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Oraldene 0.1% w/v Gargle / Mouthwash

*
General Sale: Non-prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Supply through general sale

  • Active Ingredient(s):

    Hexetidine

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

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Updated on 02 August 2024

File name

ie-pil-oraldene-2413.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 02 August 2024

File name

ie-spc-v15-oraldene-2413.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 general sale

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

Changes highlighted in blue and underlined have been added, changes highlighted in red and struck through have been removed:

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 4.2 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

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

Correction to dosing table.

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 warning for ethanol content.

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

Addition of HDPE plastic cap with PE-Alu-PET wad material.

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

Change from Pfizer Consumer healthcare, Pottery Road, Dun Laoghaire, Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24.

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

Kenvue

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