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Arret 2mg Hard Capsules

*
Pharmacy Only: Non-prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Loperamide Hydrochloride

    *Additional information is available within the SPC or upon request to the company

Updated on 07 June 2023

File name

ie-spc-clean-pa-330-42-1-bv2181.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 25 January 2023

File name

ie-mockup-pl-clean-pa 330-42-1-bv2257 and 2261 revised.pdf

Reasons for updating

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

Updated on 19 December 2022

File name

ie-mockup-pl-clean-330-42-1-bv2257 and bv2261.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 19 December 2022

File name

ie-mockup-pl-clean-bv2257-PA 330-42-1.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 25 May 2022

File name

ie-spc-clean-pa-330-42-1-bv2213.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 25 May 2022

File name

ie-mockup-pl-clean-pa-330-42-1-bv2213.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 06 July 2020

File name

ie-mockup-pl-clean-330-42-1-bv2039.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 06 July 2020

File name

ie-spc-clean-330-42-1-bv2039.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 09 August 2019

File name

ARA02 BV 1939 SPC V12.0.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose

Legal category:Supply through pharmacy only

Updated on 07 May 2019

File name

ie-spc-clean-pa 330-42-1-bv1863.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 07 May 2019

File name

ie-spc-clean-pa 330-42-1-bv1863.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 20 August 2018

File name

ie-mockup-pl-clean-arr-330-42-1-bv1741.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 20 August 2018

File name

ie-spc-clean-arret-330-42-1-bv1741.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 15 January 2018

File name

PIL_8494_28.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 15 January 2018

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

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 15 January 2018

Reasons for updating

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

Updated on 21 July 2017

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 6.6 - Special precautions for disposal and other handling

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Added text has been highlighted and underlined, removed text has been highlighted and struck through:

4.4 Special warnings and special

precautions for use

Treatment of diarrhoea with loperamide HCl is

only symptomatic. Whenever an underlying

etiology can be determined, specific treatment

should be given when appropriate.

The necessity for specific therapy, such as antiinfectives,

should be borne in mind, particularly

should treatment be required for a period longer

than three days.

Loperamide should be used with caution when

hepatic function, necessary for the drug’s

metabolism, is defective, as this may result in

relative overdose leading to CNS toxicity.

Patients with AIDS treated with Imodium for

diarrhoea should have therapy stopped at the

earliest signs of abdominal distension. There

have been isolated reports of toxic megacolon in

AIDS patients with infectious colitis from both

viral and bacterial pathogens treated with

loperamide hydrochloride.

Antimotility agents such as loperamide may

precipitate ileus and toxic megacolon in patients

with ulcerative colitis, and should be avoided in

severe acute attacks. It may be used cautiously

in mild or less severe attacks as an adjunct to

other measures, but should be discontinued

promptly should abdominal distension or other

untoward symptoms occur.

The stated dose should not be exceeded.

Patients with rare hereditary problems of

galactose intolerance, the Lapp lactase

deficiency or glucose

 

‐galactose malabsorption

 

should not take this medicine because it contains

lactose.

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.Abuse and

misuse of loperamide, as an opioid substitute,

have been described in individuals with opioid

addiction (see section 4.9 Overdose).

4.9 Overdose

Signs and symptoms:

In case of overdose (including relative overdose

due to hepatic dysfunction), CNS depression

(stupor, coordination abnormality, somnolence,

miosis, muscular hypertonia and respiratory

depression), constipation, urinary retention and

ileus may occur. Children, and patients with

hepatic dysfunction, may be more sensitive to

CNS effects.

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.In

individuals who have intentionally ingested

overdoses (reported in doses from 40 mg up to

792 mg per day) of loperamide HCl, QT interval

prolongation and or serious ventricular

arrhythmias, have been observed (see Warnings

and Precautions). Fatal cases have also been

reported.

Treatment:

In cases of overdose, ECG monitoring for QT

interval prolongation should be initiated.

If CNS symptoms of overdose occur, naloxone

may be given as an antidote. Since the duration

of action of Arret is longer than that of naloxone

(1 to 3 hours), the patient should be kept under

constant observation for at least 48 hours in

order to detect any possible depression of the

central nervous system.


5.3 Preclinical safety data

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

Warnings and Precautions), loperamide has

cardiac electrophysiological actions consisting of

inhibition of potassium (hERG) and sodium

currents, and arrhythmias.Within its

therapeutically relevant concentration range and

at significant multiples of this range (up to 47

 

 

‐

 

fold), loperamide has no significant cardiac

electrophysiological effects. However, at

extremely high concentrations associated with

intentional overdose (see section 4.4 Warnings

and Precautions), loperamide has cardiac

electrophysiological actions consisting of

inhibition of potassium (hERG) and sodium

currents, and arrhythmias in in vitro and in vivo

animal models.

6.6

 

Special precautions for disposalInstruction

 

for use and handling

No special requirements.

















Updated on 18 July 2017

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 24 November 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Added text has been highlighted in blue and underlined, text that has been removed has been struck through:

4.4 Special warnings and precautions for use

Treatment of diarrhoea with loperamide HCl is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate.

The necessity for specific therapy, such as anti-infectives, should be borne in mind, particularly should treatment be required for a period longer than three days.

Loperamide should be used with caution when hepatic function, necessary for the drug’s metabolism, is defective, as this may result in relative overdose leading to CNS toxicity.

Patients with AIDS treated with Imodium for diarrhoea should have therapy stopped at the earliest signs of abdominal distension.  There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.

Antimotility agents such as loperamide may precipitate ileus and toxic megacolon in patients with ulcerative colitis, and should be avoided in severe acute attacks.  It may be used cautiously in mild or less severe attacks as an adjunct to other measures, but should be discontinued promptly should abdominal distension or other untoward symptoms occur.

The stated dose should not be exceeded.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine because it contains lactose.

Abuse and misuse of loperamide, as an opioid substitute, have been described in individuals with opioid addiction (see section 4.9 Overdose).


4.6 Fertility, pPregnancy and lactation

 

Pregnancy

The safety of Arret in human pregnancy has not been established. 

 

Breast-Feeding

Small amounts of loperamide may appear in human breast milk.  Therefore, Arret is not recommended during breast feeding.

 

Women who are pregnant or breast feeding infants should therefore be advised to consult their doctor for appropriate treatment.

Fertility

The effect on human fertility has not been evaluated

4.9       Overdose

Signs and symptoms:

In case of overdose the following effects may be observed: constipation, urinary retention, ileus and central nervous system depression (stupor, co-ordination abnormality, myosis, muscular hypertonia, somnolence and bradypnoea).

In case of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia and respiratory depression), constipation, urinary retention and ileus may occur. Children, and patients with hepatic dysfunction, may be more sensitive to CNS effects.


In individuals who have intentionally ingested overdoses (reported in doses from 40 mg up to 792 mg per day) of loperamide HCl, QT interval prolongation and or serious ventricular arrhythmias, have been observed (see Warnings and Precautions). Fatal cases have also been reported.

 

Treatment:

In cases of overdose, ECG monitoring for QT interval prolongation should be initiated.

If intoxication is suspected CNS symptoms of overdose occur, naloxone may be given as an antidote.  Since the duration of action of Arret is longer than that of naloxone (1 to 3 hours), the patient should be kept under constant observation for at least 48 hours in order to detect any possible depression of the central nervous system


5.2.      Pharmacokinetic properties

 

The half-life of loperamide in man is 10.8 hours with a range of 9 to 14 hours.  Studies on distribution in rats show high affinity for the gut wall with preference for binding to the receptors in the longitudinal muscle layer.  Loperamide is well absorbed from the gut, but is almost completely extracted and metabolised by the liver where it is conjugated and excreted via the bile.  Due to its high affinity for the gut wall and its high first pass metabolism, very little loperamide reaches the systemic circulation.

Absorption:  Most ingested loperamide is absorbed from the gut, but as a result of significant first pass metabolism, systemic bioavailability is only approximately 0.3%.

 

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

5.3.  Preclinical safety data

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Within its therapeutically relevant concentration range and at significant multiples of this range (up to 47-fold), loperamide has no significant cardiac electrophysiological effects. However, at extremely high concentrations associated with intentional overdose (see section 4.4 Warnings and Precautions), loperamide has cardiac electrophysiological actions consisting of inhibition of potassium (hERG) and sodium currents, and arrhythmias in in vitro and in vivo animal models.


10.       DATE OF REVISION OF THE TEXT

 

16 November 2016

Updated on 24 November 2016

Reasons for updating

  • 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 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 12 August 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 07 August 2015

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

Section 4.8 - 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 06 September 2012

Reasons for updating

  • Change due to user-testing of patient information

Updated on 01 March 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4 of the SPC has been updated in line with the Core Data Sheet.

Updated on 02 July 2009

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 1:
Name of product changes to Arret 2mg Hard Capsules

Section 2:
Quantity of lactose monhtydrate added
"For a full list of excipienst see Secvtion 6.1" added

Section 3:
Changes to "Capsules, hard {short term: capsule}"

Section 9:
Date of last renewal: 03 May 2009

Section 10:
Date of revision of text: May 2009

Updated on 19 June 2009

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions

Updated on 20 March 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 Section 4.4

 Warning added:

 Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine because it contains lactose.

 Section 5.1

 ATC code added

 Section 7

 New PA holder: McNeil Healthcare (Ireland) Ltd, Airton Road, Tallaght, Dublin 24

 Section 8

New PA number: PA 823/53/1

Updated on 20 March 2009

Reasons for updating

  • Change of licence holder

Updated on 19 September 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Change to section 4.8 – Undesirable effects

Update to MedDRA and addition of ‘Very rare: Loss of consciousness, depressed level of consciousness’

Change to section 10 – Date of revision of text

August 2008

Updated on 28 August 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to section 2 – quantitative and qualitative composition

Update QRD

Change to section 4.1 – Therapeutic Indications

Update QRD

Change to section 4.2 – Posology and |Method of Administration

Update QRD

Change to section 4.3 – Contra-indications

Update QRD Lactose

Change to section 4.4 – Special Warnings and Precautions for Use

Update QRD

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Update QRD

Change to section 4.6 – Pregnancy and Lactation

Update QRD

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Update QRD

Change to section 4.8 – Undesirable effects

Update to MedDRA and Loss of consciousness, depressed level of consciousness,

Change to section 5.1 - Pharmacodynamic properties

ATC code

Change to section 5.2 - Pharmacokinetic properties

Update to QRD

Change to section 5.3 - Preclinical Safety Data

Update to QRD

Change to section 6.1 – List of Excipients

Update to QRD

Change to section 6.6 –  Instructions for use, handling and disposal

Update to QRD

Change to section 10 – Date of revision of text

August 2008

Updated on 22 July 2005

Reasons for updating

  • Change of active ingredient
  • Change of inactive ingredient
  • Change to storage instructions
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 19 July 2005

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 26 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 August 2004

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 06 August 2004

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only