Imodium Plus 2mg/125mg Tablets

Main information

  • Trade name:
  • Imodium Plus 2mg/125mg Tablets
  • Dosage:
  • 2 mg/125 milligram(s)
  • Pharmaceutical form:
  • Tablet
  • Prescription type:
  • Product not subject to medical prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Imodium Plus 2mg/125mg Tablets
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Antipropulsives; loperamide

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Marketed
  • Authorization number:
  • PA0330/050/001
  • Authorization date:
  • 20-04-2007
  • Last update:
  • 21-05-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

IE - AW_141249

Package leaflet: information for the user

Read all of this leaflet carefully before you start taking this medicine because it

contains important information for you.

Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your pharmacist.

If you get any side effects, talk to your pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

What is in this leaflet

What IMODIUM

Plus 2mg/125mg tablets are, and what they are used for.

What you need to know before you take IMODIUM

Plus 2mg/125mg tablets.

How to take IMODIUM

Plus 2mg/125mg tablets.

Possible side effects.

How to store IMODIUM

Plus 2mg/125mg tablets.

Contents of the pack and other information.

1. What IMODIUM

®

Plus 2mg/125mg tablets are, and what they are used for

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.

IMODIUM

Plus 2mg/125mg tablets are used in adults and adolescents aged 12 years and above,

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

2. What you need to know before you take IMODIUM

®

Plus 2mg/125mg tablets

Do not take IMODIUM

®

Plus 2mg/125mg tablets:

In children less than 12 years old.

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.

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.

Warnings and precautions

Talk to your doctor or pharmacist before using IMODIUM

Plus 2mg/125mg tablets.

IMODIUM

Plus 2mg/125mg 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.

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

Plus 2mg/125mg tablets.

In acute diarrhoea, the symptoms usually disappear within two days. If symptoms persist after this

period, stop taking this medicine and contact your doctor.

Children

Children under 12 years of age must not take IMODIUM

Plus 2mg/125mg tablets.

Other medicines and IMODIUM

®

Plus 2mg/125mg tablets

Talk to your doctor or pharmacist if you are taking, have taken or might take 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 diabetic insipidus)

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 2mg/125mg tablets

may interact with them.

Pregnancy and breast feeding: Pregnancy: If you are pregnant, think you may be pregnant or

are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breast feeding: IMODIUM

Plus are not recommended 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.

3. How to take IMODIUM

®

Plus 2mg/125mg tablets

Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

Check with your pharmacist if you are not sure.

Swallow the correct number of tablets whole with a drink of water

For oral use only

Do not use more than the stated dose

Use in adults over 18 years old

Swallow two tablets initially, followed by one tablet after every loose stool (bowel movement).

Do not take more than four tablets in a day. If your symptoms persist after two days, stop taking

the tablets and contact your doctor.

Use in children and adolescents aged 12 to 18 years old:

Swallow one tablet initially, followed by one tablet after every loose stool (bowel movement).

Do not take more than four tablets in a day. If your symptoms persist after two days, stop taking

the tablets and contact your doctor.

Use in children and adolescents less than 12 years old

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

If you take more IMODIUM

®

Plus 2mg/125mg tablets than you should:

If you have taken too many IMODIUM

Plus 2mg/125mg tablets, 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, weak breathing, dry

mouth or the pupils of your eyes may become small, stomach pains, feel sick or vomit or be

constipated.

Children react more strongly to large amounts of IMODIUM

Plus 2mg/125mg tablets than

adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.

If you forget to take IMODIUM

®

Plus 2mg/125mg tablets:

Take 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, this medicine 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

Plus

2mg/125mg Tablets

Loperamide Hydrochloride & Simeticone

AW_141249.pdf - Page 1 of 3 - September 18, 2018 - 10:33:44

IE - AW_141249

Uncommon side effects (less than 1 in 100 but more than 1 in 1,000 people get these):

- Drowsiness

- Dizziness

- Weakness

- Constipation

- Vomiting

- Indigestion

- Wind

- Dry mouth

- Rash

Rare side effects (less than 1 in 1,000 but more that 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 HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide

more information on the safety of this medicine.

5. How to store IMODIUM

®

Plus 2mg/125mg tablets

Keep this medicine out of the sight and reach of children. Do not use this medicine after the

expiry date which is stated 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. 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

®

Plus 2mg/125mg tablets contains:

The active substances are: loperamide hydrochloride (2 mg per tablet) and simeticone (measured

as 125 mg dimeticone per tablet).

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 IMODIUM

®

Plus 2mg/125mg tablets look like and contents of the pack:

The tablets 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 tablets in blister strips.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland.

Manufacturer:

Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, Latina, Italy.

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium: IMODIUM

Duo 2 mg/125 mg Tabletten

Bulgaria: IMODIUM

Plus 2 mg/125 mg Caplets

Cyprus: IMODIUM

Plus

Czech Republic: IMODIUM

Plus

Denmark: IMODIUM

Plus

Finland: IMODIUM

Plus Tabletit

France: IMODIUM

duo Comprimé

Germany: IMODIUM

akut N Duo

Greece: IMODIUM

Plus

Hungary: IMODIUM

Plus 2mg/125mg tabletta

Ireland: IMODIUM

Plus 2 mg/125 mg tablet

Luxemburg: IMODIUM

Duo 2 mg/125 mg comprimés

Netherlands: IMODIUM

Duo 2 mg/125 mg, tabletten

Norway: IMODIUM

Comp

Portugal: IMODIUM

Plus

Romania: IMODIUM

Plus 2mg/125mg comprimate

Slovak Republic: IMODIUM

Plus

Spain: FORTASEC

Plus 2 mg/125 mg Comprimidos

Sweden: IMODIUM

Plus 2 mg/125 mg tablett

United Kingdom: IMODIUM

Plus caplets

This leaflet was last revised in September 2018.

18-0048

Johnson & Johnson (Ireland) Limited

Airton Rd. Tallaght, Dublin 24, Ireland

AW_141249.pdf - Page 2 of 3 - September 18, 2018 - 10:33:44