GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Atomoxetine Capsules IP 10mg
B) Atomoxetine Capsules IP 18mg
C) Atomoxetine Capsules IP 25mg
D) Atomoxetine Capsules IP 40mg
E) Atomoxetine Capsules IP 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Atomoxetine Capsules IP 10mg
Each hard gelatin Capsule contains:
Atomoxetine Hydrochloride IP
Equivalent to Atomoxetine……………10mg
Excipients…………………………………………………… q.s
Approved colours used in capsules shells.

B) Atomoxetine Capsules IP 18mg
Each hard gelatin Capsule contains:
Atomoxetine Hydrochloride IP
Equivalent to Atomoxetine………………....18mg
Excipients…………………………………………...q.s
Approved colours used in capsules shells.

C) Atomoxetine Capsules IP 25mg
Each hard gelatin Capsule contains:
Atomoxetine Hydrochloride IP
Equivalent to Atomoxetine………………….25mg
Excipients………………………………………………...q.s
Approved colours used in capsules shells.

D) Atomoxetine Capsules IP 40mg
Each hard gelatin Capsule contains:
Atomoxetine Hydrochloride IP
Equivalent to Atomoxetine……………………….40mg
Excipients…………………………………………………. q.s
Approved colours used in capsules shells.

E) Atomoxetine Capsules IP 60mg
Each hard gelatin Capsule contains:
Atomoxetine Hydrochloride IP
Equivalent to Atomoxetine…………………………...60mg
Excipients……………………………………………………………q.s
Approved colours used in capsules shells.

THERAPEUTIC INDICATIONS:

Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting. It is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the brain.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A PSYCHIATRIST.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light and moisture.
Dosage: As directed by the psychiatrist.

Atomoxetine Capsules IP 60mg Technical Specification:

Product Name: Atomoxetine Capsules IP
Brand Name: Generic
Strength: 10mg, 18mg, 25mg, 40mg, 60mg
Dosage Form: Capsules (Hard gelatin)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antidepressant, Central nervous system
Indication: Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD) in children, teenagers, and adults.
Storage: Store below 30 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • A) Atomoxetine Capsules IP 10mg
  • B) Atomoxetine Capsules IP 18mg
  • C) Atomoxetine Capsules IP 25mg
  • D) Atomoxetine Capsules IP 40mg
  • E) Atomoxetine Capsules IP 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • A) Atomoxetine Capsules IP 10mg
    Each hard gelatin Capsule contains:
    Atomoxetine Hydrochloride IP
    Equivalent to Atomoxetine……………10mg
    Excipients…………………………………………………… q.s
    Approved colours used in capsules shells.
  • B) Atomoxetine Capsules IP 18mg
    Each hard gelatin Capsule contains:
    Atomoxetine Hydrochloride IP
    Equivalent to Atomoxetine………………….18mg
    Excipients……………………………………………q.s
    Approved colours used in capsules shells.
  • C) Atomoxetine Capsules IP 25mg
    Each hard gelatin Capsule contains:
    Atomoxetine Hydrochloride IP
    Equivalent to Atomoxetine………………….25mg
    Excipients…………………………………………………q.s
    Approved colours used in capsules shells.
  •  D) Atomoxetine Capsules IP 40mg
    Each hard gelatin Capsule contains:
    Atomoxetine Hydrochloride IP
    Equivalent to Atomoxetine……………………….40mg
    Excipients…………………………………………………. q.s
    Approved colours used in capsules shells.
  • E) Atomoxetine Capsules IP 60mg
    Each hard gelatin Capsule contains:
    Atomoxetine Hydrochloride IP
    Equivalent to Atomoxetine……………………………60mg
    Excipients……………………………………………………………q.s
    Approved colours used in capsules shells.

THERAPEUTIC INDICATIONS:

  • Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting. It is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the brain.

CAUTION & SCHEDULE:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A PSYCHIATRIST.

STORAGE & DOSAGE:

  • Storage: Store below 30 °C.Protect from Light and moisture.
  • Dosage: As directed by the psychiatrist.