BOTOX botulinum toxin, type A purified neurotoxin complex 50U injection vial

Main information

  • Trade name:
  • BOTOX botulinum toxin, type A purified neurotoxin complex 50U injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BOTOX botulinum toxin, type A purified neurotoxin complex 50U injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195530
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195530

BOTOX botulinum toxin, type A purified neurotoxin complex 50U injection vial

ARTG entry for

Medicine Registered

Sponsor

Allergan Australia Pty Ltd

Postal Address

Locked Bag 1514,PYMBLE, NSW, 2073

Australia

ARTG Start Date

1/07/2013

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. BOTOX botulinum toxin, type A purified neurotoxin complex 50U injection vial

Product Type

Single Medicine Product

Effective date

13/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

BOTOX (Botulinum toxin type A) purified neurotoxin complex is indicated for the following therapeutic indications: Treatment of overactive bladder with

symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic

medication. Treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord

injury or multiple sclerosis) and not controlled adequately by anticholinergic agents. Prophylaxis of headaches in adults with chronic migraine (headaches

on at least 15 days per month of which at least 8 days are with migraine). Treatment of strabismus in children and adults.Treatment of blepharospasm

associated with dystonia, including benign blepharospasm and VIIth nerve disorders (specifically hemifacial spasm) in patients twelve years and older.

Treatment of cervical dystonia (spasmodic torticollis). Treatment of focal spasticity of the upper and lower limbs, including dynamic equinus foot

deformity, due to juvenile cerebral palsy in patients two years and older. Treatment of severe primary hyperhidrosis of the axillae. Treatment of focal

spasticity in adults. Treatment of spasmodic dysphonia. BOTOX (botulinum toxin type A) purified neurotoxin complex is indicated for the following

cosmetic indications: temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow's feet and forehead lines) in adults.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

3 Years

Store at 2 to 8

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 50U vial

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Injection, powder for

Route of Administration

Subcutaneous

Intramuscular

Intradermal

Visual Identification

White powder

Active Ingredients

Botulinim toxin type a

50 U

© 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 1 of

Produced at 28.11.2017 at 03:51:10 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

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

BOTOX

®

Botulinum Toxin Type A CMI v12.0 PI v15.0

PAGE 1 OF 9

CONSUMER MEDICINE INFORMATION

BOTOX

®

(botulinum toxin, type A) purified neurotoxin complex

The information in this leaflet is ONLY a summary and is not a complete statement about BOTOX

®

injection. Your doctor

has more detailed information relating to you, your medical history and the product and should be consulted so that you

will be informed about all aspects of BOTOX

®

injection as it relates to you.

Please read this leaflet carefully before receiving BOTOX

injection and keep this leaflet handy as you

may want to refer to it in the future. If you have any concerns about receiving this medicine, ask your

doctor.

All medicines have benefits and risks. Your doctor has weighed the risks of using BOTOX

injection against

the benefits expected from using it for you.

1. PRODUCT DESCRIPTION

What is BOTOX

injection?

The injection contains a muscle relaxant obtained from the bacterium

Clostridium botulinum.

What is in BOTOX

injection?

Each vial contains either 50 units (U), 100 U or 200 U of

Clostridium botulinum

toxin type A-haemagglutinin

complex as the active ingredient. It also contains human albumin and sodium chloride.

What it looks like

The injection is supplied as a sterile white vacuum-dried powder in a clear glass vial. It is diluted before use

with 0.9% sterile non-preserved sodium chloride injection.

2. WHAT BOTOX

®

INJECTION IS USED FOR

How BOTOX

injection works

BOTOX

works by temporarily relaxing overactive or spastic (contracting) muscles. BOTOX

can also block

signals to the sweat glands thus reducing excessive sweating (hyperhidrosis), and can also block the release of

chemicals in the brain associated with the cause of pain (chronic migraine). When injected into the bladder

wall, BOTOX

works on the bladder muscle to prevent leakage of urine (urinary incontinence).

