Lamisil 1% w/w Cream

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Terbinafine hydrochloride

Saadav alates:

Haleon Ireland Limited

ATC kood:

D01AE; D01AE15

INN (Rahvusvaheline Nimetus):

Terbinafine hydrochloride

Annus:

1 percent weight/weight

Ravimvorm:

Cream

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Other antifungals for topical use; terbinafine

Volitamisolek:

Marketed

Loa andmise kuupäev:

1993-07-12

Infovoldik

62000000203240
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your
doctor or pharmacist.
– This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
– If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Lamisil 1% Cream is and what it is used for
2. Before you use Lamisil 1% Cream
3. How to use Lamisil 1% Cream
4. Possible side effects
5. How to store Lamisil 1% Cream
6. Further information.
1. WHAT LAMISIL 1% CREAM IS AND WHAT IT IS USED FOR
Lamisil 1% Cream is used to treat Athlete’s foot
(Tinea pedis), Dhobie itch (Tinea cruris), a fungal
infection of the skin known as Pityriasis versicolour
and certain yeast infections of the skin (those
caused by the genus Candida). It attacks and kills
the fungus or yeast which is causing your infection.
2. BEFORE YOU USE LAMISIL 1% CREAM
DO NOT USE LAMISIL 1% CREAM IF YOU:
• are allergic (hypersensitive) to any of the ingredients
in the product (see Section 6)
The cream is NOT recommended for use on children.
TAKE SPECIAL CARE WITH LAMISIL 1% CREAM
The cream is for external use only. Do not use on
the face. Avoid contact with the eyes. In case of
accidental contact with the eyes, rinse thoroughly
with running water.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including those obtained without a prescription.
PREGNANCY AND BREAST-FEEDING
Do not use the cream if you are pregnant or
breastfeeding, unless advised to by your doctor.
Ask your doctor or pharmacist for advice before
taking any medicine.
DRIVING AND USING MACHINES
Lamisil 1% Cream is not expected to affect your
ability to drive or operate machinery.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF LAMISIL 1% CREAM

Toote omadused

Health Products Regulatory Authority
05 July 2023
CRN00DPJ2
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil 1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbinafine hydrochloride 1% w/w.
Excipients with known effects: Each gram of cream contains 40mg cetyl
alcohol, 40mg stearyl alcohol and 10mg benzyl alcohol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White, smooth to almost smooth, glossy cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fungal infections of the skin caused by _Trichophyton_ (e.g.
_T.rubrum, T. mentagrophytes, T. verrucosum, T. violaceum_),
_Microsporum canis_ and _Epidermophyton floccosum._
Yeast infections of the skin, principally those caused by the genus
_Candida_ (e.g. _C_._albicans_).
Pityriasis (tinea) versicolor due to _Pityrosporum orbiculare_ (also
known as _Malassezia furfur_).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
LAMISIL can be applied once or twice daily depending on the
indication.
DURATION AND FREQUENCY OF TREATMENT
The likely duration of treatments are as follows:
Tineapedis: Once a day for 1 week
Tineacorporis, cruris: Once a day for 1 week
Cutaneous candidiasis: Once or twice a day for 1 to 2 weeks
Pityriasisversicolor: Once or twice a day for 2 weeks
Relief of clinical symptoms usually occurs within a few days.
Irregular use or premature discontinuation of treatment carries
the risk of recurrence. If there are no signs of improvement after two
weeks the diagnosis should be verified.
DOSING IN SPECIAL POPULATIONS:
Children
The experience with topical LAMISIL in children is still limited and
its use cannot therefore be recommended.
Elderly patients
There is no evidence to suggest that elderly patients require
different dosages or experience side effects different to those of
younger patients.
METHOD OF ADMINISTRATION
For cutaneous use.
Cleanse and dry the affected areas thoroughly before application of
LAMISIL. Apply the cream to the affected skin and
surrounding area in a thin layer