TOLTERODINE ACCORD Film-coated tablet Ref.[8038] Active ingredients: Tolterodine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Accord Healthcare Limited, Sage house, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Product name and form

Tolterodine Tartrate 1 mg Film-coated Tablet.

Pharmaceutical Form

Film-coated Tablet.

White to off white, round, approximately 6.35 mm in diameter, biconvex, film-coated tablet, debossed S16 on one side and plain on other side.

Qualitative and quantitative composition

Each film-coated tablet contains tolterodine tartrate 1 mg corresponding to 0.68 mg tolterodine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tolterodine

Tolterodine is a competitive, specific muscarinic receptor antagonist with selectivity for the urinary bladder over salivary glands in vivo.
List of Excipients

Core:

Cellulose, microcrystalline pH 102
Sodium starch glycolate (Type A)
Magnesium stearate
Colloidal anhydrous silica

Film coating:

Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 8000
Talc (E553b)

Pack sizes and marketing

PVC/PVDC– Alu blister.

Pack sizes:

Tolterodine 1 mg Film-coated Tablets are available in the following pack sizes:

Tolterodine 2 mg Film-coated Tablets are available in the following pack sizes:

Blister packs containing;

  • 14 film-coated tablets (1 strip of 14)
  • 28 film-coated tablets (2 strips of 14)
  • 56 film-coated tablets (4 strips of 14)
  • 20 film-coated tablets (2 strips of 10)
  • 50 film-coated tablets (5 strips of 10)
  • 100 film-coated tablets (10 strips of 10)
  • 30 film-coated tablets (3 strips of 10 or 2 strips of 15)
  • 60 film-coated tablets (6 strips of 10 or 4 strips of 15)
  • 90 film-coated tablets (9 strips of 10 or 6 strips of 15)

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage house, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0357

05/04/2014

 
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