Imodium

PLUS COPLGT5

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 Caplets 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 get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What the medicine is for.

2.    Before taking this medicine.

3.    How to take this medicine.

4.    Possible side-effects.

5.    Storing this medicine.

6.    Further information.

1 What the medicine is for

The caplets are used to treat a short-lived attack of diarrhoea when it occurs with stomach cramps, bloating and wind.

The caplets contain 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.

The caplets also contain simeticone, which breaks up the trapped wind in the bowel that causes cramps and bloating.

This medicine is for use in adults and children aged 12 years and over.

2 Before taking this medicine

This medicine is suitable for most adults and children aged 12 years and over, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

□ Do not take this medicine...

■    In children less than 12 years old.

■    If you are allergic (hypersensitive) to loperamide hydrochloride, simeticone or any of the other ingredients of the caplets (see section 6).

■    If you have a high temperature (e.g. above 38° C) or blood in your stools.

■    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 any of these apply to you, get advice from a doctor or pharmacist without taking Imodium Plus Caplets.

kTalkto your doctor or pharmacist...

■    Imodium Plus Caplets 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 as 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 caplets immediately and contact your doctor.

■    If you have liver disease. Check with your doctor before using the caplets. 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 Caplets may interact with them.

If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

Uf you are pregnant or breast-feeding

■    Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant, think you are pregnant or planning to become pregnant.

■    Do not take this medicine if you are breast-feeding as small amounts of the medicine may get into your milk. Talk to your doctor about a suitable treatment.

■ This medicine may make you feel dizzy, tired or sleepy. If affected do not drive or operate machinery.

3 How to take this medicine

Check the table overleaf to see how much medicine to take.

■    Swallow the correct number of caplets whole with a drink of water.

■    For oral use only.

■    Do not use more than the stated dose shown in the table.

O Children under 12 years old

Do not give the caplets to children less than 12 years old.

turn over ►

anyone takes too much of this medicine

Too many caplets 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 Imodium Plus Caplets, contact a doctor or nearest Accident and Emergency (casualty) taking this leaflet with you.

^klf you forget to take the medicine

Take one caplet 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 Caplets 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

■    Severe abdominal pain, abdominal bulging or swelling or fever which may be due to a blocked or enlarged bowel

■    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):

■    Headache

■    Feeling sick

■    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

■    Dizziness

■    Weakness

■    Constipation

■    Vomiting

■    Indigestion

■    Wind

■    Dry mouth

■    Rash

Rare side effects (less than 1 in 1000 but more than 1 in 10 000 people get these):

■    Loss of consciousness or decreased consciousness

■    Excessive contraction of the pupil of the eye

■    Skin rash, which may lead to severe blistering and peeling of the skin

■    Hives

■    Itching

■    Tiredness

^^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.

5    Storing this medicine

Keep this medicine out of the sight and reach of children. Do not use the caplets 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’s in this medicine?

The active ingredients are: Loperamide hydrochloride (2 mg per caplet) and Simeticone (measured as 125 mg dimeticone per caplet).

The other ingredients are: Calcium hydrogen phosphate anhydrous, microcrystalline cellulose, acesulfame potassium, artificial vanilla flavour (includes propylene glycol, maltodextrin and benzyl alcohol), sodium starch glycolate (type A) and stearic acid.

What the medicine looks like

The caplets are white capsule shaped tablets marked with a line between “2" and “125" on one side and “IMO" on the other side.

Each pack contains 6, 8, 10, 12, 15, 16, 18 or 20 caplets in blister strips.

Not all pack sizes may be marketed.

Marketing Authorisation holder:

McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

Manufacturer:

Janssen-Cilag SPA, ViaC. Janssen, Borgo San Michele, Latina, Italy.

This leaflet was revised June 2015.

Imodium is a registered trade mark.

McNeil

CRR: 321300

Reference: AW_104785 15-0220 Dimensions: 150x400

Date: 20/06/2015