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

Posology

Adults (including elderly)

The recommended dose is 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR≤30 ml/min) for whom the recommended dose is 1 mg twice daily (see section 4.4). In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.

The effect of treatment should be re-evaluated after 2-3 months (see section 5.1).

Paediatric population

Efficacy of Tolterodine Film-coated Tablets has not been demonstrated in children (See section 5.1). Therefore, Tolterodine Film-coated Tablets is not recommended for children.

The highest dose given to human volunteers of tolterodine L-tartrate is 12.8 mg as single dose. The most severe adverse events observed were accommodation disturbances and micturition difficulties.

In the event of tolterodine overdose, treat with gastric lavage and give activated charcoal.

Treat symptoms as follows:

• Severe central anticholinergic effects (e.g. hallucinations, severe excitation): treat with physostigmine
• Convulsions or pronounced excitation: treat with benzodiazepines
• Respiratory insufficiency: treat with artificial respiration
• Tachycardia: treat with beta-blockers
• Urinary retention: treat with catheterization
• Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room

An increase in QT interval was observed at a total daily dose of 8 mg immediate release tolterodine (twice the recommended daily dose of the immediate release formulation and equivalent to three times the peak exposure of the prolonged release capsule formulation) administered over four days. In the event of tolterodine overdose, standard supportive measures for managing QT prolongation should be adopted.

2 years.

This medicinal product does not require any special storage conditions.

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.

No special requirements.