DIFENE 50 Milligram Capsules Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DICLOFENAC SODIUM

Available from:

Astellas Pharma Co. Ltd

ATC code:

M01AB05

INN (International Name):

DICLOFENAC SODIUM

Dosage:

50 Milligram

Pharmaceutical form:

Capsules Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Acetic acid derivatives and related substances

Authorization status:

Authorised

Authorization date:

2006-06-13

Patient Information leaflet

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 irritation of the gut, if you
have or have ever suffered from a
stomach ulcer or bleeding from the stomach.
•
if you have been told that you have bleeding in the brain or other
bleeding elsewhere.
•
if you have a history of gastro-i

Summary of Product characteristics

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 oc