Toviaz

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 

 

TOVIAZ 4 mg prolonged-release tablets 

TOVIAZ 8 mg prolonged-release tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

TOVIAZ 4 mg tablets 

Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of 

fesoterodine. 

 

TOVIAZ 8 mg tablets 

Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of 

fesoterodine. 

 

Excipients with known effect 

 

TOVIAZ 4 mg tablets 

Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 91.125 mg of lactose. 

 

TOVIAZ 8 mg tablets 

Each 8 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 58.125 mg of lactose. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Prolonged-release tablet. 

 

TOVIAZ 4 mg tablets 

The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the 

letters ‘FS’. 

 

TOVIAZ 8 mg tablets 

The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters 

‘FT’. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

TOVIAZ is indicated in adults for treatment of the symptoms (increased urinary frequency and/or 

urgency and/or urgency incontinence) that may occur with overactive bladder syndrome. 

 



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4.2 Posology and method of administration 

 

Posology 

 

Adults (including elderly) 

The recommended starting dose is 4 mg once daily. Based upon individual response, the dose may 

be increased to 8 mg once daily. The maximum daily dose is 8 mg. 

 

Full treatment effect was observed between 2 and 8 weeks. Hence, it is recommended to re-

evaluate the efficacy for the individual patient after 8 weeks of treatment.  

 

In subjects with normal renal and hepatic function receiving concomitant administration of potent 

CYP3A4 inhibitors, the maximum daily dose of TOVIAZ should be 4 mg once daily (see section 

4.5).  

 

Special population 

 

Renal and hepatic impairment 

The following table provides the daily dosing recommendations for subjects with renal or hepatic 

impairment in the absence and presence of moderate and potent CYP3A4 inhibitors (see sections 

4.3, 4.4, 4.5 and 5.2). 

 

 Moderate(3) or potent(4) CYP3A4 inhibitors 

None Moderate Potent 

Renal impairment(1) Mild 4→8 mg(2) 4 mg Should be avoided 

 Moderate 4→8 mg(2) 4 mg Contraindicated 

 Severe 4 mg 
Should be 

avoided 
Contraindicated 

Hepatic impairment Mild 4→8 mg(2) 4 mg Should be avoided 

 Moderate 4 mg 
Should be 

avoided 
Contraindicated 

(1)  Mild GFR = 50-80 ml/min; Moderate GFR = 30-50 ml/min; Severe GFR = <30 ml/min 

(2)  Cautious dose increase. See sections 4.4, 4.5 and 5.2 

(3) Moderate CYP3A4 inhibitors. See section 4.5 

(4) Potent CYP3A4 inhibitors. See sections 4.3, 4.4 and 4.5 

 

TOVIAZ is contraindicated in subjects with severe hepatic impairment (see section 4.3). 

 

Paediatric population 

The safety and efficacy of TOVIAZ in children below 18 years of age have not yet been 

established. No data are available. 

 

Method of administration 

Tablets are to be taken once daily with liquid and swallowed whole. TOVIAZ can be administered 

with or without food. 

 

4.3 Contraindications 

 

• Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed 
in section 6.1 

• Urinary retention 
• Gastric retention  
• Uncontrolled narrow angle glaucoma 



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• Myasthenia gravis 
• Severe hepatic impairment (Child Pugh C) 
• Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or 

renal impairment 

• Severe ulcerative colitis 
• Toxic megacolon. 

 

4.4 Special warnings and precautions for use  

 

TOVIAZ should be used with caution in patients with: 

 

- Clinically significant bladder outflow obstruction at risk of urinary retention (e.g. clinically 

significant prostate enlargement due to benign prostatic hyperplasia, see section 4.3) 

- Gastrointestinal obstructive disorders (e.g. pyloric stenosis) 

- Gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as 

oral bisphosphonates) that can cause or exacerbate oesophagitis 

- Decreased gastrointestinal motility 

- Autonomic neuropathy 

- Controlled narrow-angle glaucoma 

 

Caution should be exercised when prescribing or uptitrating fesoterodine to patients in whom an 

increased exposure to the active metabolite (see section 5.1) is expected: 

 

- Hepatic impairment (see sections 4.2, 4.3 and 5.2) 

- Renal impairment (see sections 4.2, 4.3 and 5.2) 

- Concomitant administration of potent or moderate CYP3A4 inhibitors (see sections 4.2 and 

4.5) 

- Concomitant administration of a potent CYP2D6 inhibitor (see sections 4.5 and 5.2). 

 

Dose increases 

In patients with a combination of these factors, additional exposure increases are expected. Dose 

dependent antimuscarinic adverse reactions are likely to occur. In populations where the dose may 

be increased to 8 mg once daily, the dose increase should be preceded by an evaluation of the 

individual response and tolerability.  

 

Organic causes must be excluded before any treatment with antimuscarinics is considered. Safety 

and efficacy have not yet been established in patients with a neurogenic cause for detrusor 

overactivity.  

 

Other causes of frequent urination (treatment of heart failure or renal disease) should be assessed 

before treatment with fesoterodine. If urinary tract infection is present, an appropriate medical 

approach should be taken/antibacterial therapy should be started.  

 

Angioedema 

Angioedema has been reported with fesoterodine and has occurred after the first dose in some 

cases. If angioedema occurs, fesoterodine should be discontinued and appropriate therapy should be 

promptly provided. 

