Terbinafine 250mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Terbinafine hydrochloride

Dostępny od:

Niche Generics Ltd

Kod ATC:

D01BA02

INN (International Nazwa):

Terbinafine hydrochloride

Dawkowanie:

250mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 05020500

Ulotka dla pacjenta

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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

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terbinafine 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg terbinafine, as terbinafine hydrochloride
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round white to off-white flat bevelled edge tablet with a score line
and R250 on
reverse.
Diameter approx. 11 mm
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fungal infections of the skin and nails caused by _ Trichophyton_
(e.g. _ T. rubrum_, _ T. _
_mentagrophytes_,
_T. _
_verrucosum_,
_T. _
_violaceum_),
_Microsporum _
_canis_
and
_Epidermophyton floccosum_.
1.
Terbinafine 250 mg Tablets are indicated in the treatment of ringworm
(tinea
corporis, tinea cruris and tinea pedis) where oral therapy is
considered appropriate
due to the site, severity or extent of the infection.
2. Terbinafine 250 mg Tablets are indicated in the treatment of
onychomycosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
250mg once daily.
The duration of treatment varies according to the indication and the
severity of the
infection.
_Skin Infections _
Likely durations of treatment as follows:
Tinea pedis (interdigital, plantar/moccasin type)
2 to 6 weeks
Tinea corporis
4 weeks
Tinea cruris
2 to 4 weeks
_Onychomycosis _
The duration of treatment for most patients is between 6 weeks and 3
months.
Treatment periods of less than 3 months can be anticipated in patients
with fingernail
infection, toenail infection, other than the big toe or patients of
younger age. In the
treatment of toenail infections, 3 months is usually sufficient
although a few patients
may require treatment of 6 months or longer.
Poor nail outgrowth during the first weeks of treatment may enable
identification of
those patients where longer therapy is required.
Complete resolution of signs and symptoms of infection may not occur
until several
weeks after mycologica