Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: SmithKline Beecham Limited, Great West Road, Brentford, Middlesex TW8 9GS. trading as: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT
Seroxat 10 mg film-coated tablets.
Seroxat 20 mg film-coated tablets.
Seroxat 30 mg film-coated tablets.
Seroxat 20 mg/10 ml oral suspension.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Oral suspension. 10 mg tablet: White to pinkish-white, film-coated, oval tablets, debossed FC1 and break bar on one side and debossed GS and break bar on the other side. The 10 mg tablet can be divided into equal doses if required. 20 mg tablet: White, film-coated tablet, oval shaped biconvex tablets debossed with “Seroxat 20” or “20” on one side and a break bar on the other. The 20 mg tablet can be divided into equal doses if required. 30 mg tablet: Blue, oval shaped biconvex tablets debossed with "Seroxat 30"or “30” on one side and a break bar on the other. The break bar is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Oral Suspension: A bright orange fairly viscous suspension having an odour of oranges, free from foreign matter. |
Each film-coated tablet contains 10 mg/20 mg/30 mg paroxetine (as paroxetine hydrochloride hemihydrate).
Each 10 ml of oral suspension contains 20 mg paroxetine (as paroxetine hydrochloride hemihydrate).
Excipients with known effect – each 10 ml of oral suspension contains:
For the 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 |
|---|
10 mg tabletTablet core: Dibasic calcium phosphate dihydrate (E341) Tablet coating: Hypromellose (E464) 20 mg tabletTablet core: Dibasic calcium phosphate dihydrate (E341) Tablet coating: Hypromellose (E464) 30 mg tabletTablet core: Dibasic calcium phosphate dihydrate (E341) Tablet coating: Hypromellose (E464) Oral suspensionPolacrilin potassium |
10 mg tablet: Child-resistant blister packs comprising opaque polyvinyl chloride (PVC) backed with aluminium foil laminated with paper.
Pack sizes: 14 and 28 tablets.
Not all pack sizes may be marketed.
20 mg tablet: Child-resistant blister packs comprising opaque polyvinyl chloride (PVC) backed with aluminium foil laminated with paper. Plastic containers (bottles) made of polypropylene, with polyethylene closures, may also be used.
Pack sizes: 50 × 1 tablet or 4, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 250 and 500 tablets.
Not all pack sizes may be marketed.
30 mg tablet: Child-resistant blister packs comprising opaque polyvinyl chloride (PVC) backed with aluminium foil laminated with paper. Plastic containers (bottles) made of polypropylene, with polyethylene closures, may also be used.
Pack sizes: 28, 30, 56 and 60 tablets.
Not all pack sizes may be marketed.
Oral suspension: Amber glass bottle sealed with polypropylene child-resistant cap lined with a polyethylene wad.
A polypropylene measuring cup is included.
Pack size: 150 ml.
SmithKline Beecham Limited, Great West Road, Brentford, Middlesex TW8 9GS.
trading as:
GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT
Seroxat Tablets 10 mg: 10592/0218
Seroxat Tablets 20 mg: 10592/0001
Seroxat Tablets 30 mg: 10592/0002
Seroxat Oral suspension: 10592/0092
Seroxat Tablets 10 mg:
Date of first authorisation: 29/07/2005
Date of latest renewal: 27/09/2010
Seroxat Tablets 20 mg and 30 mg:
Date of first authorisation: 11/12/1990
Date of latest renewal: 27/09/2010
Seroxat Oral suspension:
Date of first authorisation: 08/01/1997
Date of latest renewal: 27/09/2010
| Drug | Countries | |
|---|---|---|
| SEROXAT | Austria, Cyprus, Germany, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Netherlands, Poland, Romania, Singapore, United Kingdom |
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