PI Neditol 2018-05-10T12:57:40+00:00



NEDITOL XL (Tolterodine) Capsules Prescribing Information (please refer to the full SmPC before prescribing)

Indications: Neditol XL is indicated in symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. Available strengths: Neditol XL 2 and 4mg x 28 capsules. Dosage and method of use: Capsules should be taken once daily with or without food, and must be swallowed whole. The effect of the treatment should be re-evaluated after 2-3 months. The usual dose is 4mg, except in patients with impaired liver or kidney function, whose recommended dose is 2mg. In case of troublesome side effects the dose may be reduced from 4mg to 2mg. Contraindications: Neditol XL is contraindicated in patients with a hypersensitivity to the active substance or to any of the excipients, urinary retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis or toxic megacolon. Special warnings and precautions for use: Neditol XL should be used with caution in patients with significant bladder outlet obstruction at risk of urinary retention, gastrointestinal obstructive disorders, renal impairment, hepatic disease, autonomic neuropathy, hiatus hernia and patients at risk of decrease gastrointestinal motility. Neditol XL should be used with caution in patients with risk factors for QT prolongation including; congenital or documented acquired QT prolongation, electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia, bradycardia, relevant pre-existing cardiac diseases and concomitant administration of drugs known to prolong QT-interval including Class IA and Class III anti-arrhythmics. Concomitant treatment with potent CYP3A4 inhibitors should be avoided and is not recommended. As with all treatments for symptoms of urgency and urge incontinence, organic reasons for urge and frequency should be considered before treatment. This product contains lactose and sodium. This should be taken into account in patients with diabetes mellitus and patients on a controlled sodium diet, respectively. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Concomitant treatment with other drugs that possess antimuscarinic properties may result in more pronounced therapeutic effect and side effects. Conversely, the therapeutic effect of tolterodine may be reduced by concomitant administration of muscarinic cholinergic receptor agonist. The effect of prokinetics like metoclopramide and cisapride may be decreased by tolterodine. Neditol XL is not recommended during pregnancy and should be avoided during lactation. The ability to drive and use machines may be negatively affected by Neditol XL. The product is not recommended for children. Side effects: For the full list of side effects consult the SmPC for Neditol XL. ‘Very Common’ ‘Common’ and ‘Serious’ side effects are included in the prescribing information. Due to the pharmacological effect of tolterodine it may cause mild to moderate antimuscarinic effects like dryness of the mouth (very common, ≥1/10), dyspepsia and dry eyes. Common (≥1/100 to <1/10) side effects include sinusitis, dizziness, somnolence, headache, dry eyes, abnormal vision (including abnormal accommodation), dyspepsia, constipation, abdominal pain, flatulence, diarrhoea, dysuria, fatigue and peripheral oedema. Serious Uncommon (≥1/1000 to <1/100) side effects include hypersensitivity not otherwise specified and cardiac failure. Serious side effects of a not known frequency include anaphylactoid reactions and angioedema. Cases of aggravation of symptoms of dementia have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for treatment of dementia. MA number: PL 17277/0271-0272 Cost £12.89 for 4mg 28x pack, £11.60 for 2mg 28x pack. MAH: Pharmathen S.A., 6 Dervenakion Str., 15351 Pallini, Attiki, Greece. Distributor: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire GU32 3QG. Legal category: POM. Date last reviewed: January 2017. Version number: 1010083024 v 5.0

For further information please call: 01730 231148, email: info@www.soyporteno.com or visit www.www.soyporteno.com

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148
For more information about Neditol XL, please see the abbreviated prescribing information.
Revision reference – Neditol XL_16__27/02/2017