Posology: Adults: 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 Precautions).
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 Precautions).
Hepatic impairment: Patients with mild to moderate hepatic dysfunction 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 dysfunction (see Contraindications).
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 Precautions).
Skudexa should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml/min) (see Contraindications).
Paediatric population: The safety and efficacy of Skudexa has not been studied in paediatric population. 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 Pharmacology: Pharmacokinetics under Actions), for a faster effect the tablets may be taken at least 30 minutes before meals.