Lamisil 250mg tablets
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 August 2020
File name
Lamisil REG PIL 20-031 clean_125mg typo corrected 12-Aug-2020.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Free text change information supplied by the pharmaceutical company
Correct following error in dosing section:
Children and adolescents
There is no experience with Lamisil in children under 2 years of age (usually less than 12 kg).
The dosage in children above 2 years of age depends on the body weight:
Children weighing 20 to 40 kg 250mg125 mg (half a 250 mg tablet) once daily
Children weighing more than 40 kg 250 mg (one 250 mg tablet) once daily
Updated on 02 July 2020
File name
Lamisil REG PIL 20-031 clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Free text change information supplied by the pharmaceutical company
Addition of the following statement: Lamisil and Sodium: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Updated on 02 July 2020
File name
Lamisil 250mg Tablets REG SPC PF20-031 June 2020_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of statement that Lamisil contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free '.
Updated on 02 October 2019
File name
Lamisil REG PIL_PF19-087 clean TBI 19 March 2020.pdf
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 02 October 2019
File name
Lamisil 250mg Tablets REG SPC PF19-087 clean IPHA.pdf
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
File name
Lamisil REG PIL_PF 18-151 clean.pdf
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
File name
Lamisil 250mg Tablets REG SPC PF18-151 clean IPHA.pdf
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
File name
Lamisil REG PIL 2208679 18-173 TBI 06 January 2019 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 18 July 2018
File name
Lamisil 250mg Tablets REG SPC July 2018 PF18-173 clean IPHA.pdf
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
File name
Lamisil250mgTabletsREGSPCPF18-043clean.docx
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 04 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 May 2017
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
Updated on 02 May 2017
File name
PIL_8512_574.pdf
Reasons for updating
- New PIL for new product
Updated on 02 May 2017
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
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
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 24 April 2014
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 12 August 2013
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 4.4 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 08 July 2013
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
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
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 6.3 has been updated to reduce the shelf life from 5 years to 3 years.
Updated on 13 February 2013
Reasons for updating
- Change of contraindications
- Change to side-effects
Updated on 12 December 2012
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
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
Reasons for updating
- Change of trade or active ingredient name
- Change to side-effects
Updated on 21 October 2010
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
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 06 November 2008
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
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
Updated on 07 September 2005
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 01 September 2005
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 07 April 2005
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to side-effects
Updated on 30 March 2005
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
Reasons for updating
- New PIL for medicines.ie
Updated on 13 August 2003
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
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
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)