2. What should I know before I use BOTOX®?
Check the list of ingredients at the end of the CMI. Do not use BOTOX® if you have
ever had an allergic reaction to any of them.
Talk to your doctor before you use this medicine. Ensure they are aware if you have
any other medical conditions, take any other medicines, or are pregnant or plan to
become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use BOTOX®? in the full CMI.
3. What if I am taking other medicines?
4. How is BOTOX® used?
BOTOX® injection should only be administered by a doctor familiar with the required
technique. It must be dissolved in sterile saline solution immediately before use
and should not be used in higher doses or more frequently than recommended.
More instructions can be found in Section
4. How is BOTOX® used? in the full CMI.
5. What should I know while using BOTOX®?
|
Things you should do
|
Remind any doctor, dentist, pharmacist or other health care professional you visit
that you are using BOTOX® injection.
Follow all directions given to you by your doctor before, during and after you have
your BOTOX® injection.
Be careful to resume activities gradually if you have had little exercise for a long
time.
Tell your doctor as soon as possible if you do not feel well while being treated with
BOTOX® injection.
In order to avoid urinary tract infections, female patients should pass urine after
sexual intercourse.
|
|
BOTOX® injection must not be used if:
|
you are allergic to any of the ingredients listed in section 7 (Product Details)
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 1) have either a sudden onset of urinary
tract infection (UTI) or 2) sudden inability to empty your bladder (and are not regularly
using a catheter) or 3) not willing and/or able to begin using a catheter, if required.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how BOTOX® injection affects
you.
|
|
Looking after your medicine
|
BOTOX® is an injectable medicine which will only be provided to you by your healthcare
practitioner in a clinic setting.
|
6. Are there any side effects?
The most serious side effects requiring urgent medical attention include: loss of
strength/muscle weakness, drooping eyelid, double or blurred vision, trouble speaking,
aspiration pneumonia, trouble swallowing or breathing, changes to heart beats, chest
pain, skin rash, allergic reaction (symptoms include shortness of breath, wheezing
swelling of the face, lips, tongue or other parts of the body, rash, itching or hives
on the skin); and in children: pneumonia, seizures.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
|
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.
|
Active ingredient:
[botulinum toxin type A] (bot-yu-lyn-um)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BOTOX®. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using BOTOX®.
Where to find information in this leaflet:
1. Why am I using BOTOX®?
BOTOX® injection contains the active ingredient botulinum toxin type A, a muscle relaxant obtained from the bacterium Clostridium botulinum
.
BOTOX® injection 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).
BOTOX® 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) in patients twelve years
and over
causing 'lazy eye' or squint (strabismus) in patients twelve years and over
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)
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 shoulders, hands, arms or legs (adult focal
spasticity).
BOTOX® is also used to:
treat an overactive bladder in adults 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 medicine (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
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. associated with neurologic disease
treat headaches occurring in adults with chronic migraine
treat excessive sweating from the armpits
improve the look of vertical frown lines that appear between the eyebrows, lines around
the eyes and on the forehead in adults
temporarily improve the appearance of continuous vertical bands connecting the jaw
and neck (platysma muscle) seen at maximum contraction in healthy adults.
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.
2. What should I know before I use BOTOX®?
Warnings
Do not use BOTOX® if:
you are allergic to botulinum toxin type A or any of the ingredients listed at the
end of this leaflet
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) or are not willing and/or able to use a catheter, if required
the container is damaged or shows signs of tampering, or if the product does not look
quite right.
Check with your doctor if:
you have any muscle disorders in other parts of your body, including motor neuron
disease such as amyotrophic lateral sclerosis and motor neuropathy
you are scheduled to have surgery where a general anaesthetic will be used
you are taking medicines used to thin the blood (anti-coagulants) and/or prevent blood
clots (aspirin-like products)
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
(a 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 being treated for leakage of urine and have a chronic urinary tract infection
for which you take long term antibiotics to treat
you are being treated for leakage of urine and have a urinary obstruction. Symptoms
and signs include difficulty emptying your bladder and reduced urine flow
you are being treated for leakage of urine due to an overactive bladder and have diabetes
you are pregnant or have the intention of becoming pregnant.
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.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
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®.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Use in children
The safety and effectiveness of BOTOX® has been established in children/adolescents
over the age of two years for the treatment of focal spasticity due to juvenile cerebral
palsy.
Limited information is available on the use of BOTOX® in the following conditions
in children/adolescents listed below. No recommendation on dosage can be made for
these indications.
over the age of 12 years:
persistent muscle spasms in the eyelid and face
persistent muscle spasm in the eye causing a "lazy eye" or squint
excessive sweating of the armpits
persistent muscle spasms in the throat, causing a strained, strangled sounding voice
or breathy voice with voice loss.
over the age of 16 years:
persistent muscle spasms in neck and shoulder.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with BOTOX® and may cause serious side effects. Especially
tell your doctor if you:
have received any other botulinum toxin product injected 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BOTOX®.
