SOLIFENACIN SANDOZ solifenacin succinate 5 mg film-coated tables blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
solifenacin succinate
Available from:
Sandoz Pty Ltd
Authorization status:
Registered
Authorization number:
311730

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SOLIFENACIN SANDOZ

SOLIFENACIN

SANDOZ

®

Solifenacin succinate

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

Read this leaflet carefully before

you start taking this medicine.

This leaflet answers some common

questions about Solifenacin Sandoz.

It does not contain all of the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking Solifenacin

Sandoz against the benefits they

expect it will have for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What Solifenacin

Sandoz is used for

Solifenacin Sandoz is used to treat

the symptoms of overactive bladder.

These symptoms include needing to

rush to the toilet to urinate without

warning, needing to urinate

frequently, or wetting yourself

because you did not get to the toilet

in time.

Solifenacin Sandoz belongs to a

group of medicines called

anticholinergic medicines. It works

by acting on specialised cells to

reduce the activity of your bladder

and help you control your bladder.

Your doctor may have prescribed

Solifenacin Sandoz for another

reason. Ask your doctor if you have

any questions about why Solifenacin

Sandoz has been prescribed for you.

Solifenacin Sandoz is available only

with a doctor's prescription.

There is no evidence that Solifenacin

Sandoz is addictive.

Before you take

Solifenacin Sandoz

When you must not take it

Do NOT take Solifenacin Sandoz if

you are allergic to medicines

containing solifenacin or any of the

ingredients listed at the end of this

leaflet.

Some of the symptoms of an allergic

reaction may include skin rash,

itching or hives, swelling of the face,

lips or tongue which may cause

difficulty in swallowing or breathing,

wheezing or shortness of breath.

Do not take Solifenacin Sandoz if

you:

suffer from urinary retention

(inability to urinate or empty your

bladder completely)

are undergoing haemodialysis

have severe kidney disease or

moderate liver disease and are

also taking medicines that can

decrease the removal of

Solifenacin Sandoz from the body

(see Taking other medicines)

have severe liver disease

have uncontrolled glaucoma (high

pressure in the eyes, with gradual

loss of eye sight)

have myasthenia gravis, a disease

of the muscles causing drooping

eyelids, double vision, difficulty

in speaking or swallowing and

sometimes muscle weakness in

the arms or legs

have a blocked gastro-intestinal

tract or other gastro-intestinal

disorders such as ulcerative

colitis or toxic megacolon.

Do not take Solifenacin Sandoz if

the expiry date (EXP.) printed on

the pack has passed.

Do not take Solifenacin Sandoz if

the packaging is torn or shows

signs of tampering

Before you start to take it

Tell your doctor if you are allergic

to any other medicines, foods, dyes

or preservatives.

Do not give Solifenacin Sandoz to

children.

Tell your doctor if you are

pregnant.

Solifenacin Sandoz may affect your

developing baby if you take it during

pregnancy. Your doctor will decide if

you should take it.

Do not take Solifenacin Sandoz if

you are breastfeeding.

Tell your doctor if you have, or

have had, any medical conditions,

especially the following:

low potassium levels or a family

SOLIFENACIN SANDOZ

history of heart rhythm problems.

Solifenacin Sandoz may have an

effect on the electro-cardiogram

(ECG - a heart tracing) and may

add to the effect of other

medicines on the ECG. You

should advise your doctor of any

other medicines you are currently

taking, particularly those

affecting the heart rhythm. Your

doctor may wish to perform an

ECG if you have any risks of

having an abnormal heart rhythm.

blockage to your bladder that

causes difficulty urinating

obstruction of the digestive

system (constipation)

glaucoma (high pressure in the

eyes, with gradual loss of eye

sight)

hiatus hernia or gastric reflux or

are currently being treated with

some medicines (such as

bisphosphonates) which may

make your reflux worse

autonomic neuropathy, a nerve

problem which sometimes occurs

with diabetes and can lead to

diarrhoea, impotence or low

blood pressure.

severe kidney disease.

moderate liver disease.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

Solifenacin Sandoz

.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you get without a prescription

from your pharmacy, supermarket

or health food shop.

