Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460
AROPAX CR tablets are indicated for the treatment of major depressive disorder.
AROPAX CR tablets have been shown to be effective in the treatment of panic disorder with or without agoraphobia.
AROPAX CR Tablets have been shown to be effective in the treatment of Social Phobia.
Safety and efficacy in children under 18 years of age have not been established. In clinical trials in Major Depressive Disorder (with the immediate release formulation), there were increased reports of hostility and suicide-related adverse events, such as suicidal ideation and self-harm (see section 4.3).
AROPAX CR is not indicated for use in children or adolescents aged less than 18 years (see sections 4.3 and 4.4).
The efficacy of AROPAX CR tablets has not been studied in children and adolescents aged less than 18 years; however, controlled clinical studies with AROPAX (immediate release) tablets in children and adolescents with major depressive disorder failed to demonstrate efficacy and do not support the use of AROPAX in the treatment of depression in this population (see section 4.4).
AROPAX CR tablets should be administered as a single daily dose, usually in the morning, with or without food. Patients should be informed that AROPAX CR tablets should not be chewed or crushed, and should be swallowed whole.
The recommended initial dose is 25 mg/day. Some patients not responding to a 25 mg dose may benefit from dose increases in 12,5 mg/day increments, up to a maximum of 62,5 mg/day according to patient response. Dose changes should occur at intervals of at least one week.
Dosage should be reviewed and adjusted if necessary within 2 to 3 weeks of initiation of therapy and thereafter as judged clinically appropriate.
Patients with depression should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months.
Patients should begin treatment on 12,5 mg/day and the dose increased weekly in 12,5 mg/day increments according to patient response. Some patients may benefit from having their dose increased up to a maximum of 75 mg/day.
A low initial starting dose is recommended to minimise the potential worsening of panic symptomatology which is generally recognised to occur early in the treatment of this disorder. Patients with panic disorder should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer.
The recommended initial dose is 12,5 mg daily. Some patients not responding to a 12,5 mg dose may benefit from having dose increases in 12,5 mg/day increments as required, up to a maximum of 37,5 mg/day according to the patient’s response. Dose changes should occur at intervals of at least one week.
Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects. Dosing should commence at 12,5 mg/day and may be increased up to 50 mg/day.
AROPAX CR is not indicated for use in children or adolescents aged less than 18 years (see sections 4.3 and 4.4).
Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance <30 ml/min) or hepatic impairment. The dosage should be restricted to the lower end of the range.
Abrupt discontinuation should generally be avoided (see sections 4.4. and 4.8).The taper phase regimen used in recent clinical trials involved a decrease in the daily dose by 10 mg/day (equivalent to 12,5 mg/day CR tablets) at weekly intervals. When a daily dose of 20 mg/day (equivalent to 25 mg/day CR tablets) was reached, patients were continued on this dose for one week before treatment was stopped. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the medical practitioner may continue decreasing the dose, but at a more gradual rate.
A wide margin of safety is evident from available overdose information on paroxetine. Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned under section 4.8, fever, blood pressure changes, involuntary muscle contractions, anxiety and tachycardia have been reported.
Patients have generally recovered without serious sequelae even when doses of up to 2 000 mg have been taken alone. Events such as coma or ECG changes have occasionally been reported and, very rarely a fatal outcome, but generally when paroxetine was taken in conjunction with other psychotropic medicines with or without alcohol.
No specific antidote is known.
The treatment should consist of those general measures employed in the management of overdose with any antidepressant. Supportive care with frequent monitoring of vital signs and careful observation is indicated. Patient management should be as clinically indicated, or as recommended by the national poisons centre, where available
36 months.
Store in a dry place at a temperature not exceeding 25°C.
Keep out of reach of children.
Carton containing 28 tablets, packed in PVC/Aluminium child-resistant white blister packs, in strips of 14.
Carton containing 30 tablets, packed in PVC/Aluminium child-resistant white blister packs, in strips of 10.
Carton containing 28 tablets, packed in PVC/Aluminium child-resistant white blister packs, in strips of 14.
Carton containing 30 tablets, packed in PVC/Aluminium child-resistant white blister packs, in strips of 10.
No special requirements.
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