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 lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Adults:** According to the nature and severity of pain, the recommended dosage is generally 12.5mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg. KETESSE tablets are not intended for long term use and the treatment must be limited to the symptomatic period. **Elderly:** 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. **Hepatic impairment:** Patients with mild to moderate hepatic impairment should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. KETESSE tablets should not be used in patients with severe hepatic impairment. **Renal 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). KETESSE tablets should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤59 ml / min) (see section 4.3). **Paediatric population:** KETESSE tablets 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. **Method of administration:** 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), thus in case of acute pain it is recommended that administration is at least 30 minutes before meals.
ORAL
Medical Information
**4.1. Therapeutic indications** Symptomatic treatment of pain of mild to moderate intensity, such as musculo-skeletal pain, dysmenorrhoea, dental pain.
**4.3. Contraindications** KETESSE tablets must not be administered in the following cases: - patients hypersensitive to the active substance, 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 history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. - patients with active peptic ulcer/gastrointestinal haemorrhage or any history of gastrointestinal bleeding, ulceration or perforation. - 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 score 10 – 15). - patients with haemorrhagic diathesis and other coagulation disorders. - patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - during the third trimester of pregnancy and lactation period (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
M01AE17
dexketoprofen
Manufacturer Information
A. MENARINI SINGAPORE PTE. LTD.
LABORATORIOS MENARINI SA
A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L
Active Ingredients
Documents
Package Inserts
Ketesse Tablet PI.pdf
Approved: August 25, 2021