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VESICARE 1 MG/ML ORAL SUSPENSION

Active substance(s): SOLIFENACIN SUCCINATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Vesicare 1 mg/ml oral suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Vesicare oral suspension contains 1 mg/ml solifenacin succinate, equivalent to
0.75 mg/ml solifenacin.
Excipients with known effect:
Methyl parahydroxybenzoate (E218) 1.6 mg/ml
Propyl parahydroxybenzoate (E216) 0.2 mg/ml
This medicinal product contains small amounts of ethanol (alcohol), less than
100 mg per maximum daily dose (10 ml Vesicare oral suspension). Ethanol
originates from the natural orange flavour.
For the full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Oral suspension
A white to off-white coloured aqueous, homogeneous suspension with an orange
flavour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Symptomatic treatment of urge incontinence and/or increased urinary
frequency and urgency as may occur in patients with overactive bladder
syndrome.

4.2

Posology and method of administration

Posology
Adults, including elderly
The recommended dose is 5 mg (5 ml) solifenacin succinate once daily. If needed, the
dose may be increased to 10 mg (10 ml) solifenacin succinate once daily.

Patients with renal impairment
No dose adjustment is necessary for patients with mild to moderate renal impairment
(creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine
clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5 mg
(5 ml) once daily (see Section 5.2).
Patients with hepatic impairment
No dose adjustment is necessary for patients with mild hepatic impairment. Patients
with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with
caution and receive no more than 5 mg (5 ml) once daily (see Section 5.2).
Potent inhibitors of cytochrome P450 3A4
The maximum dose of Vesicare should be limited to 5 mg (5 ml) when treated
simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4inhibitors e.g. ritonavir, nelfinavir, itraconazole (see Section 4.5).
Paediatric population
The efficacy of Vesicare in children and adolescents has not yet been established.
Therefore, Vesicare should not be used in children and adolescents under 18 years of
age. Currently available data are described in Section 5.1 and 5.2.
Method of administration
Vesicare oral suspension should be taken orally followed by a glass of water. It should
not be ingested together with food and/or other drinks. This ingestion with food
and/or drinks may cause a release of solifenacin in the mouth resulting in a bitter taste
and a feeling of numbness in the mouth.
An appropriate oral syringe should be selected to measure the correct dose (see
Section 6.6).
4.3

Contraindications
Solifenacin is contraindicated in patients with urinary retention, severe gastrointestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle
glaucoma and in patients at risk for these conditions.
Patients hypersensitive to the active substance or to any of the excipients
listed in 6.1.
-

Patients undergoing haemodialysis (see Section 5.2).

-

Patients with severe hepatic impairment (see Section 5.2).

Patients with severe renal impairment or moderate hepatic impairment and
who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole (see Section
4.5).

4.4

Special warnings and precautions for use

Other causes of frequent urination (heart failure or renal disease) should be
assessed before treatment with Vesicare. If urinary tract infection is present, an
appropriate antibacterial therapy should be started.
Vesicare should be used with caution in patients with:
clinically significant bladder outflow obstruction at risk of urinary
retention.
gastrointestinal obstructive disorders.
risk of decreased gastrointestinal motility.
severe renal impairment (creatinine clearance ≤ 30 ml/min; see Section
4.2 and 5.2), and doses should not exceed 5 mg (5 ml) for these patients.
moderate hepatic impairment (Child-Pugh score of 7 to 9; see Section 4.2
and 5.2), and doses should not exceed 5 mg (5 ml) for these patients.
concomitant use of a potent CYP3A4 inhibitor, e.g. ketoconazole (see 4.2
and 4.5).
hiatus hernia/gastro-oesophageal reflux and/or who are concurrently
taking medicinal products (such as bisphosphonates) that can cause or
exacerbate oesophagitis.
autonomic neuropathy.
QT prolongation and Torsade de Pointes have been observed in patients with
risk factors, such as pre-existing long QT syndrome and hypokalaemia.
Safety and efficacy have not yet been established in patients with a neurogenic
cause for detrusor overactivity.
Angioedema with airway obstruction has been reported in some patients on solifenacin
succinate. If angioedema occurs, solifenacin succinate should be discontinued and
appropriate therapy and/or measures should be taken.

