Description
Indications:
Symptomatic treatment of painful conditions of mild to moderate intensity, such as musculoskeletal pain, dysmenorrhea, dental pain.
How to use:
Adults:
Based on the nature and intensity of the pain, the recommended dose 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 can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). Enantyum tablets are not indicated for long-term treatments and administration should be limited to the symptomatic period only.
Elderly people:
In the elderly patient it is recommended to start therapy at the lower limit of the dosage range (50 mg total daily dose). The dosage can be increased to match that used for the general population only after good general tolerability has been established.
Liver failure:
Patients with mild to moderate hepatic impairment should start therapy at reduced doses (50 mg total daily dose) and undergo close medical supervision. Enantyum tablets must not be used in patients with severe hepatic impairment.
Kidney failure:
In patients with mild renal impairment (creatinine clearance 60 – 89 ml / min), the starting dosage should be reduced to 50 mg total daily dose (see section 4.4). Enantyum tablets must not be used in patients with moderate to severe renal impairment (creatinine clearance ≤ 59 ml / min) (see section 4.3).
Pediatric population:
Enantyum tablets have not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the product should not be used in children and adolescents.
Method of administration The tablet should be swallowed with a sufficient amount of liquid (eg a glass of water). Concomitant administration of food delays the rate of drug absorption (see section “Pharmacokinetic Properties”), therefore in case of acute pain it is recommended that administration take place at least 30 minutes before meals.
Active principle:
Dexketoprofen 25 mg
Excipients:
Tablet core: corn starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate,
Film coating: dry lacquer composed of: hypromellose, titanium dioxide, macrogol 6000, propylene glycol
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