Source: Medicines Authority (MT) Revision Year: 2023 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg
Symptomatic treatment of pain of mild to moderate intensity, such as musculo-skeletal pain, dysmenorrhoea, dental pain.
According to the nature and severity of pain, the recommended dosage is generally 12.5 mg (half a tablet) 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).
Dexketoprofen is not intended for long term use and the treatment must be limited to the symptomatic period.
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.
Patients with mild to moderate hepatic impairment should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Dexketoprofen should not be used in patients with severe hepatic impairment.
The initial dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (creatinine clearance 60–89 ml/min) (see section 4.4). Dexketoprofen should not be used in patients with moderate to severe renal impairment (creatinine clearance <59 ml/min) (see section 4.3).
Dexketoprofen has not been studied in children and adolescent. Therefore the safety and efficacy in children and adolescents have not been established and the product should not be used in children and adolescent.
The tablet 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 Pharmacokinetic Properties), thus in case of acute pain it is recommended that administration is at least 30 minutes before meals.
The symptomatology following overdose is not known. Similar medicinal products have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, headache) disorders.
In case of accidental or excessive intake, immediately institute symptomatic therapy according to the patient’s clinical condition. Activated charcoal should be administered if more than 5 mg/kg has been ingested by an adult or a child within an hour.
Dexketoprofen trometamol may be removed by dialysis.
PVC-aluminium blister: 2 years.
Aclar-aluminium blister and aluminium-aluminium blister: 3 years.
PVC-aluminium blister: do not store above 30ºC; keep the blister packs in the outer carton in order to protect from light.
Aclar-aluminium blister and aluminium-aluminium blister: this medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
Tablets are provided in blister packs (PVC-aluminium blister or Aclar-aluminium blister or aluminium-aluminium blister).
Keral 25 mg tablets – 4, 10 or 20 film-coated tablets/pack.
Keral 25 mg tablets – 30, 50 or 500 film-coated tablets/pack.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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