Anaphylactic reaction has been reported in some patients treated with
solifenacin succinate. In patients who develop anaphylactic reactions,
solifenacin succinate should be discontinued and appropriate therapy and/or
measures should be taken.
The maximum effect of Vesicare can be determined after 4 weeks at the earliest.
Vesicare oral suspension contains methyl parahydroxybenzoate and propyl
parahydroxybenzoate. This may cause allergic reactions (possibly delayed).
Vesicare oral suspension contains small amounts of ethanol (alcohol), less than
100 mg per maximum daily dose (10 ml Vesicare oral suspension).

4.5

Interaction with other medicinal products and other forms of interaction
Pharmacological interactions
Concomitant medication with other medicinal products with anticholinergic
properties may result in more pronounced therapeutic effects and undesirable

effects. An interval of approximately one week should be allowed after
stopping treatment with Vesicare, before commencing other anticholinergic
therapy. The therapeutic effect of solifenacin may be reduced by concomitant
administration of cholinergic receptor agonists.
Solifenacin can reduce the effect of medicinal products that stimulate the
motility of the gastro-intestinal tract, such as metoclopramide and cisapride.
Pharmacokinetic interactions
In vitro studies have demonstrated that at therapeutic concentrations,
solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from
human liver microsomes. Therefore, solifenacin is unlikely to alter the
clearance of drugs metabolised by these CYP enzymes.
Effect of other medicinal products on the pharmacokinetics of solifenacin
Solifenacin is metabolised by CYP3A4. Simultaneous administration of
ketoconazole (200 mg/day), a potent CYP3A4 inhibitor, resulted in a two-fold
increase of the AUC of solifenacin, while ketoconazole at a dose of 400
mg/day resulted in a three-fold increase of the AUC of solifenacin. Therefore,
the maximum dose of Vesicare should be restricted to 5 mg (5 ml), when used
simultaneously with ketoconazole or therapeutic doses of other potent
CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole) (see Section 4.2).
Simultaneous treatment of solifenacin and a potent CYP3A4 inhibitor is
contra-indicated in patients with severe renal impairment or moderate hepatic
impairment.
The effects of enzyme induction on the pharmacokinetics of solifenacin and its
metabolites have not been studied as well as the effect of higher affinity
CYP3A4 substrates on solifenacin exposure. Since solifenacin is metabolised
by CYP3A4, pharmacokinetic interactions are possible with other CYP3A4
substrates with higher affinity (e.g. verapamil, diltiazem) and CYP3A4
inducers (e.g. rifampicin, phenytoin, carbamazepin).
Effect of solifenacin on the pharmacokinetics of other medicinal products
Oral Contraceptives
Intake of Vesicare showed no pharmacokinetic interaction of solifenacin on
combined oral contraceptives (ethinylestradiol/levonorgestrel).
Warfarin
Intake of Vesicare did not alter the pharmacokinetics of R-warfarin or
S-warfarin or their effect on prothrombin time.
Digoxin
Intake of Vesicare showed no effect on the pharmacokinetics of digoxin.

4.6

Fertility, pregnancy and lactation

Pregnancy
No clinical data are available from women who became pregnant while taking
solifenacin. Animal studies do not indicate direct harmful effects on fertility,
embryonal / foetal development or parturition (see Section 5.3). The potential risk for

humans is unknown. Caution should be exercised when prescribing to pregnant
women.
Breast-feeding
No data on the excretion of solifenacin in human milk are available. In mice,
solifenacin and/or its metabolites was excreted in milk, and caused a dose dependent
failure to thrive in neonatal mice (see Section 5.3). The use of Vesicare should
therefore be avoided during breast-feeding.
Fertility
There are no clinical data available on effect of solifenacin on fertility. No effects on
fertility were observed in animals.
4.7

Effects on ability to drive and use machines
Since solifenacin, like other anticholinergics may cause blurred vision, and,
uncommonly, somnolence and fatigue (see Section 4.8 Undesirable effects),
the ability to drive and use machines may be negatively affected.

