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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 because it contains important
information for you.





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 only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What BOTOX is and what it is used for
What you need to know before you use BOTOX
How to use BOTOX
Possible side effects
How to store BOTOX
Contents of the pack and other information

1. What BOTOX is and what it is used for
BOTOX is a muscle relaxant used to treat a number of conditions
within the body. It contains the active substance Botulinum toxin
type A and is injected into either the muscles, the bladder wall 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.
1) BOTOX can be injected directly into the muscles, and can be
used to control the following conditions:
• 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.
• In adults:
◦ persistent muscle spasms in the wrist, hand or
ankle of patients who have suffered a stroke;
◦ persistent muscle spasms in the eyelid and face;
◦ persistent muscle spasms in the neck and
shoulders.
2) BOTOX is used to prevent headaches in adult 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.
3) When injected into the bladder wall, BOTOX works on
the bladder muscle to reduce leakage of urine (urinary
incontinence) and control the following conditions in adults:
• 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.
4) In adults, BOTOX can be injected deep into the skin and can
work on sweat glands to reduce excessive sweating of the
armpits, which affects the activities of daily living when other
local treatments do not help.
5) 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.

2. What you need to know 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 this medicine (listed in
section 6);
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.

Warnings and precautions

Talk to your doctor or pharmacist before using BOTOX:
• if you 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;
• if you are over 65 years of age and have other serious
illnesses;
• if you 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);
• if you have significant weakness or wasting of the muscles
which your doctor plans to inject;
• if you have had any surgery that may have in some way
changed the muscle to be injected;
• if you have had any problems with injections (such as
fainting) in the past;
• if you have inflammation in the muscles or skin area where
your doctor plans to inject;

Perforation








if you have had problems in the past with previous botulinum
toxin injections;
if you suffer from cardiovascular disease (disease of the heart
or blood vessels);
if you suffer of have suffered from seizures;
if you 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;
if you will have an operation soon;
if you are taking any blood thinning medicine.

After you have been given BOTOX

You or your caregiver should 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.

General precautions

As with any injection, it is possible for the procedure to result
in infection, pain, swelling, burning and stinging, increased
sensitivity, tenderness, redness, and/or bleeding/bruising at the
site of injection.
Side effects possibly related to the spread of toxin distant from
the site of administration have been reported with botulinum
toxin (e.g. muscle weakness, difficulty swallowing or unwanted
food or liquid in the airways). This is a particular risk for patients
with an underlying illness that makes them susceptible to these
symptoms.
If you are given BOTOX too often or the dose is too high, you
may experience muscle weakness and side effects related to
the spread of toxin, or 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 a condition that it is not
listed in this leaflet, it could result in serious reactions, particularly
in patients who already experience difficulty in swallowing or have
significant debility.




(for example anticholinesterase medicines or muscle
relaxants). Some of these medicines may increase the effect
of BOTOX.
you have recently been injected with a medicine containing
a 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).

Tell your doctor or pharmacist if you are taking or have recently
taken or might take any other medicine.

Pregnancy and breast-feeding

The use of BOTOX is not recommended during pregnancy and in
women of childbearing potential not using contraception. BOTOX
is not recommended in breast-feeding women.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before using this 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 and
experience 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;

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.



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 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.

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.
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.
BOTOX does not prevent headaches in patients with episodic
migraine, which occur less than 15 days a month.
When BOTOX is used in the treatment of vertical lines and fanshaped lines drooping of eyelid may occur after treatment.

Other medicines with BOTOX

Tell your doctor or pharmacist if:
• you are using any antibiotics (used to treat infections), or any
medicines that affect the nerves that control muscles

Dosages for older people are the same as for other adults.

The safety and effectiveness of BOTOX has not been established
in children/adolescents under the following ages;
Cerebral palsy
Persistent muscle spasms in the
wrist, hand or ankle of patients
who have suffered a stroke
Persistent muscle spasms of the
eyelid, face
Neck and shoulder
Chronic migraine
Leakage of urine
Excessive sweating of the
armpits

Vertical lines between the
eyebrows and/or fan-shaped
lines from the corner of the eyes

2 years
18 years
12 years
12 years
18 years
18 years
12 years
(limited experience in
adolescents between 12 and
17 years, speak to your
doctor for further information)
18 years

