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DICLAC

Information leaflet

                                                     Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Diclac 50 mg Gastro-resistant Tablets.

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains Diclofenac Sodium 50 mg.

 Excipients: Each tablet contains lactose monohydrate 30mg.

 For a full list of excipients, see Section 6.1.

 3 PHARMACEUTICAL FORM

 Gastro-resistant tablets.
 Yellow-brown, round film-coated gastro-resistant tablets.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 Adults: DICLAC Tablets are indicated in the management of:

     o rheumatoid arthritis including juvenile chronic arthritis, osteoarthrosis, ankylosing spondylitis, psoriatic
        arthropathy, low back pain
     o acute musculoskeletal disorders including periarthritis tendinitis, tenosynovitis, bursitis, sprains, strains
        dislocations
     o acute gout
     o post operative pain and inflammation in orthopaedic, dental and other minor surgery
     o dysmenorrhoea or adnexitis and associated menorrhagia


 4.2 Posology and method of administration

 As a general recommendation, the dose should be individually adjusted and the lowest effective dose given for the
 shortest possible duration.


 Route of Administration:

 DICLAC Tablets are for oral use and should be taken whole with liquid at mealtimes.

 Recommended Dosage Schedule:

 DICLAC 50 mg: The usual total daily dose is 100 mg in divided doses. This may be increased to 150 mg daily.

 The recommended maximum daily dose of DICLAC is 150 mg.

 Children and adolescents: not recommended.

 Elderly: Although the pharmacokinetics of DICLAC are not impaired to any clinically relevant extent in elderly
 patients, non-steroidal anti-inflammatory drugs should be used with particular caution in such patients who generally




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Date Printed 20/03/2012                               CRN 2113372                                         page number: 1
                                                     Irish Medicines Board




 are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail
 elderly patients or those with a low body weight (see also precautions).

 Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or if intolerance occurs.

 4.3 Contraindications

 o Known hypersensitivity to the active substance or to any of the excipients
 o History of gastrointestinal bleeding or perforation related to previous NSAIDs therapy
 o Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or
    bleeding)
 o Last trimester of pregnancy (see section 4.6 Pregnancy and Lactation)
 o Severe hepatic, renal or heart failure (see section 4.4 Special warnings and special precautions for use)
 o Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contra-indicated in patients in whom
    attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid/aspirin or other NSAID’s.

 4.4 Special warnings and precautions for use

 Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control
 symptoms (see section 4.2 and GI and cardiovascular risks below).

 Warnings

 Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs including
 diclofenac and may occur at any time during treatment, with or without warning symptoms or a previous history of
 serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal
 bleeding or ulceration occurs in patients receiving diclofenac, the medicinal product should be withdrawn.

 Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic
 epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see
 section 4.8 Undesirable effects).
 Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring
 in the majority of cases within the first month of treatment. Diclac should be discontinued at the first appearance of
 skin rash, mucosal lesions or any other sign of hypersensitivity.

 Allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in rare cases with NSAIDs including
 diclofenac without earlier exposure to the drug.

 Like other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.

 Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding
 and perforation which may be fatal (see section 4.2, Posology and method of administration).

 The use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women
 who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be
 considered.

 Precautions

 General

 The concomitant use of Diclac with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be
 avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable
 effects.




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Date Printed 20/03/2012                               CRN 2113372                                         page number: 2
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