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FUNGAFINE

Information leaflet

                                                               Irish Medicines Board




                                             IRISH MEDICINES BOARD ACT 1995, as amended

                           Medicinal Products (Control of Placing on the Market) Regulations, 2007, as amended




 PA0436/038/001
 Case No: 2084796

 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to

 Norton Waterford

 T/A IVAX Pharmaceuticals Ireland, Unit 301, IDA Industrial Park, Cork Road, Waterford, Ireland

 an authorisation, subject to the provisions of the said Regulations, in respect of the product

 Fungafine 250mg tablets

 the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in
 the said Regulations as listed on the reverse of this document.

 This authorisation, unless previously revoked, shall continue in force from 05/07/2010.

 Signed on behalf of the Irish Medicines Board this




 ________________

 A person authorised in that behalf by the said Board.




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Date Printed 05/07/2010                               CRN 2084796                                         page number: 1
                                                   Irish Medicines Board




                                                        Part II
                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Fungafine 250 mg Tablets

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains 250 mg terbinafine, as terbinafine hydrochloride.

 For a full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Tablet

 White, round, flat, 11 mm tablets, scored on both sides with side scores, marked “T” above and “1” below the score on
 one side.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

  1. Treatment of Terbinafine sensitive fungal infections such as Tinea corporis, Tinea cruris and Tinea pedis
     (caused by Dermatophytes see Section 5.1) is considered appropriate due to the site, severity or extent of the
     infection.

  2. The treatment of onychomycosis (terbinafine-sensitive fungal infection of the nails) caused by dermatophytes.

 N.B. Orally administered terbinafine tablets are not effective against Pityriasis versicolor.
 The official local guidelines should be borne in mind, for example, national recommendations relating to the correct
 use and prescription of antimicrobial drugs.

 4.2 Posology and method of administration

 Route of administration:

 Oral use

 The duration of treatment is dependent on the indication and the degree of severity of the infection.
 Adults:
 250mg once daily.

 Patients with impaired renal function (creatinine clearance less than 50ml/minute or serum creatinine of more than 300
 micromol/l) should receive half the normal dose.

 Skin infections
 The likely durations of treatment for Tinea pedis, Tinea corporis and Tinea cruris are 2 – 4 weeks.
 For Tinea pedis (interdigital, plantar/moccasin-type): recommended treatment periods may be up to 6 weeks.
 Complete disappearance of the symptoms of the infection may not occur until several weeks after mycological cure.




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Date Printed 05/07/2010                               CRN 2084796                                         page number: 2
                                                    Irish Medicines Board




 Onychomycosis
 In most patients the duration of successful treatment is 6-12 weeks.
 Fingernail onychomycosis: In most cases 6 weeks' treatment is sufficient in fingernail onychomycosis.
 Toenail onychomycosis: In most cases 12 weeks' treatment is sufficient in toenail onychomycosis although a few
 patients may require treatment up to 6 months. Poor nail outgrowth during the first weeks of treatment may enable
 identification of those patients in whom longer therapy is required. Complete resolution of the signs and symptoms of
 infection may not occur until several weeks after mycological cure and is only seen several months after stopping
 treatment, which is the time for growth of a healthy nail.

 Children
 A review of safety experience with oral terbinafine in children, which includes 314 patients involved in the
 UK LAMISIL® Post Marketing Surveillance study, has shown that the adverse event profile in children is
 similar to that seen in adults. No evidence of any new, unusual or more severe reactions to those seen in the
 adult population has been noted. However, as data is still limited its use is not recommended.


 Use in the elderly
 There is no evidence to suggest that elderly patients require different dosages.

 4.3 Contraindications

 Hypersensitivity to Terbinafine or to any of the excipients
 Severe renal impairment
 Severe hepatic impairment

 4.4 Special warnings and precautions for use

 Rarely, cases of cholestasis and hepatitis have been reported, these usually occur within two months of starting
 treatment. If a patient presents with signs or symptoms suggestive of liver dysfunction such as pruritis, unexplained
 persistent nausea, anorexia or tiredness, or jaundice, vomiting, fatigue, abdominal pain or dark urine, or pale stools,
 hepatic origin should be verified and Terbinafine therapy should be discontinued (see 4.8 Undesirable effects).

 Patients on terbinafine who develop a high fever or sore throat should be examined concerning possible haematological
 reactions

 Single dose pharmacokinetic studies in patients with pre-existing liver disease have shown that the clearance of
 Terbinafine can be reduced by 50% (see section 5.2). Therapeutic use of Terbinafine in patients with chronic or active
 liver disease has not been studied in prospective clinical trials, and therefore can not be recommended.

 Terbinafine should be used with caution in patients with psoriasis, as very rare cases of exacerbation of psoriasis have
 been reported.

 Terbinafine is a potent inhibitor of the isoenzyme CYP2D6, which should be considered if terbinafine is combined with
 medicinal products metabolised by this isoenzyme that are titrated individually (see section 4.5). Dose adjustments may
 be necessary.

 4.5 Interaction with other medicinal products and other forms of interaction

 The plasma clearance of terbinafine may be accelerated by drugs which induce metabolism (such as rifampicin) and
 may be inhibited by drugs which inhibit cytochrome P450 (such as cimetidine). Where co-administration of such drugs
 is required, it may be necessary to adjust the dose of Terbinafine accordingly.

 In vitro studies have shown, that terbinafine inhibits the CYP2D6-mediated metabolism. For this reason, it is important
 to monitor patients who are treated simultaneously with drugs that are mainly metabolised by this enzyme, such as




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Date Printed 05/07/2010                               CRN 2084796                                         page number: 3
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