Botox 50 Allergan units powder for solution for injection – patient leaflet, side effects, dosage

1. What BOTOX is an

BOTOX is a muscle relaxant

it is used for

efore you use BOTOX

other information

d what it is used for

used to treat a number of conditions

1. 5)

   BOT

   appe

   • V

     fr

   • F

     m

   • F

   • V

     m

when adult

within the body. It contains th type A and is injected into eit deep into the skin. It works b to any muscles that have be contractions of these muscle thought that BOTOX blocks development of a migraine.

When injected into the skin, reduce the amount of sweat

When injected into the bladd

e active substance Botulinum toxin her the muscles, the bladder wall or y partially blocking the nerve impulses en injected and reduces excessive s. In the case of chronic migraine, it is pain signals, which indirectly block the

BOTOX works on sweat glands to produced.

er wall, BOTOX works on the bladder

2. Wh

Do not

•

•

•

muscle to prevent leakage of uncontrolled contractions of

1. 1)

   BOTOX can be injected d

   used to treat the following

   • persistent muscl

     hand in children a palsy. BOTOX is us

   • persistent muscle

     children aged two can walk. BOTOX is

   • persistent muscl

     urine (urinary incontinence) due to the bladder muscle.

     irectly into the muscles, and can be conditions:

     e spasms in the elbow, wrist and ged two years or older with cerebral ed to support rehabilitation therapy; spasms in the ankle and foot in years or older with cerebral palsy, who used to support rehabilitation therapy; e spasms in the hand, arm,

     •

     Warnin Talk to before

     • if you

       liqui

       will b

shoulder, ankle o

• persistent muscl

  adult patients;

• persistent muscl

  of adult patients

• BOTOX is used to preve

  chronic migraine.

  Chronic migraine is a disea diagnosed with chronic mig or more a month. In addition

  r foot of adult patients;

  e spasms in the eyelid and face of

  e spasms in the neck and shoulders

  nt headaches in adult patients with

  se affecting the nervous system. To be raine, you must have headaches 15 days , on 8 or more days a month, your

  shou

  • if you

    illnes

  • if you

    disea Eato

  • suffe

    (suc

  • if you

    whic

  • if you

    chan

headaches must have at le

• affect only one sid
• cause a pulsating
• cause moderate to
• are aggravated by and they must cause at le
• nausea, vomiting,

• sensitivity to light a

  ast two of the following characteristics: e of the head

  pain

  severe pain

  routine physical activity

  ast one of the following:

  or both

  nd sound.

  • if you

    fainti

  • if you

    your

  • if you

    toxin

  • if you

    or bl

    BOT of da patie sess redu they

  • Whe

    the b incon

    OX has been shown to significantly reduce the frequ ys with headache and to improve the quality of life o nts suffering from chronic migraine. After two treatm ions, approximately 47% of patients had a 50% or g ction from baseline in the number of days with head experienced.

    n injected into the bladder wall, BOTOX works on ladder muscle to reduce leakage of urine (urinary tinence) and control the following conditions in adu

    ency f

    ent

    reater ache

    lts:

    • if you suffer of have suffered from se

    • if you have an eye disease called cl

      (high pressure in the eye) or were to developing this type of glaucoma;

    • if you will have an operation soon;
    • if you are taking any blood thinning

After you have been given BOTO You or your caregiver should contac

veractive bladder with leakage of urine, the sud ge to empty your bladder and needing to go to the t ore than usual;

akage of urine due to bladder problems associate pinal cord injury or multiple sclerosis.

tients who have not managed to control overactive eakage of urine with medicines called anticholinerg OX has been shown to reduce leakage of urine from ge of about 5 episodes per day down to 2 after 12 of patients had no leakage of urine at all.

den

oilet

d with

bladder ics,

an

weeks.

seek medical attention immediately if y following:

• difficulty in breathing, swallowing,

• hives, swelling including swelling o

  wheezing, feeling faint and shortne symptoms of severe allergic reactio

If you have been treated for vertical and forehead lines or vertical bands connec at maximum contraction, please inform practitioner if you see no significant imp

tients with bladder problems associated with spinal or multiple sclerosis who have not managed to con ge of urine with medicines called anticholinergics, een shown to reduce leakage of urine, from an ave t 30 episodes per week down to 10 after 6 weeks. 3 nts had no leakage of urine at all.

ults, BOTOX can be injected deep into the skin and on sweat glands to reduce excessive sweating of pits, which affects the activities of daily living when treatments do not help.

cord

trol

BOTOX rage of 7% of

can

the

other

your first course of treatment.

