Freederm Treatment 4% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nicotinamide

Available from:

Diomed Developments Ltd

INN (International Name):

Nicotinamide

Dosage:

40mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100; GTIN: 5016379262005

Patient Information leaflet

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS PRODUCT.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
IN THIS LEAFLET:
1. What Freederm Treatment Gel is and
what it is used for
2. Before you use Freederm Treatment Gel
3. How to use Freederm Treatment Gel
4. Possible side effects
5. How to store Freederm Treatment Gel
6. Further information
1. WHAT FREEDERM TREATMENT GEL
IS AND WHAT IT IS USED FOR
•
Freederm Treatment Gel is a skin treatment
for inflamed pimples and spots.
•
The medical term for this condition is mild
to moderate inflammatory acne vulgaris.
It involves inflamed pimples (papules)
and spots containing pus (pustules),
often with skin redness (erythema) and
some tenderness. The condition occurs
mainly on the face, back and chest.
•
Freederm Treatment Gel is suitable for
use by ADULTS, CHILDREN AND THE ELDERLY.
•
The ACTIVE INGREDIENT in this product
is nicotinamide. This ingredient treats
pimples and spots by its anti-inflammatory
activity, which reduces swelling, redness
and tenderness.
•
Nicotinamide is not an antibiotic, it is
related to an essential vitamin in our diet
(Vitamin B
3
).
2. BEFORE YOU USE FREEDERM
TREATMENT GEL
DO NOT USE Freederm Treatment Gel if you
are ALLERGIC (HYPERSENSITIVE) to nicotinamide
or any of the other ingredients of Freederm
Treatment Gel listed in Section 6.
TAKE CARE when using this product:
•
Only apply it to your skin.
•
When using it on your face, keep it away from
your eyes, and avoid getting it inside your
nostrils, on your lips or inside your mouth.
•
Depending on how sensitive your skin tends
to be, it may be a good idea initially to test
the gel on a small area, and wait 24 hours
before using it on larger areas. This is
especially advisable if you have unusually
sensitive skin or if you are treating the
face (as generally applies when using any
new treatment for the first time).
USING OTHER MEDICINES
Freederm Treatment Gel is not known to
affect, or to be af

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Freederm Treatment 4% w/w Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotinamide 4% w/w
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Topical gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the topical treatment of mild to moderate inflammatory acne
vulgaris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply to the affected area twice daily after the skin has been
thoroughly
washed with warm water and soap. Enough gel should be used to cover
the
affected area.
No difference in dose or dose schedule is recommended for adults,
children or
the elderly.
For topical administration only.
4.3
CONTRAINDICATIONS
Contraindicated in persons who have shown hypersensitivity to any of
its
components.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only and to be kept away from the eyes and mucous
membranes, including those of the nose and mouth. If excessive
dryness,
irritation or peeling occurs reduce the dosage to one application per
day or
every other day.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
PREGNANCY AND LACTATION
Vitamin B derivative requirements such as nicotinamide, are increased
during
pregnancy and infancy. Nicotinamide is excreted in breast milk. As
with all
medicines, care should be exercised during the first trimester of
pregnancy.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8
UNDESIRABLE EFFECTS
The most frequently encountered adverse effect reported is dryness of
the skin. Other
less frequent adverse effects include pruritus, erythema, burning
sensation and
irritation.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.