Some medicines may be affected by

Solifenacin Sandoz, or may affect

how well it works.

Some medicines can slow down the

removal of Solifenacin Sandoz from

the body. If you are taking any of the

following, 5 mg a day is the

maximum recommended dosage:

some antifungal medicines such

as ketoconazole, itraconazole

ritonavir and nelfinavir,

medicines to treat HIV infection.

If you are taking any of the above

medicines and you also have severe

kidney disease or moderate liver

disease, you should not take

Solifenacin Sandoz

.

If you are not sure whether you are

taking any of these medicines,

check with your doctor or

pharmacist.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

Solifenacin Sandoz.

How to take

Solifenacin Sandoz

How much to take

The usual dose is 5 to 10 mg of

Solifenacin Sandoz once a day. Your

doctor will decide the most suitable

dose for you.

Talk to your doctor or pharmacist if

you feel that the effect of Solifenacin

Sandoz is too strong or too weak.

Follow all directions given to you

by your doctor and pharmacist

carefully.

How to take Solifenacin

Sandoz

Try to take Solifenacin Sandoz at the

same time each day. Solifenacin

Sandoz is taken by mouth. It can be

taken with or without food.

Swallow the tablets whole with a

glass of water.

Do not crush or chew the tablets.

If you crush or chew Solifenacin

Sandoz tablets, they may not work as

well.

If you forget to take

Solifenacin Sandoz

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take the missed dose as

soon as you remember, and then go

back to taking your tablets as you

would normally.

Do not take a double dose to make

up for the dose you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

How long to take Solifenacin

Sandoz for

To properly control your condition,

Solifenacin must be taken every day.

Keep taking Solifenacin Sandoz for

as long as your doctor

recommends.

If you take too much

(overdose)

Immediately telephone your

doctor, or the Poisons Information

Centre (telephone Australia 13 11

26 or New Zealand 0800 POISON

or 0800 764766) if you think you or

anyone else may have taken too

much Solifenacin Sandoz. Do this

even if there are no signs of

discomfort or poisoning.

While you are taking

Solifenacin Sandoz

Things you must do

Before starting any new medicine,

tell your doctor or pharmacist that

you are taking Solifenacin Sandoz.

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking Solifenacin

Sandoz.

If you become pregnant while

taking Solifenacin Sandoz, tell

your doctor.

SOLIFENACIN SANDOZ

Visit your doctor regularly so they

can check on your progress.

Things you must not do

Do not stop taking Solifenacin

Sandoz, or lower the dose, without

checking with your doctor.

Do not use Solifenacin Sandoz

to

treat any other conditions unless

your doctor tells you to.

Do not give Solifenacin Sandoz to

anyone else, even if they have the

same condition as you.

Things to be careful of

Be careful driving or operating

machinery until you know how

Solifenacin Sandoz affects you.

Solifenacin Sandoz can sometimes

cause blurred vision and less

frequently drowsiness and fatigue.

Do not drive or operate machinery

if you suffer from any of these side

effects.

SIDE EFFECTS

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Solifenacin Sandoz.

Like all other medicines, Solifenacin

Sandoz may have unwanted side

effects in some people. Sometimes

they are serious, most of the time

they are not. You may need medical

treatment if you get some of the side

effects.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Stop taking Solifenacin Sandoz

and tell your doctor as soon as

possible if you experience:

allergic reactions including

swelling of the face, lips, throat

or tongue, difficulty breathing

Tell your doctor as soon as possible

if you notice any of the following:

chest pain or tightness

swelling of the feet or legs

changes in electrical activity of

the heart (ECG), irregular

heartbeat (Torsade de Points)

Tell your doctor if you notice any

of the following and they worry

you:

dry mouth

nausea, vomiting

constipation

indigestion

heartburn (dyspepsia)

stomach discomfort

urinary tract infection, bladder

pain

difficulty passing urine, inability

to empty the bladder

urgent need to urinate

blurred vision

inability to empty the bladder

dry eyes

tiredness

muscle weakness

accumulation of fluid (swelling)

in the lower limbs (oedema)

dizziness

sore / dry throat

cough

headache

sleepiness

hallucination

confusion

depression

fast heartbeat

palpitations

skin reactions such as rash,

itching or hives.

Other side effects not listed above

may occur in some patients. Tell

your doctor if you notice anything

that is making you feel unwell.

Some of these side effects (for

example, changes in electrical

activity of the heart or liver function)

can only be found when your doctor

does tests from time to time to check

your progress.

After using

Solifenacin Sandoz

Storage

Keep Solifenacin where children

cannot reach out.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Keep your tablets in a place where

the temperature stays below 25°C.

Do not store Solifenacin Sandoz or

any other medicine in the

bathroom or near a sink.

Do not leave Solifenacin Sandoz in

the car or on window sills.

Heat and dampness can destroy some

medicines.

Disposal

If your doctor tells you to stop

taking Solifenacin Sandoz, or your

tablets have passed their expiry

date, ask your pharmacist what to

do with any that are left over.

PRODUCT

DESCRIPTION

What it looks like

Solifenacin Sandoz comes in two

strengths of tablets:

Solifenacin Sandoz 5 mg tablets

are round light yellow tablets with

debossment “05” on one side.

Solifenacin Sandoz

10 mg tablets

are round light pink tablets with

debossment “10” on one side and

score line on the other side.

The 10 mg scored tablet can be

divided into equal doses.

The film-coated tablets are available

SOLIFENACIN SANDOZ

in PVC/Al blisters or polyethylene

bottles (with a polypropylene screw

cap and desiccant insert) packed in a

carton box.

Each blister pack and bottle contains

30 tablets.

Not all presentations may be

marketed

Ingredients

The active ingredient in Solifenacin

Sandoz is solifenacin succinate

5mg: each Solifenacin Sandoz

tablet contains 5 mg solifenacin

succinate

10 mg: each Solifenacin Sandoz

tablet contains 10 mg solifenacin

succinate.

The tablets also contain:

maize starch

lactose monohydrate

hypromellose

magnesium stearate

macrogol 6000

talc

titanium dioxide

iron oxide yellow (5 mg tablets

only)

iron oxide red (10 mg tablets only)

This medicine does not contain

sucrose, gluten, tartrazine or

any other azo dyes.

This medicine does contain lactose.

Supplier

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road,

Macquarie Park,

NSW 2113, AUSTRALIA

Tel: 1800 726 369

® = Registered Trademark

This leaflet was prepared in

November 2020.

Australian Register Number

5 mg tablet: AUST R 311730

(blisters)

10 mg tablet: AUST R 311729

(blisters)

5 mg tablet: AUST R 311728 (bottle)

10 mg tablet: AUST R 311727

(bottle)

Read the complete document

201104-SOLIFENACIN SANDOZ-pi

Page 1 of 14

AUSTRALIAN PRODUCT INFORMATION

SOLIFENACIN SANDOZ

®

(SOLIFENACIN SUCCINATE)

1.

NAME OF THE MEDICINE

Solifenacin succinate

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

SOLIFENACIN SANDOZ

5 mg film-coated tablet:

Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin.

SOLIFENACIN SANDOZ

10 mg film-coated tablet:

Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin.

Excipient with known effect:

Lactose monohydrate

For the full list of excipients, see Section 6.1 List of excipients.

3.

PHARMACEUTICAL FORM

SOLIFENACIN SANDOZ

5 mg film-coated tablet:

Each 5 mg tablet is a round, light-yellow tablet with debossment “05” on one side.

SOLIFENACIN SANDOZ

10 mg film-coated tablet:

Each 10 mg tablet is a round, light-pink tablet with debossment “10” on one side and score line

on the other side.

The 10 mg scored tablet can be divided into equal doses.

4.

CLINICAL PARTICULARS

4.1.

T

HERAPEUTIC INDICATIONS

SOLIFENACIN SANDOZ

is indicated for the treatment of overactive bladder with symptoms

of urge urinary incontinence, urgency or increased urinary frequency.

4.2.

D

OSE AND METHOD OF ADMINISTRATION

Dosage

Adults, including the elderly

The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be

increased to a maximum of 10 mg solifenacin succinate once daily.

Children and adolescents

Safety and effectiveness in children have not yet been established. Therefore, SOLIFENACIN

SANDOZ

should not be used in children.

201104-SOLIFENACIN SANDOZ-pi

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Method of administration

SOLIFENACIN SANDOZ

should be taken orally and should be swallowed whole with

liquids. It can be taken with or without food.

Dosage adjustment in:

renal impairment

No dose adjustment is necessary for patients with mild to moderate renal impairment

(creatinine

clearance

>

mL/min).

Patients

with

severe

renal

impairment

(creatinine

clearance ≤ 30 mL/min) should be treated with caution and receive no more than 5 mg once

daily.

hepatic impairment

No dose adjustment is necessary for patients with mild hepatic impairment. Patients with

moderate hepatic impairment (Child-Pugh B) should be treated with caution and receive no

more than 5 mg once daily. SOLIFENACIN SANDOZ

is contraindicated in patients with

severe hepatic impairment (Child-Pugh C).

co-medication

The maximum dose of SOLIFENACIN SANDOZ

should be limited to 5 mg when treated

simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4-inhibitors e.g.

ritonavir, nelfinavir, itraconazole, ciclosporin, macrolide antibiotics. (See also Section 4.5

Interactions with other medicines and other forms of interactions).

4.3.

C

ONTRAINDICATIONS

Solifenacin is contraindicated in:

patients with urinary retention

patients with uncontrolled narrow-angle glaucoma

patients who have demonstrated hypersensitivity to the drug substance or other

components of the product

severe gastro-intestinal condition (including toxic megacolon and gastric retention)

myasthenia gravis

patients undergoing haemodialysis

patients with severe hepatic impairment

patients with severe renal impairment or moderate hepatic impairment and who are on

treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole

4.4.

S

PECIAL WARNINGS AND PRECAUTIONS FOR USE

Solifenacin 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.

in patients being treated for narrow-angle glaucoma.

hiatus hernia/gastro-oesophagal reflux and/or who are concurrently taking medicinal

products that can cause or exacerbate oesophagitis.

autonomic neuropathy.

201104-SOLIFENACIN SANDOZ-pi

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known risk factors for QT prolongation, such as pre-existing long QT syndrome and

hypokalaemia.

Angioedema

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

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 taken.

QT Prolongation and Torsade de Pointes:

QT Prolongation and Torsade de Pointes have been observed in patients with known risk

factors for these conditions.

As with other drugs in this class, caution is advised in patients with known risk factors for QT-

prolongation (i.e. history of QT prolongation, long QT syndrome, hypokalaemia, bradycardia,

coadministration of drugs known to prolong the QT interval) and relevant pre-existing cardiac

diseases (i.e. myocardial ischaemia, arrhythmia, congestive heart failure) (see Sections 5.1

Pharmacodynamic properties/ Clinical trials, 4.5 Interactions with other medicines and other

forms of interactions and 4.8 Adverse effects (Undesirable effects)).

Appropriate investigations (e.g. ECG) should be considered in patients with risk factors for

QTc prolongation.

Use in hepatic impairment

Doses of solifenacin greater than 5 mg are not recommended in patients with moderate hepatic

impairment (Child-Pugh B). Solifenacin is contraindicated for patients with severe hepatic

impairment (Child-Pugh C) (See Section 4.3 Contraindications).

In patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) the C

is not

affected, AUC increased with 60% and t

doubled. Pharmacokinetics of solifenacin in patients

with severe hepatic impairment have not been studied.

Use in renal impairment

Solifenacin should be used with caution in patients with reduced renal function. Solifenacin

should be used with caution in patients with severe renal impairment (creatinine clearance <

30 mL/min), and doses should not exceed 5 mg for these patients.

The AUC and C

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 C

of about 30%, AUC of more than 100% and

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.

201104-SOLIFENACIN SANDOZ-pi

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Use in the elderly

No dosage adjustment based on patient age is required. Studies in the elderly have shown that

, AUC and t

values were 20-25% higher as compared to the younger volunteers (18-55

years). No overall differences were observed in the safety of solifenacin between older and

younger patients treated for 4 to 12 weeks with 5 to 10 mg solifenacin succinate.

Paediatric use

Safety and effectiveness in children have not yet been established. Therefore, solifenacin

should not be used in children.

Effects on laboratory tests

No data available.

4.5.

I

NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF 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 succinate is not likely to interact with the CYP mediated metabolism of co-

administered drugs.

Effect of other medicinal products on the pharmacokinetics of solifenacin

In vitro

drug metabolism studies have shown that solifenacin is a substrate of CYP3A4.

Inducers or inhibitors of CYP3A4 may alter solifenacin pharmacokinetics. 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 solifenacin

should be restricted to 5 mg, when used simultaneously with ketoconazole or therapeutic doses

other

potent

CYP3A4

inhibitors

(e.g.

ritonavir,

nelfinavir,

itraconazole,

ciclosporin,

macrolide antibiotics).

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, carbamazepine).

Effect of solifenacin on the pharmacokinetics of other medicinal products

Oral Contraceptives

Intake of solifenacin showed no pharmacokinetic interaction of solifenacin on combined oral

contraceptives (ethinyl oestradiol/levonorgestrel).

Warfarin

Intake of solifenacin did not alter the pharmacokinetics of R-warfarin or S-warfarin or their

effect on prothrombin time.

Digoxin

Intake of solifenacin showed no effect on the pharmacokinetics of digoxin.

201104-SOLIFENACIN SANDOZ-pi

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Drugs, which prolong the QT/QTc interval:

There is no satisfactory information on the concurrent use of solifenacin succinate with drugs

known to prolong the QT/QTc interval. In the absence of such information on these

combinations, the potential risk of pathological QT/QTc prolongation resulting in arrhythmias

cannot be ruled out. Drugs known to prolong the QT/QTc interval include erythromycin,

quinidine,

procainamide,

disopyramide,

sotalol,

amiodarone,

cisapride,

fluconazole,

amitriptyline, haloperidol, chlorpromazine, thioridazine, pimozide and droperidol.

4.6.

F

ERTILITY

,

PREGNANCY AND LACTATION

Effects on fertility

Solifenacin had no effect on reproductive function, fertility or early embryonic development

after oral treatment of male and female mice, which resulted in 13 times exposure at the

maximum recommended human dose (MRHD).

Use in pregnancy

Category B3

Solifenacin (and/or its metabolites) has been shown to cross the placenta in pregnant mice. No

embryotoxicity or teratogenicity was observed in mice treated with 1.2 times exposure at the

maximum recommended human dose (MRHD). In one of two studies, higher doses (3.6 times

exposure at the MRHD) resulted in maternal toxicity and reduced fetal body weight. No

embryotoxic effects were observed in rabbits at up to 1.8 times exposure at the MRHD.

In utero and lactational exposures to maternal doses of solifenacin 3.6 times exposures at the

MRHD resulted in reduced peripartum and postnatal survival, reductions in body weight gain,

and delayed physical development (e.g. eye opening).

There are no adequate and well-controlled studies in pregnant women. Because animal

reproduction studies are not always predictive of human response, solifenacin should be used

during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation

Solifenacin is excreted into the breast milk of mice. There were no significant adverse effects

at 1.2 times exposure at the maximum recommended human dose (MRHD) in a pre- and

postnatal study in mice. Pups of female mice treated at 3.6 times exposure at the MRHD

showed reduced body weights, postpartum pup mortality or delays in the onset of reflex and

physical development during the lactation period. It is expected that solifenacin is excreted in

human milk and solifenacin should not be administered during breast-feeding.

4.7.

E

FFECTS ON ABILITY TO DRIVE AND USE MACHINES

Since solifenacin, like other anticholinergics may cause blurred vision, and uncommonly

somnolence and fatigue, the ability to drive and use machines may be negatively affected (see

Section 4.8 Adverse effects (Undesirable effects)).

4.8.

A

DVERSE EFFECTS

(U

NDESIRABLE EFFECTS

)

In the four 12-week double-blind clinical trials 3027 patients were involved (1811 on

solifenacin and 1216 on placebo), and approximately 90% of these patients completed the 12-

week studies. The most frequent reason for discontinuation due to an adverse event was dry

mouth, 1.5%. There were three intestinal serious adverse events in patients all treated with

201104-SOLIFENACIN SANDOZ-pi

Page 6 of 14

solifenacin

(one

faecal

impaction,

colonic

obstruction,

intestinal

obstruction).

The table below lists the adverse events reported in

1.0% of the patients in the 12 week

studies. The relationship to study medication for most of these events is uncertain; many are

thought to represent spontaneous events reported by patients with bladder dysfunction (and

other concomitant diseases) and are not necessarily causally related to solifenacin.

Numbers (%) of patients with treatment-emergent adverse events reported by 1% or more patients:

controlled phase 3 studies (all combined)

SYSTEM ORGAN CLASS

MedDRA Preferred Term

Placebo (%)

SOLIFENACIN

5 mg (%)

SOLIFENACIN

10 mg (%)

Number of patients

1216

1233

Number of patients with treatment-emergent

GASTROINTESTINAL

DISORDERS

Dry mouth

10.9

27.6

Constipation

13.4

Nausea

Dyspepsia

Diarrhoea NOS

Vomiting NOS

Abdominal pain upper

Abdominal pain NOS

INFECTIONS AND INFESTATIONS

Urinary tract infection NOS

Upper respiratory tract infection NOS

Influenza

Sinusitis NOS

Nasopharyngitis

Pharyngitis NOS

Bronchitis

NERVOUS SYSTEM DISORDERS

Headache

Dizziness

MUSCULOSKELETAL

AND CONNECTIVE TISSUE DISORDERS

Arthralgia

Back pain

Neck pain

GENERAL DISORDERS AND ADMINISTRATION SITE DISORDERS

Fatigue

Oedema lower limb

Influenza like illness

EYE DISORDERS

Vision blurred

Dry Eye NOS

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

Cough

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

Rash

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RENAL AND URINARY DISORDERS

Urinary retention

Dysuria

PSYCHIATRIC DISORDERS

Insomnia

Depression NOS

VASCULAR DISORDERS

Hypertension NOS

Adverse reactions reported in the clinical trials with a frequency of occurrence less than 1%

are:

Gastrointestinal disorders:

flatulence, gastro-oesophageal reflux diseases, throat irritation,

eructation, dry throat

Infections and infestations:

cystitis

Nervous system disorders:

somnolence, dysgeusia, syncope

General disorders and administration site disorders:

thirst, suprapubic pain, chest tightness

Renal and urinary disorders:

difficulty in micturition, bladder pain, micturition urgency

Respiratory, thoracic and mediastinal disorders

: nasal dryness

Investigations:

abnormal liver function tests (AST, ALT, GGT), electrocardiogram QT

prolonged

Musculoskeletal and connective tissue disorders:

peripheral swelling

Skin and subcutaneous

tissue disorders:

dry skin

Vascular disorders:

hot flushes

Post Marketing Experience:

The following adverse reactions have been spontaneously reported during worldwide post-

approval use of solifenacin. The adverse reactions reported are presented below according to

System Organ Class and frequency.

Adverse event frequencies are defined as follows: Very common (≥ 10%), common (≥ 1%, <

10%), uncommon (≥ 0.1%, < 1%), rare (> 0.01%, < 0.1%) and very rare (< 0.01%), not known

(cannot be estimated from the available data).

Cardiac disorders

Very Rare: Torsade de Pointes, atrial fibrillation, palpitations, tachycardia

Eye disorders

Very rare: glaucoma

Gastrointestinal disorders

Very rare: Gastro-oesophageal reflux disease, vomiting, ileus

General disorders and administration site conditions

Very rare: Peripheral oedema

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Hepatobiliary disorders

Very rare: Liver disorders mostly characterised by abnormal liver function tests (AST, ALT,

GGT)

Immune System Disorders

Very rare: Anaphylactic reaction

Investigations

Very rare: Electrocardiogram QT prolonged

Metabolism and nutrition disorders

Very rare: Decreased appetite, hyperkalaemia

Musculoskeletal and connective tissue disorders

Very rare: Muscular weakness

Nervous system disorders

Very rare: Dizziness, headache, somnolence

Psychiatric disorders

Very rare: Hallucinations, delirium, confusion state

Renal and urinary disorders

Very rare: Renal impairment, urinary retention

Respiratory, thoracic and mediastinal disorders

Very rare: dysphonia, nasal dryness

Skin and subcutaneous tissue disorders

Very rare: Pruritus, rash, urticaria, angioedema, erythema multiforme, exfoliative dermatitis

Postmarketing pharmacovigilance data confirmed QT prolongation associated with therapeutic

doses of solifenacin succinate in cases with known risk factors (see Section 4.4 Special

warnings and precautions for use).

Reporting suspected adverse effects

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-

problems (Australia) or

https://nzphvc.otago.ac.nz/reporting/ (New Zealand)

4.9.

O

VERDOSE

Overdosage with solifenacin succinate can potentially result in severe anticholinergic effects

(headache, dry mouth, dizziness, drowsiness and blurred vision) and should be treated

accordingly. 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.

Overdosage with solifenacin succinate may prolong the QTc interval, therefore, in the event of

overdosage, ECG monitoring is recommended and standard supportive measures for managing

QT prolongation should be adopted.

201104-SOLIFENACIN SANDOZ-pi

Page 9 of 14

Treatment of overdosage:

No cases of acute overdosage have been reported. In the event of an overdose with solifenacin

succinate, treat with activated charcoal.

For information on the management of overdose, contact the Poisons Information Centre on

131126 (Australia)

and 0800 POISON or 0800 764 766 (New Zealand)

5.

PHARMACOLOGICAL PROPERTIES

5.1.

P

HARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: Urinary antispasmodics, ATC code: G04B D08.

Mechanism of action

Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an

important role in several major cholinergic mediated functions, including contractions of

urinary bladder smooth muscle and stimulation of the salivary secretion.

Clinical trials

Four randomised, double blind, placebo controlled pivotal studies were performed of 12 weeks

duration to assess solifenacin for the treatment of overactive bladder in patients having

symptoms of urinary frequency, urgency and/or urge or mixed incontinence (with the

predominance of urge). Entry criteria required that patients have symptoms of overactive

bladder for ≥ 3 months duration. These studies involved 3027 patients (1811 on solifenacin and

1216 on placebo), and approximately 90% of these patients completed the 12-week studies.

