BOTOX 100 ALLERGAN UNITS - POWDER FOR SOLUTION FOR INJECTION

Active substance: CLOSTRIDIUM BOTULINUM TYPE A NEUROTOXIN COMPLEX 900KD

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Insert - BOTOX® 50U, 100U, 200U - UK - MoH Submission

PACKAGE LEAFLET:
INFORMATION FOR THE USER

BOTOX®

50 Allergan Units,
100 Allergan Units,
200 Allergan Units,
Powder for solution for injection
Botulinum toxin type A
Read all of this leaflet carefully before you start using
this medicine.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What BOTOX is and what it is used for
Before you use BOTOX
How to use BOTOX
Possible side effects
How to store BOTOX
Further information

1. WHAT BOTOX IS AND WHAT IT IS USED FOR
What BOTOX is

BOTOX is a muscle relaxant that is injected into the muscles or deep
into the skin. It works by partially blocking the nerve impulses to any
muscles that have been injected and reduces excessive contractions
of these muscles. In the case of chronic migraine, it is thought that
BOTOX blocks pain signals, which indirectly block the development of
a migraine.
When injected into the skin, BOTOX works on sweat glands to reduce
the amount of sweat produced.
When injected into the bladder wall, BOTOX works on the bladder
muscle to prevent leakage of urine (urinary incontinence) due to
uncontrolled contractions of the bladder muscle.

What BOTOX is used for

In adults, BOTOX is used to control:
• persistent muscle spasms in the eyelid and face;
• persistent muscle spasms in the neck and shoulders;
• persistent muscle spasms in the wrist, hand or ankle of
patients who have suffered a stroke;
• excessive sweating of the armpits that affects the activities of
daily living, when other local treatments do not help;
• overactive bladder with leakage of urine, the sudden urge
to empty your bladder and needing to go to the toilet more
than usual;
• leakage of urine due to bladder problems associated with spinal
cord injury or multiple sclerosis.
In patients who have not managed to control overactive bladder with
leakage of urine with medicines called anticholinergics, BOTOX has
been shown to reduce leakage of urine from an average of about
5 episodes per day down to 2 after 12 weeks. 27% of patients had no
leakage of urine at all.
In patients with bladder problems associated with spinal cord injury or
multiple sclerosis who have not managed to control leakage of urine
with medicines called anticholinergics, BOTOX has been shown to
reduce leakage of urine, from an average of about 30 episodes per
week down to 10 after 6 weeks. 37% of patients had no leakage of
urine at all.
In adults, BOTOX is used to prevent:
• headaches in patients with chronic migraine

Chronic migraine is a disease affecting the nervous system. To be
diagnosed with chronic migraine, you must have headaches 15 days
or more a month. In addition, on 8 or more days a month, your
headaches must have at least two of the following characteristics:
• affect only one side of the head
• cause a pulsating pain
• cause moderate to severe pain
• are aggravated by routine physical activity
and they must cause at least one of the following:
• nausea, vomiting, or both
• sensitivity to light and sound.
BOTOX has been shown to significantly reduce the frequency of days
with headache and to improve the quality of life of patients suffering
from chronic migraine. After two treatment sessions, approximately
47% of patients had a 50% or greater reduction from baseline in the
number of days with headache they experienced.
When the severity of the following facial lines has an important
psychological impact in adult patients, BOTOX is used for the
temporary improvement in the appearance of:
• Vertical lines between the eyebrows seen at maximum frown
• Fan-shaped lines from the corner of the eyes seen at
maximum smile
• Fan-shaped lines from the corner of the eyes seen at
maximum smile when treated at the same time as vertical
lines between the eyebrows seen at maximum frown
In children aged two years or older with cerebral palsy, who can walk,
BOTOX is used to control:
• foot deformity caused by the persistent muscle spasms in the
legs. BOTOX relieves the persistent muscle spasms in the leg.

2. BEFORE YOU USE BOTOX
Do NOT use BOTOX






if you are allergic (hypersensitive) to botulinum toxin type
A or any of the other ingredients of BOTOX;
if you have an infection at the proposed site of injection;
when you are being treated for leakage of urine and have
either a urinary tract infection or a sudden inability to empty
your bladder (and are not regularly using a catheter), or if you
have bladder stones;
if you are being treated for leakage of urine and are not willing
to begin using a catheter if required.

