Imodium 2mg Capsules
1) WHAT THE MEDICINE IS FOR|
|2) BEFORE TAKING THIS MEDICINE|
|3) HOW TO TAKE THIS MEDICINE|
503682/PLia Imodium® 2 mg Capsules
(loperamide hydrochloride)
Patient Information Leaflet
The name of your medicine is Imodium 2 mg Capsules, throughout this leaflet it will be referred to as Imodium.
• This medicine is used for two different types of diarrhoea. They have different age limits. See Sectionl.
• 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.
Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.
Imodium 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.
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.
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 and 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.
Special warnings about this medicine
• 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 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.
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.
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.
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 aged 12 and over |
Take two capsules to start treatment 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. | |
|
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 and over |
Take two capsules to start 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.
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: (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 (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: (affects less than 1 in 100 but 1 or more in
1.000 people)
• Itchiness or hives.
• Stomach pain or swollen stomach.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 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: (affects less than 1 in 10 but 1 or more in 100 people)
• Feeling sick, constipation or wind.
• Headache.
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.
|5) STORING THIS MEDICINE|
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use your medicine after the date shown as the expiry date on the packaging.
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.
If you notice any sign of deterioration or discolouration of the capsules, tell your pharmacist immediately.
|6) FURTHER INFORMATION
The active substance in Imodium® is loperamide hydrochloride.
Each capsule contains 2 mg of loperamide hydrochloride.
Other ingredients are: lactose monohydrate, maize starch, talc and magnesium stearate (E572).
The capsule itself is made up of titanium dioxide (E171), iron oxide (E172), indigotine (E132), erythrosine (E127) and gelatin.
What the medicine looks like
Imodium® capsules have a grey body with a dark green cap. They are available in packs of 6, 12 or 18 capsules.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova Ltd, repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Imodium® 2 mg Capsules
PL No: 18067/0376
Manufactured by Famar A.B.E., Anthousa, GR 15344, Greece.
Imodium® is a registered trademark of Johnson & Johnson.
This leaflet was last approved on 18th September 2012.
To request a copy of this leaflet in Braille, large print or audio please call 01622 693000.