DIFENE 1 %w/w Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DICLOFENAC SODIUM

Available from:

Astellas Pharma Co. Ltd

ATC code:

M02AA15

INN (International Name):

DICLOFENAC SODIUM

Dosage:

1 %w/w

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiinflammatory preparations, non-steroids for topical use

Authorization status:

Authorised

Authorization date:

2006-06-13

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START USING THIS MEDICINE.
• Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your doctor 
or pharmacist.
•  This medicine has been prescribed for you. Do 
not pass it on to others. It may harm them, even if 
their symptoms are the same as yours.
•  If any of the side effects get serious, or if you 
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.  What DIFENE 1% w/w GEL is and what it is 
used for
2.  What you need to know before you use 
DIFENE 1% w/w GEL
3. How to use DIFENE 1% w/w GEL
4. Possible side effects
5. How to store DIFENE 1% w/w GEL
6. Contents of the pack and other information
  1.  WHAT DIFENE 1% W/W GEL IS AND WHAT IT IS 
USED FOR
DIFENE 1% w/w GEL contains the active 
substance diclofenac sodium, which belongs to 
the group of non-steroidal anti-inflammatory drugs 
(NSAIDs).
DIFENE 1% w/w GEL is used to relieve the acute 
pain and swelling affecting small or medium-sized 
joints and surrounding tissues due to sprains, 
strains and bruising.
It can also be used for the treatment of soft tissue 
rheumatism.
  2.  WHAT YOU NEED TO KNOW BEFORE YOU USE 

DIFENE 1% W/W GEL
DO NOT USE DIFENE 1% W/W GEL
•  If you are allergic (hypersensitive) to diclofenac 
sodium or any other ingredient of DIFENE 1% 
w/w GEL. Please refer to section 6 of this leaflet 
for the ingredients of Difene.
•  If you have ever had an allergic reaction (skin 
rash, difficulty in breathing or runny nose) to 
aspirin (acetylsalicylic acid) or any other NSAIDs 
such as ibuprofen.
•  In the last three months of pregnancy - please 
see section on ‘Pregnancy and breastfeeding’.
• If you have a stomach ulcer.
•  If you have ever had an allergic reaction to 
propylene glycol or isopropyl alcohol.
•  Use in children and adolescents is not 
recommended.
If any of these apply to you, tell you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difene 1% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac sodium 1 %w/w
Excipients with known effect: propylene glycol (250mg/g of gel)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gel.
A slightly turbid, colourless gel with the odour of isopropyl alcohol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For local symptomatic relief of pain and inflammation in
1.
Trauma of the tendons, ligaments, muscles and joints e.g. due to sprains, strains and bruises.
2.
Localised forms of soft tissue rheumatism.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical administration.
Adults: Diclofenac Gel should be rubbed gently into the skin. Depending on the size of the site to be treated, 2 to 4 g (a
circular shaped mass approximately 2 to 2.5 cm in diameter) should be applied 2 to 4 times daily. After the application
the hands should be washed unless they are the site being treated.
It is recommended that the treatment be reviewed after 14 days. These indications should not warrant treatment for
more than 6 weeks.
Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The
lowest dose compatible with adequate safe clinical control should be employed.
Children and adolescents below 14 years: Not recommend. There are insufficient data on efficacy and safety available
for children and adolescents below 14 years of age (see also contraindications section 4.3).
4.3 CONTRAINDICATIONS
Hypersensitivity to diclofenac or any of the excipients.
Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or ether non-
steroidal anti-inf1ammatory drugs (NSAIDs).
Third trimester of pregnancy