Atomoxetine hydrochloride

ATAMAX®

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THERAPEUTIC INDICATION PHARMACEUTICAL FORM POSOLOGY AND FORM OF ADMINISTRATION PRESENTATIONS

THERAPEUTIC INDICATION

Attention Deficit / Hyperactivity Disorder (ADHD)

Atamax® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children from 6 years of age, in adolescents and in adults as part of a complete treatment program.

Treatment should be started by a specialist in the treatment of ADHD, such as paediatricians, child psychiatrists, or psychiatrists. Diagnosis should be made according to current DSM criteria or the guidelines included in ICD.

In adults, the presence of ADHD symptoms already in childhood should be confirmed. It would be desirable if they were corroborated by a third party and treatment with Atamax®  should not be started when verification of ADHD symptoms in childhood is doubtful.

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PHARMACEUTICAL FORM

  • Atamax® 10 mg hard capsules EFG: Size No. 3 hard gelatin capsule (length 15.7 ± 0.4 mm), with ’10’ and ‘mg’ printed in black ink on opaque white cap and body, respectively.
  • Atamax® 18 mg hard capsules EFG: Size No. 3 hard gelatin capsule (length 15.7 ± 0.4 mm), with ’18’ and ‘mg’ printed in black ink on opaque yellow cap and opaque white body, respectively.
  • Atamax® 25 mg hard capsules EFG: Size No. 3 hard gelatin capsule (length 15.7 ± 0.4 mm), with ’25’ and ‘mg’ printed in black ink on opaque blue cap and opaque white body, respectively.
  • Atamax® 40 mg hard capsules EFG: Size No. 3 hard gelatin capsule (length 15.7 ± 0.4 mm), with ’40’ and ‘mg’ printed in black ink on opaque blue cap and body, respectively.
  • Atamax® 60 mg hard capsules EFG: Size No. 2 hard gelatin capsule (length 17.6 ± 0.4 mm), with ’60’ and ‘mg’ printed in black ink on opaque blue cap and opaque yellow body, respectively.
  • Atamax® 80 mg hard capsules EFG: Size No. 2 hard gelatin capsule (length 17.6 ± 0.4 mm), with ’60’ and ‘mg’ printed in black ink on opaque brown cap and opaque white body, respectively.
  • Atamax® 100 mg hard capsules EFG: Size No. 1 hard gelatin capsule (length 19.1 ± 0.4 mm), with ‘100’ and ‘mg’ printed in black ink on the cap and opaque brown body, respectively.

POSOLOGY AND FORM OF ADMINISTRATION

Posology

Atamax® can be administered as a single dose in the morning.

Patients who do not achieve a satisfactory clinical response (tolerance [nausea or drowsiness] or efficacy) when taking a single dose of Atamax® may benefit from taking it twice daily, in evenly divided doses in the morning and in the afternoon or early in the evening.

Treatment should be started under the supervision of a specialist in behavioural disorders in children and / or adolescents.

  • Dosage for paediatric population up to 70 kg of body weight:
    • Atamax® treatment should be started with a total daily dose of approximately 0.5 mg / kg. Keep at least 7 days.
    • The recommended maintenance dose is approximately 1.2 mg / kg / day (depending on the patient’s weight and the available presentations of atomoxetine). Keep a minimum of 7 days.
  • Dosage for paediatric population with more than 70 kg of body weight:
    • Atamax® treatment should be started with a total daily dose of 40 mg. Keep at least 7 days.
    • The recommended maintenance dose is 80 mg.
    • The maximum recommended total daily dose is 100 mg.
  • Adults:
    • Atamax® treatment should be started with a total daily dose of 40 mg. Keep at least 7 days.
    • The recommended maintenance dose is 80 mg to 100 mg.
    • The maximum recommended total daily dose is 100 mg.

Assessment before treatment:

Before prescription, it is necessary to have an appropriate medical history of the patient and to carry out an initial assessment of the patient’s cardiovascular status, including blood pressure and heart rate.

Tracing:

Assess and review the patient’s cardiovascular status after each dose adjustment and at least every 6 months.

Withdrawal of treatment:

Treatment with Atamax® is not necessarily indefinite. After one year, a reassessment of the need to continue treatment should be performed, especially when the patient has achieved a stable and satisfactory response.

Administration form

Oral administration.

Atamax® can be administered with or without food.

The capsules must not be opened and the contents of the capsules must not be removed or taken in any other way.

PRESENTATIONS

Available in packs of:

  • Atamax® 10 mg hard capsules EFG, 7 y 28 capsules
  • Atamax® 18 mg hard capsules EFG, 7 y 28 capsules
  • Atamax® 25 mg hard capsules EFG, 7 y 28 capsules
  • Atamax® 40 mg hard capsules EFG, 7 y 28 capsules
  • Atamax® 60 mg hard capsules EFG, 28 capsules
  • Atamax® 80 mg hard capsules EFG, 28 capsules
  • Atamax® 100 mg hard capsules EFG, 28 capsules
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