SOTACOR Tablet Ref.[27749] Active ingredients: Sotalol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom

Product name and form

Sotacor 80 mg Tablets.

Pharmaceutical Form

Tablets.

Round, biconvex, white tablets with a break bar on each side.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 80mg sotalol hydrochloride.

Excipient with known effect: Each tablet contains 53.8mg of lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sotalol

D,l-sotalol is a non-selective hydrophilic β-adrenergic receptor blocking agent, devoid of intrinsic sympathomimetic activity or membrane stabilizing activity. Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties.

List of Excipients

Colloidal anhydrous silica
Lactose monohydrate
Magnesium stearate
Maize starch
Mirocrystalline cellulose
Stearic acid

Pack sizes and marketing

Original packs of 28 or 30 tablets: blister strips of 2x 14 tablets or 3x 10 tablets, respectively, to a carton.

Marketing authorization holder

Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom

Marketing authorization dates and numbers

PL 45043/0047

9th August 1989

Drugs

Drug Countries
SOTACOR Australia, Brazil, Finland, Japan, New Zealand, United Kingdom

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