Take special care with BOTOX
Before using BOTOX

Tell your doctor if you:
• have had any problems with injections (such as fainting) in
the past;
• have had problems in the past with previous botulinum toxin
injections;
• have inflammation in the muscles or skin area where your
doctor plans to inject;
• have significant weakness or wasting of the muscles which
your doctor plans to inject;
• have ever had problems with swallowing or food or liquid
accidentally going into your lungs, especially if you will be
treated for persistent muscle spasms in the neck and shoulders;
• suffer from any other muscle problems or chronic diseases
affecting your muscles (such as myasthenia gravis or Eaton
Lambert Syndrome);
• suffer from certain diseases affecting your nervous system
(such as amyotrophic lateral sclerosis or motor neuropathy);
• have an eye disease called closed-angle glaucoma (high
pressure in the eye) or were told you are at risk for developing this
type of glaucoma;
• have had any surgery that may have in some way changed the
muscle to be injected;
• will have an operation soon;
• are taking any blood thinning medicine.

After you have been given BOTOX

Contact your doctor and seek medical attention immediately if you
experience any of the following:
• difficulty in breathing, swallowing, or speaking;
• hives, swelling including swelling of the face or throat,
wheezing, feeling faint and shortness of breath (possible
symptoms of severe allergic reaction).
If you have been treated for vertical and/or fan-shaped lines, please
inform your doctor if you see no significant improvement of your lines
one month after your first course of treatment.

Perforation

General precautions

The dosage of BOTOX and the duration of its effect will vary
depending on the condition for which you are treated. Below are
details corresponding to each condition.

Duration of treatment effect
When the effect starts to wear off, you can have the treatment again if
needed, but not more often than every 12 weeks.



For excessive sweating of the armpits

If you have not done much exercise for a long time before receiving
BOTOX treatment, then after your injections you should start any
activity gradually.

The safety and effectiveness of BOTOX in the treatment of
persistent muscles spasms of the eyelid, face, neck and shoulder
in children (under 12 years) have not been demonstrated;



It is unlikely that this medicine will improve the range of motion of
joints where the surrounding muscle has lost its ability to stretch.

The safety and effectiveness of BOTOX in the treatment of chronic
migraine have not been studied in children (under 18 years);



When treating adults with post-stroke ankle muscle spasms, BOTOX
should only be used if it is expected to result in improvement in
function (e.g. walking) or symptoms (e.g. spasms or pain) or to help
with patient care. Furthermore, for patients who may be more likely to
fall, your doctor will judge if this treatment is suitable.

The safety and effectiveness of BOTOX in the treatment of
vertical lines between the eyebrows and/or fan-shaped lines from
the corner of the eyes in individuals under 18 years of age have
not been demonstrated and such use is not recommended;



The safety and effectiveness of BOTOX in the treatment of
excessive sweating of the armpits have not been investigated
in children under 12 years. There is limited experience with
BOTOX in the treatment of excessive sweating of the armpits
in adolescents between age of 12 and 17 using BOTOX.
The effectiveness of BOTOX in this population has not been
confirmed. Speak to your doctor for further information;

If you are given BOTOX too often or the dose is too high, your body
may start producing some antibodies, which can reduce the effect of
BOTOX. To limit this risk, the interval between two treatments must not
be less than two or three months depending on the indication.

When BOTOX is used in the treatment of persistent muscle spasms in
the eyelid, it could make your eyes blink less often, which may harm the
surface of your eyes. In order to prevent this, you may need treatment
with eye drops, ointments, soft contact lenses or even protective
covering which closes the eye. Your doctor will tell you if this is required.



When BOTOX is used in the treatment of vertical lines and fan-shaped
lines drooping of eyelid may occur after treatment.

The safety and effectiveness of BOTOX have not been
established in children below the age of 2 years for cerebral palsy;



The safety and effectiveness of BOTOX in the treatment of upper
and lower limb spasticity associated with stroke have not been
established in children and adolescents under 18 years;



The safety and effectiveness of BOTOX in the treatment of
leakage of urine have not been established in children under
18 years;



There is limited experience of using BOTOX in the treatment of
vertical and/or fan-shaped lines in patients older than 65 years.

BOTOX does not prevent headaches in patients with episodic
migraine, which occur less than 15 days a month.

Taking other medicines

Tell your doctor or pharmacist if:
• you are using any antibiotics (used to treat infections),
anticholinesterase medicines, medicines to control your heart
rhythm, or muscle relaxants. Some of these medicines may
increase the effect of BOTOX.
• you have recently been injected with a medicine containing
botulinum toxin (the active substance of BOTOX), as this may
increase the effect of BOTOX too much.
• you are using any anti-platelet (aspirin-like) products and/or
anticoagulants (blood thinners).
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription.

Pregnancy and breast-feeding

The use of BOTOX is not recommended during pregnancy and in
women of childbearing potential not using contraception. Contact your
doctor if you are pregnant, plan pregnancy or become pregnant whilst
being treated. Your doctor will discuss with you whether you should
continue with your treatment.
BOTOX is not recommended in breast-feeding women.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

BOTOX may cause dizziness, sleepiness, tiredness or problems with
your vision. If you experience any of these effects, do not drive or use
any machines. If you are not sure, ask your doctor for advice.

