IMODIUM PLUS CHEWABLE TABLETS
Active substance: SIMETICONE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Imodium Plus Chewable Tablet Loperamide hydrochloride Simeticone
Please read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Imodium Plus Chewable Tablets carefully to get the best results. Keep this leaflet. You may need to read it again. Ask your pharmacist, if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after two days. 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 Imodium Plus Chewable Tablets are, and what they are used for 2.Before you use Imodium Plus Chewable Tablets 3.How to take Imodium Plus Chewable Tablets 4.Possible side effects 5.How to store Imodium Plus Chewable Tablets 6. Further information
1. What Imodium Plus Chewable Tablets are, and what they are used for The tablets are used to treat a short-lived attack of diarrhoea when it occurs with stomach cramps, bloating and wind. The tablets contain two active ingredients: Loperamide hydrochloride which helps reduce diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel. Simeticone, which breaks up the gas bubbles in the bowel that causes cramps and bloating.
2. Before you take Imodium Plus Chewable Tablets Do not take Imodium Plus Chewable Tablets If the patient is a child less than 12 years. If you are allergic (hypersensitive) to loperamide hydrochloride, simeticone or any of the other ingredients of the tablets (see section 6). If you have a high temperature (e.g. above 38 C) or blood in your stools.
1
If you are having a flare up of an inflammatory bowel condition like ulcerative colitis. If you have severe diarrhoea after taking antibiotics. If you are constipated or your stomach appears swollen. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.
Take special care with Imodium Plus Chewable Tablets: Imodium Plus Chewable Tablets only treat the symptoms of diarrhoea. In some cases, the cause of your diarrhoea may require treatment, if symptoms persist or worsen, please contact your doctor if you have severe diarrhoea your body loses more fluid, sugars and salts than normal. You will need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about special powders which replace the sugars and salts. If you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and contact your doctor. If you have liver disease, check with your doctor before using the tablets. Some of the side effects might be more troublesome. Taking other medicines Talk to your doctor or pharmacist if you are taking any other medicines including: quinidine (used to treat abnormal heart rhythms or malaria) itraconazole or ketoconazole (antifungal medicines) gemfibrozil (used to treat high cholesterol) ritonavir (used to treat HIV infection and AIDS) desmopressin (used to control thirst and urine production in patients with diabetes insipidus) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription because Imodium Plus Chewable Tablets may interact with them. Pregnancy and breast feeding: Pregnancy: If you are pregnant or if you think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. Breast feeding: Do not take Imodium Plus Chewable Tablets if you are breast feeding. Small amounts of the medicine could end up in your milk. Driving and using machines: This medicine may make you feel, dizzy, tired or sleepy. If affected do not drive or operate machinery. Important information about some of the ingredients of Imodium Plus Chewable tablets This medicine contains sucrose and sorbitol (E420). If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Imodium Plus Chewable Tablets Unless your doctor has told you otherwise, follow these instructions: Adults over 18 years old: Chew two tablets initially, followed by one tablet after every loose stool (bowel movement). Do not take more than four tablets in a day. If you are no better after two days, stop taking the tablets and contact your doctor.
Adolescents aged 12 to 18 years old: Chew one tablet initially, followed by one tablet after every loose stool (bowel movement). Do not take more than four tablets in a day. If you are no better after two days, stop taking the tablets and contact your doctor. Do not give the tablets to children less than 12 years old. If you take more Imodium Plus Chewable Tablets than you should: Too many tablets may make you feel drowsy, or make it difficult to think clearly or carry out normal activities. Your muscles may feel stiff or you may experience breathing difficulties. You may have a dry mouth or the pupils of your eyes may become small. You may have stomach pain, feel sick or vomit, be constipated or have difficulty passing water. If you have taken too many tablets, contact a doctor or hospital for advice. If you forget to take Imodium Plus Chewable Tablets: Chew one tablet after the next loose stool (bowel movement). Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects Like all medicines, Imodium Plus Chewable Tablets can cause side effects, although not everybody gets them. If you experience any of the following stop using the medicine and seek immediate medical help: Allergic reactions including swelling of the face, tongue or throat, difficulty swallowing, unexplained wheezing, shortness of breath which may be accompanied by skin rash or hives. If you experience any of the following, stop using the medicine and talk to your doctor: -Difficulties passing water -Stomach pain or swollen stomach -Severe constipation Other effects which may occur include Common side effects (less than 1 in 10 but more than 1 in 100 people get these): -Feeling sick, or a change in the way some things taste. Uncommon side effects (less than 1 in 100 but more than 1 in 1000 people get these): -Drowsiness, constipation, rash Other effects -Vomiting, indigestion, wind, dizziness, loss of consciousness or decreased consciousness
If any of these side effects becomes serious, contact a doctor or hospital immediately. If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist as soon as possible.