 

Potent CYP3A4 inducers 

The concomitant use of fesoterodine with a potent CYP3A4 inducer (i.e. carbamazepine, rifampicin, 

phenobarbital, phenytoin, St John’s Wort) is not recommended (see section 4.5).  

 



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QT prolongation 

TOVIAZ should be used with caution in patients with risk for QT prolongation (e.g. hypokalaemia, 

bradycardia and concomitant administration of medicines known to prolong QT interval) and 

relevant pre-existing cardiac diseases (e.g. myocardial ischaemia, arrhythmia, congestive heart 

failure), (see section 4.8). This especially holds true when taking potent CYP3A4 inhibitors (see 

sections 4.2, 4.5 and 5.1). 

 

Lactose 

TOVIAZ prolonged-release tablets contain lactose. Patients with rare hereditary problems of 

galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not 

take this medicine. 

 

4.5 Interaction with other medicinal products and other forms of interaction  

 

Pharmacological interactions 

Caution should be exercised in coadministration of fesoterodine with other antimuscarinics and 

medicinal products with anticholinergic properties (e.g. amantadine, tri-cyclic antidepressants, 

certain neuroleptics) as this may lead to more pronounced therapeutic - and side-effects (e.g. 

constipation, dry mouth, drowsiness, urinary retention). 

Fesoterodine may reduce the effect of medicinal products that stimulate the motility of the 

gastro-intestinal tract, such as metoclopramide. 

 

Pharmacokinetic interactions 

In vitro data demonstrate that the active metabolite of fesoterodine does not inhibit CYP1A2, 2B6, 

2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, or induce CYP1A2, 2B6, 2C9, 2C19, or 3A4 at clinically 

relevant plasma concentrations. Thus fesoterodine is unlikely to alter the clearance of medicinal 

products that are metabolised by these enzymes. 

 

CYP3A4 inhibitors 

 

Potent CYP3A4 inhibitors 

Following inhibition of CYP3A4 by co-administration of ketoconazole 200 mg twice daily, Cmax and 

AUC of the active metabolite of fesoterodine increased 2.0 and 2.3-fold in CYP2D6 extensive 

metabolisers and 2.1 and 2.5-fold in CYP2D6 poor metabolisers, respectively. Therefore, the 

maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent 

CYP3A4 inhibitors (e.g. atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, 

nefazodone, nelfinavir, ritonavir (and all ritonavir boosted PI-regimens), saquinavir and 

telithromycin (see sections 4.2 and 4.4)). 

 

Moderate CYP3A4 inhibitors 

Following blockade of CYP3A4 by coadministration of the moderate CYP3A4 inhibitor fluconazole 

200 mg twice a day for 2 days, Cmax and AUC of the active metabolite of fesoterodine increased 

approximately 19% and 27%, respectively. No dosing adjustments are recommended in the 

presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and 

grapefruit juice). 

 

Weak CYP3A4 inhibitors 

The effect of weak CYP3A4 inhibitors (e.g. cimetidine), was not examined; it is not expected to be 

in excess of the effect of moderate inhibitor. 

 

CYP3A4 inducers 

Following induction of CYP3A4 by coadministration of rifampicin 600 mg once a day, Cmax and 

AUC of the active metabolite of fesoterodine decreased by approximately 70% and 75%, 

respectively, after oral administration of fesoterodine 8 mg.  



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Induction of CYP3A4 may lead to subtherapeutic plasma levels. Concomitant use with CYP3A4 

inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin, St John’s Wort) is not 

recommended (see section 4.4). 

 

CYP2D6 inhibitors 

The interaction with CYP2D6 inhibitors was not tested clinically. Mean Cmax and AUC of the active 

metabolite are 1.7 and 2-fold higher, respectively, in CYP2D6 poor metabolisers as compared to 

extensive metabolisers. Co-administration of a potent CYP2D6 inhibitor may result in increased 

exposure and adverse events. A dose reduction to 4 mg may be needed (see section 4.4). 

 

Oral contraceptives 

Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception. In the 

presence of fesoterodine there are no changes in the plasma concentrations of combined oral 

contraceptives containing ethinylestradiol and levonorgestrel. 

 

Warfarin 

A clinical study in healthy volunteers has shown that fesoterodine 8 mg once daily has no significant 

effect on the pharmacokinetics or the anticoagulant activity of a single dose of warfarin. 

 

Paediatric population  

Interaction studies have only been performed in adults. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

There are no adequate data from the use of fesoterodine in pregnant women. Reproductive toxicity 

studies with fesoterodine in animals show minor embryotoxicity. In animal reproduction studies, 

oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in 

fetotoxicity at maternal exposures that were 6 and 3 times the maximum recommended human dose 

(MRHD), respectively, based on AUC (see section 5.3). The potential risk for humans is unknown. 

TOVIAZ is not recommended during pregnancy. 

 

Breast-feeding 

It is unknown whether fesoterodine/metabolites are excreted into human milk; therefore, 

breast-feeding is not recommended during treatment with TOVIAZ. 

 

Fertility 

No clinical trials have been conducted to assess the effect of fesoterodine on human fertility.  

Findings in mice at exposures approximately 5 to 19 times those at the MRHD show an effect on 

female fertility, however, the clinical implications of these animal findings are not known (see 

section 5.3). Women of child bearing potential should be made aware of the lack of human fertility 

data, and TOVIAZ should only be given after consideration of individual risks and benefits.  

