Imodium 1 Mg/5 Ml Oral Solution
© J-C 2014
Package leaflet: Information for the user
Imodium ® 1 mg/5 ml oral solution
Loperamide hydrochloride
Imodium is a registered trademark
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. 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 signs of illness are the same as yours
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1 |
What Imodium oral solution is and what it is used for |
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2 |
What you need to know before you use Imodium oral solution |
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3 |
How to use Imodium oral solution |
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4 |
Possible side effects |
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5 |
How to store Imodium oral solution |
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6 |
Contents of the pack and other information |
1 What Imodium oral solution is and what it is used for
The name of your medicine is Imodium 1mg/5ml oral solution. It is called Imodium oral solution in this leaflet.
What Imodium oral solution is used for
Imodium oral solution is used:
• To treat sudden short-lived (acute) attacks of diarrhoea in adults and children over
4 years of age
• To treat long-lasting (chronic) diarrhoea in adults
If your child is using Imodium oral solution, the ‘you’ stated everywhere below should be read as ‘your child’.
How Imodium oral solution works
Imodium oral solution contains 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 What you need to know before you use Imodium oral solution
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Do not use Imodium oral solution:
• If you are allergic to anything in Imodium oral solution (listed in section 6 below)
• If you have severe diarrhoea after taking antibiotics
• If you are having a flare up of ulcerative colitis
• If you are constipated or your stomach appears swollen
• For a child less than 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 oral solution.
Warnings and precautions
Check with your doctor before using Imodium oral solution 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 suffer from liver problems
• You have AIDS and your stomach becomes swollen. Stop taking the oral solution immediately and contact your doctor
You may still be able to use Imodium oral solution, but you should discuss this with your doctor first.
Replacing fluid and salts
Imodium oral solution only treats the symptoms of diarrhoea. When you have diarrhoea, your body loses large amounts of fluid and salts. You should therefore replace this lost fluid 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 fluid and salts lost during diarrhoea.
Other medicines and Imodium oral solution
Please tell your doctor or pharmacist if you are taking, have recently taken or might take 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)
• gemfibrozil (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
Pregnancy and breast-feeding
Tell your doctor before taking Imodium oral solution if you are pregnant, think you may be pregnant or might become pregnant.
Do not take this medicine if you are breast-feeding as small amounts may get into your breast 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 and using machines
This medicine may make you feel dizzy, tired or sleepy. You may also lose consciousness, feel faint or less alert. If affected do not drive or operate machinery.
Imodium oral solution contains
• sodium saccharin (4.85 mg of sodium in 5 ml): To be taken into consideration by patients on a controlled sodium diet
• methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These may cause an allergic reaction. This reaction may happen some time after you have taken Imodium oral solution
• cochineal red A (E124) which may cause allergic reactions
• small amounts of ethanol (alcohol), less than 100 mg per dose
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3 How to use Imodium oral solution
Always use Imodium oral solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the correct number of 5 ml doses of the oral solution
How to use the measuring cup
The measuring cup provided is marked with a 5 ml graduation line.
Keep the measuring cup the same way up as it sits on the bottle cap. To be certain that you fill the correct side, make sure that the side with the graduations (the side that holds less) is uppermost. This is the side you have to fill. The arrow on the side should also be pointing up.
How much to take
The dose of Imodium oral solution that you will need will depend on whether your diarrhoea is a sudden attack (acute) or a long-lasting condition (chronic).
Short-lived (acute) diarrhoea
Adults
• Take four 5 ml doses (20 ml) of the oral solution straight away
• From then on take two 5 ml doses (10 ml) after each episode of diarrhoea
• Never take more than sixteen 5 ml doses (80 ml) of the oral solution in any 24 hour period
Children aged 9 and above
• Take two 5 ml doses (10 ml) of the oral solution 4 times a day until diarrhoea is controlled
3 How to use Imodium oral solution (continued)
Children aged 4-8 years old
• Take one 5 ml dose of the oral solution 3 to 4 times a day until the diarrhoea is controlled
If you are not getting better within 2 days of taking your first dose of Imodium oral solution, go btaki ng this medicin e and go mack toyo ur doctor.e eorslae maywontto hxam incyoh1:ocheck on why you have diarrhoea.
Long-lasting (chronic) diarrhoea
Adults
• Your doctor will tell you how much Imodium oral solution to take. This will depend on how serious your condition is
• You will probably start with a dose
of between four to eight 5 ml doses (20 ml to 40 ml) spread out over a day
• Your doctor will find the dose that suits you best. He or she may then suggest you take the oral solution twice a day
• Never take more than sixteen 5 ml doses (80 ml) of the oral solution in any 24 hour period
Children
• Imodium oral solution is not recommended for long-lasting (chronic) diarrhoea in children
If you forget to take Imodium oral
solution
• 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 oral solution than you should
If you take more Imodium oral solution 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.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Imodium oral solution 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)
Tell your doctor if you notice any of the following side effects while using Imodium oral solution:
Common side effects (affects more than 1 in 100 patients)
• Headache
• Feeling dizzy
• Feeling sick (nausea)
• Constipation
• Wind
Uncommon side effects (affects fewer than 1 in 100 patients)
• Feeling sleepy or drowsy
• Dry mouth
• Being sick (vomiting), indigestion (dyspepsia)
• Rash
Rare side effects (affects fewer than 1 in 1000 patients)
• Tiny pupils
• Itchy skin
• Difficulty passing water
• Feeling tired
• Problems with co-ordination
• Unusually stiff muscles causing poor control of movement
Some of the listed side effects 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.
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.
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5 How to store Imodium oral solution
Keep this medicine out of the sight and reach of children.
Do not use Imodium oral solution after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Imodium oral solution contains
• The active substance is loperamide hydrochloride.
Each 5 ml dose of oral solution contains 1 mg loperamide hydrochloride. (The oral solution contains 0.2 mg of loperamide hydrochloride in each millilitre.)
• The other ingredients are glycerol, sodium saccharin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), cochineal red A (E124), raspberry flavour, redcurrant flavour, ethanol, citric acid and water.
What Imodium oral solution looks like and contents of the pack
Imodium oral solution is a red, fruit-flavoured, sugar-free oral solution.
It is available in 100 ml amber glass bottles with a plastic measuring cup.
Marketing Authorisation Holder:
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK
Manufacturer:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX16 4RS, UK
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last revised in June2015