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HSA Approval

SKUDEXA FILM-COATED TABLET 75 MG/25 MG

SIN15394P

SKUDEXA FILM-COATED TABLET 75 MG/25 MG

SKUDEXA FILM-COATED TABLET 75 MG/25 MG

December 13, 2017

A. MENARINI SINGAPORE PTE. LTD.

A. MENARINI SINGAPORE PTE. LTD.

Regulatory Information

A. MENARINI SINGAPORE PTE. LTD.

A. MENARINI SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**4.2. Posology and method of administration** Posology The recommended dosage is one film-coated tablet (corresponding to 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen). Additional doses can be taken as needed, with a minimum dosing interval of 8 hours. The total daily dose should not exceed three film-coated tablets per day (corresponding to 225 mg of tramadol hydrochloride and 75 mg of dexketoprofen). SKUDEXA is intended for short term use only and the treatment must be strictly limited to the symptomatic period and in any case not more than 5 days. Switching to a single agent analgesia should be considered according to pain intensity and response of the patient. Undesirable effects may be minimised by using the lowest number of doses for the shortest duration necessary to control symptoms (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Elderly:_ In elderly patients the starting recommended dosage is one film-coated tablet; additional doses can be taken as needed with the minimum dose interval of 8 hours and not exceeding the total daily dose of 2 film-coated tablets (corresponding to 150 mg of tramadol hydrochloride and 50 mg of dexketoprofen). The dosage may be increased to a maximum of 3 daily film-coated tablets as recommended for the general population only after good general tolerance has been ascertained. Limited data are available in patients over 75 years, therefore SKUDEXA should be used with caution in these patients (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic impairment:_ Patients with mild to moderate hepatic impairment should start therapy at reduced number of doses (total daily dose 2 film-coated tablets SKUDEXA) and be closely monitored. SKUDEXA should not be used in patients with severe hepatic impairment (see section 4.3). _Renal impairment:_ The initial total daily dosage should be reduced to 2 film-coated tablets SKUDEXA in patients with mildly impaired renal function (creatinine clearance 60 – 89 ml / min) (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). SKUDEXA should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤59 ml / min) (see section 4.3). _Paediatric population:_ The safety and efficacy of SKUDEXA in children and adolescents have not been established. No data are available. Therefore SKUDEXA should not be used in children and adolescents. Method of administration Oral use. SKUDEXA should be swallowed with a sufficient amount of fluid (e.g. one glass of water). Concomitant administration with food delays the absorption rate of the drug (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), for a faster effect the tablets may be taken at least 30 minutes before meals.

ORAL

Medical Information

**4.1. Therapeutic indications** Symptomatic short term treatment of moderate to severe acute pain in adult patients whose pain is considered to require a combination of tramadol and dexketoprofen.

**4.3. Contraindications** The contraindications reported for dexketoprofen and tramadol as single agents should be taken into account. Dexketoprofen must not be administered in the following cases: - hypersensitivity to dexketoprofen, to any other NSAID, or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_; - 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; - known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates; - patients with active peptic ulcer/gastrointestinal haemorrhage or any history of gastrointestinal bleeding ulceration or perforation; - patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; - patients with chronic dyspepsia; - patients who have other active bleedings or bleeding disorders; - patients with Crohn’s disease or ulcerative colitis; - patients with severe heart failure; - patients with moderate to severe renal impairment (creatinine clearance ≤59 ml/min); - patients with severely impaired hepatic function (Child-Pugh C); - patients with haemorrhagic diathesis and other coagulation disorders; - patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake). Tramadol must not be administered in the following cases: - hypersensitivity to tramadol or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_; - in acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products; - in patients receiving MAO inhibitors, or who have taken them within the last 14 days (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); - in patients with epilepsy not adequately controlled by treatment (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); - Severe respiratory depression. SKUDEXA is contraindicated during pregnancy and lactation (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

N02AJ14

tramadol and dexketoprofen

Manufacturer Information

A. MENARINI SINGAPORE PTE. LTD.

MENARINI - VON HEYDEN GmbH

Active Ingredients

TRAMADOL HYDROCHLORIDE

75 mg

Tramadol

DEXKETOPROFEN TROMETAMOL 36.90 mg eqv. to DEXKETOPROFEN

25 mg

Dexketoprofen

Documents

Package Inserts

SKUDEXA TABLET PI.pdf

Approved: August 5, 2021

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