PROPANOLOL Film-coated tablets Ref.[7557] Active ingredients: Propranolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

PROPRANOLOL TABLETS BP 160mg.

Pharmaceutical Form

Pink film-coated tablets.

Pink, circular, biconvex film-coated tablets impressed “C” on one face and the identifying letters “P” and “D” on either side of a central division line on the reverse.

Qualitative and quantitative composition

Each tablet contains 160mg Propranolol hydrochloride PhEur.

Excipients with known effect:

Each 160mg tablet contains 230.00mg Lactose.

Each tablet contains Carmoisine (E122).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Propranolol

Propranolol is a competitive antagonist at both beta, and beta2-adrenoceptor, but has membrane stabilising activity at concentrations exceeding 1-3mg/litre, though such concentrations are rarely achieved during oral therapy. Competitive beta-blockade has been demonstrated in man by a parallel shift to the right in the dose-heart rate response curve to beta-agonists such as isoprenaline.
List of Excipients

The tablets contain:

Lactose
Magnesium stearate
Maize starch
Stearic acid
Hypromellose (E464)

The coating contains:

Carmoisine (E122)
Hypromellose (E464)
Polysorbate
Titanium dioxide (E171)
Iron oxide red (E172)

Pack sizes and marketing

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.

The product may also be supplied in blister packs and cartons:

  • Carton: Printed carton manufactured from white folding box board.
  • Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500, 1000.

Bulk pack: 50,000

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/0142

Date of first authorisation: 05 February 1980

Date of latest renewal: 16 September 2005

 
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