Lamisil 250mg tablets

  • Name:

    Lamisil 250mg tablets

  • Company:
    info
  • Active Ingredients:

    Terbinafine hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/10/19

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Summary of Product Characteristics last updated on medicines.ie: 2/10/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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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 2 October 2019 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Editorial changes due to new QRD template

Updated on 2 October 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Editorial changes (QRD template)

Updated on 14 March 2019 PIL

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 6 - what the product looks like and pack contents

Updated on 14 March 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 3: Addition of the following text: “The tablet can be divided into equal doses”.
  • Section 4.2: Dosing for Children – removal of reference to the 125mg tablet (as it is not available in Ireland). Reference to “half a 250mg tablet” and “one 250mg tablet” is included instead.

Updated on 22 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 18 July 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 29 May 2018 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 4 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 4 May 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Removal of dosing instructions for children weighing less than 20kg

Updated on 2 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 May 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - use in children/adolescents

Updated on 21 February 2017 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3 and 4.4: Chronic or active hepatic disease is added as a contraindication to Section 4.3and section 4.4 is updated accordingly.

Section 4.2 is updated to include dosage recommendations for paediatric patients

Section 5.1: Corrections to the efficacy study data for Tinea and Candidiasis infections

Some editorial changes were also made to other sections.

Updated on 17 December 2014 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 24 April 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 12 August 2013 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 has been revised to update the method of administration.

Section 4.4 has been revised to include psoriasis or lupus erythematosus in the dermatological effects section.

Section 4.6 has been revised to include information for women of child-bearing potential and a section on fertility.

Section 4.8 has been revised to include more information on advserse drug reactions from spontaneous reports and literature cases

Section 5.1 has been revised to include a section on onchomycosis

Section 5.2 has been revised to include the following statement: Multiple dose administration followed by extended blood sampling revealed a triphasic elimination with a terminal half-life of approximately 16.5 days.

Updated on 8 July 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Deletion of a pack size

Updated on 24 June 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 has been updated with the following text: therefore periodic monitoring (after 4-6 weeks of treatment) of liver function test is recommended. Lamisil should be immediately discontinued in case of elevation of liver function test.

Lamisil should be used with caution in patients with pre-existing psoriasis or lupus erythematosus as very rare cases of lupus have been reported.

Section 4.6 has been updated as follows: Since clinical experience in pregnant women is very limited, Lamisil tablets should not be used during pregnancy unless clinical condition of the woman requires treatment with oral terbinafine and the potential benefits for the mother outweigh any potential risks for the foetus.

Fertility

Foetal toxicity and fertility studies in animals suggest no adverse effects.

Section 4.8 has been updated with new adverse events (frequency not known) - Anaemia, Anaphylactic reactions, serum sickness-like reaction and Anosmia.

Section 6.3 has been updated to reduce the shelf life from 5 years to 3 years.

Updated on 13 February 2013 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects

Updated on 12 December 2012 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.5, the following has been added:

Fluconazole increased the Cmax and AUC of terbinafine by 52% and 69% respectively, due to inhibition of both CYP2C9 and CYP3A4 enzymes. Similar increase in exposure may occur when other drugs which inhibit both CYP2C9 and CYP3A4 such as ketoconazole and amiodarone are concomitantly administered with terbinafine.

 

There was no effect of terbinafine on the pharmacokinetics of fluconazole. Further there was no clinically relevant interaction between terbinafine and the potential comedications cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline.

In studies in healthy subjects characterized as extensive metabolisers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine increased the dextromethorphan/dextrorphan metabolic ratio in urine by 16- to 97-fold on average. Thus, terbinafine may convert extensive CYP2D6 metabolisers to poor metaboliser status.


In section 4.8, the following has been added:

Ear and labyrinth disorders: hypoacusis, impaired hearing, tinnitus.
Psychiatric disorders: anxiety and depressive symptoms secondary to taste disturbances.
Skin and subcutaneous tissue disorders: photosensitivity reactions (e.g. photodermatosis, photosensitivity allergic reaction and polymorphic light eruption).

Updated on 17 December 2010 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to side-effects

Updated on 21 October 2010 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.1, the last sentence has been changed to:
Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure

In section 4.8, the following information has been added:

Other adverse drug reactions from post-marketing spontaneous reports:

The following adverse drug reactions have been identified based on post-marketing spontaneous reports and are organized by system organ classes. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Blood and lymphatic system disorders: anaemia.

Immune system disorders: anaphylactic reaction, serum sickness-like reaction.

Vascular disorders: vasculitis.

Nervous system disorders: anosmia including permanent anosmia, hyposmia.

Gastrointestinal disorders: pancreatitis.

Musculoskeletal and connective tissue disorders: rhabdomyolysis.

General disorders and administration site conditions: influenza-like illness, pyrexia.

Investigations: blood creatine phosphokinase increased.  

The heading for section 6.6 has been changed to match that in the licence provided by the IMB at renewal.

The renewal date in section 9 has been updated to reflect the new licence renewal date

The date of revision of the text of the SmPC has been updated to October 2010.

Updated on 6 November 2008 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 4.5 - 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 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2: Posology and method of administration: - Addition of information on special populations

Section 4.4: Special warnings and precautions for use - Addition of information on liver impairment, Addition of statement on dermatological reactions, Addition of statement on haematological disorders, Change in the recommendation in patients with renal impairment, Change statement on antiarrhythmics (include 1A and 1B in addition to 1C)

Section 4.5: Interaction with other medicinal products and other forms of interaction: Change statement on antiarrhythmics (include 11A and 1B in addition to 1C)

Section 4.7: Effects on ability to drive and use machines: Addition of cautionary statement due to possible impact of new ADR dizziness

Section 4.8: Undesirable effects: Addition of new ADRs: pancytopenia, dizziness, paraesthesia, hypoaesthesia.

Section 5.3: Preclinical safety data: Addition of statement on new PCS data.

Updated on 25 June 2008 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to Section 3: Tablet markings have changed

Updated on 7 September 2005 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 September 2005 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 7 April 2005 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to side-effects

Updated on 30 March 2005 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 August 2003 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 July 2003 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)