Methylphenidate hydrochloride

Rubifen Retard®

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THERAPEUTIC INDICATION PHARMACEUTICAL FORM POSOLOGY AND FORM OF ADMINISTRATION

THERAPEUTIC INDICATION

Attention Deficit / Hyperactivity Disorder (ADHD).

Methylphenidate is indicated as part of a comprehensive treatment program for attention deficit hyperactivity disorder (ADHD) in children from 6 years of age and adults when other measures have proven insufficient by themselves.

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PHARMACEUTICAL FORM

Modified-release hard tablet.

Rubifen Retard® 10 mg modified-release hard tablet EFG: Opaque hard gelatin capsule (size 3), strong yellow cap and white body with “10” imprint in black ink. Containing white or off-white pellets.

Rubifen Retard® 20 mg: Opaque hard gelatin capsule (size 3), white cap and white body with “20” imprint in black ink. Containing white or off-white pellets.

Rubifen Retard® 30 mg: Opaque hard gelatin capsule (size 2), ivory cap and ivory body with “30” imprinted in black ink. Containing white or off-white pellets.

Rubifen Retard® 40 mg: Opaque hard gelatin capsule (size 1), strong yellow cap and strong yellow body with “40” imprint in black ink. Containing white or off-white pellets.

POSOLOGY AND FORM OF ADMINISTRATION

Treatment should be initiated and supervised by a specialist in behavioral disorders in children and/or adolescents, a child and adolescent psychiatrist, or a psychiatrist.

  • Pre-treatment screening
    Before prescribing, a baseline assessment of the patient’s cardiovascular status, including blood pressure and heart rate, is required. Concomitant medication, past and present medical and psychiatric comorbid disorders or symptoms, family history of sudden cardiac/unexplained death, and, in children, a detailed record of height and weight before treatment on a growth chart should be documented in the full story.
  • Continuous monitoring
    Growth (in children / adolescents), weight (in adults), and psychiatric and cardiovascular states should be continuously monitored.
    Patients should be monitored for the risk of methylphenidate misuse, abuse, and trafficking.
  • Dose adjustment
    Careful dose adjustment is necessary when starting treatment with methylphenidate. Dose adjustment should be started with the lowest possible dose. Adult dose adjustment can be started with 20 mg.
    Rubifen Retard’s specific formula simulates twice-daily administration of an immediate-release formulation of methylphenidate. About 50% of the total amount of the active ingredient is available in its immediate release form, while the remaining 50% is released after about 4 hours.
    The dose should be adjusted individually, depending on the needs and responses of the patient. For ADHD treatment, you must choose the timing of administration which should correspond with the periods of greatest academic, behavioral, or social stress.
    The maximum daily dose of methylphenidate is 60 mg for the treatment of ADHD in children and 80 mg for the treatment of ADHD in adults.
  • Administration form
    Rubifen Retard® modified-release hard capsules) is administered orally once daily in the morning.
    Rubifen Retard® can be administered with or without food. The capsules must be swallowed whole or they can be administered by pouring the contents of the capsule over a small amount of food (see specific instructions below).
    Rubifen Retard® capsules must not be crushed, chewed, or divided.
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