TIOCONAZOLE

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

TIOCONAZOLE

थमां उपलब्ध:

Creo Pharma Limited

ए.टी.सी कोड:

D01AC07

INN (इंटरनेशनल नाम):

TIOCONAZOLE

डोज़:

283 Mg/Ml

फार्मास्यूटिकल फॉर्म:

Medicated Nail Lacquer

प्रशासन का मार्ग:

Cutaneous use

पैकेज में यूनिट:

12 ml

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

द्वारा बनाया गया:

Doppel Farmaceutic

चिकित्सीय समूह:

: Imidazole and triazole derivatives

चिकित्सीय क्षेत्र:

tioconazole

चिकित्सीय संकेत:

Tioconazole is indicated for the topical treatment of nail infections due to susceptible fungi (dermatophytes and yeasts) and bacteria.

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2015-09-03

सूचना पत्रक

IMPORTANT
Please ensure that the TEXTS AND LAYOUT are to
your satisfaction as the studio cannot accept
liability for any errors overlooked.
COLOURS may not reproduce accurately on this
proof. You should refer to Pantone Reference
Guides for accurate colour match.
NO. OF DRAFT
DATE
REASON FOR DRAFT
_01
27/01/2015
New file
_02
22/04/2015
Add codes
_03
19/08/2015
Text revisions
_04
20/08/2015
Text revision
Process
Black
Product Title
TIOCONAZOLE
Date
27/01/2015
Strength
283 mg/ml Lacquer
Client
Creo Pharma
PIL Format
150 x 170 mm
Country
UK
Initial Code
JOB NO.
CRE-TIO-PIL-132
No of Colours
1
Typefaces
Myriad Pro
9/10 pt
_ARTWORK PREPARED BY DAVID HEATON [phone]_
[e-mail]
CRE-TIO-PIL-132_04
20/08/2015
30103374.001
Black PACKAGE LEAFLET: INFORMATION FOR THE USER
TIOCONAZOLE 283 MG/ML MEDICATED
NAIL LACQUER
Tioconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING 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 Tioconazole is and what it is used for
2. What you need to know before you use
Tioconazole
3. How to use Tioconazole
4. Possible side effects
5. How to store Tioconazole
6. Contents of the pack and other information
1. WHAT TIOCONAZOLE IS AND WHAT IT IS
USED FOR
Tioconazole is one of a group of medicines called
antifungals. The active ingredient is tioconazole.
Tioconazole is used in adults and children to treat
nail infections caused by certain fungi.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE TIOCONAZOLE
DO NOT USE TIOCONAZOLE:
•
If you are allergic to:
º
Tioconazole or any of the other
ingredients of thi

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tioconazole 283mg/ml medicated nail lacquer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of product contains 283 mg of tioconazole.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Medicated nail lacquer
Tioconazole is a clear pale yellow solution for topical application.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tioconazole is indicated for the topical treatment of nail infections
due to susceptible fungi (dermatophytes and yeasts)
and bacteria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Cutaneous use.
Posology
ADULTS: The solution should be applied to the affected nails and
immediately surrounding skin every twelve hours
using the applicator brush supplied.
The duration of treatment depends on the severity of the infection,
the infectious microorganism and the location of the
area to be treated.
Usually, the duration of treatment is up to six months, but may be
extended to twelve months.
USE IN THE ELDERLY: No special precautions are required. Use the adult
dose.
PAEDIATRIC POPULATION: No special precautions are required. Use the
adult dose.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Tioconazole is contra-indicated in individuals who have been shown to
be hypersensitive to imidazole antifungal
agents.
Use is contra-indicated during pregnancy (see section 4.6).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Tioconazole is not for ophthalmic use.
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