3. HOW TO USE BOTOX
BOTOX must only be injected by doctors with specific skills on how to
use the medicine.

Method and route of administration

BOTOX is injected into your muscles (intramuscularly), into the
bladder wall via a specific instrument (cystoscope) to inject into the
bladder or into the skin (intradermally). It is injected directly into the
affected area of your body; your doctor will usually inject BOTOX into
several sites within each affected area.

General information about dosage




The number of injections per muscle and the dose vary
depending on the indications. Therefore, your doctor will decide
how much, how often, and in which muscle(s) BOTOX will be
given to you. It is recommended that your doctor uses the lowest
effective dose;
Dosages for the elderly are the same as for other adults.

For persistent muscle spasms of the eyelid and face

Dosage
In the first treatment session, your doctor may give multiple injections
in the affected muscles with 1.25 to 2.5 Units of BOTOX into each
injection site.
The maximum dose for the first treatment session is 25 Units per
affected area (for example per eye). For the following treatment
sessions, the total maximum dose can be increased up to 100 Units,
if needed.
Duration of treatment effect
You will usually see an improvement within 3 days after the injection.
The maximum effect is usually seen 1 to 2 weeks after treatment.
When the effect starts to wear off, you can have the treatment again if
needed, but not more often than every 3 months.

For persistent muscle spasms of the neck and shoulders
Dosage
Your doctor may give multiple injections in the affected muscles with
up to 50 Units of BOTOX into each injection site.
The maximum dose for the first treatment session is 200 Units.
Duration of treatment effect
When the effect starts to wear off, you can have the treatment again if
needed, but not more often than every 12 weeks.

For persistent muscle spasms in the wrist and hand of
patients who have had a stroke

Dosage
Your doctor may give multiple injections in the affected muscles. The
dose and number of injections will vary depending on a number of
factors, including your needs, the muscles to be injected, the size of
the muscles, severity of spasms, etc.
Duration of treatment effect
You will usually see an improvement within the first 2 weeks after the
injection.
The maximum effect is usually seen about 4 to 6 weeks after treatment.
When the effect starts to wear off, you can have the treatment again if
needed, but not more often than every 12 weeks.

For persistent muscle spasms in the ankle of patients
who have had a stroke

Dosage
Your doctor may give multiple injections in the affected muscles. The
total dose is 300 Units divided among 3 muscles for each treatment
session.

Dosage
Your doctor will give multiple injections with a total of 50 Units of
BOTOX in each armpit.
Duration of treatment effect
You will usually see an improvement within the first week after
injection.
On average the effect usually lasts 4-7 months after the first injection.
When the effect starts to wear off, you can have the treatment again if
needed.

For persistent muscle spasms in the legs of children
who have cerebral palsy

Dosage
The doctor may give multiple injections in the affected muscles. The
dose will depend on the weight of your child.
Duration of treatment effect
The improvement usually appears within the first 2 weeks after the
injection.
When the effect starts to wear off, further treatment is possible, but
not more often than every 2 months.

For the prevention of headache in adults who have
chronic migraine

Dosage
Your doctor may give you multiple injections (between 31 and 39) in
7 muscular groups of the face, head, neck and shoulders, with up
to 5 Units of BOTOX into each injection site. Injections are divided
across muscles in your forehead, your temples on the side of
your head, the back of your head, your upper neck area, and your
shoulders. The injections are given to both the left, and right side of
these head and neck muscles, except for one injection given to the
muscle that is between your eyebrows.
The total dose range is between 155 Units and 195 Units per
treatment session.
Duration of treatment effect
When the effect starts to wear off, further treatment is possible, but
not more often than every 12 weeks.

For overactive bladder with leakage of urine

Dosage
Your doctor will give multiple injections into the bladder wall. The total
dose is 100 Units of BOTOX.
Your doctor will give you antibiotics around the time of the injection to
help prevent urinary tract infection. The injection will be administered
by a procedure called cystoscopy. An instrument with a light source
at the end will be introduced into your bladder through the opening by
which you let out the urine (called urethra). This enables the doctor to
see the inside of the bladder and place the injections into the bladder
wall. Please ask your doctor to explain further details of the procedure
to you.
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.
You will be observed for at least 30 minutes after the injection before
you can leave to see if you can pass urine spontaneously.
If you were not using a catheter (a soft, hollow tube that is inserted into
your urethra to help empty urine from the bladder) before treatment
with BOTOX, you should 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. If your
doctor assesses you have too much urine left in your bladder you will
be instructed to use a catheter to empty your bladder. Your doctor will
decide if and when you need to return for the same test.
You must contact your doctor if at any time you are unable to pass
urine because it is possible that you may need to start using a catheter.
In clinical trials, approximately 6 out of 100 patients not using
a catheter before treatment may need to use a catheter after treatment.
Duration of treatment effect
You will usually see an improvement within 2 weeks after the injection.
Typically the effect lasts approximately 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 neurogenic bladder

