The Pharmaceutical Journal
Vol 280 No 7506 p713
14 June 2008

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Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

New medicines
• Toviaz

Recall Scheriproct ointment 30g

Caution in use alert Clexane syringes

New medicines

Toviaz

Composition: Fesoterodine fumarate.

Presentation: Prolonged-release tablets.

Class: Urinary antispasmodic.

Indications: Treatment of the symptoms (increased urinary frequency, urgency or urgency incontinence) that may occur in patients with overactive bladder syndrome.

Dosage: Initially 4mg once daily. The dose may be increased to 8mg once daily based upon individual response. The maximum daily dose is 8mg.

Contraindications:

• Hypersensitivity to the active substance, or to peanut, soya or any of the excipients
• Urinary retention
• Gastric retention
• Uncontrolled narrow angle glaucoma
• myasthenia gravis
• Severe hepatic impairment
• Concomitant use of potent cytochrome P450 CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
• Severe ulcerative colitis
• Toxic megacolon

Precautions:

Patients should be evaluated for efficacy of treatment after eight weeks.

For patients with normal renal and hepatic function taking potent inhibitors of CYP3A4 concomitantly, the maximum dose of Toviaz should be 4mg daily.

For patients taking moderate inhibitors of CYP3A4 concomitantly with Toviaz, a dose increase to 8mg should be preceded by evaluation of the patient’s individual response.

Dosing recommendations for patients with degrees of renal or hepatic impairment receiving or not receiving concomitant CYP3A4 inhibitors are included in the summary of product characteristics for Toviaz.

Caution is required when combining Toviaz with moderate or potent CYP3A4 inhibitors or potent CYP2D6 inhibitors.

Toviaz should be used with caution for patients at risk of QT-interval prolongation and those with relevant pre-existing cardiac conditions.

Caution should be exercised when treating patients with:

• Clinically significant bladder outflow obstruction at risk of urinary retention
• Gastrointestinal obstruction (eg, pyloric stenosis)
• Gastro-oesophageal reflux (or patients taking medicines that can cause or exacerbate oesophagitis)
• Decreased gastrointestinal motility
• Autonomic neuropathy
• Controlled narrow-angle glaucoma

Co-administration of Toviaz with other antimuscarinic agents and medicines with anticholinergic properties could lead to more pronounced therapeutic and adverse effects. As with other antimuscarinic medicines, caution should be exercised with driving or using machines because of possible side effects such as blurred vision, dizziness and somnolence.

Side effects: Very common (>=1/10) dry mouth. Common (>=1/100 to <1/10) dizziness, headache, dry eyes, dry throat, abdominal pain, diarrhoea, dyspepsia, constipation, nausea, dysuria, insomnia.

Legal category: POM.

Net price:
28 x 4mg, £29.03
28 x 8mg, £29.03

Contact details: Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT13 9NJ.

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