Lamisil 1% w/w Cream

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Terbinafine hydrochloride

Commercializzato da:

PCO Manufacturing Ltd.

Codice ATC:

D01AE; D01AE15

INN (Nome Internazionale):

Terbinafine hydrochloride

Dosaggio:

1 percent weight/weight

Forma farmaceutica:

Cream

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Other antifungals for topical use; terbinafine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2005-12-02

Foglio illustrativo

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LAMISIL
® 1% W/W CREAM
terbinafine hydrochloride
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 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 INFORMATIO

Scheda tecnica

Health Products Regulatory Authority
24 January 2024
CRN00F2SC
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil 1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 10 mg terbinafine hydrochloride (1% w/w).
Excipient(s) with known effect: Contains cetyl alcohol and stearyl
alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
_Product imported from Greece and Spain:_
White, smooth, glossy cream.
4 CLINICAL PARTICULARS
As per PA0678/121/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0678/121/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium hydroxide
Benzyl alcohol
Sorbitan stearate
Cetyl palmitate
Cetyl alcohol
Stearyl alcohol
Polysorbate 60
Isopropyl myristate
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Health Products Regulatory Authority
24 January 2024
CRN00F2SC
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium or laminate tube of 15 g and 30 g cream contained in an
outer cardboard carton.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/151/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 02 December 2005
Date of last renewal: 01 December 2010
10 DATE OF REVISION OF THE TEXT
January 2024