It is used to treat medical conditions associated with overactive muscles:

causing excessive eyelid blinking (blepharospasm) in patients twelve years and over

of the face (hemifacial spasm and VIIth nerve disorders)

causing ‘lazy eye’ or squint (strabismus) in children and adults

in the throat, causing a strained, strangled sounding voice or breathy voice with voice loss (spasmodic

dysphonia)

causing the head to be in an unusual posture or pain in the neck associated with twisting of the head

(cervical dystonia)

CONTENTS

This leaflet answers some common questions about

1. Product description

2. What BOTOX

injection is used for

3. What to be careful of

4. How to use BOTOX

injection

5. Side effects

6. Storage and disposal

7. Further information

BOTOX

®

Botulinum Toxin Type A CMI v12.0 PI v15.0

PAGE 2 OF 9

in children aged two years and older, causing altered and unnatural position or movements in the hand

and arm as well as legs, including those muscles that cause abnormal ankle position and walking gait

(juvenile cerebral palsy)

in adults, causing focal spasticity in the hands, arms or legs (adult focal spasticity).

BOTOX

is also used:

to treat overactive bladder with leakage of urine (urinary incontinence), the sudden urge to empty your

bladder and needing to go to the toilet more than usual when another drug (called an anticholinergic)

did not help. BOTOX

has been shown to markedly reduce leakage of urine and improve the quality

of life of patients suffering from leakage of urine due to overactive bladder.

to treat leakage of urine (urinary incontinence) in adults with overactive bladder due to neurologic

disease. BOTOX

has been shown to reduce leakage of urine and improve the quality of life of

patients suffering from leakage of urine due to neurogenic bladder.

to treat headaches occurring in adults with chronic migraine

to treat excessive sweating from the armpit area

to improve the look of vertical frown lines that appear between the eyebrows, lines around the eyes

and on the forehead.

Availability

The Department of Health has approved BOTOX

injection for the uses listed above. However, your doctor

may use this medicine for another purpose. If you want more information, ask your doctor.

3. WHAT TO BE CAREFUL OF

BOTOX

injection must not be used if:

you are allergic to any of the ingredients listed in section 1 (Product Description)

you have an infection in the muscles where it would normally be injected

you have any muscle disorders in other parts of your body, such as myasthenia gravis or Eaton Lambert

Syndrome

you are being treated for leakage of urine and

have either a sudden onset of urinary tract infection (UTI) or

have a sudden inability to empty your bladder (and are not regularly using a catheter)

are not willing and/or able to begin using a catheter, if required

the container is damaged or shows signs of tampering, or if the product does not look quite right

Tell your doctor if:

you have any muscle disorders in other parts of your body, including amyotrophic lateral sclerosis, and

motor neuropathy

you are scheduled to have surgery using a general anaesthetic

you are taking anti-platelets (aspirin-like products) and/or anti-coagulants (blood thinners)

you have inflammation or severe weakness in the muscles where BOTOX

would be injected

you have a breathing problem, such as asthma or emphysema

your child who is being treated with BOTOX

for juvenile cerebral palsy has or has had neurological

problems, swallowing problems, lung disease or aspiration pneumonia (serious lung infection)

you have swallowing problems

you have bleeding problems

you have had surgery on your face or in your eye

you have drooping eyelids

you have any other change in the way your face normally looks

you have angle closure glaucoma

you have problems with your heart or circulation

you have had seizures

you are pregnant or have the intention of becoming pregnant

BOTOX

®

Botulinum Toxin Type A CMI v12.0 PI v15.0

PAGE 3 OF 9

you are breastfeeding or planning to start breastfeeding

you are being treated for leakage of urine and

have chronic urinary tract infection which you take long term antibiotic to treat

have urinary obstruction. Symptoms and signs include difficulty emptying your bladder and

reduced urine flow

you are being treated for leakage of urine due to overactive bladder and have diabetes

In these circumstances it may not be possible to use BOTOX

. Tell your doctor if you have problems

swallowing, speaking or breathing. These problems can happen hours to weeks after an injection of BOTOX

usually because the muscles that you use to breathe and swallow can become weak after the injection.

Swallowing problems may last for several months. People who already have swallowing or breathing

problems before receiving BOTOX

have the highest risk of getting these problems.

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 and BOTOX

may interfere with each

other.

