules are green/grey capsules marked 'Imodium' and 'JANSSEN'. They are available in blister packs of 30 capsules or tubs of 250 capsules (for the pharmacist).
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last approved in 01/2012.
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.