General precautions

As with any injection, it is possible for th in infection, pain, swelling, burning and sensitivity, tenderness, redness, and/or site of injection.

Side effects possibly related to the spre site of administration including sympto reported with botulinum toxin (e.g. doub

OX is used for the temporary improvement in the arance of:

ertical lines between the eyebrows seen at maximu own and/or

an-shaped lines from the corner of the eyes seen at aximum smile and/or,

orehead lines seen at maximum raised eyebrows, ertical bands connecting the jaw and neck seen at aximum contraction,

the severity has an important psychological impac patients.

m

t in

and/or drooping of both eyelids, trouble excessive muscle weakness, difficulty s food or liquid in the airways). This is a p with an underlying illness that makes th symptoms.

If you are given BOTOX too often or the may experience muscle weakness and the spread of toxin, or your body may s antibodies, which can reduce the effect risk, the interval between two treatment

at you need to know before you use B

use BOTOX

if you are allergic (hypersensitive) to botulinum to type A or any of the other ingredients of this medic (listed in section 6);

if you have an infection at the proposed site of injection;

when you are being treated for leakage of urine an

OTOX

xin

ine

d

or three months depending on the indic

When BOTOX is used in the treatment listed in this leaflet, it could result in ser in patients who already experience diffi significant debility.

If you have not done much exercise for receiving BOTOX treatment, then after start any activity gradually.

have either a urinary tract infection or a sudden in 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 ar willing to begin using a catheter if required.

gs and precautions

your doctor or pharmacist or healthcare practitio using BOTOX:

have ever had problems with swallowing or food d accidentally going into your lungs, especially e treated for persistent muscle spasms in the neck

ability

e not

ner

or

if you and

It is unlikely that this medicine will impr joints where the surrounding muscle ha

When treating adults with ankle muscle only be used if it is expected to result in i (e.g. walking) or symptoms (e.g. spasm patient care. Furthermore, for patients w to fall, your doctor or healthcare practiti treatment is suitable.

When BOTOX is used in the treatment spasms in the eyelid, it could make you

lders;

are over 65 years of age and have other serious ses;

suffer from any other muscle problems or chronic ses affecting your muscles (such as myasthenia gr n Lambert Syndrome);

r from certain diseases affecting your nervous sys h as amyotrophic lateral sclerosis or motor neuropat have significant weakness or wasting of the mu h your doctor or healthcare practitioner plans to inje have had any surgery that may have in some way ged the muscle to be injected;

avis or

tem hy);

scles ct;

which may harm the surface of your ey you may need treatment with eye drops lenses or even protective covering whic doctor or healthcare practitioner will tell

BOTOX does not prevent headaches in migraine, which occur less than 15 da

When BOTOX is used in the treatment o and/or forehead lines drooping of eyelid

have had any problems with injections (such as ng) in the past;

have inflammation in the muscles or skin area doctor or healthcare practitioner plans to inject; have had problems in the past with previous botuli injections;

suffer from cardiovascular disease (disease of the ood vessels);

where

num

heart

Other medicines with BOTOX Tell your doctor or pharmacist or heal

• you are using any antibiotics (used

  any medicines that affect the nerves (for example anticholinesterase m relaxants). Some of these medicine of BOTOX.

  izures;

  osed-angle glaucoma ld you are at risk for

  medicine.

  X

  t your doctor and

  • you have recen

    a botulinum to

    may increase th

  • you are using a

    anticoagulants

Tell your doctor or taking or have rece

Pregnancy and

ou experience any of the

or speaking;

f the face or throat,

ss of breath (possible n).

/or fan-shaped and/or ting the jaw and neck seen your doctor or healthcare rovement one month after

The use of BOTOX women of childbea is not recommende If you are pregnant or are planning to h healthcare practitio

Driving and usi

BOTOX may cause tiredness or proble these effects, do n

e procedure to result stinging, increased

bleeding/bruising at the

ad of toxin distant from the ms of botulism have been le vision, blurred vision

sure, ask your doct

BOTOX contain

This medicinal pro per vial, i.e. essent

3. How to use

BOTOX must only with specific skills

Method and rou

breathing or speaking, wallowing or unwanted articular risk for patients em susceptible to these

dose is too high, you side effects related to tart producing some

of BOTOX. To limit this s must not be less than two

BOTOX is injected bladder wall via a s the bladder or into into the affected ar practitioner will usu each affected are

General inform

• The number of

  depending on t healthcare prac

ation.

of a condition that it is not ious reactions, particularly culty in swallowing or have

a long time before

your injections you should

and in which m recommended the lowest effec

• Dosages for old

The dosage of BO depending on the c details correspond

The safety and effe children/adolescen of persistent muscl

ove the range of motion of s lost its ability to stretch.

spasms, BOTOX should mprovement in function s or pain) or to help with ho may be more likely oner will judge if this

of persistent muscle r eyes blink less often,

and foot, associate

Limited information conditions in childr below. No recomm indications.