Especially tell your doctor if you:

have received any other botulinum toxin product in the last four months

have recently received an antibiotic by injection, such as gentamycin or tobramycin

take muscle relaxants

take an allergy or cold medicine

take a sleep medicine.

4. HOW TO USE BOTOX

®

INJECTION

BOTOX

injection should only be administered by a doctor familiar with the required technique. It must be

dissolved in sterile non-preserved saline solution immediately before use and should not be used in higher

doses or more frequently than recommended.

The usual dosage of BOTOX

is as follows:

For leakage of urine due to overactive bladder

Dosage

Your doctor will give multiple injections into the bladder wall via a specific instrument (cystoscope). The total

dose is 100 U of BOTOX

. You may be given a local anaesthetic before the injections (your bladder would be

filled with anaesthetic solution for a while and then drained). You may also be given a sedative.

Duration of treatment effect

You will usually see an improvement within 2 weeks after the injection.

Typically, the effect lasts 5-6 months after the injection.

When the effects start to wear off, you can have the treatment again if needed, but not more often than every 3

months.

For leakage of urine due to bladder problems associated with spinal cord injury or multiple

sclerosis

Dosage

Your doctor will give multiple injections into the bladder wall via a specific instrument (cystoscope). The

total dose is 200 U of BOTOX

You may be given a local or general anaesthetic before the injections. You

may also be given a sedative.

BOTOX

®

Botulinum Toxin Type A CMI v12.0 PI v15.0

PAGE 4 OF 9

Duration of treatment effect

You will usually see an improvement within 2 weeks after the injection.

Typically, the effect lasts 8-10 months after the injection.

When the effects start to wear off, you can have the treatment again if needed, but not more often than every 3

months.

Blepharospasm, Hemifacial Spasm and VIIth Nerve Disorders

The recommended dose is 1.25 U to 2.5 U (0.05 mL to 0.1 mL) for each muscle injected. The initial effect

occurs within 3 days, with the maximum muscle relaxation reached within 1-2 weeks, and lasting

approximately 3 months. After this, you should return for a repeat dose. The total maximum dose in a 2

month period should not be more than 200 U.

Strabismus

The volume of BOTOX

injected for the treatment of strabismus or squint should be between 0.05 to 0.15 mL

per eye muscle. The muscle relaxation effect begins one to two days after the injection and lasts 2 to 6 weeks.

You may need to return for a repeat dose if the effect is inadequate or if the squint recurs. The maximum

recommended dose as a single injection for any one muscle is 25 U.

Spasticity in Children Two Years and Older

The recommended total dose is up to 8 U/kg injected into the spastic muscles. The maximum total dose is 300

U per treatment session or in a 3 month interval. The initial effect occurs within 2 weeks after injection. The

dose is dependent on the size of the spastic muscle and the degree of spasticity. The dose can then be repeated

but not more often than every 3 months.

Focal Spasticity in Adults

Your doctor will determine the appropriate dose and the number of injection sites based on the number of

spastic muscles, the severity of the spasticity and the site and location of the muscles involved. Your doctor

may also tailor your dose depending on any muscle weakness that may be present and your response to the

injection. Improvement generally occurs within the first 2 weeks after injection, with maximum effect

occurring after 4-6 weeks and the effect lasting approximately 3-4 months.

In general, the total maximum dose should not be more than 360 U for the treatment of upper limb spasticity

and 400 U for the treatment of lower limb spasticity in each treatment session.

Cervical Dystonia

The recommended dose depends on the type of muscle spasm, the position of the head and neck, whether

muscle weakness is present, where pain is felt, your weight and response to the injection. Your doctor will

prescribe the proper dose for you. Improvement generally occurs within the first 2 weeks after the injection,

with the maximum effect after 6 weeks and the effect lasting approximately 3-4 months. In general, the total

maximum dose in a 2 month period should not be more than 360 U.

Spasmodic Dysphonia

Your doctor will determine the appropriate dose for you at each treatment session. Improvement generally

occurs within 2-4 days. The maximum effect is seen within approximately 7 days with the effect lasting

approximately 3-4 months.

Chronic Migraine

The recommended dose for treating chronic migraine is 155 U to 195 U administered intramuscularly as 0.1

ml (5 U) injections across 7 specific muscle areas in the head and neck. The dose can then be repeated every

12 weeks, for up to 3 cycles, and then assessment of the need for further treatment should be conducted.

