Terbza 98 mg/ml cutaneous solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Terbinafine hydrochloride

Available from:

Moberg Pharma AB (publ)

ATC code:

D01AE15

INN (International Name):

Terbinafine hydrochloride

Pharmaceutical form:

Cutaneous solution

Therapeutic area:

terbinafine

Authorization status:

Not marketed

Authorization date:

2023-07-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TERBZA 98 MG/ML CUTANEOUS SOLUTION
terbinafine
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 Terbza is and what it is used for
2.
What you need to know before you use Terbza
3.
How to use Terbza
4.
Possible side effects
5.
How to store Terbza
6.
Contents of the pack and other information
1.
WHAT TERBZA IS AND WHAT IT IS USED FOR
Terbza contains the active substance terbinafine, which belongs to a
group of medicines known as
antifungals. It kills a variety of fungi that can cause nail
infections.
Terbza is used to treat mild to moderate
FUNGAL INFECTIONS
of the
FINGERNAILS AND TOENAILS
in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TERBZA
DO NOT USE TERBZA
•
if you are allergic to terbinafine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Terbza if :
•
the part of the nail next to the cuticle is affected
•
you have diabetes
•
you have a disease affecting the immune system or take any medicines
that might affect the
immune system
•
you have poor circulation, swelling or ulcers, in your legs or feet
(peripheral vascular disease)
•
you have injured, painful or severely damaged nails
•
you have psoriasis that causes red itchy skin and scaly patches or any
other chronic skin condition
•
you have yellow nails together with oedema and breathing difficulties
(yellow nail syndrome)
Terbza is for use only on nails. Avoid c

Summary of Product characteristics

Health Products Regulatory Authority
28 July 2023
CRN00CVSF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Terbza 98 mg/ml cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbinafine hydrochloride equivalent to 98 mg/ml terbinafine.
Excipients with known effect
Each milliliter of solution contains 0.7 g propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mild to moderate fungal infections of the nails caused by
dermatophytes and/or other terbinafine‑sensitive fungi. Terbza is
indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The product is intended for use on fingernails and toenails only.
Posology
Terbza should be applied to all affected nails once daily.
In general, the duration of treatment for fingernails is about 6
months while for toenails it is 9 to 12 months.
Alternative therapy including oral therapy should be considered in
cases of inadequate response at the end of the treatment
period.
_Paediatric population_
The safety and efficacy of Terbza in children and adolescents below 18
years of age have not yet been established. No data are
available.
Method of administration
Cutaneous use only (for application on the nails).
Before application of Terbza, remove any nail polish or other cosmetic
product from the nails and adjacent skin.
Apply Terbza in a thin layer once daily over the entire surface of the
affected nails and under the free nail edge of the nail using
the tip of the tube. Do not apply Terbza on the surrounding skin. Wait
about 5 minutes until the solution has completely dried.
The treated nails should not be washed or get wet for at least 8
hours. Therefore, application in the evening before going to
bed and after showering or bathing is recommended.
Terbza does not need to be removed by any solvent or abrasives (i.e.,
nail filing).
Do not apply Terbza to the nail bed if the affected nail or parts of