Niddafin 1% creme, creme 10 mg/g

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

TERBINAFINEHYDROCHLORIDE 10 mg/g

Beschikbaar vanaf:

Teva Pharma B.V. Swensweg 5 2031 GA HAARLEM

ATC-code:

D01AE15

INN (Algemene Internationale Benaming):

TERBINAFINEHYDROCHLORIDE 10 mg/g

farmaceutische vorm:

Crème

Samenstelling:

BENZYLALCOHOL (E 1519) ; CETOSTEARYLALCOHOL ; CETYLALCOHOL ; CETYLPALMITAAT ; ISOPROPYLMYRISTAAT ; NATRIUMHYDROXIDE (E 524) ; POLYSORBAAT 60 (E 435) ; SORBITANMONOSTEARAAT (E 491) ; WATER, GEZUIVERD,

Toedieningsweg:

Cutaan gebruik

Therapeutisch gebied:

Terbinafine

Product samenvatting:

Hulpstoffen: BENZYLALCOHOL (E 1519); CETOSTEARYLALCOHOL; CETYLALCOHOL; CETYLPALMITAAT; ISOPROPYLMYRISTAAT; NATRIUMHYDROXIDE (E 524); POLYSORBAAT 60 (E 435); SORBITANMONOSTEARAAT (E 491); WATER, GEZUIVERD;

Autorisatie datum:

2005-12-13

Bijsluiter

Terbinafine, tablets, Niddafin NL/H/0747/001, Binanidda NL/H/0748/001
Excipients guideline, QRD, 04.05.20
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIDDAFIN 1% CREME, CREME 10 MG/G
terbinafine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 1 to 2 weeks.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you use [Nationally completed name]
3.
How to use [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
- [Nationally completed name] belongs to the group of antifungal
preparations. [Nationally completed
name] is used to treat patients with fungal and yeast infections of
the skin.
- [Nationally completed name] is active against certain yeasts and
skin fungi, of which athlete’s foot is the
most well-known. See also section 3 for more information about the
other fungal infections.
You must talk to your doctor, if you do not feel better or if you feel
worse after 1 to 2 weeks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE [NATIONALLY COMPLETED NAME]
DO NOT USE [NATIONALLY COMPLETED NAME]
-
if you are allergic to terbinafine or any of the other ingredients of
this medicine (listed in section 6).
You can recognise hypersensitivity for example by red spots and lumps
on the skin or itching.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using [Nationally c

Productkenmerken

Terbinafine 250 mg, tablets, NL/H/0747+0748/001
Excipients guideline, 04.05.20
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Niddafin 1% crème, crème 10 mg/g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 10 mg of terbinafine hydrochloride.
Excipients with known effect
80 mg Cetyl alcohol and Cetostearyl alcohol/gram cream.
10 mg benzyl alcohol/gram cream.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White or almost white cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fungal infections of the skin, caused by dermatophytes, such as
Trichophyton (e.g. T. Rubrum, T.
Mentagrophytes, T. Verrucosum, T. Violaceum), Microsporum canis and
Epidermophyton floccosum.
Yeast infections of the skin, principally those caused by the genus
Candida (e.g. Candida albicans).
Pityriasis (tinea) versicolor, caused by Pityrosporum orbiculare
(Malassezia furfur).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and adolescents (>12 years of age) _
Duration and frequency of the treatment
Tinea pedis:
once daily for one week.
Tinea cruris and tinea corporis: once daily for one week
Cutaneous candidiasis:
once daily for 1 to 2 weeks
Pityriasis versicolor:
once or twice daily for 2 weeks
[Nationally completed name] 10 mg/g cream can be applied once or twice
daily. The skin should be dry and
clean. The cream should be applied to the affected
_ _
skin and surrounding area in a thin layer and then rubbed in
gently. If the event of intertriginous infection
_ _
(submammary, interdigital, intergluteal or inguinal) the skin
may be covered with a sterile gauze following application of the
cream, especially at night.
Relief of symptoms usually occurs within a few days.
Terbinafine 250 mg, tablets, NL/H/0747+0748/001
Excipients guideline, 04.05.20
2
Irregular use or premature discontinuation increases the risk of
recurrence of the symptoms. If no
improvement is seen after two weeks, the diagnosis should be
reconsidered.
_Elderly _
There are no indications t