Primary Hyperhidrosis

Recommended dose is 50 U of BOTOX

(2.0 mL) per armpit, evenly distributed in multiple sites

approximately 1-2 cm apart within the armpit area. Injections should be repeated when the effects from the

previous injection wear off but not more often than every 4 months.

BOTOX

®

Botulinum Toxin Type A CMI v12.0 PI v15.0

PAGE 5 OF 9

Frown Lines

The recommended dose of BOTOX

for the treatment of frown lines is 20 U. This is usually injected into the

muscles around your eyebrows in 5 different places. The recommended injection volume per muscle site is

0.1 mL. However, the optimum dose levels and number of injections sites per muscle may vary among

patients. Improvement in the severity of the lines generally occurs within one week after the injections and

has been shown to last for up to 4 months. This will vary between individual people and may depend on the

severity of the frown lines.

Crow’s Feet

The recommended dose of BOTOX

injection for the treatment of crow’s feet lines is 6-18 U per side. This is

usually injected into the muscles around your eyes, where most lines are seen when a smile is forced, in 3

different places. Improvement in the severity of the lines generally occurs within one week after the injections

and has been shown to last for up to 4 months.

Forehead Lines

The recommended dose of BOTOX

for the treatment of forehead lines is 8-24 U. This is usually injected

into the forehead muscle in 4 different places. Improvement in the severity of the lines generally occurs

within two weeks after the injections and has been shown to last for up to 6 months.

Use in pregnancy

Use of BOTOX

when pregnant or breast-feeding is not recommended. Tell your doctor or pharmacist if you

become pregnant while being treated with BOTOX

Use in children

Use in patients below the age of 18 years has not been established for the treatment of urinary incontinence.

Use in children below the age of 18 years has not been established for chronic migraine.

Use in children below the age of 12 has not been established for blepharospasm, VIIth nerve disorders,

cervical dystonia, hyperhidrosis, spasmodic dysphonia or frown lines.

Use in children two years or older is only recommended for focal spasticity (e.g. juvenile cerebral palsy,

spasticity of the arm, hip).

Things to be careful of

Tell your doctor as soon as possible if you do not feel well while being treated with BOTOX

injection.

Be careful to resume activities gradually if you have had little exercise for a long time.

Be careful driving or operating machinery until you know how BOTOX

affects you.

Urinary incontinence due to overactive bladder

You will be seen by your doctor approximately 2 weeks after the injection. You will be asked to pass urine

and will then have the volume of urine left in your bladder measured using ultrasound. Your doctor will

decide if you need to return for the same test during the next 12 weeks. You must contact your doctor if at

any time you find it difficult to pass urine because it is possible that you may need to start using a catheter.

In order to avoid urinary tract infections, female patients should pass urine after sexual intercourse.

Please note only a small percentage (12.2%) of patients included in the main clinical trials were male. The

improvement seen in male patients following use in BOTOX

is smaller than in female patients and may

not be beneficial. No significant reduction in incontinence frequency was seen and a majority of men in

the clinical trials felt that their condition was unchanged or worsened after receiving BOTOX

. There are

also side effects such as urinary tract infection and inability to empty your bladder (urinary retention)

associated with BOTOX treatment. The decision to receive treatment with BOTOX

should be discussed

with your doctor.

Urinary incontinence due to neurogenic bladder

You will be seen by your doctor approximately 2 weeks after the injection, if you were not using a

catheter before the injection. You will be asked to pass urine and will then have the volume of urine left in

your bladder measured using ultrasound. Your doctor will decide if you need to return for the same test

during the next 12 weeks. You must contact your doctor if at any time you find it difficult to pass urine

BOTOX

®

Botulinum Toxin Type A CMI v12.0 PI v15.0

PAGE 6 OF 9

because it is possible that you may need to start using a catheter. In order to avoid urinary tract infections,

female patients should pass urine after sexual intercourse.

Overdose

Telephone your doctor or Poisons Information Centre on 13 11 26 (Australia) for advice or go to casualty at

your nearest hospital immediately if you think that you or anyone else may have swallowed or accidentally

injected BOTOX

injection, even if there are no signs of discomfort or poisoning. You may need to be

watched for several days for signs of muscle weakness or loss of muscle movement.