4.8

Undesirable effects
Summary of the safety profile
Due to the pharmacological effect of solifenacin, Vesicare may cause
anticholinergic undesirable effects of (in general) mild or moderate severity.
The frequency of anticholinergic undesirable effects is dose related.
The most commonly reported adverse reaction with Vesicare was dry mouth.
It occurred in 11% of patients treated with 5 mg once daily, in 22% of patients
treated with 10 mg once daily and in 4% of placebo-treated patients. The
severity of dry mouth was generally mild and did only occasionally lead to
discontinuation of treatment. In general, medicinal product compliance was
very high (approximately 99%) and approximately 90% of the patients treated
with Vesicare completed the full study period of 12 weeks treatment.

Tabulated list of adverse reactions in adults

MedDRA
system organ
class

Very
common
≥1/10

Common
≥1/100,
<1/10

Infections and
infestations

Uncommon
Rare
≥1/1000, ≥ 1/10000,
<1/100
<1/1000

Anaphylactic
reaction*
Decreased
appetite*
Hyperkalaemia*
Hallucinations* Delirium*
Confusional
state*

Blurred
vision

Somnolence Dizziness*,
Dysgeusia Headache*
Dry eyes

Glaucoma*

Cardiac
disorders

Respiratory,
thoracic and
mediastinal
disorders
Gastrointestinal Dry
disorders
mouth

Torsade de
Pointes*
Electrocardiogram
QT prolonged*
Atrial fibrillation*
Palpitations*
Tachycardia*
Dysphonia*

Nasal
dryness

Constipation
Nausea
Dyspepsia
Abdominal
pain

Gastrooesophageal
reflux
diseases
Dry throat

Colonic
obstruction
Faecal
impaction,
Vomiting*

Ileus*
Abdominal
discomfort*

Hepatobiliary
disorders
Skin and
subcutaneous
tissue disorders
Musculoskeletal
and connective
tissue disorders
Renal and
urinary
disorders

Not known
(cannot be
estimated from
the available
data)

Urinary
tract
infection
Cystitis

Immune system
disorders
Metabolism and
nutrition
disorders
Psychiatric
disorders
Nervous system
disorders
Eye disorders

Very rare
<1/10,000

Dry skin

Pruritus*,
Rash*,

Erythema
multiforme* ,
Urticaria*
Angioedema*

Liver disorder*
Liver function test
abnormal*
Exfoliative
dermatitis*

Muscular
weakness*
Difficulty
in
micturition

Urinary
retention

Renal
impairment*

MedDRA
system organ
class

Very
common
≥1/10

Common
≥1/100,
<1/10

General
disorders and
administration
site conditions

Uncommon
Rare
≥1/1000, ≥ 1/10000,
<1/100
<1/1000

Very rare
<1/10,000

Not known
(cannot be
estimated from
the available
data)

Fatigue
Peripheral
oedema

*observed post-marketing
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
4.9

Overdose
Symptoms
Overdosage with solifenacin succinate can potentially result in severe
anticholinergic effects. The highest dose of solifenacin succinate accidentally
given to a single patient was 280 mg in a 5 hour period, resulting in mental
status changes not requiring hospitalization.
Treatment
In the event of overdose with solifenacin succinate the patient should be
treated with activated charcoal. Gastric lavage is useful if performed within 1
hour, but vomiting should not be induced.
As for other anticholinergics, symptoms can be treated as follows:
Severe central anticholinergic effects such as hallucinations or
pronounced excitation: treat with physostigmine or carbachol.
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.
As with other antimuscarinics, in case of overdosing, specific attention should
be paid to patients with known risk for QT-prolongation (i.e. hypokalaemia,
bradycardia and concurrent administration of medicinal products known to
prolong QT-interval) and relevant pre-existing cardiac diseases (i.e.
myocardial ischaemia, arrhythmia, congestive heart failure).

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, Drugs for urinary frequency and
incontinence, ATC code: G04B D08.
Mechanism of action
Solifenacin is a competitive, specific cholinergic-receptor antagonist.
The urinary bladder is innervated by parasympathetic cholinergic nerves.
Acetylcholine contracts the detrusor smooth muscle through muscarinic
receptors of which the M3 subtype is predominantly involved. In vitro and in
vivo pharmacological studies indicate that solifenacin is a competitive
inhibitor of the muscarinic M3 subtype receptor. In addition, solifenacin
showed to be a specific antagonist for muscarinic receptors by displaying low
or no affinity for various other receptors and ion channels tested.
Pharmacodynamic effects
Adults:
Treatment with Vesicare in doses of 5 mg and 10 mg daily was studied in
several double blind, randomised, controlled clinical trials in men and women
with overactive bladder.
As shown in the table below, both the 5 mg and 10 mg doses of Vesicare
produced statistically significant improvements in the primary and secondary
endpoints compared with placebo. Efficacy was observed within one week of
starting treatment and stabilises over a period of 12 weeks. A long-term open
label study demonstrated that efficacy was maintained for at least 12 months.
After 12 weeks of treatment approximately 50% of patients suffering from
incontinence before treatment were free of incontinence episodes, and in
addition 35% of patients achieved a micturition frequency of less than 8
micturitions per day. Treatment of the symptoms of overactive bladder also
results in a benefit on a number of Quality of Life measures, such as general
health perception, incontinence impact, role limitations, physical limitations,
social limitations, emotions, symptom severity, severity measures and
sleep/energy.

Results (pooled data) of four controlled Phase 3 studies with a treatment
duration of 12 weeks
Placebo

Vesicare
5 mg o.d.

Vesicare
10 mg o.d.

Tolterodine
2 mg b.i.d.

No. of micturitions/24 h
Mean baseline
11.9
12.1
11.9
12.1
Mean reduction from baseline
1.4
2.3
2.7
1.9
% change from baseline
(12%)
(19%)
(23%)
(16%)
n
1138
552
1158
250
p-value*
<0.001
<0.001
0.004
No. of urgency episodes/24 h
Mean baseline
6.3
5.9
6.2
5.4
Mean reduction from baseline
2.0
2.9
3.4
2.1
% change from baseline
(32%)
(49%)
(55%)
(39%)
n
1124
548
1151
250
p-value*
<0.001
<0.001
0.031
No. of incontinence episodes/24 h
Mean baseline
2.9
2.6
2.9
2.3
Mean reduction from baseline
1.1
1.5
1.8
1.1
% change from baseline
(38%)
(58%)
(62%)
(48%)
n
781
314
778
157
p-value*
<0.001
<0.001
0.009
No. of nocturia episodes/24 h
Mean baseline
1.8
2.0
1.8
1.9
Mean reduction from baseline
0.4
0.6
0.6
0.5
% change from baseline
(22%)
(30%)
(33%)
(26%)
n
1005
494
1035
232
p-value*
0.025
<0.001
0.199
Volume voided/micturition
Mean baseline
166 ml
146 ml
163 ml
147 ml
Mean increase from baseline
9 ml
32 ml
43 ml
24 ml
% change from baseline
(5%)
(21%)
(26%)
(16%)
n
1135
552
1156
250
p-value*
<0.001
<0.001
<0.001
No. of pads/24 h
Mean baseline
3.0
2.8
2.7
2.7
Mean reduction from baseline
0.8
1.3
1.3
1.0
% change from baseline
(27%)
(46%)
(48%)
(37%)
n
238
236
242
250
p-value*
<0.001
<0.001
0.010
Note: In 4 of the pivotal studies, Vesicare 10 mg and placebo were used. In 2 out of the
4 studies also Vesicare 5 mg was used and one of the studies included tolterodine
2 mg bid.
Not all parameters and treatment groups were evaluated in each individual study.
Therefore, the numbers of patients listed may deviate per parameter and
treatment group.
*
P-value for the pair wise comparison to placebo

