Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: MENARINI INTERNATIONAL O.L.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 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).
Keral tablets are 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 dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Keral tablets should not be used in patients with severe hepatic dysfunction.
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). Keral tablets should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml/min) (see section 4.3).
Keral 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.
Aclar-aluminium blister and aluminium-aluminium blister: 3 years.
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).
Keral 25 mg tablets – 4, 10, 20, 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.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
