Lamisil AT 1% cream

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Ladda ner Bipacksedel (PIL)
27-01-2023
Ladda ner Produktens egenskaper (SPC)
11-11-2022

Aktiva substanser:

Terbinafine hydrochloride

Tillgänglig från:

Karo Healthcare UK Ltd

ATC-kod:

D01AE15

INN (International namn):

Terbinafine hydrochloride

Dos:

10mg/1gram

Läkemedelsform:

Cutaneous cream

Administreringssätt:

Cutaneous

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 13100200; GTIN: 5051562015402 5012131700105

Bipacksedel

                                _S181 LEAFLET Lamisil 20221027 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMISIL
® 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 if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Lamisil Cream is and what it is used for
2.
Before you use Lamisil Cream
3.
How to use Lamisil Cream
4.
Possible side effects
5.
How to store Lamisil Cream
6.
Further information.
1.
WHAT LAMISIL CREAM IS AND WHAT IT IS USED FOR
Lamisil Cream is used to treat patients with fungal and certain yeast
infections of the skin. It attacks and kills the fungus or yeast which
is causing your infection.
2.
BEFORE YOU USE LAMISIL CREAM
DO NOT USE LAMISIL 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 CREAM
The cream is for external use only. Do not use on the face. Avoid
contact with eyes. In case of accidental contact with 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 Cream is not expected to affect your ability to drive or
operate machinery.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF LAMISIL
CREAM
•
This medicine contains 36 mg benzyl alcohol in each daily
dosage whic
                                
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Produktens egenskaper

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lamisil AT 1% Cream
Boots Athlete’s Foot 1%w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbinafine hydrochloride 1% w/w
Excipients with known effect
Each gram of cream contains 40mg cetyl alcohol, 40mg stearyl alcohol
and
10mg benzyl alcohol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of tinea pedis (athlete’s foot) and tinea cruris
(dhobie itch/jock
itch) caused by _Trichophyton_ (e.g. _T. rubrum, T. mentagrophytes, T.
_
_verrucosum, T. violaceum) and Epidermophyton floccosum. _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 16 years of age
Lamisil AT 1% Cream is applied once daily.
DURATION AND FREQUENCY OF TREATMENT
Duration of treatment is one week for tinea pedis and tinea cruris.
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 by a
physician.
DOSING IN SPECIAL POPULATIONS:
Paediatric population
The experience with topical Lamisil AT 1% Cream in children is still
limited and its
use in children under 16 years 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.
The affected area should be cleaned and dried thoroughly before
application of
Lamisil AT 1% Cream. The cream should be applied to the affected skin
and
surrounding area in a thin layer and rubbed in lightly. In the case of
intertriginous
infections (interdigital, intergluteal, inguinal) the application may
be covered with a
gauze strip, especially at night.
4.3
CONTRAINDICATIONS
Hypersensitivity to terbinafine or to any of the excipients contained
in the
cream, listed in section 6.1.
4
                                
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