Onytec 80mg/g medicated nail lacquer

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Ciclopirox

Prieinama:

Polichem S.A.

ATC kodas:

D01AE; D01AE14

INN (Tarptautinis Pavadinimas):

Ciclopirox

Dozė:

80 milligram(s)/gram

Vaisto forma:

Medicated nail lacquer

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Other antifungals for topical use; ciclopirox

Autorizacija statusas:

Not marketed

Leidimo data:

2012-09-28

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ONYTEC 80 MG/G MEDICATED NAIL LACQUER
For adults
ciclopirox
[For medicines available only on prescription]
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 Onytec is and what it is used for
2.
What you need to know before you use Onytec
3.
How to use Onytec
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT ONYTEC IS AND WHAT IT IS USED FOR
Onytec contains the active substance ciclopirox, which belongs to a
group of medicines
known as antifungals. It kills a wide range of fungi that can cause
nail infections.
Onytec is used to treat mild to moderate fungal infections of the
nails without nail
matrix/lunula (white half-moon of the nail) involvement in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ONYTEC
•
Mild to moderate nail fungal infection affects up to 75% of the nail
surface,
involving a maximum of 5 nails in total (including toenails and/or
fingernails),
without involving nail matrix (lunula).
DO NOT USE ONYTEC:
•
if you are allergic to ciclopirox or any of the other ingredients of
this medicine
(listed in section 6)
•
in children and adolescents below 18 years of age due to insufficient
experience in
this age group
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING ONYTEC
•
In case of involvement of more than 75% of nail surface, or of
multiple nails (> 5
nails), or of nail matrix (lunula)
•
If you become sensitive to the product, please stop treatment and
consult a do

Prekės savybės

Health Products Regulatory Authority
23 November 2022
CRN00D5YF
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Onytec 80mg/g medicated nail lacquer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of medicated nail lacquercontains 80 mg of ciclopirox.
Excipient with known effect:
One gram of solution of medicated nail lacquer contains 10 mg
cetostearyl alcohol and 730 mg ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated nail lacquer. Clear, colourless to slightly yellowish
solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mild to moderate fungal infections of the nails caused by
dermatophytes, yeasts and moulds, without nail matrix/lunula
involvement.
Onytec 80 mg/g medicated nail lacquer is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Paediatric population_
The safety and efficacy of Onytec in children and adolescents below 18
years of age have not yet been established. No data are
available.
METHOD OF ADMINISTRATION:
_Cutaneous use _
For topical use on fingernails, toenails and immediately adjacent skin
(perionychium, hyponychium).
Unless otherwise directed, Onytec nail lacquer is applied in a thin
layer once a day on the affected nail/s after careful washing
and drying. The medicated nail lacquer shall be applied over the
entire nail plate, 5 mm of surrounding skin and, if possible
under the free edge of the nail. Onytec nail lacquer needs about 30
seconds for drying. The treated nails should not be washed
for at least six hours, therefore, application in the evening before
going to bed is recommended. After that time, normal
hygienic practices could be followed.
Onytec nail lacquer does not need to be removed by any solvent or
abrasives (i.e. nail filing), it is sufficient to wash the nails. In
case of unintentional removal by washing, Onytec nail lacquer can be
applied again.
Regular removal of the nail free edge and any onycholitic material by
nail clipping, is recommended.
Treatment should be