4. How is BOTOX® used?
How much to use
BOTOX® product must be dissolved in sterile saline solution immediately before use
and should not be used in higher doses or more frequently than recommended.
When treating paediatric patients, for one or more indications, the maximum cumulative
BOTOX® dose in a 3-month period should generally not exceed 8 Units/kg body weight
or 300 Units, whichever is lower (refer to indication-specific maximum dosing recommendations).
When to use BOTOX®
You may receive follow-up BOTOX® injection(s) if the effect begins to wear off, depending
on the condition for which you are being treated.
How to use BOTOX®
BOTOX® injection should only be administered by a doctor familiar with the required
technique.
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.
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 400 U divided among involved
muscles for treating adult upper limb spasticity, and maximum dose of 400 U divided
among involved muscles for treating adult lower limb spasticity in any 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 dosage 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.
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 muscles 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.
Continuous vertical bands connecting the jaw and neck (platysma muscle) seen at maximum
contraction
BOTOX® is injected directly into the muscle of the affected area at each side of the
neck. The usual dose is either 26, 31, or 36 Units. You will be injected with the
recommended volume of 0.05 ml (2 Units) of BOTOX® into 4 sites in the upper segment
of platysma muscle, below the jawline on each side. In addition, you will be injected
with 0.025 ml (1 Unit) of BOTOX® into 5 sites along each vertical neck band, 1 to
2 vertical neck bands per side. Depending on platysma continuous bands severity, the
total dose may be 26 Units (1 band/side), 31 Units (1 band one side, 2 bands other
side), or 36 Units (2 bands/side). You cannot receive another platysma treatment sooner
than 3 months.
If you use too much BOTOX®
If you think you or anyone else may have swallowed or accidentally injected BOTOX®,
immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this 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. There is an anti-toxin to the toxin in BOTOX® but it is only likely to be effective
if injected within 30 minutes after a BOTOX® injection.
Tell your doctor if you feel any general weakness, local muscle weakness, difficulty
in breathing or swallowing in the weeks following your injection.
5. What should I know while using BOTOX®?
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 the transmission of Creutzfeldt-Jakob disease (CJD) is considered
extremely remote.
No cases of transmission of viral diseases or CJD have ever been identified for albumin.
Things you should do
Be careful to resume activities gradually if you have had little exercise for a long
time.
Tell your doctor as soon as possible if you do not feel well while being treated with
BOTOX® injection.
Remind any doctor, dentist, pharmacist, or other health care professional you visit
that you are using BOTOX®.
In order to avoid urinary tract infections, female patients should pass urine after
sexual intercourse.
If you are being treated for 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.
If you are being treated for 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
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.
Call your doctor straight away if you:
Feel any general weakness, local muscle weakness, difficulty in breathing or swallowing
in the weeks following your injection
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)
Driving or using machines
Be careful driving or operating machinery until you know how BOTOX® affects you.
Looking after your medicine
BOTOX® is an injectable medicine which will only be provided to you by your healthcare
practitioner in a clinic setting.
Getting rid of any unwanted medicine
Any unused medicine left in a vial will be thrown away by your doctor or nurse.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Note that some side effects can occur hours, and up to weeks after a BOTOX® injection.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Very serious side effects
|
Very serious side effects
|
What to do
|
|
Applicable to any condition being treated:
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
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.
The following symptoms have been reported on rare occasions:
changes in the way the heart beats, chest pain
skin rash
symptoms of an allergic reaction, including 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).
Spasticity in children two years and older:
Less common side effects include:
severe infection on the chest (pneumonia)
seizures (fits)
|
Go straight to the Emergency Department at your nearest hospital if you notice any
of these very serious side effects.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Applicable to any condition being treated:
infection
feeling generally unwell
weakness
Injections in the bladder wall for leakage of urine due to overactive bladder:
urinary tract infection
unable to completely empty your bladder (urine retention)
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
problems with walking, falling over
Common side effects related to the injection procedure
incomplete emptying of the bladder
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:
inward or outward turning of the eye
inflammation of the eye
swelling of the eyelid skin lasting several days
Strabismus
vertical turning of the eye
bleeding beneath the eye lids and at the front of the eye
bleeding behind the eye ball
piercing of the sclera (tough skin covering part of the eye bulb)
dilation of the pupil
loss of awareness of space and past pointing (inability to place a finger on another
part of the body accurately)
inability to focus
increased pressure in the eye
Spasticity in children two years and older:
clumsiness
falling
localised, and/or generalised muscle weakness
localised pain
problems with walking
bruising and discomfort at the injection site
Less common side effects include:
leg cramps
fever
knee or ankle pain
increased frequency of passing urine
bruising
generally feeling unwell
running nose
abnormal skin sensations (tingling or numbness)
flu
viral infections
ear pain or infection
muscle spasms
vomiting
feeling sleepy or drowsy
joint dislocation
Cervical Dystonia:
difficulty in swallowing
upper respiratory tract infection
fever
shortness of breath
Spasmodic Dysphonia:
breathiness
inhalation of fluid or food particles from the stomach
narrowed air passages causing a harsh breathing sound
pain
Chronic Migraine:
difficulty in swallowing
Continuous vertical bands connecting the jaw and neck (platysma muscle)
difficulty swallowing
|
Call your doctor straight away, if you notice any of these serious side effects.
