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Lamisil Once 1% cutaneous solution

  • Name:

    Lamisil Once 1% cutaneous solution

  • Company:
    info
  • Active Ingredients:

    Terbinafine hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/01/20

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Summary of Product Characteristics last updated on medicines.ie: 23/1/2020

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Address: 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Medical Information Direct Line: 1800 441 442

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Medicine Name Corsodyl 1% w/w Dental Gel Active Ingredients Chlorhexidine digluconate
Medicine Name Corsodyl Freshmint 0.2% w/v Mouthwash Active Ingredients Chlorhexidine digluconate
Medicine Name Corsodyl Mint 0.2% w/v Mouthwash Active Ingredients Chlorhexidine digluconate
Medicine Name Day Nurse Capsules Active Ingredients Paracetamol, Pholcodine, Pseudoephedrine Hydrochloride
Medicine Name Duofilm Cutaneous Solution Active Ingredients Lactic Acid, Salicylic Acid
Medicine Name Excedrin 250 mg /250 mg /65 mg film-coated tablets Active Ingredients Aspirin, Caffeine, Paracetamol
Medicine Name Flixonase Allergy Relief Nasal Spray Active Ingredients Fluticasone Propionate
Medicine Name Lamisil 1% w/w Cream Active Ingredients Terbinafine hydrochloride
Medicine Name Lamisil AT Cream Active Ingredients Terbinafine hydrochloride
Medicine Name Lamisil Once 1% cutaneous solution Active Ingredients Terbinafine hydrochloride
Medicine Name Nicotinell Cool Mint 2mg medicated chewing gum Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Cool Mint 4mg medicated chewing gum Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Fruit 2mg medicated chewing-gums Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Fruit 4mg Medicated Chewing-Gums Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Mint 1mg Compressed Lozenges Active Ingredients nicotine bitartrate dihydrate
Medicine Name Nicotinell Mint 2mg compressed Lozenges Active Ingredients nicotine bitartrate dihydrate
Medicine Name Nicotinell TTS 10, 7 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Nicotinell TTS 20, 14 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Nicotinell TTS 30, 21 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Night Nurse Capsules Active Ingredients Dextromethorphan Hydrobromide, Paracetamol, Promethazine hydrochloride
Medicine Name Night Nurse Cold Remedy Active Ingredients Dextromethorphan Hydrobromide, Paracetamol, Promethazine hydrochloride
Medicine Name Otrivine Adult 0.1% w/v Nasal Drops, Solution Active Ingredients Xylometazoline Hydrochloride
Medicine Name Otrivine Adult 0.1% w/v Nasal Spray, Solution Active Ingredients Xylometazoline Hydrochloride
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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 23 January 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Safety changes to the leaflet

Updated on 23 January 2020 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 4.2

Updated on 20 March 2019 PIL

Reasons for updating

  • Removal/change of distributor

Updated on 3 November 2016 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Correction of typographical errors

Updated on 3 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 November 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 November 2016 PIL

Reasons for updating

  • Company name change or merger

Updated on 3 October 2016 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 7, 8 & 10 updated following Change of Ownership approval

Updated on 29 April 2016 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 November 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.1

Clarification of indication to specify that it is for adults

Section 4.4

Addition of “after sun exposure or severe skin scaling”

Addition of “sight and” before “reach of children”

Section 4.7

Addtion of “or negligible”

Section 4.8

Headings added and explanation of frequencies

Section 5.1

Addition of heading and paragraph regarding relapse or reinfection.

Section 7

Address amended to Watchmoor Park

Section 10

Date of revision updated from 21 Jan 2013 to 20th November 2015

Updated on 13 February 2013 SmPC

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 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 

Addition of  “Cutaneous use”

Addition of subheadings

Section 4.3

“terbinafine” replaced with “active substance”

Section 4.4

Add “should be kept out of reach of children” and statement about use in patients with lesions and use on the face.

Information about ethanol content reworded

Section 4.5

Section replaced with “No drug interactions are known with Lamisil Once 1% cutaneous solution.”

Section 4.6

Addition of fertility section

Section 4.7

Sentence reworded

Section 4.9

Section reworded with additional information about  accidental oral ingestion and how to treat.

Updated on 9 March 2012 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



Section 4.6

Change to heading from ‘Pregnancy and lactation’ to ‘Fertility, pregnancy and lactation’.

 

Section 6.1

Deletion of ‘hyprolose’ and addition of ‘hydroxypropylcellulose’.

 

Section 10

 

Addition of date 29 July 2011

 

Updated on 23 July 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)