 

4.7 Effects on ability to drive and use machines  

 

TOVIAZ has minor influence on the ability to drive and use machines.  

 

Caution should be exercised when driving or using machines due to possible occurrence of side 

effects such as blurred vision, dizziness, and somnolence (see section 4.8).  

 



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4.8 Undesirable effects 

 

Summary of the safety profile 

The safety of fesoterodine was evaluated in placebo-controlled clinical studies in a total of 

2859 patients with overactive bladder, of which 780 received placebo. 

 

Due to the pharmacological properties of fesoterodine, treatment may cause mild to moderate 

antimuscarinic effects like dry mouth, dry eye, dyspepsia and constipation.  Urinary retention may 

occur uncommonly. 

 

Dry mouth, the only very common adverse reactions, occurred with a frequency of 28.8% in the 

fesoterodine group compared to 8.5% in the placebo group. The majority of adverse reactions 

occurred during the first month of treatment with the exception of cases classified as urinary 

retention or post void residual urine greater than 200 ml, which could occur after long term 

treatment and was more common in male than female subjects.  

 

Tabulated list of adverse reactions 

The table below gives the frequency of treatment emergent adverse reactions from placebo-

controlled clinical trials and from post-marketing experience. The adverse reactions are reported in 

this table with the following frequency convention: very common (≥1/10), common (≥1/100 to 

<1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000). 

 

Within each frequency grouping, adverse reactions are presented in order of decreasing 

seriousness. 

 

System organ class Very common Common Uncommon Rare 

Infections and 

infestations 

 

  Urinary tract 

infection 

 

Psychiatric disorders  Insomnia  Confusional 

state 

Nervous system 

disorders 

 Dizziness; 

Headache 

Dysgeusia; 

Somnolence 

 

 

Eye disorders  Dry eye Blurred vision  

Ear and labyrinth 

disorders 

  Vertigo  

Cardiac disorders 

 

  Tachycardia; 

Palpitations 

 

Respiratory, thoracic 

and mediastinal 

disorders 

 Dry throat Pharyngolaryng

eal pain; Cough; 

Nasal dryness 

 

Gastrointestinal 

disorders 

Dry mouth Abdominal pain; 

Diarrhoea; 

Dyspepsia; 

Constipation; 

Nausea 

Abdominal 

discomfort; 

Flatulence, 

Gastroesophage

al reflux 

 

Hepatobiliary disorders 

 

  ALT increased; 

GGT increased 

 

Skin and subcutaneous 

tissue disorders 

  

 

Rash; Dry skin; 

Pruritus 

Angioedema; 

Urticaria 



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System organ class Very common Common Uncommon Rare 

Renal and urinary 

disorders 

 Dysuria Urinary 

retention 

(including 

feeling of 

residual urine; 

micturition 

disorder); 

Urinary 

hesitation 

 

General disorders and 

administration site 

conditions 

  Fatigue  

 

Description of selected adverse reactions 

In clinical trials of fesoterodine, cases of markedly elevated liver enzymes were reported with the 

occurrence frequency no different from the placebo group. The relation to fesoterodine treatment is 

unclear. 

 

Electrocardiograms were obtained from 782 patients treated with 4 mg, 785 treated with 8 mg, 222 

treated with 12 mg fesoterodine and 780 with placebo. The heart rate corrected QT interval in 

fesoterodine treated patients did not differ from that seen in placebo treated patients. The incidence 

rates of QTc 500 ms post baseline or QTc increase of 60 ms is 1.9%, 1.3%, 1.4% and 1.5%, 

for fesoterodine 4 mg, 8 mg, 12 mg and placebo, respectively. The clinical relevance of these 
findings will depend on individual patient risk factors and susceptibilities present (see section 4.4) . 

 

Post-marketing cases of urinary retention requiring catheterisation have been described, generally 

within the first week of treatment with fesoterodine. They have mainly involved elderly (≥ 65 years) 

male patients with a history consistent with benign prostatic hyperplasia (see section 4.4). 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 

 

Overdose with antimuscarinics, including fesoterodine can result in severe anticholinergic effects. 

Treatment should be symptomatic and supportive. In the event of overdose, ECG monitoring is 

recommended; standard supportive measures for managing QT prolongation should be adopted. 

Fesoterodine has been safely administered in clinical studies at doses up to 28 mg/day. 

 

In the event of fesoterodine 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 catheterisation 

- Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room. 

 



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5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: Urologicals, Urinary antispasmodics, ATC code: G04BD11. 

 

Mechanism of action 

Fesoterodine is a competitive, specific muscarinic receptor antagonist. It is rapidly and extensively 

hydrolysed by non-specific plasma esterases to the 5-hydroxymethyl derivative, its primary active 

metabolite, which is the main active pharmacological principle of fesoterodine.  

 

Clinical efficacy and safety 

The efficacy of fixed doses of fesoterodine 4 mg and 8 mg was evaluated in two Phase 3 

randomised, double-blind, placebo-controlled, 12-week studies. Female (79%) and male (21%) 

patients with a mean age of 58 years (range 19-91 years) were included. A total of 33% of patients 

were ≥65 years of age and 11% were ≥75 years of age. 

