Terbinafine 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Terbinafine hydrochloride

Available from:

Genus Pharmaceuticals Ltd

ATC code:

D01BA02

INN (International Name):

Terbinafine hydrochloride

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020500

Patient Information leaflet

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Production Site:
Wehr
WO:
1673018
ACC:
Morath, Kerstin
Comp. Description:
LFT LAMISIL TAB 250MG GB
Printing Colours:
Black
Comp. No. New:
1673018_ GB_WEH
Comp. No. Old:
N/A
Format/Dimension:
190 x 297 mm
Tech. Drawing No.:
0000000
Technical Colours:
Cutting
Min. Font Size Text:
9 pt
Font Type:
News Gothic
Proof No.:
1
Date: 04 Jan 2018
J.N.: 330375
Braille:
N/A
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Telephone [phone]
[e-mail]
www.perigord-as.com
Unit 1, Lyncon Court
IDA Business & Technology Park
Snugborough Rd
Blanchardstown
Dublin 15
1673018 GB WEH
LAMISIL
® TABLETS 250 MG
(TERBINAFINE)
Patient Information Leaflet
WHAT YOU NEED TO KNOW ABOUT LAMISIL TABLETS
Your doctor has decided that you need this
medicine to help treat your condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START TO TAKE YOUR MEDICINE. IT CONTAINS
IMPORTANT INFORMATION. Keep the leaflet in a
safe place because you may want to read it
again.
If you have any other questions, or if there
is something you don’t understand,
please ask your doctor or pharmacist.
This medicine has been prescribed for you.
Never give it to someone else. It may not be
the right medicine for them even if their
symptoms seem to be the same as yours.
If any side effects get 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 Tablets are, and what they
are used for
2. Things to consider before you start to
take Lamisil Tablets
3. How to take Lamisil Tablets
4. Possible side effects
5. How to store Lamisil Tablets
6. Further information
1. WHAT LAMISIL TABLETS ARE AND WHAT
THEY ARE USED FOR
Terbinafine, the active ingredient in Lamisil
Tablets, is an antifungal medicine.
Lamisil Tablets are used to treat a number
of fungal infections of the skin and nails.
2. THINGS TO CONSIDER BEFORE YOU START
TO TAKE LAMISIL TABLETS
SOME PEOPLE MUST NOT TAKE LAMISIL
TABLETS. TALK TO YOUR DOCTOR IF:
• you think you may be

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terbinafine 250 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg terbinafine (as 281.250 mg terbinafine
hydrochloride).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, round, uncoated, biconvex bevelled edge tablets
with breakline
and ‘D’ debossed on one side and ‘74’ on the other side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of fungal infections of the skin caused by terbinafine
sensitive
dermatophytes in cases of _tinea corporis_, _tinea cruris_ and _tinea
pedis_, when oral
therapy is considered appropriate due to the site, severity or extent
of the infection.
Treatment of onychomycosis caused by terbinafine sensitive
dermatophytes.
Consideration should be given to official guidance concerning the
appropriate use and
prescription of antifungals.
In contrast to topical terbinafine, oral terbinafine is not effective
in Pityriasis
versicolor
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_ _
_ADULTS:_
250 mg once daily however, the duration of treatment will vary
according to the
indication and the severity of the infection.
_SKIN INFECTIONS: _
Duration of the treatment
The likely durations of treatments are as follows:
_Tinea pedis_ (interdigital, plantar/moccasin type): 2 to 6 weeks
_Tinea corporis_: 2 to 4 weeks
_Tinea cruris_: 2 to 4 weeks
Complete resolution of the signs and symptoms of infection may not
occur until
several weeks after mycological cure.
ONYCHOMYCOSIS
The duration of treatment is usually between 6 weeks and 3 months.
Treatment of 6
weeks for onychomycosis of the finger nails is generally sufficient.
Regarding
onychomycosis of the toe nails, a 12 week treatment is usually
sufficient, although a
few patients with poor nail outgrow may require a longer treatment
duration (6
months or longer).
Complete resolution of the signs and symptoms of infection may not
occur unt