|
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Applicable to any condition being treated:
Pain, tenderness
inflammation
tingling or numbness
swelling (including swelling of the eyelid following injection)
dry mouth
redness of the skin
bleeding and/or bruising at the site of injection
constipation
Injections in the bladder wall for leakage of urine due to overactive bladder
Common side effects include:
bacteria in the urine
pain when passing urine (may be related to the injection procedure)
frequent daytime urination
blood in the urine (only related to injection procedure)
Injections in the bladder wall for leakage of urine due to bladder problems associated
with spinal cord injury or multiple sclerosis
difficulty sleeping, tiredness
muscle spasm
blood in the urine (only related to the injection procedure)
painful urination (only related to the injection procedure)
constipation
muscle weakness
bulge in the bladder wall
Blepharospasm, Hemifacial Spasm or VIIth Nerve Disorders:
eye irritation or tearing
dry eye
not being able to close the eye
sensitivity to light
dizziness
tiredness
Strabismus
headache
dizziness
discomfort/irritation of the eye
Focal spasticity in adults:
Most side effects reported in patients being treated for focal spasticity were mild
to moderate and got better without needing medical attention
nausea
weakness of muscles
pain in extremities such as hands and feet
tiredness and swelling of the extremities such as hands and feet
Cervical Dystonia:
soreness or bruising at the site of injection
neck pain
weakness of the neck
headache
feeling drowsy or sleepy
dry mouth
nausea
flu-like symptoms
increased muscle tension, muscle stiffness
decreased skin sensation
dizziness
Side effects if they occur tend to appear after the first week of injection.
Chronic Migraine:
loss of movement in the face
drooping of the eyelids
skin rash and itching
pain at the injection site
neck pain
muscle pain, tenderness or weakness
muscle spasms or tightness
quizzical or Spock's eyebrow, when the outer end of the eyebrow is located above the
inner end (Mephisto sign)
headache, including worsening of migraine, has been 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
Less common side effects:
pain of skin
pain of jaw
Primary hyperhidrosis:
increased sweating in other areas of the body
hot flushes
pain at the site of injection
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
nausea
inability to completely close the eyelid
quizzical or Spock’s eyebrow, when the outer end of the eyebrow is located above the
inner end (Mephisto sign)
Crow’s feet:
bruising at the site of injection
headache
flu-like symptoms
inability to completely close the eyelid
Forehead lines:
headache
bruising
drooping of the eyebrows
eyelid swelling
aching/itching forehead
nausea
feeling of tension
flu-like symptoms
Continuous vertical bands connecting the jaw and neck (platysma muscle)
weakness in the lower part of the face
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
This medicine is only available with a doctor's prescription.
What BOTOX® injection contains
|
Active ingredient
(main ingredient)
|
Botulinum toxin type A
|
|
Other ingredients
(inactive ingredients)
|
albumin
sodium chloride
|
Do not use this medicine if you are allergic to any of these ingredients.
Your doctor or nurse will store BOTOX® in the fridge (at 2°C to 8°C.)
Keep all medicines where young children cannot reach them.
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.
This medicine should not be used after the expiry date.
What BOTOX® looks like
BOTOX® injection is supplied as a sterile white vacuum-dried powder in a clear glass
vial. It is diluted before use with non-preserved, sterile 0.9% w/w sodium chloride
injection. It is supplied in three strengths:
BOTOX® 50 U (Aust R 195530)
BOTOX® 100 U (Aust R 67311)
BOTOX® 200 U (Aust R 172264)
(Not all presentations may be available)
Who distributes BOTOX®?
BOTOX® is distributed in Australia by:
AbbVie Pty Ltd
Mascot NSW 2020
Australia
This leaflet was prepared in September 2025.
BOTOX® and its design are trademarks of Allergan, Inc., an AbbVie company.
©2025 AbbVie. All rights reserved.