Synalar C cream

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Clioquinol; Fluocinolone acetonide

Saadav alates:

Reig Jofre UK Ltd

ATC kood:

D07BC02

INN (Rahvusvaheline Nimetus):

Clioquinol; Fluocinolone acetonide

Annus:

30mg/1gram ; 250microgram/1gram

Ravimvorm:

Cutaneous cream

Manustamisviis:

Cutaneous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 13040000; GTIN: 5012564001879

Infovoldik

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Patient Information Leaflet
cream
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 cream 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 cream
Synalar N cream
6. Contents of the pack and other information
3. How to use Synalar N cream
1. WHAT SYNALAR N CREAM IS AND WHAT IT IS USED FOR
Synalar N cream 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 cream 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 CREAM
Do not use Synalar N cream:
•
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 cream into the ears.
•
If it is for a child under the age of one.
•
If breast-feeding, do not apply to the breasts prior to nu

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
‘Synalar’ N Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluocinolone Acetonide Ph. Eur
0.025% w/w
Neomycin Sulfate Ph. Eur
3250 IU/g
3
PHARMACEUTICAL FORM
Cream
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
Adults (including the elderly) and Children
A small quantity of the 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.
Treatment should not normally be for longer than seven days, and it is
preferable to identify’ the causative organism.
It is recommended that treatment on the face and for children should
not
normally be extended beyond five days and occlusion should not be
used.
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.
4.3
CONTRAINDICATIONS
Synalar N is contra-indicated in primary infections of the skin caused
by
bacteria, fungi or viruses and in rosacea, acne, perioral dermatitis
and napkin
eruption.
Synalar preparations are not advised in the treatment of children
under one
year of age.
Synalar N is contra-indicated in those patients with a history of
hypersensitivity to neomycin.
Topical neomycin preparation should not be applied to the external
auditory
canal of patients with perforated eardrums.
The eyes should be avoided.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term cont