Tell your doctor if you feel any general weakness, local muscle weakness, difficulty in breathing or

swallowing in the weeks following your injection. There is an anti-toxin to the toxin in BOTOX

, but it is

only likely to be effective if injected within 30 minutes after the BOTOX

injection. If you have questions or

concerns or are not sure about something, please consult your doctor or pharmacist.

5. SIDE EFFECTS

All medicines can have side effects. Sometimes they are serious, most of the time they are not. Some patients

may experience unwanted effects with BOTOX

treatment, and may need further medical treatment. Ask

your doctor to answer any questions you may have.

If while undergoing treatment with BOTOX

®

injection you experience any side-effects or symptoms

which may be due to this medication (whether or not it is mentioned below) please inform your doctor

as early as possible.

This product contains albumin, an extract of human blood. Based on effective donor screening and product

manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical

risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of

transmission of viral diseases or CJD have ever been identified for albumin.

Things which may occur:

General

Pain, tenderness, inflammation, tingling or numbness, swelling, dry mouth, redness of the skin, infection,

bleeding and/or bruising at the site of injection; generally feeling unwell and weakness.

The following symptoms have been reported on rare occasions: changes in the way the heart beats, chest pain,

skin rash and allergic reaction (symptoms: shortness of breath, wheezing or difficulty breathing; swelling of

the face, lips, tongue or other parts of the body; rash, itching or hives on the skin).

In some cases, the effect of botulinum toxin may be observed beyond the site of injection and the following

symptoms may occur:

loss of strength and muscle weakness

drooping of the upper eyelid

double or blurred vision

trouble speaking or saying words clearly

constipation

aspiration pneumonia (serious lung infection)

trouble swallowing or breathing, which can be life-threatening.

These symptoms can happen hours to weeks after injection and are more likely to occur in patients treated

with high doses or who have underlying conditions that would predispose them to these symptoms.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you experience any

of the above symptoms.

BOTOX

®

Botulinum Toxin Type A CMI v12.0 PI v15.0

PAGE 7 OF 9

Injections in the bladder wall for leakage of urine due to overactive bladder

Very common side effects: urinary tract infection, painful urination after the injection

Common side effects: bacteria in the urine, inability to empty your bladder (urinary retention), incomplete

emptying of the bladder, frequent daytime urination, blood in the urine after the injection

*

This side effect may also be related to the injection procedure.

**

This side effect is only related to the injection procedure.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your

doctor or pharmacist.

Injections in the bladder wall for leakage of urine due to bladder problems associated with spinal cord

injury or multiple sclerosis

Very common side effects: urinary tract infection, inability to empty your bladder (urinary retention).

Common side effects: difficulty in sleeping, constipation, muscle weakness, muscle spasm, bulge in the

bladder wall, tiredness, problems with walking, fall.

Common side effects related to the injection procedure: blood in the urine after the injection, painful urination

after the injection, possible uncontrolled reflex reaction of your body (e.g. profuse sweating, throbbing

headache or increase in pulse rate) around the time of the injection.

Blepharospasm, Hemifacial Spasm or VIIth Nerve Disorders

Drooping of the eyelids, irritation or tearing, dry eye, not being able to close the eye, sensitivity to light,

dizziness and tiredness.

Less common side effects include: inward or outward turning of the eye, inflammation of the eye, double

vision, and swelling of the eyelid skin lasting several days.

Strabismus

Drooping of the eyelids, vertical turning of the eye, double vision, bleeding beneath the eye lids and at the

front of the eye.

Less common side effects include: bleeding behind the eye ball, piercing of the sclera (the tough skin covering

part of the eye bulb), dilation of the pupil, loss of awareness of space and past pointing (the inability to place a

finger on another part of the body accurately), headache, inability to focus, dizziness, discomfort/irritation of

the eye, increased pressure in the eye.

Spasticity in Children Two Years and Older

Falling, clumsiness, localised, and/or generalised muscle weakness, localised pain, problems with walking, flu,

viral infections, ear infection and pain, bruising and discomfort at the injection site.