Persistent muscle in the eyelid and f Persistent muscle in neck and shoul Excessive sweatin armpits

es. In order to prevent this, , ointments, soft contact h closes the eye. Your you if this is required.

patients with episodic ys a month.

f vertical and/or fan-shaped may occur after treatment.

Paediatric neurog detrusor overactiv Paediatric overact bladder

In addition, there is

thcare practitioner if: to treat infections), or that control muscles edicines or muscle

s may increase the effect

tly been injected with a medicine containing xin (the active substance of BOTOX), as this e effect of BOTOX too much.

ny anti-platelet (aspirin-like) products and/or (blood thinners).

pharmacist or healthcare practitioner if you are ntly taken or might take any other medicine.

breast-feeding

is not recommended during pregnancy and in ring potential not using contraception. BOTOX d in breast-feeding women.

or breast-feeding, think you may be pregnant ave a baby, ask your doctor or pharmacist or ner for advice before using this medicine.

ng machines

dizziness, muscle weakness, sleepiness, ms with your vision. If you experience any of ot drive or use any machines. If you are not

or or healthcare practitioner for advice.

s Sodium

duct contains less than 1 mmol sodium (23 mg) ially “sodium free”.

BOTOX

be injected by doctors or healthcare practitioners and experience on how to use the medicine.

te of administration

into your muscles (intramuscularly), into the pecific instrument (cystoscope) to inject into the skin (intradermally). It is injected directly ea of your body; your doctor or healthcare ally inject BOTOX into several sites within a.

ation about dosage

injections per muscle and the dose vary he indications. Therefore, your doctor or titioner will decide how much, how often,

uscle(s) BOTOX will be given to you. It is that your doctor or healthcare practitioner uses tive dose;

er people are the same as for other adults.

TOX and the duration of its effect will vary ondition for which you are treated. Below are ing to each condition.

ctiveness of BOTOX has been established in ts over the age of two years for the treatment e spasms in the elbow, wrist and hand or ankle

d with cerebral palsy.

is available on the use of BOTOX in the following en/adolescents over the ages listed in the table endation on dosage can be made for these

spasms

ace

12 years

spasms

der

12 years

g of the 12 years

(limited experience in adolescents

between 12 and 17 years, speak to your doctor or healthcare practitioner for further information)

enic ity

5 - 17 years

ive

12 - 17 years

limited experience of using BOTOX in the

treatment of vertica

l and/or fan-shaped and/or forehead lines, and

of vertical bands c

onnecting the jaw and neck seen at maximum

contraction in patie

nts older than 65 years.

The total dose for t conjunction with gl

Dosage

The dosage of BO depending on the c details correspond

reatment of forehead lines (20 Units) in abellar lines (20 Units) is 40 Units.

TOX and the duration of its effect will vary ondition for which you are treated. Below are ing to each condition.

Information for patients treated for leaka

Your doctor or healthcare practitioner will give the time of the injection to help prevent urinar injection will be administered by a procedure * The doctor or healthcare practitioner may s ** If you are treated for fan-shaped lines from eyebrows seen at maximum frown, you will re *** If you are treated for all 3 facial lines at the between the eyebrows seen at maximum frow

ge of

you a y tra calle

urine

ntibiotics around

ct infection. The

d cystoscopy.

a dose that would mean the treatment may be up to orner of the eyes seen at maximum smile at the sa e a total dose of 44 Units.

time (fan-shaped lines from the corner of the eyes se d forehead lines seen at maximum raised eyebrows)

For leakage of urine due to with spinal cord injury or m

You may be given a local or ge

You will be observed for at lea before you can leave. At the ti

An instrument with a light source at the end w your bladder through the opening by which y (called urethra). This enables the doctor or h to see the inside of the bladder and place the bladder wall. Please ask your doctor or healt explain further details of the procedure to you

If you were not using a catheter (a soft, hollow t your urethra to help empty urine from the bladd with BOTOX, you should be seen by your docto 2 weeks after the injection. You will be asked to then have the volume of urine left in your bladde

ill be ou let ealthc injec hcare .