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

Dosage
Indication
Persistent muscle spasms in
the legs of children who have
cerebral palsy
Persistent muscle spasms in the
wrist and hand of patients who
have had a stroke
Persistent muscle spasms in the
ankle of patients who have had
a stroke
Persistent muscle spasms of the
eyelid and face
Persistent muscle spasms of the
neck and shoulders
Headache in adults who have
chronic migraine
Overactive bladder with leakage
of urine
Leakage of urine due to bladder
problems associated with spinal
cord injury or multiple sclerosis
Excessive sweating of the armpits
Vertical lines between the
eyebrows seen at maximum frown

Maximum dose
(Units per affected area)
First treatment
Following treatments
4 Units/kg (hemiplegia)
4 Units/kg (hemiplegia)
6 Units/kg (diplegia)
6 Units/kg (diplegia)

Minimal time between
treatments
3 months*

The exact dosage and number of
injection sites per hand/wrist is
tailored to individual needs up to
a maximum of 240 Units
Multiple injections in the affected
muscles. The total dose is
300 Units divided among 3 muscles
Up to 25 Units per eye

The exact dosage and number
12 weeks
of injection sites is tailored to
individual needs up to a maximum
of 240 Units
The total dose is 300 Units divided 12 weeks
among 3 muscles
Up to 100 Units

3 months

Up to 200 Units

Up to 300 Units

10 weeks

155 to 195 Units

155 to 195 Units

12 weeks

100 Units

100 Units

3 months

200 Units

200 Units

3 months
The effects of more than
two treatment sessions
have not been evaluated.
16 weeks
3 months
The effects of more than
four treatment sessions
have not been evaluated.
3 months

50 Units per armpit
20 Units**

Fan-shaped lines from the corner
24 Units**
of the eyes seen at maximum smile

50 Units per armpit
Up to 50 Units

24 Units

* The doctor may select a dose that would mean the treatment may be up to 6 months apart.
** 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.
Information for patients treated for leakage of urine
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.
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.
For overactive bladder with leakage of urine.
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 may experience possible uncontrolled reflex reaction of your
body (e.g. profuse sweating, throbbing headache or increase in
pulse rate).

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
or other vulnerable anatomic structures.
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.
There have been rare spontaneous reports of death sometimes
associated with aspiration pneumonia in children with severe cerebral
palsy after treatment with botulinum toxin, including following off-label
use (e.g. neck area). Extreme caution should be exercised when
treating paediatric patients who have significant neurologic debility,
dysphagia, or have a recent history of aspiration pneumonia or
lung disease.
Treatment in patients with poor underlying health status should be
administered only if the potential benefit to the individual patient is
considered to outweigh the risks.
Refer to the Summary of Product Characteristics for complete
information for BOTOX.
Reconstitution of the medicinal product:

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.

It is good practice to perform vial reconstitution and syringe
preparation over plastic-lined paper towels to catch any spillage.

Time to Improvement and Duration of Effect

Dilution table for BOTOX 50, 100 and 200 Allergan Units vial
size for all indications except bladder disorders:

For persistent muscle spasms in the legs of children who
have cerebral palsy, the improvement usually appears within the
first 2 weeks after the injection.
For persistent muscle spasms in the wrist and hand of patients
who have had a stroke, 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.
For persistent muscle spasms of the eyelid and face, you will
usually see an improvement within 3 days after the injection and
the maximum effect is usually seen after 1 to 2 weeks.

You will be observed for at least 30 minutes after the injection
before you can leave to see if you can pass urine spontaneously.

For persistent muscle spasms of the neck and shoulders, you
will usually see an improvement within 2 weeks after the injection.
The maximum effect is usually seen about 6 weeks after treatment.

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.

For leakage of urine due to overactive bladder, you will usually
see an improvement within 2 weeks after the injection. Typically
the effect lasts approximately 6 months after the injection.

For leakage of urine due to bladder problems associated with
spinal cord injury or multiple sclerosis
You may be given a local or general anaesthetic before the procedure.

For leakage of urine due to bladder problems associated
with spinal cord injury or multiple sclerosis, you will usually
see an improvement within 2 weeks after the injection. Typically
the effect lasts approximately 10 months after the injection.

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,

For excessive sweating of the armpits, 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.

Reconstitute BOTOX only with sterile unpreserved normal saline
(0.9% sodium chloride solution for injection). Draw up an appropriate
amount of diluent (see dilution table or instructions below) into
a syringe.

