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ENANTYUM

Information leaflet

                                                    Irish Medicines Board




                                Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 ENANTYUM 25 mg film-coated tablets.

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains: Dexketoprofen trometamol 36.9 mg corresponding to dexketoprofen 25 mg.
 For a full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Film coated tablets.
 White, round, scored film-coated tablets. The tablets can be divided into equal halves.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 Symptomatic treatment of pain of mild to moderate intensity, such as musculo-skeletal pain, dysmenorrhoea, dental
 pain.

 4.2 Posology and method of administration

 Adults:
 According to the nature and severity of pain, the recommended dosage is generally 12.5 mg every 4-6 hours or 25 mg
 every 8 hours. The total daily dose should not exceed 75 mg.

 Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control
 symptoms (see section 4.4).

 ENANTYUM tablets are not intended for long term use and the treatment must be limited to the symptomatic period.

 Concomitant administration with food delays the absorption rate of the drug (see Pharmacokinetic Properties), thus in
 case of acute pain it is recommended that administration is at least 30 minutes before meals.

 Elderly:
 In elderly patients it is recommended to start the therapy at the lower end of the dosage range (50 mg total daily dose).
 The dosage may be increased to that recommended for the general population only after good general tolerance has
 been ascertained.

 Hepatic dysfunction:
 Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and
 be closely monitored. ENANTYUM tablets should not be used in patients with severe hepatic dysfunction.

 Renal dysfunction:
 The initial dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function
 (creatinine clearance 50 – 80 ml / min) (see section 4.4). ENANTYUM tablets should not be used in patients with
 moderate to severe renal dysfunction (creatinine clearance <50 ml / min) (see section 4.3).

 Children and adolescents:
 ENANTYUM tablets have not been studied in children and adolescents. Therefore, safety and efficacy have not been
 established and the product should not be used in children and adolescents.




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Date Printed 18/07/2011                               CRN 2092063                                         page number: 1
                                                    Irish Medicines Board




 4.3 Contraindications

 ENANTYUM tablets must not be administered in the following cases:
 - patients hypersensitive to dexketoprofen, to any other NSAID, or to any of the excipients of the product.
 - patients in whom substances with a similar action (e.g. acetylsalicylic acid, or other NSAIDs) precipitate attacks of
 asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema.
 - patients with active or suspected peptic ulcer/haemorrhage or history of recurrent peptic ulcer/haemorrhage (two or
 more distinct episodes of proven ulceration or bleeding) or chronic dyspepsia.
 - patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
 - patients who have gastrointestinal bleeding or other active bleedings or bleeding disorders.
 - patients with Crohn’s disease or ulcerative colitis.
 - patients with a history of bronchial asthma.
 - patients with severe heart failure.
 - patients with moderate to severe renal dysfunction (creatinine clearance <50 ml/min).
 - patients with severely impaired hepatic function (Child-Pugh score 10 - 15).
 - patients with haemorrhagic diathesis and other coagulation disorders.
 - during the third trimester of pregnancy and lactation period (see section 4.6).

 4.4 Special warnings and precautions for use

 The safe use in children and adolescents has not been established.

 Administer with caution in patients with a history of allergic conditions.

 The use of Enantyum with concomitant other NSAIDs including cyclooxygenase-2 selective inhibitors should be
 avoided.

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

 Gastrointestinal bleeding, ulceration or perforation which can be fatal, have been reported with all NSAIDs at anytime
 during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. When
 gastrointestinal bleeding or ulceration occurs in patients receiving Enantyum, the treatment should be withdrawn.
 The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a
 history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly.

 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).
 These patients should commence treatment on the lowest dose available.

 As with all NSAIDs, any history of oesophagitis, gastritis and/or peptic ulcer must be sought in order to ensure their
 total cure before starting treatment with dexketoprofen trometamol.
 Patients with gastrointestinal symptoms or history of gastrointestinal disease should be monitored for digestive
 disturbances, especially gastrointestinal bleeding.
 NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s
 disease) as their condition may be exacerbated (see section 4.8).
 Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these
 patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal
 risk (see below and section 4.5).
 Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal
 symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
 Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or
 bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-
 platelet agents such as aspirin (see section 4.5).




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Date Printed 18/07/2011                               CRN 2092063                                         page number: 2
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