Dosage
Your doctor will give multiple injections into the bladder wall. The total
dose is 200 Units of BOTOX.
Your doctor will give you antibiotics around the time of the injection to
help prevent urinary tract infection. The injection will be administered
by a procedure called cystoscopy. An instrument with a light source
at the end will be introduced into your bladder through the opening by
which you let out the urine (called urethra). This enables the doctor to
see the inside of the bladder and place the injections into the bladder
wall. Please ask your doctor to explain further details of the procedure
to you. You may be given a local or general anaesthetic before the
procedure.
You will be observed for at least 30 minutes after the injection before
you can leave. At the time of the injection, due to the procedure by
which the injection is delivered into your bladder, you may experience
possible uncontrolled reflex reaction of your body (e.g. profuse
sweating, throbbing headache or increase in pulse rate).
If you were not using a catheter (a soft, hollow tube that is
inserted into your urethra to help empty urine from the bladder)
before treatment with BOTOX, you should 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. If your doctor assesses you have too much urine left in
your bladder you will be instructed to use a catheter to empty your
bladder. Your doctor will decide if and when you need to return for the
same test.
You must contact your doctor if at any time you are unable to
pass urine because it is possible that you may need to start using
a catheter. In clinical trials, approximately one fifth of patients reported
an inability to completely empty their bladder after BOTOX treatment.
At least one third of patients not using a catheter before treatment
may need to use a catheter after treatment.
Duration of treatment effect
You will usually see an improvement within 2 weeks after the injection.
Typically the effect lasts approximately 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.

For vertical lines between the eyebrows seen at
maximum frown

The usual dose is 20 Units. You will be injected with the recommended
volume of 0.1 millilitre (ml) (4 Units) of BOTOX into each of
5 injection sites.
Improvement of severity of the lines located between the eyebrows
seen at maximum frown generally occurs within one week after
treatment, the maximum effect being observed 5 to 6 weeks after
injection. The treatment effect has been demonstrated for up to
4 months after injection.
The interval between two treatments must not be less than three
months.

For fan-shaped lines from the corner of the eyes seen at
maximum smile

Your doctor will inject BOTOX directly into the affected area at the
side of each eye. The usual dose is 24 Units. You will be injected with
the recommended volume of 0.1 millilitre (ml) (4 Units) of BOTOX into
each of 6 injection sites (3 injection sites at the side of each eye).
Improvement of severity of the fan-shaped lines from the corner of the
eyes seen at maximum smile generally occurs within one week after
treatment. The treatment effect has been demonstrated for an average
of 4 months after injection.
If you are treated for fan-shaped lines from the corner of the eyes
seen at maximum smile at the same time as vertical lines between
the eyebrows seen at maximum frown, you will receive a total dose of
44 Units.
The interval between two treatments must not be less than three
months.
The efficacy and safety of repeated injections of BOTOX beyond
12 months has not been evaluated.

If you have received more BOTOX than you should

The signs of too much BOTOX may not appear for several days after
the injection. Should you swallow BOTOX or have it accidentally
injected, you should see your doctor who might keep you under
observation for several weeks.

The following information is intended for
medical or healthcare professionals only:
Please refer to the Summary of Product
Characteristics for complete prescribing
information for BOTOX.
For all indications:
Side effects related to spread of toxin distant from the site of
administration have been reported, sometimes resulting in death,
which in some cases was associated with dysphagia, pneumonia
and/or significant debility. The symptoms are consistent with the
mechanism of action of botulinum toxin and have been reported hours
to weeks after injection. The risk of symptoms is probably greatest in
patients who have underlying conditions and comorbidities that would
predispose them to these symptoms, including children and adults
treated for spasticity, and are treated with high doses.
Patients treated with therapeutic doses may also experience
exaggerated muscle weakness.
Pneumothorax associated with injection procedure has been reported
following administration of BOTOX near the thorax. Caution is warranted
when injecting in proximity to the lung, particularly the apices.
Serious adverse events including fatal outcomes have been reported
in patients who had received off-label injections of BOTOX directly into
salivary glands, the oro-lingual-pharyngeal region, oesophagus and
stomach. Some patients had pre-existing dysphagia or significant debility.
Reconstitution of the medicinal product:
It is good practice to perform vial reconstitution and syringe
preparation over plastic-lined paper towels to catch any spillage.
Reconstitute BOTOX only with sterile unpreserved normal saline
(0.9% sodium chloride for injection). Draw up an appropriate amount
of diluent (see dilution table or instructions below) into a syringe.
Dilution table for BOTOX 50, 100 and 200 Allergan Units
vial size:
Resulting dose
(Units per
0.1 ml)

