Oraldene Icemint 0.1% w/v Gargle / Mouthwash
- Name:
Oraldene Icemint 0.1% w/v Gargle / Mouthwash
- Company:
Johnson & Johnson (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through general sale
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/08/20
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Johnson & Johnson (Ireland) Ltd
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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 3 August 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 3 August 2020
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
Updated on 3 April 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 3 April 2019
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Updated on 18 October 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 18 October 2017 SPC
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 general sale
Free text change information supplied by the pharmaceutical company
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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.
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Updated on 18 October 2017
Reasons for updating
- New SmPC for new product
Legal category: Supply through general sale
Updated on 18 October 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 4 April 2017 SPC
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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 general sale
Free text change information supplied by the pharmaceutical company
Text highlighted in blue has been added, text highlighted in red and struck through has been removed:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Hexetidine 0.10% w/v
Excipients with known effect: contain 4.3 g Ethanol (96%) per 100ml
i.e.: up to 0.611 g ethanol per 15ml dose.
For
a the full list of excipients, see section 6.1
[…]
4.1 Therapeutic indications
Hexetidine
Oraldene Icemint is recommended as a topical antiseptic in
the management of superficial infections of the oropharynx and in their
prophylaxis in the preoperative period of dental surgery or pharyngeal
surgery in geriatric nursing.
Hexetidine Oraldene Icemint can also be
used as an adjunct to systemic therapy of oropharyngeal infections.
4.2 Posology and Method of Administration
Route of administration
Oromucosal
Dosage
Posology
Usual dosage for adults and children 6 years and over
Rinse the mouth or gargle with at least 15 ml of solution two or three
times daily or as directed. Do not swallow.
Elderly
As for adults.
Under 6 years: Not recommended
Method of administration
For oromucosal use
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Oraldene Icemint is contraindicated in patients known to be
hypersensitive to Hexetidine or related compounds.
4.4 Special warnings and precautions for use
Oraldene Icemint should not be taken internally.
Oraldene Icemint is for external use only; the solution must therefore
not be swallowed.
This medicinal product contains 5vol % Ethanol (alcohol), i.e.: up to
0.611 g per dose, equivalent to 15.48ml beer, 6.45ml wine per dose.
Harmful for those suffering from alcoholism. To be taken into account
in pregnant or breast-feeding women, children and high-risk groups
such as patients with liver disease, or epilepsy.
If there is evidence of increased inflammation, the treatment should be
stopped.
Not suitable for persistent symptoms.
4.5 Interaction with other medicinal products and other forms
of interaction
No interactions are known.
None known
4.6 Fertility, Pregnancy & Lactation
No
formal Formal studies have been conducted in man. However, on
the basis of animal studies and in theory, the negligible systemic
absorption it is considered highly unlikely that the use of Oraldene
during pregnancy will present a risk to the foetus. (….)
4.7 Effects on ability to drive and operate machinery
Oraldene Icemint has no or negligible influence on the ability to drive
and use machines.
None known
4.9 Overdosage
Symptoms
Hexetidine is a bactericide and fungicide.
No adverse events have been reported in overdose other than those seen
in normal use. There are no reports of alcoholic intoxication from
overdose with hexetidine.
Hexetidine, at the strength present in hexetidine products is non-toxic.
Acute alcoholic intoxication is extremely unlikely; however it is
theoretically possible that, if a massive dose were swallowed by a small
child, alcoholic intoxication may occur due to the ethanol content.
There is no evidence to suggest that repeated, excessive administration
of hexetidine would lead to hypersensitivity-type reactions.
Management
Treatment of overdose is symptomatic, but rarely required. In the event
of accidental ingestion of the contents of a bottle by a child, a doctor
should be consulted immediately. Gastric lavage should be considered
within two hours of ingestion and management should relate to
treatment of alcoholic intoxication.
5.1 Pharmacodynamics properties
Pharmacotherapeutic group: Antiinfectives and antiseptics for local oral
treatment, ATC code: A01AB12.
None known
5.2 Pharmacokinetic
s properties
6.3 Shelf life
2 years
24 months
6.4 Special precautions for storage
Do not store above 25°C. Keep the bottle in the outer carton.
in order
to protect from light.
6.6 Special precautions for disposal
of a used medicinal product
or waste materials derived from such medicinal product
and other
handling
of the product
No special requirements for disposal. Any unused medicinal product or
waste material should be disposed of in accordance with local
requirements.
No special requirements.
10. DATE OF REVISION OF TEXT
April 2015 March
2017
Updated on 3 April 2017 PIL
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 30 June 2015 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.2 Heading updated to Usual dosage in adults and children 6 years and over
Section 4.4 - additional warnings added
Oraldene is for external use only; the solution must therefore not be swallowed.
Not suitable for persistent symptoms.
Section 4.8 - adverse events updated & information for reporting of Adverse events added
Section 4.9 - updated
SNAS BV 1205
Updated on 29 June 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 27 June 2013 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 20 July 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 13 November 2008 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 19 May 2008 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 2 May 2008 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 28 August 2007 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated to 4.6 Pregnancy and Lactation
No Formal studies have been conducted in man. However, on the basis of animal studies and in theory, the negligible systemic absorption it is considered highly unlikely that the use of Oraldene during pregnancy will present a risk to the foetus.
It is not known whether hexetidine is excreted in human breast milk, however, in view of the negligible amount of hexetidine which could be predicted to be systemically absorbed, it is unlikely that concentrations of hexetidine in the milk will present any risk to the neonate / infant.
Updated on 28 February 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 19 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through general sale