Difflam 3% cream

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Benzydamine hydrochloride

Διαθέσιμο από:

Mawdsley-Brooks & Company Ltd

Φαρμακολογική κατηγορία (ATC):

M02AA05

INN (Διεθνής Όνομα):

Benzydamine hydrochloride

Δοσολογία:

30mg/1gram

Φαρμακοτεχνική μορφή:

Cutaneous cream

Οδός χορήγησης:

Cutaneous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 10030200

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

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.
Contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl
alcohol and propylene glycol
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
To avoid possible irritation, Difflam 3% Cream/ Difflam-P 3% Cream
should
be kept away from eyes and mucosal surfaces.
Cetyl alcohol may cause local skin reactions (e.g. dermatitis).
Propylene
glycol may cause skin irritation.
Benzydamine use is not advisable in p