Oraldene 0.1% w/v Gargle / Mouthwash
*Company:
KenvueStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 May 2023
File name
ie-mockup-pl-oraldene-clean-rfi-bv2265.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 23 May 2023
File name
ie-spc-clean-oraldene-rfi-bv2265.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 28 November 2022
File name
ie-mockup-pl-clean-updated-2171.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 28 November 2022
File name
ie-spc-clean-2171.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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 17 December 2020
File name
ie-mockup-oraldene-pl-clean-bv2103.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 17 December 2020
File name
ie-spc-clean-oraldene-bv2103.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 general sale
Updated on 03 August 2020
File name
ie-mockup-pl-oraldene-clean-bv2060.pdf
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 03 August 2020
File name
ie-spc-clean-oraldende-bv2060.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 general sale
Updated on 03 April 2019
File name
ie-mockup-pl-oraldene-clean-bv1670.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- 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 03 April 2019
File name
ie-spc-oraldene-clean-bv1670.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 18 October 2017
File name
PIL_10705_271.pdf
Reasons for updating
- New PIL for new product
Updated on 18 October 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 18 October 2017
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
|
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 18 October 2017
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 04 April 2017
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 4.7 - 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 6.6 - 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
2
. QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Hexetidine 0.10% w/v
Excipients
with known effect: contain 4.3mg g Ethanol (96%) per
100ml i
.e.: up to 0.611 mg g ethanol per 15ml dose and trace amounts
of Azorubine 85% (E122)
For a full list of excipients, see section 6.1
[…]
4.1 Therapeutic indications
Hexetidine
Oraldene 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 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 in 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
Oraldene is contraindicated in patients known to be hypersensitive to
Hexetidine or related compounds.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special warnings and precautions for use
Oraldene should not be taken internally.
Oraldene 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
mg 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.
Azorubine (E122) may cause allergic reaction
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
4.7 Effects on ability to drive and operate machinery
None known
Oraldene has no or negligible influence on the
ability to drive and use machines.
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 Pharmacodynamic properties
Pharmacotherapeutic group: Antiinfectives and antiseptics for local oral
treatment, ATC code: A01AB12.
None known
5.2 Pharmacokinetic
properties
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 03 April 2017
Reasons for updating
- 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 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 04 August 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 30 June 2015
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 - how to report a side effect
- Change to section 4.9 - Overdose
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
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 4.9 - updated
SNAS BV 1205
Updated on 29 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- PIL retired pending re-submission
Updated on 27 June 2013
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
Reasons for updating
- Change due to user-testing of patient information
Updated on 02 March 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 13 November 2008
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
Reasons for updating
- Change to marketing authorisation holder
Updated on 02 May 2008
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 15 February 2006
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 15 February 2006
Reasons for updating
- New PIL for medicines.ie