Imodium Plus 2mg/125mg Tablets

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Summary of Product Characteristics last updated on medicines.ie: 13/3/2020

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACTIFED 30 mg/1.25 mg per 5 ml Syrup Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name ACTIFED 60 mg / 2.5 mg Tablets Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Arret 2mg Hard Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Benylin Children's Chesty Coughs Active Ingredients Guaifenesin
Medicine Name Benylin Children's Dry Coughs Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Cough Medicine Syrup Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Day and Night Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Dry Coughs Syrup Active Ingredients Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Dual Action Dry Syrup Active Ingredients Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Benylin Four Flu Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Non- Drowsy for Chesty Coughs Active Ingredients Guaifenesin, Levomenthol
Medicine Name BENYLIN Non-Drowsy Dry Coughs, Syrup Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Benylin Phlegm Cough plus Decongestant Syrup Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
Medicine Name Benylin Phlegm Cough Syrup Active Ingredients Guaifenesin, Levomenthol
Medicine Name Calpol 120mg/5ml Infant Oral Suspension Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (bottle) Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (sachets) Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus 250mg/5ml Oral Suspension Active Ingredients Paracetamol
Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets Active Ingredients Paracetamol
Medicine Name Colpermin Gastro-Resistant Capsules Active Ingredients Peppermint Oil
Medicine Name Daktarin 2% w/w Cream Active Ingredients Miconazole nitrate
Medicine Name Daktarin 2% w/w Cutaneous Powder Active Ingredients Miconazole nitrate
Medicine Name DAKTARIN 20mg/g Oral Gel Active Ingredients Miconazole
Medicine Name Imodium 2 mg Capsules Active Ingredients Loperamide Hydrochloride
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13 March 2020 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 March 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 22 November 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 11 July 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 14 March 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents

Updated on 14 March 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 19 June 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 16 November 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Description of change:

PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd. Change in PA number. Note the address and contact details remain the same.

Updated on 16 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 16 November 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 18 July 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 27 June 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Please note that the approval date is 06 June 2017, however the date of revision of the text was in April.


Text that has been added has been highlighted and underlined:

4.4 Special warnings and precautions for use

..........

Although no pharmacokinetic data are available in patients with hepatic

impairment, Imodium Plus should be used with caution in such patients

because of reduced first pass metabolism. This medicine must be used with

caution in patients with hepatic impairment as it may result in a relative

overdose leading to central nervous system (CNS) toxicity. Imodium Plus

should be used under medical supervision in patients with severe hepatic

dysfunction.

Cardiac events including QT prolongation and torsades de pointes

have been reported in association with overdose. Some cases had a

fatal outcome (see section 4.9). Patients should not exceed the

recommended dose and/or the recommended duration of treatment.

 

 

4.9 Overdose

Symptoms

In case of overdosage (including relative overdosage due to hepatic

dysfunction), central nervous system depression (stupor, co_ordination

abnormality, somnolence, miosis, muscular hypertonia, respiratory

depression), dry mouth, abdominal discomfort, nausea and vomiting,

constipation, urinary retention and paralytic ileus may occur.

In individuals who have ingested overdoses of loperamide HCL,

 

cardiac events such as QT interval prolongation, torsades de pointes,

other serious ventricular arrhythmias, cardiac arrest and syncope have

been observed (see section 4.4). Fatal cases have also been reported.


5.3 Preclinical safety data

Acute and chronic studies on loperamide showed no specific toxicity.

Results of in vivo and

 

 

in vitro studies carried out indicated that loperamide

 

is not genotoxic. In reproduction studies, very high doses (40 mg/kg/day -

20 times the maximum human use level, based on body surface area)

loperamide impaired fertility and foetal survival in association with

maternal toxicity in rats. Lower doses had no effects on maternal or foetal

health and did not affect peri_ and post_natal development.

Non-clinical in vitro and in vivo evaluation of loperamide indicates no

significant cardiac electrophysiological effects within its

therapeutically relevant concentration range and at significant

multiples of this range (up to 47-fold). However, at extremely high

concentrations associated with overdoses (see section 4.4), loperamide

has cardiac electrophysiological actions consisting of inhibition of

potassium (hERG) and sodium currents, and arrhythmias.