20 Units
10 Units
5 Units
4 Units
2.5 Units
1.25 Units

50 unit vial
Amount of
diluent (sodium
chloride
9 mg/ml (0.9%)
solution for
injection)
added in
a 50 unit vial
0.25 ml
0.5 ml
1 ml
1.25 ml
2 ml
4 ml

100 unit vial
Amount of
diluent (sodium
chloride
9 mg/ml (0.9%)
solution for
injection)
added in
a 100 unit vial
0.5 ml
1 ml
2 ml
2.5 ml
4 ml
8 ml

200 unit vial
Amount of
diluent (sodium
chloride
9 mg/ml (0.9%)
solution for
injection)
added in
a 200 unit vial
1 ml
2 ml
4 ml
5 ml
8 ml
N/A

Since BOTOX is denatured by bubbling or similar vigorous agitation,
inject the diluent gently into the vial. Discard the vial if a vacuum
does not pull the diluent into the vial. Reconstituted BOTOX is a clear
colourless to slightly yellow solution free of particulate matter. The
reconstituted solution should be visually inspected for clarity and
absence of particles prior to use. When reconstituted in the vial, BOTOX
may be stored in a refrigerator (2°C - 8°C) for up to 24 hours prior to use.
From a microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2°C - 8°C.
Dilution instructions for treatment of urinary incontinence due
to overactive bladder:
It is recommended that a 100 Unit or two 50 Unit vials are used
for convenience of reconstitution.
Should you need to use a 200 Unit vial, reconstitute a 200 Unit vial
of BOTOX with 8 ml of 0.9% non-preserved saline solution and mix
gently. Draw 4 ml from the vial into a 10 ml syringe. Complete the
reconstitution by adding 6 ml of 0.9% non-preserved saline solution
into the 10 ml syringe and mix gently. This will result in a 10 ml
syringe containing a total of 100 Units of reconstituted BOTOX. Use
immediately after reconstitution in the syringe. This product is for
single use only and any unused reconstituted product should be
disposed of. Dispose of any unused saline.
Or, reconstitute a 100 Unit vial of BOTOX with 10 ml of
0.9% non-preserved saline solution and mix gently. Draw the 10 ml from
the vial into a 10 ml syringe. This will result in a 10 ml syringe containing
a total of 100 Units of reconstituted BOTOX. Use immediately after
reconstitution in the syringe. Dispose of any unused saline.

