Lamisil 250mg Tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

TERBINAFINE HYDROCHLORIDE

متاح من:

Imbat Limited

ATC رمز:

D01BA; D01BA02

INN (الاسم الدولي):

TERBINAFINE HYDROCHLORIDE

جرعة:

250 milligram(s)

الشكل الصيدلاني:

Tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Antifungals for systemic use; terbinafine

الوضع إذن:

Authorised

تاريخ الترخيص:

2007-06-08

نشرة المعلومات

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMISIL
® 250MG TABLETS
Terbinafine
Your medicine is available using the above name but will be
referred to as Lamisil throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE – BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

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 only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lamisil is and what it is used for
2.
What you need to know before you take Lamisil
3.
How to take Lamisil
4.
Possible side effects
5.
How to store Lamisil
6.
Contents of the pack and other information
1.
WHAT LAMISIL IS AND WHAT IT IS USED FOR
Lamisil contains a medicine called terbinafine hydrochloride.
It is an “anti-fungal” medicine.
Lamisil is used in adults and older people to treat a number of
fungal infections of the skin and nails. It kills the fungus or
stops it growing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LAMISIL
DO NOT TAKE LAMISIL IF:

you are allergic to terbinafine hydrochloride or any of
the other ingredients of this medicine (listed in section
6).

you have or had any liver problems

you are breast-feeding

you are pregnant or trying to become pregnant.
Do not take Lamisil if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking
Lamisil.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lamisil if:

you have ever had liver or kidney problems

you have or experienced thickened patches of red/silver
skin (psoriasis) or facial rash, joint pain, muscle
disorder, fever
(cutaneous and systemic lupus
erythematosus). Lamisil can make t

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil 250mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains terbinafine hydrochloride equivalent to 250mg
terbinafine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Greece & Spain:_
Round, white tablet that is scored on one side and printed ‘LAMISIL
250’ on the reverse.
4 CLINICAL PARTICULARS
As per PA0013/045/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0013/045/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Magnesium stearate
Hypromellose
Microcrystalline cellulose
Sodium starch glycolate
Silica colloidal anhydrous
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be 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
_Product imported from Spain:_
Do not store above 30°C.
Keep blisters in the outer carton to protect from light.
_Product imported from Greece:_
Do not store above 25ºC.
Keep blisters in the outer carton to protect from light.
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6.5 NATURE AND CONTENTS OF CONTAINER
Calendar blister packs in a cardboard carton, containing 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICIN