Difene 50mg Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diclofenac sodium

Available from:

Glenwood GmbH

ATC code:

M01AB; M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

50 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Acetic acid derivatives and related substances; diclofenac

Authorization status:

Marketed

Authorization date:

1990-08-28

Patient Information leaflet

Page 1 of 8
Package Leaflet – Difene 25 mg Capsules / Difene 50 mg Capsules –
Glenwood GmbH
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFENE® 25 MG CAPSULES
DIFENE® 50 MG CAPSULES
(diclofenac sodium)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, 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 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 is and what it is used for
2. What you need to know before you take Difene
3. How to take Difene
4. Possible side effects
5. How to store Difene
6. Contents of the pack and other information
_ _
1._ _WHAT DIFENE IS AND WHAT IT IS USED FOR
_ _
Difene contains diclofenac sodium as the active ingredient which is a
non-steroidal anti-inflammatory
drug (NSAID). This means that it is a “painkilling” medicine which
reduces
inflammation and swelling, but it does not contain any steroid
medicine.
Difene is used to relieve pain and inflammation.
It is used to relieve painful conditions associated with your bones
and joints and to reduce swelling
and inflammation (e.g. arthritis) and for sprains, strains and
bruising of tendons and ligaments, and
in acute gout. It can also be used to reduce pain or inflammation
after surgery.
_ _
2._ _WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIFENE
_ _
DO NOT TAKE DIFENE:
•
if you are allergic (hypersensitive) to diclofenac or to any of the
other ingredients of Difene
listed in section 6.
•
if you have ever had an allergic reaction (skin reaction, difficulty
in breathing or runny nose)
to aspirin (acetylsalicylic acid) or any other NSAID such as
ibuprofen.
•
if you suffer from an upset stomach or irritatio

Summary of Product characteristics

Health Products Regulatory Authority
23 December 2022
CRN00D677
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difene 50mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac Sodium 50mg
Each capsule contains 50mg of diclofenac sodium
Excipients with known effect: sucrose (67.68mg/capsule)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant hard capsule.
Size 2 hard gelatin capsules with dark blue opaque caps and colourless
transparent bodies, printed with “D50” in white on both
cap and body and containing white to cream coloured pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Difene can be used in the symptomatic management of rheumatoid
arthritis including juvenile chronic arthritis, osteoarthritis,
ankylosing spondylitis, psoriatic arthropathy, low back pain and acute
musculoskeletal disorders including peri-arthritis,
tendinitis, tenosynovitis, bursitis, sprains, strains, dislocations
and in acute gout.
It can also be of use in the management of post operative pain and
inflammation in orthopaedic, dental and other minor
surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only. Swallow whole, do not chew.
Adults: The usual daily dose is 100 mg in divided doses. This may be
increased to 150 mg daily.
Children aged 9 years (min. 35 kg body weight) or over and adolescents
should be given up to 2 mg/kg body weight per day in
3 divided doses, depending on the severity of the disorder.
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. See also Section 4.4, Special warnings and
precautions for use.
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4, special warnings