Or reconstitute two 50 Unit vials of BOTOX, each with 5 ml of
0.9% non-preserved saline solution and mix each vial gently. Draw
the 5 ml from each vial into a single 10 ml syringe. This will result in
a single 10 ml syringe containing a total of 100 Units of reconstituted
BOTOX. Use immediately after reconstitution in the syringe. Dispose
of any unused saline.
Dilution instructions for treatment of Urinary incontinence due
to neurogenic detrusor overactivity:
It is recommended that a 200 Unit or two 100 Unit vials are used
for convenience of reconstitution
Reconstitute a 200 Unit vial of BOTOX with 6 ml of 9 mg/ml (0.9%)
preservative-free sodium chloride solution for injection and mix gently.
Draw 2 ml from the vial into each of three 10 ml syringes. Complete
the reconstitution by adding 8 ml of 9 mg/ml (0.9%) preservative-free
sodium chloride solution for injection into each of the 10 ml syringes,
and mix gently. This will result in three 10 ml syringes containing
a total of 200 Units of reconstituted BOTOX. Use immediately after
reconstitution in the syringe. Dispose of any unused saline.
Or, reconstitute two 100 Unit vials of BOTOX, each with 6 ml of
9 mg/ml (0.9%) preservative-free sodium chloride solution for injection
and mix the vials gently. Draw 4 ml from each vial into each of two
10 ml syringes. Draw the remaining 2 ml from each vial into a third
10 ml syringe. Complete the reconstitution by adding 6 ml of 9 mg/ml
(0.9%) preservative-free sodium chloride solution for injection into
each of the 10 ml syringes, and mix gently. This will result in three
10 ml syringes containing a total of 200 Units of reconstituted BOTOX.
Use immediately after reconstitution in the syringe. Dispose of any
unused saline.
Should you need to use 50 Unit vials, reconstitute four 50 Unit vials
of BOTOX, each with 3 ml of 9 mg/ml (0.9%) preservative-free sodium
chloride solution for injection and mix the vials gently. Draw 3 ml from
the first vial and 1 ml from the second vial into one 10 ml syringe. Draw
3 ml from the third vial and 1 ml from the fourth vial into a second
10 ml syringe. Draw the remaining 2 ml from the second and fourth
vials into a third 10 ml syringe. Complete the reconstitution by adding
6 ml of 9 mg/ml (0.9%) preservative-free sodium chloride solution
for injection into each of the three 10 ml syringes, and mix gently.
This will result in three 10 ml syringes containing a total of 200 Units
of reconstituted BOTOX. Use immediately after reconstitution in the
syringe. Dispose of any unused saline.
This product is for single use only and any unused solution should be
discarded.
Procedure to follow for safe disposal of vials, syringes and
materials used
For safe disposal, unused vials should be reconstituted with a small
amount of water and then autoclaved. Any used vials, syringes,
and spillages etc. should be autoclaved, or the residual BOTOX
inactivated using dilute hypochlorite solution (0.5%) for 5 minutes.
Identification of the product
In order to verify receipt of actual BOTOX product from Allergan,
look for a tamper-evident seal that contains a translucent silver
Allergan logo on the top and bottom flaps of the BOTOX cartons and
a holographic film on the vial label. In order to see this film, examine
the vial under a desk lamp or fluorescent light source. Rotating the
vial back and forth between your fingers, look for horizontal lines
of rainbow colour on the label and confirm that the name “Allergan”
appears within the rainbow lines.
Do not use the product and contact your local Allergan office for
additional information if:
• the horizontal lines of rainbow colour or the word “Allergan” are
not present on the vial label
• the tamper-evident seal is not intact and present on both ends of
the carton
• the translucent silver Allergan logo on the seal is not clearly
visible or has a black circle with a diagonal line through it (i.e.,
prohibition sign)
Additionally, Allergan has created detachable stickers on the BOTOX
vial label, which include the lot number and expiry date of the product
you have received. These stickers can be peeled off and placed in
your patient’s clinical file for traceability purposes. Note that once
you remove the sticker off the BOTOX vial label, the word “USED”
will show, which is to provide you with further assurance that you are
using an authentic BOTOX product manufactured by Allergan.

If you have received too much BOTOX, you may have any of the
following symptoms and you must contact your doctor immediately.
He/she will decide if you have to go to hospital:
• difficulty in breathing, swallowing or speaking due to muscle
paralysis;
• food or liquid accidentally going into your lungs which might
cause pneumonia (infection of the lungs) due to muscle paralysis;
• drooping of the eyelids, double vision;
• generalised weakness.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
If you have any difficulty in breathing, swallowing or speaking
after receiving BOTOX, contact your doctor immediately.
If you experience hives, swelling including swelling of the
face or throat, wheezing, feeling faint and shortness of breath,
contact your doctor immediately.
Like all medicines, BOTOX can cause side effects, although not
everybody gets them. In general, side effects occur within the first few
days following injection.
They usually last only for a short time, but they may last for several
months and in rare cases, longer.
As expected for any injection procedure, pain/burning/stinging,
swelling and/or bruising may be associated with the injection.

72625MD039F

BOTOX®

The side effects are classified into the following categories,
depending on how often they occur:
Very common
Common
Uncommon
Rare
Very rare

occur in more than 1 out of 10 people who use the
medicine
occur in less than 1 out of 10 people but more than
1 out of 100 people who use the medicine
occur in less than 1 out of 100 people but more
than 1 out of 1,000 people who use the medicine
occur in less than 1 out of 1,000 people but more
than 1 out of 10,000 people who use the medicine
occur in less than 1 out of 10,000 people who use
the medicine

Below are lists of side effects which vary depending on the part of the
body where BOTOX is injected:

Injections in the eyelid and face for muscle spasms
Very common side effect:
• drooping of the eyelid.

Common side effects:
• swelling of the face;
• pinpoint damage of the cornea (transparent surface covering the
front of the eye);
• difficulty in completely closing the eye;
• overflow of tears;
• irritation;
• dry eyes, eye irritation and sensitivity to light;
• bruising under the skin.
Uncommon side effects:
• dizziness;
• difficulties in seeing clearly;
• blurred vision;
• double vision;
• tiredness;
• inflammation of the cornea (transparent surface covering the front
of the eye);
• weakness of the face muscles;
• droop of the muscles on one side of the face;
• rash;
• abnormal turning of the eyelids outwards or inwards.
Rare side effect:
• swelling of the eyelid.

Injections in the neck and shoulder
Very common side effects:
• difficulty in swallowing;
• pain;
• muscle weakness.