Special populations:
Children and adolescents (age 5 years and older):
Treatment with Vesicare oral suspension was studied in two clinical studies. A
12-week double-blind, randomised, placebo-controlled, clinical trial (905-CL076) in 189 paediatric patients with OAB (73 children aged 5 to 11 years and 22
adolescents aged 12 to 17 years were treated with solifenacin). This was
followed by a 40-week long-term open-label extension study (905-CL-077) in
148 paediatric patients (119 children and 29 adolescents were treated with
solifenacin). In both studies, the majority of patients were up-titrated to the
weight-based equivalent of 10 mg in adults.
In study 905-CL-076 Vesicare oral suspension did not show a statistically
significant improvement in the primary endpoint of mean volume voided per
micturition compared with placebo in the overall population. 11
In children (aged 5 to 11 years) a statistically significant difference was
observed for this primary endpoint. No statistically significant improvement
was observed in the secondary endpoints of micturition frequency, number of
incontinence episodes per day and number of dry days per week. No unexpected
or unlisted adverse events were reported for the entire dose range tested.
In the open-label extension study, no unexpected or unlisted adverse events
were reported. The safety profile for solifenacin in paediatric patients during
long-term exposure was comparable to that observed in adults.

5.2

Pharmacokinetic properties
Absorption
After oral intake of solifenacin succinate, maximum solifenacin plasma
concentrations (Cmax) are reached after 4 to 12 hours. The tmax is independent
of the dose. The Cmax and area under the curve (AUC) increase in proportion
to the dose between 5 to 40 mg. Absolute bioavailability is approximately
90%.
Food intake does not affect the Cmax and AUC of solifenacin.
Distribution
The apparent volume of distribution of solifenacin following intravenous
administration is about 600 L. Solifenacin is to a great extent (approximately
98%) bound to plasma proteins, primarily α1-acid glycoprotein.
Biotransformation
Solifenacin is extensively metabolised by the liver, primarily by cytochrome
P450 3A4 (CYP3A4). However, alternative metabolic pathways exist, that can
contribute to the metabolism of solifenacin. The systemic clearance of
solifenacin is about 9.5 L/h and the terminal half life of solifenacin is 45 - 68
hours. After oral dosing, one pharmacologically active (4R-hydroxy
solifenacin) and three inactive metabolites (N-glucuronide, N-oxide and 4Rhydroxy-N-oxide of solifenacin) have been identified in plasma in addition to
solifenacin.

Elimination
After a single administration of 10 mg [14C-labelled]-solifenacin, about 70%
of the radioactivity was detected in urine and 23% in faeces over 26 days. In
urine, approximately 11% of the radioactivity is recovered as unchanged
active substance; about 18% as the N-oxide metabolite, 9% as the 4Rhydroxy-N-oxide metabolite and 8% as the 4R-hydroxy metabolite (active
metabolite).
Linearity/non-linearity
Pharmacokinetics are linear in the therapeutic dose range.
Other special populations
Elderly
No dosage adjustment based on patient age is required. Studies in elderly have
shown that the exposure to solifenacin, expressed as the AUC, after
administration of solifenacin succinate (5 mg and 10 mg once daily) was
similar in healthy elderly subjects (aged 65 through 80 years) and healthy
young subjects (aged less than 55 years). The mean rate of absorption
expressed as tmax was slightly slower in the elderly and the terminal half-life
was approximately 20% longer in elderly subjects. These modest differences
were considered not clinically significant.
Children and adolescents (age 5 years and older):
The pharmacokinetics of solifenacin following weight-adjusted dosing in
children and adolescents with OAB were similar to those observed in adults,
with a slightly shorter tmax and t1/2; these differences were not considered
clinically significant.
Gender
The pharmacokinetics of solifenacin are not influenced by gender.
Race
The pharmacokinetics of solifenacin are not influenced by race.
Renal impairment
The AUC and Cmax of solifenacin in mild and moderate renally impaired
patients, was not significantly different from that found in healthy volunteers.
In patients with severe renal impairment (creatinine clearance ≤ 30 ml/min)
exposure to solifenacin was significantly greater than in the controls with
increases in Cmax of about 30%, AUC of more than 100% and t½ of more than
60%. A statistically significant relationship was observed between creatinine
clearance and solifenacin clearance.
Pharmacokinetics in patients undergoing haemodialysis have not been studied.
Hepatic impairment
In patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) the
Cmax is not affected, AUC increased with 60% and t½ doubled.
Pharmacokinetics of solifenacin in patients with severe hepatic impairment
have not been studied.

