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CATAFLAM SACHETS

Information leaflet

                                                      Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Cataflam Sachets 50 mg Powder for Oral Solution.

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 The active ingredient is potassium [o-(2,6-dichlorophenyl)-amino]-phenyl-acetate
 (diclofenac potassium)

 One sachet contains 50mg diclofenac potassium

 The sachet also contains 50 mg aspartame (E951)

 For a full list of excipients, see section 6.1

 3 PHARMACEUTICAL FORM

 Powder for oral solution.
 White to light yellow powder for oral solution.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 Short-term treatment of all grades of pain and inflammation in the following acute conditions:

       Post-traumatic pain, inflammation and swelling, e.g. due to sprains.
       Acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder).
       Post operative pain, inflammation and swelling, e.g. following dental or orthopaedic surgery.
       Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis and associated
       menorrhagia.
       Migraine attacks.
       Painful syndromes of the vertebral column.
       Non-articular rheumatism.
       As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis,
       otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy,
       as appropriate. Fever alone is not an indication.

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

 The contents of the sachet should be dissolved with stirring in a glass of natural (non-carbonated) water. The solution
 may remain slightly opalescent, but this should not influence the efficacy of the preparation. The solution should be
 swallowed preferably before meals.

 Adults
 The recommended initial dosage is 100 to 150mg. In milder cases 50 to 100mg daily are usually sufficient.

 The daily dosage should generally be divided in 2 to 3 doses.




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Date Printed 26/10/2010                               CRN 2049740                                         page number: 1
                                                     Irish Medicines Board




 In primary dysmenorrhoea, the daily dosage should be individually adjusted and is generally 50 to 150mg. Initially a
 dose of 50 to 100mg should be given and, if necessary, increased over the course of several menstrual cycles up to a
 maximum of 200 mg/day. Treatment should be started on appearance of the first symptoms and, depending on the
 symptomatology, continued for a few days.

 In migraine an initial dose of 50mg should be taken at the first signs of an impending attack. In cases where pain relief
 within 2 hours after the first dose is not sufficient, a further dose of 50mg may be taken. If needed, further doses of
 50mg may be taken at intervals of 4 to 6 hours, not exceeding a total dose of 200mg per day.

 Children and adolescents

 Cataflam 50mg powder for oral solution is not recommended for use in children and adolescents below 14 years of age.
 For treatment in children and adolescents below 14 years of age, oral drops and suppositories of diclofenac 12.5mg are
 available.

 For adolescents aged 14 years and over, 50 to 100mg daily are usually sufficient, given as 1 to 2 divided doses.

 The maximum daily dose of 150 mg should not be exceeded.

 The use of Cataflam 50mg powder for oral solution in migraine attacks has not been established in children and
 adolescents.

 4.3 Contraindications

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

 4.4 Special warnings and precautions for use

 Warnings

 Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs and may
 occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal
 events. 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). When gastrointestinal
 bleeding or ulceration occurs in patients receiving Cataflam, the medicinal product should be withdrawn.

 Serious skin reaction, 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 Cataflam (see
 section 4.8 Undesirable effects). Patients appear to be at a 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.

 Cataflam should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of
 hypersensitivity.

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

 Like other NSAIDs, Cataflam may mask the signs and symptoms of infection due to its pharmacodynamic properties.
 The use of diclofenac sodium may impair female fertility and is not recommended in women attempting to conceive. In




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Date Printed 26/10/2010                               CRN 2049740                                         page number: 2
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