Common side effects:
• dizziness;
• flu syndrome;
• sleepiness;
• muscle cramps;
• decreased skin sensation;
• feeling of weakness;
• feeling generally unwell;
• feeling sick;
• headache;
• stiff or sore muscles;
• swelling and irritation inside the nose (rhinitis);
• blocked or runny nose, cough, sore throat, tickle or irritation in the
throat;
• dry mouth.
Uncommon side effects:
• shortness of breath;
• double vision;
• fever;
• drooping of the eyelid;
• changes in your voice.
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 wrist and hand of patients who have
had a stroke
Common side effects:
• muscle weakness;
• increased muscle tension;
• bruising and bleeding under the skin causing red patches
(ecchymosis or purpura);
• bleeding or burning where the injection was given;
• pain in the hand and fingers;
• pain where the injection was given;
• fever;
• flu syndrome.

Uncommon side effects:
• depression;
• a fall in blood pressure on standing up which causes dizziness,
light headedness or fainting;
• feeling of dizziness or “spinning” (vertigo);
• lack of coordination of movements;
• loss of memory;
• general weakness;
• pain;
• joint pain or inflammation;
• decreased skin sensation;
• numbness;
• swelling of the extremities such as the hands and feet;
• inflammation of the skin (dermatitis);
• headache;
• feeling generally unwell;
• feeling sick;
• increased sensitivity where the injection was given;
• rash;
• numbness around the mouth;
• difficulty in sleeping (insomnia);
• itching.
Some of these uncommon side effects may also be related to your
disease.
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 legs of patients who have had a stroke

Very rare side effect:
• ulcer, damage to the cornea (transparent surface covering the
front of the eye).
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.

Artwork created at 100%
Drop keylines and notes before printing
PDF proof output to A3 laser at 48%
Part Number: 72625MD039F
Drawing Number: 0316102

Common side effects:
• rash;
• joint pain or inflammation;
• stiff or sore muscles;
• swelling of the extremities such as the hands and feet.

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.

Perforation

Injections for excessive sweating of the armpits
Very common side effects:
• Injection site pain.

Common side effects:
• pain where the injection was given;
• headache;
• numbness;
• hot flushes;
• increased sweating at sites other than the armpit;
• abnormal skin odour;
• itching;
• hair loss;
• lump under the skin;
• pain in the extremities, such as the hands and fingers;
• pain;
• reactions and swelling, bleeding or burning and increased
sensitivity pain where the injection was given.
Uncommon side effects:
• muscle weakness;
• feeling of weakness;
• muscle pain;
• problem with the joints;
• feeling sick.
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 legs of children with cerebral palsy
Very common side effects:
• viral infection;
• ear infection.

Common side effects:
• sleepiness;
• muscle weakness;
• problems with walking;
• numbness;
• muscle pain;
• urinary incontinence (leakage of urine);
• feeling generally unwell;
• fall;
• rash;
• pain where the injection was given;
• feeling of weakness.
There have been rare spontaneous reports of death sometimes
associated with aspiration pneumonia in children with severe cerebral
palsy after treatment with BOTOX.
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 head and neck to prevent headache in
patients who suffer from chronic migraine
Common side effects:
• headache, migraine;
• rash, itching;
• pain where the injection was given;
• drooping of the eyelid;
• muscle weakness;
• neck pain;
• muscle pain, cramp;
• muscle stiffness, tightness.
Uncommon side effects:
• difficulty in swallowing;
• skin pain;
• jaw pain;
• swollen eyelid.
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 overactive bladder with
leakage of urine
Very common side effects:
• urinary tract infection;
• painful urination after the injection*.

Common side effects:
• bacteria in the urine, white blood cells in the urine;
• inability to empty your bladder (urinary retention);
• incomplete emptying of the bladder;
• frequent daytime urination.

Injections in the fan-shaped lines from the corner of the
eyes, when treated at the same time as injections in the
forehead for vertical lines

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

Common side effects are:
• injection site bruising.

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.

Uncommon side effects are:
• injection site bleeding;
• injection site pain.

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 (in about half the patients);
• inability to empty your bladder (urinary retention; see section 3).
Common side effects:
• difficulty in sleeping (insomnia)†;
• tiredness†;
• constipation†;
• muscle weakness† or spasm;
• blood in the urine after the injection*;
• bulge in the bladder wall (bladder diverticulum);
• problems with walking (gait disturbance)†;
• possible uncontrolled reflex reaction of your body (e.g. profuse
sweating, throbbing headache or increase in pulse rate) around
the time of the injection (autonomic dysreflexia; see section 3)*;
• fall†.
*some of these common side effects may also be related to the
injection procedure.

only in multiple sclerosis
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 forehead for vertical lines
Common side effects are:
• headaches;
• drooping eye lid;
• skin redness;
• localised muscle weakness;
• face pain.