50 unit vial
Resulting dose Amount of
(Units per
diluent (sodium
0.1 ml)
chloride
9 mg/ml (0.9%)
solution for
injection)
added in
a 50 unit vial
20 Units
0.25 ml
10 Units
0.5 ml
5 Units
1 ml
4 Units
1.25 ml
2.5 Units
2 ml
1.25 Units
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 9 mg/ml (0.9%) preservative-free
sodium chloride solution and mix gently. Draw 4 ml from the vial
into a 10 ml syringe. Complete the reconstitution by adding 6 ml
of 9 mg/ml (0.9%) preservative-free sodium chloride 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. Dispose of any
unused saline.
Or, reconstitute a 100 Unit vial of BOTOX with 10 ml of 9 mg/ml
(0.9%) preservative-free sodium chloride 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
9 mg/ml (0.9%) preservative-free sodium chloride 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.
This product is for single use only and any unused reconstituted
product should be disposed of.
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%) preservativefree 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.

For vertical lines between the eyebrows seen at maximum
frown, you will usually see an improvement within 1 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.

Injections in the wrist and hand of patients who have
had a stroke
Common

For fan-shaped lines from the corner of the eyes seen at
maximum smile you will usually see an improvement within 1 week
after treatment. The treatment effect has been demonstrated for an
average of 4 months after injection.

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.
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:
• muscle weakness which could be local or distant from the site
of injection;
• 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.
72625MD017G

BOTOX®

4. Possible side effects


Uncommon

Like all medicines, this medicine 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.







may affect more than 1 in 10 people
may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
may affect up to 1 in 10,000 people

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








Viral infection, ear infection
Sleepiness, problems with walking, numbness
Muscle pain, muscle weakness, pain of the
extremities
Urinary incontinence (leakage of urine)
Feeling generally unwell or weak
Pain where the injection was given
Fall
Rash

There have been rare spontaneous reports of death sometimes
associated with aspiration pneumonia in children with severe
cerebral palsy after treatment with BOTOX.

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Perforation

Muscle weakness, increased muscle tension
Pain in the hand and fingers
Bruising and bleeding under the skin
causing red patches (ecchymosis or
purpura)
Bleeding, burning, pain where the injection
was given
Fever, flu manifestations
Depression, difficulty in sleeping (insomnia)
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, decreased skin sensation,
numbness, headache
General weakness, feeling generally unwell
Feeling sick, numbness around the mouth
Pain, swelling of the extremities such as the
hands and feet
Joint pain or inflammation
Inflammation of the skin (dermatitis), rash,
itching, increased sensitivity where the
injection was given

Some of these uncommon side effects may also be related to your
disease.

Injections in the legs of patients who have had a stroke
Common





Rash
Joint pain or inflammation, stiff or sore
muscles
Swelling of the extremities such as the
hands and feet

Injections in the eyelid and face for muscle spasms
Very Common •
Common

Uncommon

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







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.













Rare

Very rare







Drooping of the eyelid

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, dry eyes, eye irritation and
sensitivity to light
Bruising under the skin
Irritation
Dizziness, weakness of the face muscles,
drooping of the muscles on one side of
the face
Visual disturbance, blurred vision,
double vision, inflammation of the cornea
(transparent surface covering the front of
the eye), abnormal turning of the eyelids
outwards or inwards
Rash
Tiredness
Swelling of the eyelid
Damage to the cornea (transparent surface
covering the front of the eye) including ulcer
and perforation

Injections in the neck and shoulder
Very Common •


Common






Uncommon





Difficulty in swallowing
Pain
Muscle weakness
Dizziness, sleepiness, headache
Feeling of weakness or generally unwell, flu
manifestations
Feeling sick, dry mouth
Muscle cramps, stiff or sore muscles,
increased muscle tension
Decreased skin sensation
Swelling and irritation inside the nose (rhinitis),
signs of infection of the nose or throat (blocked
or runny nose, cough, sore throat)
Shortness of breath, changes in voice
Double vision, drooping of the eyelid
Fever

Injections in the head and neck to prevent headache
in patients who suffer from chronic migraine
Common

Uncommon












Increase in headache or migraine
Weakness of the face muscles
Drooping of the eyelid
Rash, itching
Pain where the injection was given
Muscle weakness, neck pain, muscle pain or
cramp, muscle stiffness or tightness
Difficulty in swallowing
Swollen eyelid
Skin pain
Jaw pain

Injections in the bladder wall for overactive bladder
with leakage of urine
Very common •
Common




Urinary infection, painful urination after the
injection*
Inability to empty the bladder (urinary
retention), incomplete emptying of the
bladder, frequent daytime urination
Bacteria or white blood cells in the urine

*This side effect is related to the injection procedure.

