Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
1.25 mg tablet only: Bisoprolol fumarate 1.25 mg film-coated tablets.
2.5 mg tablet only: Bisoprolol fumarate 2.5 mg film-coated tablets.
3.75 mg tablet only: Bisoprolol fumarate 3.75 mg film-coated tablets.
5 mg tablet only: Bisoprolol fumarate 5 mg film-coated tablets.
7.5 mg tablet only: Bisoprolol fumarate 7.5 mg film-coated tablets.
10 mg tablet only: Bisoprolol fumarate 10 mg film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablet (tablet). 1.25 mg tablet only: White, oval, biconvex film coated tablets; approximately 9 mm x 7 mm; ‘BL’ & ‘1’ engraved on one face of the tablet; ‘M’ engraved on the other face of the tablet. 2.5 mg tablet only: White to off-white, oval, biconvex film coated tablets with side notches; approximately 9 mm x 7 mm; ‘BL’ & ‘2’ engraved on either side of the scoreline on one face of the tablet; ‘M’ engraved on the other face of the tablet. 3.75 mg tablet only: Cream, oval, biconvex film coated tablets with side notches; approximately 9 mm x 7 mm; ‘BL’ & ‘3’ engraved on either side of the scoreline on one face of the tablet; ‘M’ engraved on the other face of the tablet. 5 mg tablet only: Pale yellow, oval, biconvex film coated tablets with side notches; approximately 9 mm x 7 mm; ‘BL’ & ‘4’ engraved on either side of the scoreline on one face of the tablet; ‘M’ engraved on the other face of the tablet. 7.5 mg tablet only: Yellow, oval, biconvex film coated tablets with side notches; approximately 9 mm x 7 mm; ‘BL’ & ‘5’ engraved on either side of the scoreline on one face of the tablet; ‘M’ engraved on the other face of the tablet. 10 mg tablet only: Pale orange to light orange, oval, biconvex film coated tablets with side notches; approximately 9 mm x 7 mm; ‘BL’ & ‘6’ engraved on either side of the scoreline on one face of the tablet; ‘M’ engraved on the other face of the tablet. 2.5mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg tablet only: The tablet can be divided into equal doses. |
1.25 mg tablet only: Each tablet contains 1.25 mg of bisoprolol fumarate.
2.5 mg tablet only: Each tablet contains 2.5 mg of bisoprolol fumarate.
3.75 mg tablet only: Each tablet contains 3.75 mg of bisoprolol fumarate.
5 mg tablet only: Each tablet contains 5 mg of bisoprolol fumarate.
7.5 mg tablet only: Each tablet contains 7.5 mg of bisoprolol fumarate.
10 mg tablet only: Each tablet contains 10 mg of bisoprolol fumarate.
5 mg tablet only:
Each tablet contains: 0.007 mg sunset yellow (E110).
7.5 mg tablet only:
Each tablet contains: 0.010 mg sunset yellow (E110).
10 mg tablet only:
Each tablet contains: 0.042 mg sunset yellow (E110).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Bisoprolol is a potent highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and without relevant membrane stabilising activity. |
| List of Excipients | |||||||||||||||||||||
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PVC/Al blister packs. Blister pack comprises of clear transparent PVC film with backing of aluminium foil coated with heat seal lacquer containing 10, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets.
White HDPE bottles with white opaque polypropylene cap containing 10, 28, 30, 50, 56, 84, 98, 100, 500 and 1000 filmcoated tablets.
Bottle contains a perforated HDPE canister holding silica gel and activated carbon desiccant.
Not all pack sizes may be marketed.
Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
PL 04569/1254
PL 04569/1255
PL 04569/1256
PL 04569/1257
PL 04569/1258
PL 04569/1259
10/10/2015
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