Uncommon side effects are:
• infection;
• anxiety;
• numbness;
• dizziness;
• inflammation of the eyelid;
• eye pain;
• visual disturbance;
• nausea (feeling sick);
• dry mouth;
• skin tightness;
• swelling (face, eyelid, around the eyes);
• sensitivity to light;
• itching;
• dry skin;
• muscle twitching;
• flu syndrome;
• lack of strength;
• fever.
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 fan-shaped lines from the corner of
the eyes
Common side effects are:
• swelling of the eyelid;
• injection site bleeding;
• injection site bruising.

Uncommon side effects are:
• injection site pain;
• injection site tingling or numbness.
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.

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.

General information about other side effects

Side effects related to the spread of BOTOX far away from the site of
injection have been reported very rarely and include
• muscle weakness;
• constipation;
• difficulty in swallowing;
• food or liquid accidentally going into the lungs which in some
cases may lead to pneumonia.
The difficulty in swallowing may range from mild to severe and in
some cases you may need treatment. In rare cases, people have died
because of swallowing difficulties.
Side effects affecting the heart have been rarely reported:
• irregular heartbeat;
• heart attacks.
Some of these people have died. However, some of these patients
were already suffering from heart complaints.
Serious or immediate allergic reactions have been rarely reported,
including
• hives;
• swelling including swelling of the face or throat;
• wheezing;
• feeling faint;
• shortness of breath.
There have been very rare reports of
• glaucoma (high pressure in the eye).
There have been reports of
• seizures or convulsions after treatment with BOTOX,
particularly in patients who have previously experienced these
symptoms. These effects occurred mainly when BOTOX was
used for the treatment of persistent muscle spasms in the legs of
children with cerebral palsy.
As with any injection, you may suffer from injection related side
effects:
• pain, bruising, bleeding or infection where the injection is given;
• numbness;
• decreased skin sensation;
• tenderness;
• swelling/puffiness;
• redness;
• a drop in blood pressure or fainting may be caused by
needle-related pain and/or anxiety.
After injection of BOTOX patients have also suffered
• fever and flu-like symptoms.
The following list describes additional side effects reported for
BOTOX, in any disease, since it has been marketed:
• allergic reactions, which can be serious (swelling of the face and
airways, difficulty in breathing);
• loss of nerve supply to/shrinkage of injected muscle;
• respiratory depression and/or respiratory failure;
• aspiration pneumonia (lung inflammation caused by accidentally
breathing in food, drink, saliva or vomit);
• chronic disease affecting the muscles (myasthenia gravis);
• blurred vision;
• difficulties in seeing clearly;
• slurred speech;
• strabismus (squint);
• numbness, tingling and pain in hands and feet;
• fainting;
• pain/numbness/or weakness starting from the spine;
• drooping of the muscles on one side of the face;
• weakness of the face muscles;
• difficulty moving the arm and shoulder;
• decreased skin sensation;
• muscles pain;


















abdominal pain;
diarrhoea, vomiting, loss of appetite;
dry mouth;
feeling sick;
fever;
different types of red blotchy skin rashes;
feeling generally unwell;
speech problems;
itching;
excessive sweating;
hair loss;
loss of eyebrows;
decreased hearing;
noises in the ear;
feeling of dizziness or “spinning” (vertigo);
numbness.

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.

5. HOW TO STORE BOTOX
Keep out of the reach and sight of children.
Store in a refrigerator (2°C - 8°C), or store in a freezer (at or
below -5°C).
After the solution is made up, immediate use of the solution is
recommended; however it can be stored for up to 24 hours in
a refrigerator (2°C - 8°C).
Your doctor should not use BOTOX after the expiry date which is
stated on the label after ‘EXP’. The expiry date refers to the last day of
that month.

6. FURTHER INFORMATION
What BOTOX contains



The active substance is: Botulinum toxin type A from Clostridium
botulinum.
The other ingredients are human albumin and sodium chloride.

What BOTOX looks like and content of the pack

BOTOX is presented as a white powder in a transparent glass vial.
Prior to injection, the product must be dissolved in a sterile saline
solution.
Each vial contains either 50, 100 or 200 Allergan Units of botulinum
toxin type A.
Each pack contains 1, 2, 3 or 6 vials. Not all pack sizes may be
marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Allergan Ltd.,
Marlow International,
The Parkway, Marlow,
Bucks,
SL7 1YL,
UK.

Manufacturer:
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
This medicinal product is authorised in the Member States of the EEA
under the following name: BOTOX
Austria, Belgium, Czech Republic, Cyprus, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Spain,
Sweden, Slovak Republic, United Kingdom
This leaflet was last revised in February 2014.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

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

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