Two of the four studies evaluated the 5 and 10 mg solifenacin doses and the other two evaluated

only the 10 mg dose. The studies assessed the standard primary efficacy endpoint of number

of micturitions per 24 hours, along with a number of usual secondary endpoints, including

incontinence episodes, urgency episodes, urge incontinence episodes, nocturia episodes, all per

24 hours, and volume voided per micturition, using patient diaries.

As shown in the table below, both the 5 mg and 10 mg doses of solifenacin 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. 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. All patients

completing the 12-week studies were eligible to enter an open label, long term extension study

patients

enrolling

completed

additional

40-week

treatment

period

demonstrating maintenance of effect. 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.

201104-SOLIFENACIN SANDOZ-pi

Page 10 of 14

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

Placebo

Solifenacin

5 mg o.d.

Solifenacin

10 mg o.d.

No. of micturitions/24 h

Mean baseline

Mean reduction from baseline

% change from baseline

Diff. vs placebo (95% CI)

p-value*

11.9

(12%)

1138

12.1

(19%)

0.9(0.6;1.3)

< 0.001

11.9

(23%)

1158

1.3(1.0;1.6)

< 0.001

No. of urgency episodes/24 h

Mean baseline

Mean reduction from baseline

% change from baseline

Diff. vs placebo (95% CI)

p-value*

(32%)

1124

(49%)

1.1(0.7;1.5)

< 0.001

(55%)

1151

1.5(1.2;1.8)

< 0.001

No. of incontinence episodes/24 h

Mean baseline

Mean reduction from baseline

% change from baseline

Diff. vs placebo (95% CI)

p-value*

(38%)

(58%)

0.7(0.4;1.1)

< 0.001

(62%)

0.7(0.5;1.0)

< 0.001

No. of nocturia episodes/24 h

Mean baseline

Mean reduction from baseline

% change from baseline

Diff. vs placebo (95% CI)

p-value*

(22%)

1005

(30%)

0.1(0.0;0.3)

0.025

(33%)

1035

0.2(0.0;0.3)

< 0.001

Volume voided/micturition

Mean baseline

Mean increase from baseline

% change from baseline

Diff. vs placebo (95% CI)

p-value*

166 mL

9 mL

(5%)

1135

146 mL

32 mL

(21%)

25(19;32)

< 0.001

163 mL

43 mL

(26%)

1156

34(29;39)

< 0.001

No. of pads/24 h

Mean baseline

Mean reduction from baseline

% change from baseline

Diff. vs placebo (95% CI)

p-value*

(27%)

(46%)

0.6(0.2;0.9)

< 0.001

(48%)

0.7(0.3;1.0)

< 0.001

Note:

In 4 of the pivotal studies, solifenacin succinate 10 mg and placebo were used. In 2 out of the 4 studies also

solifenacin succinate 5 mg was used.

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

As estimated from the statistical model

Read the complete document

Public Summary

Summary for ARTG Entry:

311730

SOLIFENACIN SANDOZ solifenacin succinate 5 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road, Macquarie Park, NSW, 2113

Australia

ARTG Start Date

4/11/2020

Product Category

Medicine

Status

Active

Approval Area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods Under

Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or

Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1 . SOLIFENACIN SANDOZ solifenacin succinate 5 mg film-coated tables blister pack

Product Type

Single Medicine Product

Effective Date

4/11/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Solifenacin Sandoz is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1 . SOLIFENACIN SANDOZ solifenacin succinate 5 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light yellow, round film-coated tablet with debossment 05 on one side

Active Ingredients

solifenacin succinate

5 mg

Equivalent: solifenacin

3.8 mg

Other Ingredients (Excipients)

Public Summary

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Produced at 13.01.2021 at 07:50:02 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

hypromellose

iron oxide yellow

lactose monohydrate

macrogol 6000

magnesium stearate

pregelatinised maize starch

purified talc

titanium dioxide

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 13.01.2021 at 07:50:02 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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