Freederm 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 5016379262517

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 Gel is and what it is
used for
2. Before you use Freederm Gel
3. How to use Freederm Gel
4. Possible side effects
5. How to store Freederm Gel
6. Further information
1. WHAT FREEDERM GEL IS
AND WHAT IT IS USED FOR
•
Freederm 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 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 GEL
DO NOT USE Freederm Gel if you are ALLERGIC
(HYPERSENSITIVE) to nicotinamide or any of
the other ingredients of Freederm 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).
•
If you have groups of spots that are very
inflamed and painful causing lots of damage
to your skin, you may have severe acne.
Ask your doctor or pharmacist for advice
about alt

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Freederm Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotinamide 4 % w/w
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Gel.
A translucent 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.
Treatment should continue for as long as necessary. Depending on the
severity of the condition, individual courses of treatment may take
several
weeks.
If there is no improvement within 12 weeks, or if the condition
deteriorates at
any stage, patients should seek advice from a doctor or pharmacist.
For cutaneous use.
4.3.
CONTRAINDICATIONS
Contraindicated in persons who have shown hypersensitivity to any of
its
ingredients.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product is not suitable for patients with severe acne, who should
be
encouraged to seek treatment advice from a doctor or pharmacist.
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 pruri