SECTRAL Capsule Ref.[27568] Active ingredients: Acebutolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom

Product name and form

Sectral 100mg Capsules.

Pharmaceutical Form

Capsule.

Hard gelatin capsules, the bodies being opaque yellowish-buff and the caps opaque white in colour. Length approximately 17mm, diameter of body approximately 6mm. Both body and cap are printed in black:

Sectral 100

ACB 100

The capsules contain a white or almost white powder.

Qualitative and quantitative composition

Each capsule contains 111mg of the active substance Acebutolol hydrochloride (equivalent to 100mg of base).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Acebutolol

Acebutolol is a beta adrenoceptor antagonist which is cardioselective, i.e. acts preferentially on beta-1 adrenergic receptors in the heart. Its principal effects are to reduce heart rate especially on exercise and to lower blood pressure in hypertensive subjects.

List of Excipients

Starch Potato
Silica colloidal anhydrous (E551)
Magnesium Stearate (E572)
Capsule Shell

Body:

Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin

Cap:

Titanium dioxide (E171)
Gelatin

Ink:

Opacode S-1-8100 Black containing
Shellac glaze
Black iron oxide (E172)
Lecithin
Antifoam DC 1501

Pack sizes and marketing

Aluminium foil/UPVC blister strip packs of 84 capsules.

Securitainer of 100 or 500 capsules.

Bottle of 100 or 500 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 45043/0059

07/12/2010

Drugs

Drug Countries
SECTRAL France, Tunisia, United Kingdom, South Africa

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