 

Fesoterodine treated patients had statistically significant mean reductions in the number of 

micturitions per 24 hours and in the number of urge incontinence episodes per 24 hours at the end 

of treatment compared to placebo. Likewise, the response rate (% of patients reporting that their 

condition has been “greatly improved” or “improved” using a 4-point Treatment Benefit Scale) was 

significantly greater with fesoterodine compared to placebo. Furthermore, fesoterodine improved 

the mean change in the voided volume per micturition, and the mean change in the number of 

continent days per week (see Table 1 below). 

 

Table 1: Mean changes from Baseline to end of treatment for primary and selected 

secondary endpoints 

 Study 1 Study 2 

Parameter Placebo Fesoterodine 

4 mg 

Fesoterodine 

8 mg 

Active 

comparator 

Placebo Fesoterodine 

4 mg 

Fesoterodine 

8 mg 

Number of micturitions per 24 hours# 

 N=279 N=265 N=276 N=283 N=266 N=267 N=267 

Baseline 12.0 11.6 11.9 11.5 12.2 12.9 12.0 

Change from 

baseline 

-1.02 -1.74 -1.94 -1.69 -1.02 -1.86 -1.94 

p-value  <0.001 <0.001   0.032 <0.001 

Responder rate (treatment response)# 

 N=279 N=265 N=276 N=283 N=266 N=267 N=267 

Responder 

rate 

53.4% 74.7% 79.0% 72.4% 45.1% 63.7% 74.2% 

p-value  <0.001 <0.001   <0.001 <0.001 

Number of urge incontinence episodes per 24 hours 

 N=211 N=199 N=223 N=223 N=205 N=228 N=218 

Baseline 3.7 3.8 3.7 3.8 3.7 3.9 3.9 

Change from 

baseline 

-1.20 -2.06 -2.27 -1.83 -1.00 -1.77 -2.42 

p-value  0.001 <0.001   0.003 <0.001 



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Number of continent days per week  

 N=211 N=199 N=223 N=223 N=205 N=228 N=218 

Baseline 0.8 0.8 0.6 0.6 0.6 0.7 0.7 

Change from 

baseline 

2.1 2.8 3.4 2.5 1.4 2.4 2.8 

p-value  0.007 <0.001   <0.001  <0.001 

Voided volume per micturition (ml) 

 N=279 N=265 N=276 N=283 N=266 N=267 N=267 

Baseline 150 160 154 154 159 152 156 

Change from 

baseline 

10 27 33 24 8 17 33 

p-value  <0.001 <0.001   0.150 <0.001 

 

# primary end points 

 

Cardiac electrophysiology 

The effect of fesoterodine 4 mg and 28 mg on the QT interval was thoroughly evaluated in a 

double-blind, randomised, placebo- and positive-controlled (moxifloxacin 400 mg) parallel group 

study with once-daily treatment over a period of 3 days in 261 male and female subjects aged 45 to 

65 years. Change from baseline in QTc based on the Fridericia correction method did not show any 

differences between the active treatment and placebo group. 

 

5.2 Pharmacokinetic properties 

 

Absorption 

After oral administration, due to rapid and extensive hydrolysis by non-specific plasma esterases, 

fesoterodine was not detected in plasma.  

 

Bioavailability of the active metabolite is 52%. After single or multiple-dose oral administration of 

fesoterodine in doses from 4 mg to 28 mg, plasma concentrations of the active metabolite are 

proportional to the dose. Maximum plasma levels are reached after approximately 5 hours. 

Therapeutic plasma levels are achieved after the first administration of fesoterodine. No 

accumulation occurs after multiple-dose administration. 

 

Distribution 

Plasma protein binding of the active metabolite is low with approximately 50% bound to albumin 

and alpha-1-acid glycoprotein. The mean steady-state volume of distribution following intravenous 

infusion of the active metabolite is 169 l. 

 

Biotransformation 

After oral administration, fesoterodine is rapidly and extensively hydrolysed to its active metabolite. 

The active metabolite is further metabolised in the liver to its carboxy, carboxy-N-desisopropyl, and 

N-desisopropyl metabolite with involvement of CYP2D6 and CYP3A4. None of these metabolites 

contribute significantly to the antimuscarinic activity of fesoterodine. Mean Cmax and AUC of the 

active metabolite are 1.7 and 2-fold higher, respectively, in CYP2D6 poor metabolisers as compared 

to extensive metabolisers. 

 

Elimination 

Hepatic metabolism and renal excretion contribute significantly to the elimination of the active 

metabolite. After oral administration of fesoterodine, approximately 70% of the administered dose 

was recovered in urine as the active metabolite (16%), carboxy metabolite (34%), 



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carboxy-N-desisopropyl metabolite (18%), or N-desisopropyl metabolite (1%), and a smaller 

amount (7%) was recovered in faeces. The terminal half-life of the active metabolite following oral 

administration is approximately 7 hours and is absorption rate-limited. 

 

Age and gender 

No dose adjustment is recommended in these subpopulations. The pharmacokinetics of fesoterodine 

are not significantly influenced by age and gender. 

 

Paediatric population 

The pharmacokinetics of fesoterodine have not been evaluated in paediatric patients.  

 

Renal impairment 

In patients with mild or moderate renal impairment (GFR 30 – 80 ml/min), Cmax and AUC of the 

active metabolite increased up to 1.5 and 1.8-fold, respectively, as compared to healthy subjects. In 

patients with severe renal impairment (GFR < 30 ml/min), Cmax and AUC are increased 2.0 and 

2.3-fold, respectively.  