Less common side effects include: leg cramps, fever, knee or ankle pain, increased frequency of passing urine,

joint dislocation and muscle spasms.

Seizures, pneumonia, vomiting, bruising, rash, abnormal skin sensations (e.g. tingling or numbness), feeling

drowsy or sleepy,

generally feeling unwell and running nose were also reported

Focal Spasticity in Adults

Most side effects that have been reported in patients being treated for focal spasticity were mild to moderate

and got better without needing medical attention.

Side effects reported include: pain in the affected limb, changes in ease of movement of the muscle, increased

sensitivity to touch or pain, headache, muscular weakness, pain at the injection site, fever, flu-like illness, joint

pain, swelling of the extremities such as the hands and feet and bruising under the skin.

Less common side effects include: weakness or a loss of energy, skin problems, nausea, ‘pins & needles’,

itching, rash, pain and lack of coordination.

BOTOX

®

Botulinum Toxin Type A CMI v12.0 PI v15.0

PAGE 8 OF 9

Cervical Dystonia

Soreness or bruising where the injection was given, difficulty in swallowing, neck pain, headache, weakness

of the neck, dizziness, feeling drowsy or sleepy, dry mouth, nausea, flu-like illness, upper respiratory tract

infection, increased muscle tension, muscle stiffness and decreased skin sensation.

Less common side effects include: general weakness, fever, shortness of breath, double vision and drooping of

the eyelid. Side effects, if they occur, tend to appear in the first week after injection.

However, in rare instances, patients may have serious difficulty in breathing and swallowing that could occur

within hours of injection and may persist for weeks after injection and may develop into a more serious

condition. Make sure you tell your doctor immediately if you experience any difficulty in swallowing.

Spasmodic Dysphonia

Breathiness, difficulty in swallowing, inhalation of fluid or food particles from the stomach, narrowed air

passages causing a harsh sound in breathing and pain were among the more common side effects reported in

clinical trials.

Chronic Migraine

Loss of movement on the face, drooping of the eyelids, skin rash, itching, pain at the injection site, neck pain,

muscle pain, tenderness or weakness, muscle spasms or tightness.

Less common side effects include: pain of skin, pain of jaw and difficulty in swallowing.

Headache, including worsening migraine, has been also reported, usually occurring within the first month after

treatment; however, these reactions did not always reoccur with following treatments and the overall incidence

decreased with repeated treatments.

Primary hyperhidrosis

Increase in sweating in other areas of the body, hot flushes and pain at the injection site.

Frown Lines

Drooping of the eyelids, headache, face pain, redness, swelling at the injection site, bruising, skin tightness,

muscle weakness, numbness or a feeling of pins and needles or nausea were among the more common effects

reported in clinical trials. Inability to completely close the eyelid has been reported in post-marketing

experience.

Crow’s Feet

Bruising at the injection site, headache, flu-like symptoms and inability to completely close the eyelid.

Forehead Lines

Headache, bruising, drooping of the eyebrows, eyelid swelling, aching/itching forehead, nausea, feeling of

tension and flu-like symptoms.

6. STORAGE AND DISPOSAL

BOTOX

injection should not be used after the date marked on the label (expiry date).

KEEP ALL MEDICINES WHERE YOUNG CHILDREN CANNOT REACH THEM.

BOTOX

injection should be stored in the refrigerator. The injection should be given within 24 hours

after being reconstituted and stored in a refrigerator during this time. The injection should be clear,

colourless and free from particles. Each vial is intended for use by a single individual patient.

7. FURTHER INFORMATION

If you have any further questions on your BOTOX

treatment or are unsure of the information, please see

your doctor, who will be able to assist you.

BOTOX

®

Botulinum Toxin Type A CMI v12.0 PI v15.0

PAGE 9 OF 9

Supplier

ALLERGAN AUSTRALIA PTY LTD

810 Pacific Highway

Gordon NSW 2072

ABN 85 000 612 831

Australian Registration Number

BOTOX

50 U - AUST R 195530

BOTOX

100 U - AUST R 67311

BOTOX

200 U - AUST R 172264

Date of preparation

May 2019

® Registered trademark of Allergan, Inc.

© 2018 Allergan. All rights reserved