Injections in the bladder wall for leakage of urine due
to bladder problems associated with spinal cord injury
or multiple sclerosis
Very common • Urinary infection (in about half the patients)
• Inability to empty the bladder (urinary
retention; see section 3)
Common
• Muscle spasm
• Bulge in the bladder wall (bladder diverticulum)
The following side effects have only be reported
in multiple sclerosis:
• Difficulty in sleeping (insomnia)
• Tiredness, problems with walking (gait
disturbance)
• Constipation
• Muscle weakness, fall
The following side effects are related to the
injection procedure:
• Blood in the urine after the injection
• Uncontrolled reflex reaction of the body
(profuse sweating, throbbing headache or
increase in pulse rate) around the time of the
injection (autonomic dysreflexia; see section 3)

Injections for excessive sweating of the armpits
Very common • Pain where the injection was given
Common
• Headache, numbness
• Hot flushes
• Increased sweating at sites other than the
armpit, abnormal skin odour, itching, lump
under the skin
• Hair loss
• Pain in the extremities, such as the hands and
fingers
• Pain, reaction where the injection was
given such as swelling, bleeding, burning or
increased sensitivity
Uncommon • Muscle weakness, muscle pain, problem with
the joints
• Feeling weak
• Feeling sick

Injections in the forehead for vertical lines
Common

Uncommon















Headache
Drooping of the eyelid
Localised muscle weakness
Face pain
Skin redness
Infection
Anxiety
Numbness, dizziness
Inflammation of the eyelid, eye pain, visual
disturbance
Swelling (face, eyelid, around the eyes), skin
tightness, skin sensitivity to light, dry skin, itching
Feeling sick, dry mouth
Muscle twitching
Fever, flu manifestations, feeling weak

Injections in the fan-shaped lines from the corner of
the eyes
Common




Uncommon



Swelling of the eyelid
Injection site bleeding*, injection site
bruising*
Injection site pain*, injection site tingling or
numbness

*Side effects related to the injection procedure.

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
Common
Uncommon




Injection site bruising*
Injection site bleeding*, injection site pain*

*Side effects related to the injection procedure.

General information about other side effects

The following list describes additional side effects reported for
BOTOX, in any disease, since it has been marketed:
Affecting the immune system
• sudden allergic reactions, which can be serious (swelling of
the face or throat, difficulty in breathing, feeling faint)
• delayed reaction which may include fever, skin reaction, joint
pain (serum sickness)
• hives
Affecting metabolism
• loss of appetite
Affecting the nervous system
• nerve damage (brachial plexopathy)
• slurred speech, speech problems
• weakness or drooping of the muscles on one side of the face
• decreased skin sensation
• muscle weakness
• chronic disease affecting the muscles (myasthenia gravis)
• difficulty moving the arm and shoulder
• numbness, tingling and pain in hands and feet
• pain/numbness/or weakness starting from the spine
• seizures, fainting
Affecting the eyes
• increase in eye pressure
• difficulty in completely closing the eye
• strabismus (squint)
• blurred vision
• visual disturbance
Affecting the ears
• decreased hearing
• noises in the ear
• feeling of dizziness or “spinning” (vertigo)
Affecting the cardiovascular system
• heart problems including heart attack
Affecting the respiratory system
• aspiration pneumonia (lung inflammation caused by accidentally
breathing in food, drink, saliva or vomit)
• breathing problems, respiratory depression and/or respiratory
failure
Affecting the gastrointestinal system
• abdominal pain
• diarrhoea, constipation
• dry mouth
• difficulty swallowing
• feeling sick, vomiting
Affecting the skin
• hair loss, loss of eyebrows
• different types of red blotchy skin rashes
• excessive sweating
• itching
• rash
Affecting muscles
• muscles pain, loss of nerve supply to/shrinkage of injected muscle

Affecting the body
• feeling generally unwell
• fever
Reporting of side effects
If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this leaflet. You can
also report side effects directly via Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this
medicine.

5. How to store BOTOX
Keep out of the sight and reach 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. Contents of the pack and other 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 leaflet was last revised in March 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

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

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