 

Hepatic impairment 

In patients with moderate hepatic impairment (Child Pugh B), Cmax and AUC of the active metabolite 

increased 1.4 and 2.1-fold, respectively, as compared to healthy subjects. Pharmacokinetics of 

fesoterodine in patients with severe hepatic impairment have not been studied.  

 

5.3 Preclinical safety data 

 

In non-clinical safety pharmacology, general toxicity, genotoxicity and carcinogenicity studies no 

clinically relevant effects have been observed, except those related to the pharmacological effect of 

the active substance. 

 

Reproduction studies have shown minor embryotoxicity at doses close to maternally toxic ones 

(increased number of resorptions, pre-implantation and post-implantation losses). 

 

Supratherapeutic concentrations of the active metabolite of fesoterodine, have been shown to inhibit 

K+ current in cloned human ether-à-go-go-related gene (hERG) channels and prolong action 

potential duration (70% and 90% repolarisation) in canine isolated Purkinje fibres. However in 

conscious dogs, the active metabolite had no effect on the QT interval and QTc interval at plasma 

exposures at least 33-fold higher than mean peak free plasma concentration in human subjects who 

are extensive metabolisers and 21-fold higher than measured in subjects who are poor CYP2D6 

metabolisers after fesoterodine 8 mg once daily. 

 

In a study of fertility and early embryonic development in mice, fesoterodine had no effect on male 

reproductive function or fertility at doses up to 45 mg/kg/day. At 45 mg/kg/day, a lower number of 

corpora lutea, implantation sites and viable foetuses was observed in female mice administered 

fesoterodine for 2 weeks prior to mating and continuing through day 7 of gestation. The maternal 

No-Observed-Effect Level (NOEL) and the NOEL for effects on reproduction and early embryonic 

development were both 15 mg/kg/day. Based on AUC, the systemic exposure was 0.6 to 1.5 times 

higher in mice than in humans at the MRHD, whereas based on peak plasma concentrations, the 

exposure in mice was 5 to 9 times higher. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Tablet core 

Xylitol 

Lactose monohydrate 



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Microcrystalline cellulose 

Hypromellose 

Glycerol dibehenate 

Talc 

 

Film-coating 

Poly(vinyl alcohol) 

Titanium dioxide (E171) 

Macrogol (3350) 

Talc 

Soya lecithin 

Indigo carmine aluminium lake (E132) 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

2 years 

 

6.4 Special precautions for storage  

 

Do not store above 25C. 

Store in the original package in order to protect from moisture. 

 

6.5 Nature and contents of container 

 

TOVIAZ 4 mg and 8 mg tablets are packed in aluminium-aluminium blisters in cartons containing 7, 

14, 28, 30, 56, 84, 98 or 100 tablets. In addition, TOVIAZ 4 mg and 8 mg tablets are also packed in 

HDPE bottles containing 30 or 90 tablets.  

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal  

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

TOVIAZ 4 mg tablets 

EU/1/07/386/001-005 

EU/1/07/386/011 

EU/1/07/386/013-014 



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EU/1/07/386/017 

EU/1/07/386/019 

 

TOVIAZ 8 mg tablets  

EU/1/07/386/006-010 

EU/1/07/386/012 

EU/1/07/386/015-016 

EU/1/07/386/018 

EU/1/07/386/020 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 20 April 2007 

Date of latest renewal: 15 March 2012 

 

 

10. DATE OF REVISION OF THE TEXT 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu.  



14 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER(S)RESPONSIBLE FOR BATCH 

RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturers responsible for batch release 

 

R-Pharm Germany GmbH 

Heinrich-Mack-Str. 35, 89257 Illertissen 

Germany 

 

Pfizer Manufacturing Deutschland GmbH 

Betriebsstätte Freiburg 

Mooswaldallee 1  

79090 Freiburg 

Germany 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription. 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

• Periodic Safety Update Reports  
 

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

 

D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT 

 

• Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in 

the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 

subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 

as the result of an important (pharmacovigilance or risk minimisation) milestone being 

reached. 

 



16 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



17 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



18 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

Outer carton 4 mg 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

TOVIAZ 4 mg prolonged-release tablets 

fesoterodine fumarate 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 4 mg fesoterodine fumarate 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose and soya lecithin: see the package leaflet for further information.  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

7 prolonged-release tablets 

14 prolonged-release tablets 

28 prolonged-release tablets 

30 prolonged-release tablets 

56 prolonged-release tablets 

84 prolonged-release tablets 

98 prolonged-release tablets 

100 prolonged-release tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

  

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Sealed pack 

Do not use if box has been opened 

 



19 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25oC.  

Store in the original package in order to protect from moisture.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/07/386/001 7 prolonged-release tablets 

EU/1/07/386/002 14 prolonged-release tablets 

EU/1/07/386/003 28 prolonged-release tablets 

EU/1/07/386/019 30 prolonged-release tablets 

EU/1/07/386/004 56 prolonged-release tablets 

EU/1/07/386/005 98 prolonged-release tablets 

EU/1/07/386/011 84 prolonged-release tablets 

EU/1/07/386/017 100 prolonged-release tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 



20 

16. INFORMATION IN BRAILLE 

 

TOVIAZ 4 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE   

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN:  

 



21 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister label 4 mg 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

TOVIAZ 4 mg prolonged-release tablets 

fesoterodine fumarate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG (as MA Holder logo) 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

Monday 

Tuesday 

Wednesday 

Thursday 

Friday 

Saturday 

Sunday 



22 

 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

Immediate packaging HDPE Bottle – 4 mg 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

TOVIAZ 4 mg prolonged-release tablets 

fesoterodine fumarate 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 4 mg fesoterodine fumarate 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose and soya lecithin: see the package leaflet for further information.  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

30 prolonged-release tablets 

90 prolonged-release tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



23 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25oC.  