5. How to store Imodium Plus Chewable Tablets Keep out of the reach and sight of children. Do not use the tablets after the expiry date on the blister and box. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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 protect the environment.
6. Further information What Imodium Plus Chewable Tablets contain: The active substances are: loperamide hydrochloride (2mg per tablet) and simeticone (measured as 125 mg dimeticone per tablet). The other ingredients are sucrose and corn starch, microcrystalline cellulose, basic butylated methacrylate copolymer, cellulose acetate, sorbitol (E420), dextrates, natural and artificial vanilla mint flavour (including sucrose, maltodextrin, modified corn starch, corn syrup solids, polyglycerol ester of fatty acids, calcium phosphate, enzyme modified milk powder), saccharin sodium, stearic acid and calcium phosphate What Imodium Plus Chewable Tablets look like and contents of the pack: The chewable tablets are round, white, flat tablets with IMO on one side which smell of vanilla and mint. Each pack contains 2, 4, 5, 6, 8, 10, 12, 15,16, 18 or 20 tablets in blister strips. Not all pack sizes may be marketed.
Marketing Authorisation Holder: To be completed nationally Manufacturer Janssen Cilag SPA, Via C. Janssen, Borgo San Michele, Latina, Italy. This medicinal product is authorised in other countries under the following names: Austria: Imodium Plus Belgium: Imodium Duo 2 mg/125 mg kauwtabletten Denmark: Imodium Plus Germany: Imodium akut plus Greece: Imodium Plus Dual Action Ireland: Imodium Plus 2mg/125mg Chewable Tablets Luxembourg: Imodium Duo 2 mg/125 mg kauwtabletten
Portugal: Imodium Plus 2 mg/125 mg comprimidos mastigveis Sweden: Imodium Plus tuggtablett Spain: Imodium Duo 2mg/125mg Chewable Tablets
The leaflet was last revised in May 2011
Imodium Plus Chewable Tablet Loperamide hydrochloride Simeticone
Please read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Imodium Plus Chewable Tablets carefully to get the best results. Keep this leaflet. You may need to read it again. Ask your pharmacist, if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after two days. 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 Imodium Plus Chewable Tablets are, and what they are used for 2.Before you use Imodium Plus Chewable Tablets 3.How to take Imodium Plus Chewable Tablets 4.Possible side effects 5.How to store Imodium Plus Chewable Tablets 6. Further information
1. What Imodium Plus Chewable Tablets are, and what they are used for The tablets are used to treat a short-lived attack of diarrhoea when it occurs with stomach cramps, bloating and wind. The tablets contain two active ingredients: Loperamide hydrochloride which helps reduce diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel. Simeticone, which breaks up the gas bubbles in the bowel that causes cramps and bloating.
2. Before you take Imodium Plus Chewable Tablets Do not take Imodium Plus Chewable Tablets If the patient is a child less than 12 years. If you are allergic (hypersensitive) to loperamide hydrochloride, simeticone or any of the other ingredients of the tablets (see section 6). If you have a high temperature (e.g. above 38 C) or blood in your stools.
1
If you are having a flare up of an inflammatory bowel condition like ulcerative colitis. If you have severe diarrhoea after taking antibiotics. If you are constipated or your stomach appears swollen. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.
