PROZAC LIQUID fluoxetine 20mg/5mL (as hydrochloride) oral liquid

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

fluoxetine hydrochloride, Quantity: 4.47 mg/mL (Equivalent: fluoxetine, Qty 4 mg/mL)

Disponible desde:

Eli Lilly Australia Pty Ltd

formulario farmacéutico:

Oral Liquid

Composición:

Excipient Ingredients: glycerol; purified water; benzoic acid; sucrose; Flavour

Vía de administración:

Oral

Unidades en paquete:

35, 70 and 140mL

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

The treatment of major depressive disorders as defined in the approved product information. The treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in the DSM-III-R; ie. the obsessions and compulsions cause marked distress, are time consuming, or significantly interfere with social or occupational functioning. INDICATIONS AS AT 6 JUNE 2000: For the treatment of: Major depression. Obsessive Compulsive Disorders. Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria. The essential features of PMDD, according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating a

Resumen del producto:

Visual Identification: A clear, colourless solution, mint odour.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

1993-07-13

Ficha técnica

AUSTRALIAN PRODUCT INFORMATION
vA13-18Jun21
SUPERSEDES: vA12-6May20
Page 1 of 23
PROZAC (FLUOXETINE HYDROCHLORIDE) TABLETS, CAPSULES AND
ORAL LIQUIDS
1.
NAME OF THE MEDICINE
Fluoxetine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROZAC TABLETS (_NOT AVAILABLE IN AUSTRALIA_)
Fluoxetine 20 mg (present as the hydrochloride).
Excipients with known effect: Prozac tablets contain saccharin.
PROZAC CAPSULES
Fluoxetine 20 mg fluoxetine (present as the hydrochloride).
PROZAC LIQUID (_NOT AVAILABLE IN AUSTRALIA_)
Fluoxetine 20 mg/5 mL (present as the hydrochloride).
Excipients with known effect: Prozac liquid contains sugars (as
sucrose) and benzoate.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
TABLETS
PROZAC 20 mg tablets are white, elongated, scored dispersible tablets
embossed with
“4400”.
CAPSULES
PROZAC 20 mg capsules have an opaque green cap and opaque yellow body.
Imprinted with
“Lilly 3105”.
LIQUID (_NOT AVAILABLE IN AUSTRALIA_)
PROZAC Liquid is a clear, colourless, mint flavoured oral solution
(M-5120).
vA13-18Jun21
SUPERSEDES: vA12-6May20
Page 2 of 23
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROZAC is indicated for the treatment of:
Major depression.
Obsessive Compulsive Disorder.
Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria.
The essential features of PMDD, according to the Diagnostic and
Statistical Manual-4th
edition (DSM-IV) include markedly depressed mood, anxiety or tension,
affective lability and
persistent anger or irritability. Other features include decreased
interest in usual activities,
difficulty concentrating, lack of energy, change in appetite or sleep
and feeling out of control.
Physical symptoms associated with PMDD include breast tenderness,
headache, joint and
muscle pain, bloating and weight gain. These symptoms occur regularly
during the luteal
phase and remit within a few days following onset of menses; the
disturbance markedly
interferes with work or school or with usual social activities