10/20/30 mg tablet
3 years.
Oral suspension
2 years (1 month after opening).
Not applicable.
10 mg tablet
Tablet core:
Dibasic calcium phosphate dihydrate (E341)
Sodium starch glycolate (Type A)
Magnesium stearate (E470b).
Tablet coating:
Hypromellose (E464)
Macrogol 400
Polysorbate 80 (E433)
Titanium dioxide (E171)
Iron oxide red (E172).
20 mg tablet
Tablet core:
Dibasic calcium phosphate dihydrate (E341)
Sodium starch glycolate (Type A)
Magnesium stearate (E470b).
Tablet coating:
Hypromellose (E464)
Macrogol 400
Polysorbate 80 (E433)
Titanium dioxide (E171).
30 mg tablet
Tablet core:
Dibasic calcium phosphate dihydrate (E341)
Sodium starch glycolate (Type A)
Magnesium stearate (E470b).
Tablet coating:
Hypromellose (E464)
Macrogol 400
Polysorbate 80 (E433)
Titanium dioxide (E171)
Indigo carmine (E132).
Oral suspension
Polacrilin potassium
Dispersible cellulose (E460)
Propylene glycol
Glycerol (E422)
Sorbitol (E420)
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Sodium citrate dihydrate (E331)
Citric acid anhydrate (E330)
Sodium saccharin (E954)
Natural orange flavour
Natural lemon flavour
Colouring agent sunset yellow FCF (E110)
Simethicone emulsion
Purified water.
23 October 2015
SmithKline Beecham Limited
Great West Road
Brentford
Middlesex TW8 9GS.
trading as:
SmithKline Beecham Pharmaceuticals
Welwyn Garden City
Hertfordshire AL7 1EY
And/or
GlaxoSmithKline UK,
Stockley Park West,
Uxbridge,
Middlesex UB11 1BT
10/20/30 mg tablet
Do not store above 30°C.
Store in the original package in order to protect from light.
Oral suspension
Do not store above 25°C.
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 x 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.
Seroxat Tablets 10 mg: 10592/0218
Seroxat Tablets 20 mg: 10592/0001
Seroxat Tablets 30 mg: 10592/0002
Seroxat Oral suspension:10592/0092
No special requirements.
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
