pfizer_advert_Layout 1 09/02/2010 10:25 Page IFC1
Celebrating choice in
OAB treatment
Pfi zer brings you Toviaz
®
– an antimuscarinic agent
for the treatment of overactive bladder (OAB)
• Toviaz is effective in relieving bothersome symptoms of OAB* at both
4mg and 8mg doses compared to placebo
1
• Treatment effects at both doses were also observed as early as week two
(pooled analysis)
2
**
• T oviaz is generally well tolerated with less than 1% of patients discontinuing
Toviaz due to dry mouth or constipation (pooled analysis)
2
**
†
*Bothersome symptoms of OAB including increased micturition frequency, urgency, UUI, and MVV
1
.
** Pooled analysis of data from two 12-week, randomised, placebo-controlled, phase 3 trials with fesoterodine 4mg, 8mg and tolterodine ER 4mg.
†
Discontinuation due to all adverse events was: 3.4% in the placebo group; 4.9% in the Toviaz 4mg group; and 7.2% in the Toviaz 8mg group
2
.
L
I
I
F
E
V
E
YO
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L
TOVIAZ
®
Abbreviated Prescribing Information: isomaltase insuffi ciency. Fesoterodine should be used with caution in patients with risk increased. The heart rate corrected QT interval in fesoterodine treated patients did
(See Toviaz Summary of Product characteristics for full Prescribing Information) factors for QT-prolongation including: congenital or documented acquired QT not differ from that seen in placebo treated patients. See Full Prescribing
Presentation: Prolonged-release tablets containing fesoterodine fumarate. The 4mg prolongation; electrolyte disturbances, bradycardia and concomitant administration Information. Driving and operating machinery: The ability to drive and use
is light blue, oval, engraved FS containing 3.1mg of fesoterodine. The 8mg is blue, of drugs known to prolong QT-interval, relevant pre-existing cardiac diseases machines may be affected by blurred vision, dizziness and somnolence, see side
oval, engraved FT containing 6.2mg of fesoterodine. Indications: Symptomatic especially when taking potent CYP3A4 inhibitors. Concomitant treatment with potent effects. Overdose: Treat with gastric lavage and give activated charcoal. Treat
treatment of urge incontinence and/or urinary frequency and/or urgency that may CYP2D6 inhibitors may increase exposure, and the dose should be increased with symptomatically. Legal Category: POM. Marketing authorisation holder:
occur in patients with overactive bladder syndrome. Dosage: Adults (including caution especially in patients with hepatic or renal impairment. Patients with a Pfi zer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. Package quantities,
Elderly): 4mg once daily. The tablet should be taken whole with some liquid. The dose combination of hepatic or renal impairment or concomitant administration of potent or Marketing Authorisation numbers and basic NHS price: TOVIAZ 4mg,
may be increased to max daily dose of 8mg once daily. The max dose in patients with moderate CYP3A4 inhibitors or potent CYP2D6 inhibitors are expected to have 28 prolonged-release tablets, EU/1/07/386/003 £25.78; TOVIAZ 8mg,
severe renal impairment or moderate hepatic impairment is 4mg. Treatment should be additional exposure increases and dose dependant side effects – dose increase to 28 prolonged-release tablets, EU/1/07/386/008 £25.78. Further information
re-valuated after 8 weeks. Children: Not recommended. Cautious dose increase 8mg where possible should be preceded by an evaluation of response and tolerability. is available on request from: Medical Information at Pfi zer Limited, Walton
recommended in patients with mild or moderate renal impairment or mild hepatic Organic reasons for urge, frequency or overactive bladder should be considered Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Tel: +44 (0) 1304 616161
impairment. Max dose with patients using moderate CYP3A4 inhibitors with mild or before treatment. Drug Interactions: Concomitant use of other antimuscarinic Date of Preparation: December 2008.
moderate renal impairment or mild hepatic impairment is 4mg. Use should be agents and medicinal products with anticholinergic properties or with strong inhibitors Company reference: TV2_0
avoided in patients with mild renal or hepatic impairment using potent CYP3A4 of CYP3A4, may lead to more pronounced therapeutic and side-effects. Moderate
inhibitors, or patients with severe renal impairment or moderate hepatic impairment CYP3A4 inhibitors are expected to cause a lesser increase of exposure to the active
Adverse events should be reported. Reporting forms and
using moderate CYP3A4 inhibitors. In patients receiving concomitant potent CYP3A4 metabolite. Induction of CYP3A4 may lead to subtherapeutic plasma levels.
information can be found at www.yellowcard.gov.uk
inhibitors the max. daily dose is 4mg. Contraindications: Hypersensitivity to Concomitant use with CYP3A4 inducers is not recommended. Fesoterodine
fesoterodine, soya, peanut or excipients, urinary retention, gastric retention, may reduce the effect of products that stimulate the motility of the gastro-intestinal
Adverse events should also be reported to
uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment tract. Co-administration of Toviaz with potent CYP2D6 inhibitors may lead to
Pfi zer Medical Information on 01304 616161
(Child Pugh C), severe ulcerative colitis, toxic megacolon. Concomitant use of potent increased exposure and adverse events. A dose reduction to 4mg may be required.
CYP3A4 inhibitors in patients with moderate or severe renal impairment, or patients Pregnancy & Lactation: Not recommended. See Full Prescribing Information. References: 1. Chapple C, Van Kerrebroeck P, Tubaro A et al. Clinical
with moderate hepatic impairment. Warnings and Precautions: Use with caution Side Effects: In clinical trials, the most commonly reported adverse reaction was dry Effi cacy, Safety, and Tolerability of Once-Daily Fesoterodine in Subjects With
in patients with signifi cant bladder outlet obstruction at risk of urinary retention, mouth. Common reported events include dizziness, headache, dry eye, dry throat, Overactive Bladder. Eur Urol. 2007 Oct; 52(4):1204-1212. 2. Khullar V, Rovner E,
gastrointestinal obstructive disorders, e.g. pyloric stenosis, gastro-oesophageal refl ux, abdominal pain, diarrhoea, dyspepsia, constipation, nausea, dysuria, insomnia; Dmochowski R et al. Fesoterodine dose response in subjects with overactive
concurrent medicinal products that may cause or exacerbate gastro-oesophageal uncommon (5 or more cases) tachycardia, dysgeusia, somnolence, vertigo, bladder syndrome. Urology 2008 May; 71(5): 839-843.
refl ux, autonomic neuropathy, controlled narrow-angle glaucoma, decreased pharyngolaryngeal pain, cough, nasal dryness, abdominal discomfort, fl atulence,
gastrointestinal motility. Toviaz should not be used in patients with hereditary urinary retention (including feeling of residual urine, micturation disorder), urinary Date of preparation: May 2009
problems of fructose intolerance, glucose-galactose malabsorption or sucrase- hesitation, rash, dry skin, urinary tract infection, fatigue, ALT increased, GGT TOV289
Presse UK AK-MEX-1.indd 1 17/11/09 12:29:20
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