Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460
AROPAX CR 12,5 Controlled release tablet.
AROPAX CR 25 Controlled release tablet.
| Pharmaceutical Form |
|---|
|
12,5 mg tablets: Yellow, round, biconvex, debossed, film-coated tablets with bevelled edges. One face is engraved with ‘GSK’ and the other face is engraved with ‘12.5’. 25 mg tablets: Pink, round, biconvex, debossed, film-coated tablets with bevelled edges. One face is engraved with ‘GSK’ and the other face is engraved with ‘25’. |
AROPAX CR tablets 12,5 mg contains paroxetine hydrochloride hemihydrate equivalent to 12,5 mg free base. Contains sugar (lactose monohydrate 79,17 mg per tablet). Contains Opadry Yellow (YS-1-2007).
AROPAX CR tablets 25 mg contains paroxetine hydrochloride hemihydrate equivalent to 25 mg paroxetine free base. Contains sugar (lactose monohydrate 79,14 mg per tablet).
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Paroxetine |
Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) uptake and its antidepressant action and effectiveness in the treatment of OCD, Social Anxiety disorder/Social Phobia, General Anxiety Disorder, Post-Traumatic Stress Disorder and Panic Disorder is thought to be related to its specific inhibition of 5-HT uptake in brain neurones. |
| List of Excipients |
|---|
|
Hypromellose, povidone, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, glyceryl behenate, methacrylic acid copolymer dispersion, talc, triethyl citrate, Opadry yellow, YS1-2007 (12,5 mg tablets), Opadry pink, Y-1-1262 (25 mg tablets) and the following colourants: yellow ferric oxide (12,5 mg tablets) and red ferric oxide (25 mg tablets). |
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.
GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460
AROPAX CR 12,5 mg: A38/1.2/0612
AROPAX CR 25 mg: A38/1.2/0613
AROPAX CR 12,5 mg: 18 March 2005
AROPAX CR 25 mg: 18 March 2005
| Drug | Countries | |
|---|---|---|
| AROPAX | Australia, Brazil, New Zealand, South Africa |
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