IMODIUM 1 MG / 5 ML ORAL SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - IMODIUM 1 MG / 5 ML ORAL SOLUTION

Imodium®

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

What Imodium oral solution is and what it is used for

What you need to know before you use Imodium oral solution

How to use Imodium oral solution

Possible side effects

How to store Imodium oral solution

Contents of the pack and other information

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.

What you need to know before you use Imodium oral solution

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.

Do not take this product for anything other than its intended use (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (symptoms of which include fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in Imodium oral solution.

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 breastfeeding 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

glycerol: may cause headache, stomach upset and diarrhoea
sodium saccharin (4.85 mg of sodium in

5 ml): This medicine contains less than

1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’.

methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). May cause allergic reactions (possibly delayed)
cochineal red A (E124). May cause allergic reactions
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml

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

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, stop taking this medicine and go back to your doctor. He or she may want to examine you to check on why you have

diarrhoea.

turn over

How to use Imodium oral solution (continued)

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 use more Imodium oral solution than you should

If you have taken too much Imodium oral solution, immediately contact a doctor or hospital for advice. Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

Children react more strongly to large amounts of Imodium oral solution than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

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: or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

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

McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX 16 4RS, UK

For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last revised in March 2020.