Lamisil 250 mg Tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Terbinafine

Tillgänglig från:

PCO Manufacturing Ltd.

ATC-kod:

D01BA02

INN (International namn):

Terbinafine

Dos:

250 milligram(s)

Läkemedelsform:

Tablet

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

terbinafine

Bemyndigande status:

Authorised

Tillstånd datum:

2003-04-17

Bipacksedel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMISIL
® 250 MG TABLETS
terbinafine
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.
•
This medicine will be referred to as Lamisil in this leaflet.
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. 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 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
these problems worse.
If any of the above apply to you (or you are not su

Produktens egenskaper

Health Products Regulatory Authority
09 May 2023
CRN00DDDX
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains terbinafine hydrochloride equivalent to 250 mg
terbinafine.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the Czech Republic and Portugal _
Circular, biconvex white tablets with 'LAMISIL 250' on one side and a
breakline on the other.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
As per PA0896/015/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/015/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Magnesium stearate
Hypromellose
Microcrystalline cellulose
Sodium starch glycolate
Colloidal anhydrous silica
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 25 °C.
Keep the blisters in the outer carton in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 14 or 28 tablets contained in an outer
cardboard carton.
Not all pack sizes may be marketed.
Health Products Regulatory Authority
09 May 2023
CRN00DDDX
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/096/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17 April 2003
Date of last renewal: 17 April 2008
10 DATE OF REVISION OF THE TEXT
May 2023