Arret 2mg Hard Capsules
*Company:
KenvueStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 May 2024
File name
ie-pl-arret-2340.pdf
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 23 May 2024
File name
ie-spv-v16-arret-2340.pdf
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
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
Reasons for updating
- New SPC for new product
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
- 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
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
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
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 evaluated4.9 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.
If5.2. 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
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
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
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
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