.......



















































































Updated on 15 June 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 2 November 2016 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to section 5.3 of the SPC (Preclinical Safety Data) in line with the latest published version of the company core data sheet (CCDS).

Revision date was updated to "21 October 2016"

Updated on 23 August 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Text that has been highlighted and underlined has been added, text that has been highlighted and struck through has been removed:

4.2 Posology and method of administration

Posology

The tablets should be taken with liquid.

Adults over 18 years

 

:

 

……..

Adolescents between 12 and 18 years

 

:

 

……..

Use in children

 

 

Paediatric population

 

Imodium Plus

 

must not be used is contraindicated in children under 12 years (see section 4.3).

 

Use in the elderly

 

:

 

…….

Use in renal impairment

 

:

 

No dosage adjustment is necessary in

 

 

patients with renal impairment.

 

Use in

 

 

hepatic impairment:

 

……….

Method of administration

The tablets should be taken with liquid

 

 

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

 

4.3 Contraindications

Imodium Plus must not be used in:

- Children less than 12 years of age

-

 

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

 

Patients with a known hypersensitivity (allergy) to loperamide hydrochloride, simeticone or any of

the excipients

………………

Imodium Plus

 

should must not be used when inhibition of peristalsis is to be avoided due to the

 

possible risk of significant sequelae including ileus, megacolon and toxic megacolon. It must be

discontinued promptly if constipation, ileus or abdominal distension develop.

4.5 Interaction with other medicinal products and other forms of interaction

……………..

Since simeticone is not absorbed from the gastrointestinal tract, no relevant interactions between

simeticone and other drugs are expected.

Paediatric population

Interaction studies have only been performed in adults.

4.6

 

Fertility, Ppregnancy and lactation

 

Use in pP

 

 

regnancy

 

……...

Use in lactation Breast-feeding

……..

Fertility

The effect on human fertility has not been evaluated.

4.7 Effects on ability to drive and use machines

Imodium Plus has no or negligible influence on the ability to drive and use machines.

However, Tt

 

 

iredness, dizziness and drowsiness have been reported in patients taking loperamide. If

 

affected, patients should not drive or operate machinery may occur in the setting of diarrheal

syndromes treated with loperamide HCl (see section 4.8). Therefore, it is advisable to use caution

when driving a car or operating machinery.. (Ssee sSection 4.8Undesirable effects..

4.8 Undesirable effects

……….

Paediatric pPopulation

The safety of loperamide HCl was evaluated in 607 patients aged 10 days to 13

years who participated in 13 controlled and uncontrolled clinical trials of

loperamide HCl used for the treatment of acute diarrhoea. The only ADR

reported for

 

1% of loperamide HCl treated patients was vomiting.

 

……

Table 1: Adverse Drug Reactions

System

Organ

Class

 

 

Adverse events

Frequency

Common

 

 

Uncommon

 

 

Rare

Immune

sS

 

 

ystem dDisorders

 

 

Hypersensitivity reaction

 

a, Anaphylactic

 

reaction (including Anaphylactic shock)

 

a, Anaphylactoid reactiona

Nervous

sS

 

 

ystem dDisorders

Headache

 

b,

 

Dysgeusia

 

 

Somnolence

 

a,

 

Dizziness

 

c

Loss of consciousness

 

a, Depressed level

 

of consciousness

 

a, Stupora, Hypertoniaa, Coordination abnormalitya

Eye

dD

 

 

isorders

 

 

Miosis

 

a

Gastrointestinal dDisorders Nausea Abdominal   pain, Abdominal discomfortb, Abdominal pain upperb, Vomiting, Constipation, Abdominal distensionc, Dyspepsiac, Flatulence,  

Megacolona (including toxic megacolond)

 


 

 

System Organ

Class

 

 

Adverse events

Frequency

Common

 

 

Uncommon

Rare

Skin and

sS

 

 

ubcutaneous tTissue dDisorders

 

Rash

 

 

