Oraldene Icemint 0.1% w/v Gargle / Mouthwash

  • Name:

    Oraldene Icemint 0.1% w/v Gargle / Mouthwash

  • Company:
    info
  • Active Ingredients:

    Hexetidine

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/04/19

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Summary of Product Characteristics last updated on medicines.ie: 3/4/2019

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

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1 - 0 of 65 items.Total: Infinity pages

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 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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 18 October 2017 SmPC

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 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 SmPC

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 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 November 2008 SmPC

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 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 2 May 2008 SmPC

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 28 August 2007 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale