SOTALOL Tablets Ref.[7103] Active ingredients: Sotalol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Product name and form

Sotalol 40mg Tablets.

Pharmaceutical Form

Tablet.

Round, white to off-white, flat bevelled edged tablets.

Qualitative and quantitative composition

Each tablet contains 40mg Sotalol hydrochloride.

For excipients: see 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

Calcium hydrogen phosphate dihydrate
Maize starch
Povidone K30
Sodium starch glycollate (Type A)
Talc
Magnesium stearate

Pack sizes and marketing

The tablets are packed in 14-tablets blisters constituted from PVC/PVdC and aluminium foil.

Pack sizes: 28 and 56 tablets.

Marketing authorization holder

Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL16363/0175

18th July 2005

Drugs

Drug Countries
SOTALOL Netherlands

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