Bullous eruption (including

Stevens-Johnson

syndrome

 

a, Toxic epidermal necrolysisa and Erythema multiformea), Angioedemaa, Urticariaa, Pruritusa

Renal and

uU

 

 

rinary dDisorders

 

 

Urinary retention

 

a

General

dD

 

 

isorders and aAdministratio n sSite cConditions

 

Asthenia

 

 

Fatigue

 

a

 

 

a

 

 

Inclusion of this term is based on post-marketing reports for loperamide HCl. As the process for determining

 

post-marketing ADRs did not differentiate between chronic and acute indications or adults and children, the

frequency is estimated from all clinical trials with loperamide HCl combined, including trials in children

 

12 years (N=3683).

 

b

 

 

Inclusion of this term is based on ADRs reported in clinical trials with loperamide HCl. Frequency

 

category assigned based on clinical trials with loperamide HCl in acute diarrhoea (N=2755).

c

 

 

Inclusion of this term is based on post-marketing experience with loperamide-simeticone. Frequency

 

category assigned based on clinical trials with loperamide-simeticone in acute diarrhoea (N = 618). Dizziness

and abdominal distension were also identified as clinical trial ADRs with loperamide HCl.

d

 

 

See section 4.4 Special Warnings and Special Precautions for use.

 

4.9 Overdose

Symptoms

In case of overdosage (including relative overdosage due to hepatic dysfunction), central nervous

system depression (stupor, co-ordination abnormality, somnolence, miosis, muscular hypertonia,

respiratory depression), dry mouth, abdominal discomfort, nausea and vomiting, constipation,

urinary retention and paralytic ileus may occur.

 

Children may be more sensitive to CNS effects than

 

adults.

………..

Paediatric population

Children may be more sensitive to CNS effects than adults.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antipropulsive antidiarrheals, ATC code: A07D A53

Mechanism of Action

Loperamide HCl

…….

Simeticone

Simeticone is an inert surface-active agent with anti-foaming properties thereby potentially relieving

gas-related symptoms associated with diarrhoea.

Simeticone is liquid dimethicone activated with finely divided silicon dioxide to enhance the

defoaming properties of the silicone.

5.2 Pharmacokinetic properties

A

 

 

bsorption

 

Most ingested loperamide is absorbed from the gut, but as a result of significant first pass

metabolism, systemic bioavailability is only approximately 0.3%. The simeticone component of

loperamide-simeticone is not absorbed.

Distribution

Studies on distribution in rats show a high affinity for the gut wall with a preference for binding to

receptors of the longitudinal muscle layer. The plasma protein binding of loperamide is 95%, mainly

to albumin. Non-clinical data have shown that loperamide is a P-glycoprotein substrate.

Metabolism Biotransformation

Loperamide is almost completely extracted by the liver, where it is predominantly metaboli

 

szed,

 

conjugated and excreted via the bile. Oxidative N-demethylation is the main metabolic pathway for

loperamide, and is mediated mainly through CYP3A4 and CYP2C8. Due to this very high first pass

effect, plasma concentrations of unchanged drug remain extremely low.

Elimination

The half-life of loperamide in man is about 11 hours with a range of 9-14 hours. Excretion of the

unchanged loperamide and the metabolites mainly occurs through the faeces.

6.6 Special precautions for disposal

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

10. DATE OF REVISION OF THE TEXT

10 August 2016

Updated on 16 August 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to improve clarity and readability

Updated on 11 May 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 30 April 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of the following text

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.

Updated on 30 May 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of side effects to section 4.8 of the SPC.

Updated on 28 May 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 20 March 2012 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Additional warning and precautions in SPC.

Updated on 10 October 2011 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to the ADME information.

Updated on 13 July 2011 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 23 February 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to tabbring SPC in line with the embossing on the tablet - White, capsule-shaped tablets debossed with “IMO” on one side, the other side is debossed with a line between “2and 125.

Updated on 14 December 2009 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

MAH change from McNeil Limited UK to McNeil Healthcare (Ireland) Limited, Ireland.

Updated on 7 December 2009 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 May 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only