5.3

Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of
safety pharmacology, repeated dose toxicity, fertility, embryofetal development,
genotoxicity, and carcinogenic potential. In the pre- and postnatal development study
in mice, solifenacin treatment of the mother during lactation caused dose-dependent
lower postpartum survival rate, decreased pup weight and slower physical
development at clinically relevant levels. Dose related increased mortality without
preceding clinical signs occurred in juvenile mice treated from day 10 or 21 after
birth with doses that achieved a pharmacological effect and both groups had higher
mortality compared to adult mice. In juvenile mice treated from postnatal day 10,
plasma exposure was higher than in adult mice; from postnatal day 21 onwards, the
systemic exposure was comparable to adult mice. The clinical implications of the
increased mortality in juvenile mice are not known. Vesicare oral suspension showed
no potential for irritation to the eyes when tested in rabbits.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Polacrilin potassium
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Propylene glycol (E1520)
Simethicone emulsion 30%; consisting of simethicone, polyethylene glycol sorbitan
tristearate (E436), methylcellulose (E461), polyethylene glycol stearate, glycerides,
xanthan gum (E415), benzoic acid (E210), sorbic acid (E200), sulphuric acid (E513)
and water.
Carbomer
Xylitol (E967)
Acesulfame potassium (E950)
Natural orange flavour; consisting of orange essential oils, natural flavouring
substances, ethanol, propylene glycol (E1520), butylated hydroxyanisol (E320) and
water
Sodium hydroxide
Purified water

6.2

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed
with other medicinal products or food.

6.3

Shelf life
2 years.
After first opening of the bottle, the oral suspension can be stored for 28 days.

6.4

Special precautions for storage
Store in the original bottle in order to protect from light.
This product does not require any special temperature storage conditions.

6.5

Nature and contents of container
150 ml Vesicare oral suspension in amber polyethylene terephthalate (PET) bottle
with polyethylene (PE) screw-cap with a pulp and vinylseal liner, packed in a carton.

6.6

Special precautions for disposal
No special requirements.
Discard any medicine remaining after 28 days after opening the bottle. Any unused
medicinal product or waste material should be disposed of in accordance with local
requirements. Medicines should not be disposed of via wastewater or household
waste. These measures will help to protect the environment.
An appropriate commercially available oral syringe and adaptor suitable for
dispensing of liquid medicines should be selected by the health care professional to
measure the correct dose. For example for a dose of 5 ml, an oral syringe of 5 ml and
for a dose of 10 ml, an oral syringe of 10 ml. As for the adaptor; a commercially
available adaptor could be selected that is suitable for use in combination with the
selected oral syringe and fits the bottle neck size for example a press in bottles
adaptor, 24 mm or universal bottle adapter.

7

MARKETING AUTHORISATION HOLDER
Astellas Pharma Ltd.
2000 Hillswood Drive
Chertsey
Surrey
KT16 0RS

United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00166/0406

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/08/2015

10

DATE OF REVISION OF THE TEXT
14/07/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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