Store in the original package in order to protect from moisture.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/07/386/013 30 prolonged-release tablets 

EU/1/07/386/014 90 prolonged-release tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE   

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



24 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Outer carton 8 mg 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

TOVIAZ 8 mg prolonged-release tablets 

fesoterodine fumarate 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 8 mg fesoterodine fumarate 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose and soya lecithin: see the package leaflet for further information.  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

7 prolonged-release tablets 

14 prolonged-release tablets 

28 prolonged-release tablets 

30 prolonged-release tablets 

56 prolonged-release tablets 

84 prolonged-release tablets 

98 prolonged-release tablets 

100 prolonged-release tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Sealed pack 

Do not use if box has been opened 

 



25 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25oC.  

Store in the original package in order to protect from moisture.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/07/386/006 7 prolonged-release tablets 

EU/1/07/386/007 14 prolonged-release tablets 

EU/1/07/386/008 28 prolonged-release tablets 

EU/1/07/386/020 30 prolonged-release tablets 

EU/1/07/386/009 56 prolonged-release tablets 

EU/1/07/386/010 98 prolonged-release tablets 

EU/1/07/386/012 84 prolonged-release tablets 

EU/1/07/386/018 100 prolonged-release tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 



26 

16. INFORMATION IN BRAILLE 

 

TOVIAZ 8 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE   

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN:  

 

 



27 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister label 8 mg 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

TOVIAZ 8 mg prolonged-release tablets 

fesoterodine fumarate 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG (as MA Holder logo) 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

Monday 

Tuesday 

Wednesday 

Thursday 

Friday 

Saturday 

Sunday 



28 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 

PACKAGING 

 

Immediate Packaging HDPE Bottle – 8 mg 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

TOVIAZ 8 mg prolonged-release tablets 

fesoterodine fumarate 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 8 mg fesoterodine fumarate 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose and soya lecithin: see the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

30 prolonged-release tablets 

90 prolonged-release tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



29 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25oC.  

Store in the original package in order to protect from moisture.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/07/386/015 30 prolonged-release tablets 

EU/1/07/386/016 90 prolonged-release tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE   

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 



30 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



31 

Package leaflet: Information for the user 

 

TOVIAZ 4 mg prolonged-release tablets 

TOVIAZ 8 mg prolonged-release tablets 

fesoterodine fumarate 

 

Read all of this leaflet carefully before you start taking this medicine  because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor or pharmacist.  

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm 

them, even if their signs of illness are the same as yours. 

- If you get any side effects talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What TOVIAZ is and what it is used for 

2. What you need to know before you take TOVIAZ 

3. How to take TOVIAZ 

4. Possible side effects 

5. How to store TOVIAZ 

6. Contents of the pack and other information 

 

 

1. What TOVIAZ is and what it is used for 

 

TOVIAZ contains an active substance called fesoterodine fumarate, and is a so called 

antimuscarinic treatment which reduces the activity of an overactive bladder and it is used in adults 

to treat the symptoms.  

 

TOVIAZ treats the symptoms of an overactive bladder such as  

• not being able to control when you empty your bladder (called urgency incontinence) 

• suddenly needing to empty your bladder (called urgency) 

• having to empty your bladder more often than usual (called increased urinary frequency) 

 

 

2. What you need to know before you take TOVIAZ 

 

Do not take TOVIAZ: 

- if you are allergic to fesoterodine or to peanut or soya or to any of the other ingredients of 

TOVIAZ (listed in section 6) (see section 2, “TOVIAZ contains lactose and soya oil”) 

- if you are not able to completely empty your bladder (urinary retention) 

- if your stomach empties slowly (gastric retention) 

- if you have an eye disease called narrow angle glaucoma (high pressure in the eye), which is 

not under control 

- if you have excessive weakness of the muscles (myasthenia gravis) 

- if you have ulceration and inflammation of the colon (severe ulcerative colitis) 

- if you have an abnormally large or distended colon (toxic megacolon) 

- if you have severe liver problems. 

- if you have kidney problems or moderate to severe liver problems and are taking medicines 

containing any of the following active substances: itraconazole or ketoconazole (used to treat 

fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicine 



32 

for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections) and 

nefazodone (used to treat depression) 

 

Warnings and Precautions 

Fesoterodine may not always be suitable for you. Talk to your doctor before taking TOVIAZ, if any 

of the following apply to you: 

- if you have difficulties in completely emptying your bladder (for example due to prostate 

enlargement) 

- if you ever experience decreased bowel movements or suffer from severe constipation 

- if you are being treated for an eye disease called narrow angle glaucoma 

- if you have serious kidney or liver problems, your doctor may need to adjust your dose 

- if you have a disease called autonomic neuropathy which you notice from symptoms such as 

changes in your blood pressure or disorders in the bowel or sexual function 

- if you have a gastrointestinal disease that affects the passage and/or digestion of food 

- if you have heartburn or belching.  

