Seroxat

Shelf life

10/20/30 mg tablet

3 years.

Oral suspension

2 years (1 month after opening).

Seroxat price

Average cost of Seroxat 10 mg per unit in online pharmacies is from 2.44$ to 3.03$, per pack from 85$ to 205$.

Incompatibilities

Not applicable.

List of excipients

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.

Date of revision of the text

23 October 2015

Marketing authorisation holder

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

Special precautions for storage

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.

Nature and contents of container

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.

Marketing authorisation number(s)

Seroxat Tablets 10 mg: 10592/0218

Seroxat Tablets 20 mg: 10592/0001

Seroxat Tablets 30 mg: 10592/0002

Seroxat Oral suspension:10592/0092

Special precautions for disposal and other handling

No special requirements.

Date of first authorisation/renewal of the authorisation

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