DIFENE 100 Milligram Capsules Modified Release

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:

100 Milligram

Pharmaceutical form:

Capsules Modified Release

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Acetic acid derivatives and related substances

Authorization status:

Authorised

Authorization date:

2005-12-09

Patient Information leaflet

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 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, 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 this medicine (listed in
section 6).
• have ever had an allergic reaction (skin rash, difficulty in
breathing or 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 stomach.
• if you have been told that you have bleeding in the brain or other
bleeding elsewhere
• have had any gastrointestinal problems after taking any other
NSAID, e.g. vomiting blood or p

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difene 100 mg Dual Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac sodium 100mg
Each capsule contains diclofenac sodium 100mg in a modified release formulation (25mg in the form of enteric coated
release pellets and 75mg in the form of sustained release pellets)
For the full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Modified release capsule, hard
Size 1, hard gelatin capsules with light blue opaque caps and colourless transparent bodies, printed with “D100M” in
white, containing white to cream-coloured spherical pellets.
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. Swallowed whole with liquid, do not chew.
Adults: The daily dose is one capsule.
Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events.
Children: Use in children or adolescents is not recommended.
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 and precautions for use).
Treatment should be reviewed at regular intervals and discontinued if no benefit is seen o