Synalar N ointment

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Fluocinolone acetonide; Neomycin sulfate

Mevcut itibaren:

Reig Jofre UK Ltd

ATC kodu:

D07CC02

INN (International Adı):

Fluocinolone acetonide; Neomycin sulfate

Doz:

250microgram/1gram ; 5mg/1gram

Farmasötik formu:

Cutaneous ointment

Uygulama yolu:

Cutaneous

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 13040000; GTIN: 5012564001817

Bilgilendirme broşürü

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Patient Information Leaflet
ointment
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Synalar N ointment is and what it is used for
4.
Possible side effects
2. What you need to know before you use
5.
How to store Synalar N ointment
Synalar N ointment
6.
Contents of the pack and other
3. How to use Synalar N ointment
information
1. WHAT SYNALAR N OINTMENT IS AND WHAT IT IS USED FOR
Synalar N ointment contains two active ingredients. One is called
fluocinolone acetonide which is a
steroid and reduces inflammation. The other is called neomycin sulfate
which is an antibiotic effective
against bacterial skin infections.
Synalar N ointment is used to treat certain inflammatory, itchy or
allergic skin conditions such as
eczema and dermatitis when infection may be present.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SYNALAR N OINTMENT
Do not use Synalar N ointment:
•
If you are allergic to fluocinolone acetonide, neomycin sulfate or any
of the other ingredients of this
medicine (listed in section 6).
•
Where infection is the main cause of the skin problem.
•
For acne.
•
For nappy rash.
•
If you have a skin condition called rosacea which is red rash,
sometimes with spots and pustules, on
the cheeks of the face.
•
If you have a skin condition called perioral dermatitis which is a dry
sore red rash around the mouth.
•
If you have a damaged ear drum do not put any ointment into the ears.
•
If it is for a child under the age of one.
•
If breast-feeding, do not

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Synalar N Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluocinolone Acetonide Ph. Eur
0.025% w/w
Neomycin Sulfate Ph. Eur
3250 IU/g
3
PHARMACEUTICAL FORM
Ointment
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Synalar-N combines the effective topical corticosteroid fluocinolone
acetonide with
an effective antibacterial agent neomycin sulfate.
It is indicated for inflammatory dermatoses including eczema,
dermatitis, seborrhoea
and intertrigo, where secondary bacterial infection is present or is
likely to occur.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A small quantity of Synalar N preparation is applied lightly to the
affected
area two or three times a day and massaged gently and thoroughly into
the
skin. These recommendations apply to both children and adults,
including the
elderly.
If an occlusive dressing is indicated, the affected area should first
be
thoroughly cleansed. The Synalar N preparation is then applied and
covered
with a suitable dressing.
Synalar N cream is particularly suitable for very inflamed or weeping
surfaces
and for flexures of the body, whilst Synalar N ointment is more
suitable for
dry scaly lesions.
Treatment should not normally be longer than seven days and it is
preferable
to identify the causative organism.
If used in childhood or on the face, courses should be limited to five
days and
occlusion in such cases should not be used.
4.3
CONTRAINDICATIONS
Synalar N preparations are contra indicated in primary infections of
the skin
caused by bacteria, fungi or viruses and in rosacea, acne, perioral
dermatitis,
and napkin eruptions.
Synalar preparations are not advised in the treatment of children
under one
year of age. The eyes should be avoided.
Synalar N is contraindicated in those patients with a history of
hypersensitivity
to neomycin.
Topical neomycin preparations should not be applied to the external
auditory
canal of patients with perforated eardrums.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long term