Difflam 3% cream

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Benzydamine hydrochloride

Disponible depuis:

Viatris UK Healthcare Ltd

Code ATC:

M02AA05

DCI (Dénomination commune internationale):

Benzydamine hydrochloride

Dosage:

30mg/1gram

forme pharmaceutique:

Cutaneous cream

Mode d'administration:

Cutaneous

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 10030200; GTIN: 5000485000798

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE
USER
DIFFLAM-P 3% CREAM
OR
DIFFLAM 3%
CREAM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist
or
nurse have told
you.
• This medicine is available without prescription. However, you
still need to use it carefully to get
the
best
results.
• Keep this leaflet. You may need to read it
again.
• Ask your doctor or pharmacist if you need more information or
advice.
• You must contact a doctor if your symptoms worsen or do not
improve.
• 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 Difflam-P 3 % Cream or Difflam 3 % Cream is and what it is
used
for
2. What you need to know before you use Difflam-P 3 % Cream or Difflam
3 %
Cream
3. How to use Difflam-P 3 % Cream or Difflam3 %
Cream
4. Possible side
effects
5. How to store Difflam-P 3 % Cream or Difflam 3 %
Cream
6. Contents of the pack and other
information.
1. WHAT DIFFLAM-P 3 % CREAM OR DIFFLAM 3 % CREAM IS AND WHAT IT IS
USED
FOR
Difflam-P 3 % Cream or Difflam 3 % Cream contains the active substance
benzydamine
hydrochloride
and belongs to a group of medicines
called nonsteroidal
anti-inflammatory
drugs
or
NSAIDS.
Difflam-P
3
%
Cream
or
Difflam
3
%
Cream
works
by stopping
pain
and
swelling
(inflammation). When rubbed into the skin of the affected area it is
used to treat aches and
pains
including:
•
Sprains
•
Strains
•
Bruises
• Sore
muscles
• Stiff
joints.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIFFLAM-P 3 % CREAM OR DIFFLAM
3 %
CREAM
Do not use Difflam-P 3 % Cream or Difflam 3 % Cream
if
• you are allergic to benzydamine
hydrochloride.
• you are allergic to any of the other ingredients of Difflam-P 3 %
Cream or Difflam 3 % Cream
(see
section
6).
WARNINGS AND
PRECAUTIONS:
Talk to your doctor, pharmacist or nurse before using Difflam-P 3%
Cream or

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Difflam Cream
or
Difflam 3% P Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tube of Difflam 3% Cream/ Difflam-P 3% Cream contains Benzydamine
Hydrochloride 3% w/w.
EXCIPIENTS WITH KNOWN EFFECTS
Contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol
propylene glycol, benzyl alcohol, benzyl benzoate, citral,
citronellol, coumarin,
eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, limonene
and
linalool.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream for topical application to skin.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Difflam 3% Cream/ Difflam-P 3% Cream is a topical analgesic and
non-steroidal
anti-inflammatory agent.
It is recommended as a short-term treatment for the relief of symptoms
associated
with painful inflammatory conditions of the musculo-skeletal system,
including:
Acute inflammatory disorders such as myalgia and bursitis.
Traumatic conditions such as sprains, strains, contusions and the
after-effects of
fractures.
Difflam 3% Cream/ Difflam-P 3% Cream is well absorbed through the skin
and has
been shown to have anti-inflammatory and local anaesthetic actions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Difflam Cream/ Difflam 3% P Cream should be massaged lightly into the
affected area. Depending on the size of the site to be treated, 35 -
85 mm (1 -
2 g) should be applied three times daily and at the discretion of the
doctor, up
to six times daily in more severe conditions. It is recommended that
treatment
be limited to not more than ten days.
ELDERLY:
No special dosage recommendations are made for elderly patients.
4.3
CONTRAINDICATIONS
Difflam 3% Cream/ Difflam-P 3% Cream is contraindicated in patients
with known
hypersensitivity to the active substance benzydamine hydrochloride or
to any of the
excipients listed in section 6.1.
4.4 Special warnings and precautions for use
This product should not be applied to the eyes or mucosal surfaces.
Cetyl alcohol may cau