DIFENE DUAL RELEASE 75 Milligram Capsules Modified Release

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

DICLOFENAC SODIUM

Disponível em:

Astellas Pharma Co. Ltd

Código ATC:

M01AB05

DCI (Denominação Comum Internacional):

DICLOFENAC SODIUM

Dosagem:

75 Milligram

Forma farmacêutica:

Capsules Modified Release

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Acetic acid derivatives and related substances

Status de autorização:

Authorised

Data de autorização:

2005-12-09

Folheto informativo - Bula

151195
Difene DR
Cap 75
Ireland
LFT 148 x 544 mm
LFT_239
Project 40254
Eq. to: N/A
16.01.2017
Black
kj
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 stomach.
• if you have been told that you have bleeding in the brain or other
bleeding elsewhere

Características técnicas

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. The capsules should be swallowed whole with liquid.
Adults: One or two capsules (75 - 150 mg) in divided doses, daily. The daily dose should not exceed 150 mg.
Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events.
Children: Use in children and 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).
Treat