- if you have an infection of the urinary tract, your doctor may need to prescribe some 

antibiotics  

 

Heart problems: Talk to your doctor if you suffer from any of the following conditions 

- you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking 

any medicine known to cause this 

- you have a slow heart rate (bradycardia) 

- you suffer from heart disease such as myocardial ischaemia (reduced blood flow to the heart 

muscle), irregular heartbeat or heart failure 

- you have hypokalaemia, which is a manifestation of abnormally low levels of potassium in 

your blood. 

 

Children and adolescents 

Do not give this medicine to children and adolescents below 18 years of age because it is yet to be 

established whether it would work for them and whether it would be safe. 

 

Other medicines and TOVIAZ 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. Your doctor will tell you whether you can take TOVIAZ with other medicines. 

 

Please inform your doctor if you are taking medicines according to the following list. Taking them 

at the same time as fesoterodine may make side effects such as dry mouth, constipation, difficulty 

in completely emptying your bladder or drowsiness more serious or occur more often.  

- medicines containing the active substance amantadine (used to treat Parkinson’s disease) . 

- certain medicines used to enhance gastrointestinal motility or to relieve stomach cramps or 

spasm and to prevent travel sickness like medicines containing metoclopramide. 

- certain medicines used to treat psychiatric diseases, like anti-depressives and neuroleptics. 

 

Please also inform your doctor if you are taking any of the following medicines: 

- medicines containing any of the following active substances may increase the break-down of 

fesoterodine and thus decrease its effect: St. John’s Wort (herbal medicinal product), 

rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital 

(used, among others, to treat epilepsy).  

- medicines containing any of the following active substances may increase the blood levels of 

fesoterodine: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, 

atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicine for treating HIV), 

clarithromycin or telithromycin (used to treat bacterial infections), nefazodone (used to treat 

depression), fluoxetine or paroxetine (used to treat depression or anxiety), bupropion (used 



33 

for smoking cessation or to treat depression), quinidine (used to treat arrhythmias) and 

cinacalcet (used to treat hyperparathyroidism). 

- medicines containing the active substance methadone (used in the treatment of severe pain 

and abuse problems). 

 

Pregnancy and breast-feeding 

You should not take TOVIAZ if you are pregnant, as the effects of fesoterodine on pregnancy and 

the unborn baby are not known. 

 

It is not known whether fesoterodine is excreted into human milk; therefore, do not breast-feed 

during treatment with TOVIAZ.  

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 

ask your doctor or pharmacist for advice before taking this medicine. 

 

Driving and using machines 

TOVIAZ can cause blurred vision, dizziness, and sleepiness. If you experience any of these effects, 

do not drive or use any tools or machines. 

 

TOVIAZ contains lactose and soya oil 

TOVIAZ contains lactose. If you have been told by your doctor that you have an intolerance to 

some sugars, contact your doctor before taking this medicinal product. 

 

TOVIAZ contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.  

 

 

3. How to take TOVIAZ 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or 

pharmacist if you are not sure. 

 

The recommended starting dose of TOVIAZ is one 4 mg tablet a day. Based on how you respond to 

the medicine, your doctor may prescribe you a higher dose; one 8 mg tablet a day.  

 

You should swallow your tablet whole with a glass of water. Do not chew the tablet.  TOVIAZ can 

be taken with or without food. 

 

To help you remember to take your medicine, you may find it easier to take it at the same time 

every day. 

 

If you take more TOVIAZ than you should 

If you have taken more tablets than you have been told to take, or if someone else accidentally takes 

your tablets, contact your doctor or hospital for advice immediately. Show them your pack of 

tablets. 

 

If you forget to take TOVIAZ 

If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than 

one tablet in one day. Do not take a double dose to make up for a forgotten tablet.  

 

If you stop taking TOVIAZ 

Do not stop taking TOVIAZ without talking to your doctor, as your symptoms of overactive 

bladder may come back again or become worse once you stop taking TOVIAZ. 

 



34 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them.  

 

Some side effects could be serious 

Serious allergic reactions including angioedema occurred rarely. You should stop taking TOVIAZ 

and contact your doctor immediately if you develop swelling of the face, mouth or throat.  

 

Other side effects 

 

Very common (may affect more than 1 in 10 people) 

You may get a dry mouth. This effect is usually mild or moderate. This may lead to a greater risk of 

dental caries. Therefore, you should brush your teeth regularly twice daily and see a dentist when in 

doubt.  

 

Common (may affect up to 1 in 10 people) 

• dry eye 

• constipation 

• trouble digesting food (dyspepsia) 

• straining or pain when emptying the bladder (dysuria) 

• dizziness 

• headache 

• pain in the stomach 

• diarrhoea 

• feeling sick (nausea) 

• difficulty sleeping (insomnia) 

• dry throat 

 

Uncommon (may affect up to 1 in 100 people) 

• urinary tract infection 

• sleepiness (somnolence) 

• difficulty tasting (dysgeusia) 

• vertigo 

• rash 

• dry skin 

• itching 

• an uncomfortable feeling in the stomach 

• wind (flatulence) 

• difficulty in completely emptying the bladder (urinary retention) 

• delay in passing urine (urinary hesitation) 

• extreme tiredness (fatigue) 

• increased heart beat (tachycardia) 

• palpitations 

• liver problems 

• cough 

• nasal dryness 

• throat pain 

• stomach acid reflux 

• blurred vision 

 



35 

Rare (may affect up to 1 in 1,000 people) 

• urticaria 

• confusion 

 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store TOVIAZ 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and the blister after 

“EXP”. The expiry date refers to the last day of that month. 

