Synalar C ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clioquinol; Fluocinolone acetonide

Available from:

Reig Jofre UK Ltd

ATC code:

D07BC02

INN (International Name):

Clioquinol; Fluocinolone acetonide

Dosage:

30mg/1gram ; 250microgram/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5012564001787

Patient Information leaflet

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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 C 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 C ointment
Synalar C ointment
6. Contents of the pack and other
3. How to use Synalar C ointment
information
1. WHAT SYNALAR C OINTMENT IS AND WHAT IT IS USED FOR
Synalar C ointment contains two active ingredients. One is called
fluocinolone acetonide which is a
steroid and reduces inflammation. The other is called clioquinol which
is effective against bacterial and
fungal skin infections.
Synalar C ointment is used to treat certain inflammatory, itchy or
allergic skin conditions such as eczema
and dermatitis when a bacterial or fungal infection may be present.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SYNALAR C OINTMENT
Do not use Synalar C ointment:
•
If you are allergic to fluocinolone acetonide, clioquinol 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 are allergic to iodine.
•
If it is for a child under the age of one.
•
If breast-feeding, do not apply to the breasts prior to n

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Synalar C Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluocinolone Acetonide
Ph. Eur
0.025% w/w
Clioquinol
BP
3.0% w/w
3
PHARMACEUTICAL FORM
Ointment
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
‘Synalar’ C combines the effective topical corticosteroid
‘Synalar’ with the
effective antibacterial and antifungal agent clioquinol BP.
It is indicated for inflammatory dermatoses - including eczema,
dermatitis,
seborrhoea and intertrigo where secondary bacterial and/or fungal
infection is
present or likely to occur.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Topical Administration
A small quantity of the ‘Synalar’ C preparation is applied lightly
to the
affected area two or three times a day, and massaged gently and
thoroughly
into the skin. If occlusive dressing is indicated, the affected area
is first
thoroughly
cleansed,
the
‘Synalar’
C
preparation
is
then
applied
with
a
suitable dressing.
‘Synalar’ C Cream is particularly suitable for very inflamed or
weeping
surfaces and for flexures of the body, whilst ‘Synalar’ C ointment
is more
suitable for dry scaly lesions.
Treatment should not normally be for longer than a week, and it is
preferable
to identify the causative organism.
These recommendations apply too both children and adults, including
the
elderly.
4.3
CONTRAINDICATIONS
‘Synalar’ C 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’ C preparations are not advised in the treatment of
children under one
year of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long term continuous topical steroid therapy can produce local
atrophic skin changes
and dilation of the superficial blood vessels, particularly when
occlusive dressings are
used or where skin folds are involved. Prolonged use of topical
steroids or treatment
of extensive areas, even without occlusion, can result in suff