Difene 75 mg Dual Release 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:

75 milligram(s)

Pharmaceutical form:

Modified-release 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:

1994-06-16

Patient Information leaflet

Page 1 of 8
Package Leaflet – Difene 75 mg Dual Release Capsules – Glenwood
GmbH
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFENE 75 MG DUAL RELEASE CAPSULES
(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, 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 IS IT 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, acute gout and for period pain. 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).
•
have ever had an allergic reaction (difficulty in breathing, skin rash
and runny nose)
to aspirin (acetylsalicylic acid) or any other NSAID such as
ibuprofen.
•
have or have ever suffered from a stomach ulcer or bleeding from the
stom

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 75 mg Dual Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac Sodium 75mg
Each capsule contains diclofenac sodium 75mg in a modified release
formulation (25mg in the form of enteric coated release
pellets and 50mg in the form of sustained release pellets).
For a full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Modified release capsule, hard
Size 2, gelatin capsules with light blue opaque caps and colourless
transparent bodies, containing white to cream-coloured
spherical pellets. The capsules are printed “D75M” in white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a non-steroidal anti-inflammatory analgesic in the symptomatic
management of rheumatoid arthritis, osteoarthritis and
ankylosing spondylitis, acute musculo-skeletal disorders such as
periarthritis, tendinitis, tenosynovitis, bursitis, sprains, strains
and dislocations, relief of pain in fractures, low back pain, acute
gout, psoriatic arthropathy. In the management of pain and
inflammation associated with orthopaedic, dental and minor surgery.
In the management of dysmenorrhoea and associated menorrhagia.
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.
Undesir