Difene Spray Gel 4% w/w Cutaneous Spray, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diclofenac sodium

Available from:

Glenwood GmbH

ATC code:

M02AA; M02AA15

INN (International Name):

Diclofenac sodium

Dosage:

4 percent weight/weight

Pharmaceutical form:

Cutaneous spray, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiinflammatory preparations, non-steroids for topical use; diclofenac

Authorization status:

Marketed

Authorization date:

2003-05-02

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER DIFENE SPRAY GEL 4%W/W CUTANEOUS SPRAY, SOLUTION
Diclofenac sodium
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, please ask your doctor or
pharmacist.
·
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
:
1.
What
Difene Spray Gel
is and what it is used for
2.
What you need to know before you use Difene Spray Gel
3.
How to use Difene Spray Gel
4.
Possible side effects
5.
How to store Difene Spray Gel
6.
Content of the pack and other information
1.
WHAT DIFENE SPRAY GEL IS AND WHAT IT IS USED FOR
Difene Spray Gel
contains the active substance diclofenac sodium, which belongs to the
group of non-
steroidal anti-inflammatory drugs (NSAID). Difene Spray Gel
is used for the local symptomatic relief
of mild to moderate pain and inflammation following acute blunt trauma
of small and medium-sized
joints and surrounding structures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DIFENE SPRAY GEL
DO NOT USE DIFENE SPRAY GEL
•
If you are allergic to diclofenac sodium, peanut, soya or any of the
other ingredients of Difene
Spray Gel
(listed in section 6).
•
If you have ever had an allergic reaction to aspirin (acetylsalicylic
acid) or any other NSAID
such as ibuprofen with difficulty in breathing, skin rash and runny
nose.
•
In the last three months of pregnancy – please see section on
pregnancy and breast-feeding.
•
On open injuries, inflammations or infections of the skin as well as
on eczema or mucous
membranes.
•
In children and adolescents under 14 years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using

Summary of Product characteristics

Health Products Regulatory Authority
16 March 2023
CRN00D888
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difene Spray Gel 4% w/w Cutaneous Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1g of solution contains 40 mg of diclofenac sodium.
Excipients with known effects: 150 mg propylene glycol (E1520) / gram
solution
100 mg Soybean lecithin / gram solution
33,3 mg anhydrous ethanol / gram solution
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous spray, solution.
A golden-yellow, transparent solution, which turns to a gel-like
consistency after administration.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the local symptomatic relief of mild to moderate pain and
inflammation following acute blunt trauma of small and
medium-sized joints and periarticular structures.
Difene Spray Gel is indicated in adults and for children aged 14 years
and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Sufficient solution of Difene Spray Gel should be sprayed onto the
skin of the affected site. Depending on the size of area to be
treated 4-5 pump strokes (0.8-1.0 g of spray containing 32-40 mg of
diclofenac sodium) should be applied 3 times daily in
regular intervals. A maximum single dose of 1.0 g of the product
should not be exceeded. The maximum daily dose is 15 pump
strokes (3.0 g of spray containing 120 mg of diclofenac sodium).
Difene Spray Gel should be massaged gently into the skin. After this
the hands should be washed unless they are the site to be
treated. After application some minutes for drying should be allowed
before dressing or binding the treated area.
The treatment may be discontinued when the symptoms (pain and
swelling) have subsided. Treatment should not be
continued beyond 7-8 days without review. The patient is requested to
consult the doctor if no improvement is seen after 3
days or if symptoms worsen.
_Paediatric population_
There are insufficient data on efficacy and safety available for the
child