 

Do not store above 25C. 

 

Store in the original package in order to protect from moisture.  

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 

to throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What TOVIAZ contains 

 

• The active substance is fesoterodine fumarate. 

 

TOVIAZ 4 mg 

Each prolonged-release tablet contains 4 mg fesoterodine fumarate, equivalent to 3.1 mg of 

fesoterodine. 

TOVIAZ 8 mg 

Each prolonged-release tablet contains 8 mg fesoterodine fumarate, equivalent to 6.2 mg of 

fesoterodine. 

 

• The other ingredients are: 

 

The tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol 

dibehenate, talc. 

The coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soya lecithin, indigo 

carmine aluminium lake (E132). 

 

What TOVIAZ looks like and contents of the pack  

 

TOVIAZ 4 mg prolonged-release tablets are light blue, oval, curved outwards on both sides, film-

coated tablets, and engraved on one side with the letters ‘FS’.  

 

TOVIAZ 8 mg prolonged-release tablets are blue, oval, curved outwards on both sides, film-coated 

tablets, and engraved on one side with the letters ‘FT’. 



36 

 

TOVIAZ is available in blister packs of 7, 14, 28, 30, 56, 84, 98 and 100 prolonged-release tablets. In 

addition, TOVIAZ is also available in HDPE bottles containing 30 or 90 tablets. 

 

Please note that not all the above pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer 

 

Marketing Authorisation Holder: 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

Manufacturer: 

 

R-Pharm Germany GmbH 

Heinrich-Mack-Str. 35, 89257 Illertissen 

Germany 

 

Pfizer Manufacturing Deutschland GmbH 

Betriebsstätte Freiburg 

Mooswaldallee 1  

79090 Freiburg 

Germany 

  

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België /Belgique / Belgien 

Pfizer S.A./ N.V. 

Tél/Tel: +32 (0)2 554 62 11 

 

Luxembourg/Luxemburg 

Pfizer S.A. 

Tél/Tel: +32 (0)2 554 62 11 

 

България  

Пфайзер Люксембург САРЛ, Клон България 

Тел.: +359 2 970 4333 

 

Magyarország 

Pfizer Kft.  

Tel.: + 36 1 488 37 00  

 

Česká Republika 

Pfizer PFE, spol. s r.o.  

Tel: +420 283 004 111 

 

Malta 

Vivian Corporation Ltd. 

Tel: +356 21344610 

Danmark 

Pfizer ApS 

Tlf: +45 44 20 11 00 

 

Nederland 

Pfizer bv 

Tel: +31 (0)10 406 43 01 

 

Deutschland 

Pfizer Pharma GmbH 

Tel: +49 (0)30 550055 51000 

 

Norge 

Pfizer Norge AS 

Tlf: +47 67 52 61 00 

 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal 

Tel: +372 666 7500 

 

Österreich 

Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

 



37 

Ελλάδα 

Pfizer Ελλάς A.E. 

Τλ: +30 210 6785800 

 

Polska 

Pfizer Polska Sp. z o.o.  

Tel.: +48 22 335 61 00 

 

España 

Pfizer S.L. 

Tel: +34 91 490 99 00 

 

Portugal 

Pfizer Biofarmacêutica, Sociedade Unipessoal Lda  

Tel: +351 21 423 5500 

 

France 

Pfizer 

Tél: +33 (0)1 58 07 34 40 

 

România 

Pfizer România S.R.L. 

Tel: +40 (0)21 207 28 00 

 

Hrvatska 

Pfizer Croatia d.o.o. 

Tel: +385 1 3908 777 

 

Slovenija 

Pfizer Luxembourg SARL, Pfizer, podružnica za 

svetovanje s področja farmacevtske dejavnosti, 

Ljubljana 

Tel: + 386 (0)1 52 11 400 

 

Ireland 

Pfizer Healthcare Ireland 

 

Tel: 1800 633 363 (toll free) 

Tel: +44 (0)1304 616161 

 

Slovenská republika 

Pfizer Luxembourg SARL, organizačná zložka 

Tel: +421–2–3355 5500 

 

Ísland 

Icepharma hf. 

Sími: + 354 540 8000 

 

Suomi/Finland 

Pfizer Oy 

Puh/Tel: +358(0)9 43 00 40 

 

Italia 

Pfizer S.r.l. 

Tel: +39 06 33 18 21 

 

Sverige  

Pfizer Innovations AB 

Tel: +46 (0)8 550 520 00 

 

Κύπρος 

Pfizer Ελλάς A.E. (Cyprus Branch)  

Τηλ: +357 22 817690 

 

United Kingdom 

Pfizer Limited 

Tel: +44 (0)1304 616161 

 

Latvija 

Pfizer Luxembourg SARL, filiāle Latvijā 

Tel: +371 670 35 775 

 

 

Lietuva 

Pfizer Luxembourg SARL, filialas Lietuvoje 

Tel. +3705 2514000 

 

 

 

This leaflet was last revised in 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu.  


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET