Lamisil 1% w/w Cream

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

TERBINAFINE HYDROCHLORIDE

Dostopno od:

IMED Healthcare Ltd.

Koda artikla:

D01A; D01AE15

INN (mednarodno ime):

TERBINAFINE HYDROCHLORIDE

Farmacevtska oblika:

Cream

Terapevtsko območje:

ANTIFUNGALS FOR TOPICAL USE; terbinafine

Datum dovoljenje:

2022-07-15

Navodilo za uporabo

PATIENT INFORMATION
L
E
A
F
L
E
T
LAMISIL 1% W/W CRE
A
M
terbinafine
hyd
r
o
ch
l
or
id
e
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 machine

Lastnosti izdelka

Health Products Regulatory Authority
15 July 2022
CRN00CRPZ
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).
Excipients with known effects: Contains cetyl alcohol, stearyl alcohol
and benzyl alcohol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
_Product imported from France._
White, smooth to almost 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.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
15 July 2022
CRN00CRPZ
Page 2 of 2
This medication comes in the form of a 15g tube of cream contained in
an outer cardboard carton.
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
IMED Healthcare Ltd.,
Unit 625 Kilshane Avenue,
Northwest Business Park,
Ballycoolin,
Dublin 15,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/192/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 15
th
July 2022
10 DATE OF REVISION OF THE TEXT