Take special care with Imodium Plus Chewable Tablets: Imodium Plus Chewable Tablets only treat the symptoms of diarrhoea. In some cases, the cause of your diarrhoea may require treatment, if symptoms persist or worsen, please contact your doctor if you have severe diarrhoea your body loses more fluid, sugars and salts than normal. You will need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about special powders which replace the sugars and salts. If you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and contact your doctor. If you have liver disease, check with your doctor before using the tablets. Some of the side effects might be more troublesome. Taking other medicines Talk to your doctor or pharmacist if you are taking any other medicines including: quinidine (used to treat abnormal heart rhythms or malaria) itraconazole or ketoconazole (antifungal medicines) gemfibrozil (used to treat high cholesterol) ritonavir (used to treat HIV infection and AIDS) desmopressin (used to control thirst and urine production in patients with diabetes insipidus) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription because Imodium Plus Chewable Tablets may interact with them. Pregnancy and breast feeding: Pregnancy: If you are pregnant or if you think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. Breast feeding: Do not take Imodium Plus Chewable Tablets if you are breast feeding. Small amounts of the medicine could end up in your milk. Driving and using machines: This medicine may make you feel, dizzy, tired or sleepy. If affected do not drive or operate machinery. Important information about some of the ingredients of Imodium Plus Chewable tablets This medicine contains sucrose and sorbitol (E420). If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Imodium Plus Chewable Tablets Unless your doctor has told you otherwise, follow these instructions: Adults over 18 years old: Chew two tablets initially, followed by one tablet after every loose stool (bowel movement). Do not take more than four tablets in a day. If you are no better after two days, stop taking the tablets and contact your doctor.
Adolescents aged 12 to 18 years old: Chew one tablet initially, followed by one tablet after every loose stool (bowel movement). Do not take more than four tablets in a day. If you are no better after two days, stop taking the tablets and contact your doctor. Do not give the tablets to children less than 12 years old. If you take more Imodium Plus Chewable Tablets than you should: Too many tablets may make you feel drowsy, or make it difficult to think clearly or carry out normal activities. Your muscles may feel stiff or you may experience breathing difficulties. You may have a dry mouth or the pupils of your eyes may become small. You may have stomach pain, feel sick or vomit, be constipated or have difficulty passing water. If you have taken too many tablets, contact a doctor or hospital for advice. If you forget to take Imodium Plus Chewable Tablets: Chew one tablet after the next loose stool (bowel movement). Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects Like all medicines, Imodium Plus Chewable Tablets can cause side effects, although not everybody gets them. If you experience any of the following stop using the medicine and seek immediate medical help: Allergic reactions including swelling of the face, tongue or throat, difficulty swallowing, unexplained wheezing, shortness of breath which may be accompanied by skin rash or hives. If you experience any of the following, stop using the medicine and talk to your doctor: -Difficulties passing water -Stomach pain or swollen stomach -Severe constipation Other effects which may occur include Common side effects (less than 1 in 10 but more than 1 in 100 people get these): -Feeling sick, or a change in the way some things taste. Uncommon side effects (less than 1 in 100 but more than 1 in 1000 people get these): -Drowsiness, constipation, rash Other effects -Vomiting, indigestion, wind, dizziness, loss of consciousness or decreased consciousness
If any of these side effects becomes serious, contact a doctor or hospital immediately. If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist as soon as possible.
5. How to store Imodium Plus Chewable Tablets Keep out of the reach and sight of children. Do not use the tablets after the expiry date on the blister and box. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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 protect the environment.
6. Further information What Imodium Plus Chewable Tablets contain: The active substances are: loperamide hydrochloride (2mg per tablet) and simeticone (measured as 125 mg dimeticone per tablet). The other ingredients are sucrose and corn starch, microcrystalline cellulose, basic butylated methacrylate copolymer, cellulose acetate, sorbitol (E420), dextrates, natural and artificial vanilla mint flavour (including sucrose, maltodextrin, modified corn starch, corn syrup solids, polyglycerol ester of fatty acids, calcium phosphate, enzyme modified milk powder), saccharin sodium, stearic acid and calcium phosphate What Imodium Plus Chewable Tablets look like and contents of the pack: The chewable tablets are round, white, flat tablets with IMO on one side which smell of vanilla and mint. Each pack contains 2, 4, 5, 6, 8, 10, 12, 15,16, 18 or 20 tablets in blister strips. Not all pack sizes may be marketed.
Marketing Authorisation Holder: To be completed nationally Manufacturer Janssen Cilag SPA, Via C. Janssen, Borgo San Michele, Latina, Italy. This medicinal product is authorised in other countries under the following names: Austria: Imodium Plus Belgium: Imodium Duo 2 mg/125 mg kauwtabletten Denmark: Imodium Plus Germany: Imodium akut plus Greece: Imodium Plus Dual Action Ireland: Imodium Plus 2mg/125mg Chewable Tablets Luxembourg: Imodium Duo 2 mg/125 mg kauwtabletten
Portugal: Imodium Plus 2 mg/125 mg comprimidos mastigveis Sweden: Imodium Plus tuggtablett Spain: Imodium Duo 2mg/125mg Chewable Tablets
The leaflet was last revised in May 2011
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.