ube th er) be r app pass r me

introduced into out the urine are practitioner tions into the practitioner to

at is inserted into fore treatment roximately

urine and will asured. If your

procedure by which the inject may experience possible unc (e.g. profuse sweating, throbbi

You must contact your doctor you are unable to pass urine b to start using a catheter. In clin patients reported an inability t BOTOX treatment. At least on before treatment may need to

doctor assesses you have too much urine left in be instructed to use a catheter to empty your bl decide if and when you need to return for the sa

For overactive bladder with leakage of ur

You may be given a local anaesthetic before bladder would be filled with anaesthetic solut then drained). You may also be given a sedat

your adder me te

ine

the in ion fo ive.

bladder you will . Your doctor will st.

jections (your r a while and

Time to Improvement and Du

For persistent muscle spas or ankle and foot in childre cerebral palsy, the improvem 2 weeks after the injection.

For persistent muscle spas of adult patients, you will us first 2 weeks after the injectio seen about 4 to 6 weeks after

You will be observed for at least 30 minutes a before you can leave to see if you can pass u

You must contact your doctor or healthcare p time you are unable to pass urine because it may need to start using a catheter. In clinical 6 out of 100 patients not using a catheter bef need to use a catheter after treatment.

fter t rine s

ractit is po trials ore tr

he injection pontaneously.

ioner if at any ssible that you , approximately eatment may

For persistent muscle spas adult patients, when the effe the treatment again if needed 12 weeks.

For persistent muscle spas usually see an improvement the maximum effect is usually

Indication

Maximum dose

)Units per affected area(

st treatment Following treatment

Minimal time between treatments

Fir

s

Persistent muscle spasms in the elbow, wrist and hand or ankle and foot in children who have cerebral palsy

Elbow,

or 200

Ankle

300 Un

wrist

Units,

& foo

its, w

& hand: 3 to 6 Units/kg whichever is lower;

t: 4 to 8 Units/kg or hichever is lower

When treating the elbow, wr hand & ankle & foot togethe both legs the maximum dos not to exceed the lower of 10 Units/kg or 340 Units

ist & r or e is

12 weeks*

Persistent muscle spasms in the

hand, arm and shoulder of adult patients

The ex

act d

osage and number of

injectio is tailor to a ma

n sites ed to ximu

per hand/arm/shoulder individual needs up m of 400 Units

The exact dosage and num

ber

of injection sites is tailored to individual needs up to a maximum of 400 Units

12 weeks

Persistent muscle spasms in the ankle and foot of adult patients

Multipl muscle 300 Un among

e inje s.Th its to up to

ctions in the affected e total dose is

400 Units divided 6 muscles

The total dose is 300 Units 400 Units divided among up 6 muscles

to

to

12 weeks

Persistent muscle spasms of the eyelid and face

Up to 2

5 Un

its per eye

Up to 100 Units

3 months

Persistent muscle spasms of the neck and shoulders

Up to 2

00 U

nits

Up to 300 Units

10 weeks

Headache in adults who have chronic migraine

155 to

195 U

nits

155 to 195 Units

12 weeks

Overactive bladder with leakage of urine

100 Un

its

100 Units

3 months

Leakage of urine due to bladder problems associated with spinal cord injury or multiple sclerosis in adult patients

200 Un

its

200 Units

3 months

The effects of more than two treatment sessions have not been evaluated.

Excessive sweating of the armpits

50 Unit

s per

armpit

50 Units per armpit

16 weeks

Vertical lines between the eyebrows seen at maximum frown

20 Unit

s**

Up to 50 Units

3 months

The effects of more than four

treatment sessions have not been evaluated.

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

24 Unit

s**

24 Units

3 months

Forehead lines seen at maximum raised eyebrows

20 Unit

s***

3 months

Vertical bands connecting the jaw and neck seen at maximum contraction

Depen dose s (1 ban on one side), o

ding hould d/side side, r 36

on severity, the total not exceed 26 Units ), 31 Units (1 band 2 bands on the other Units (2 bands/side).

Depending on severity, the dose should not exceed 26 (1 band/side), 31 Units (1 b on one side, 2 bands on the side), or 36 Units (2 bands/

total

Units and

other side).

3 months

elect the c ceiv same n, an

6 months apart.

me time as vertical lines between the

en at maximum smile, vertical lines you will receive a total dose of 64 Units bladder problems associated ultiple sclerosis

neral anaesthetic before the procedure.

st 30 minutes after the injection me of the injection, due to the

ion is delivered into your bladder, you ontrolled reflex reaction of your body ng headache or increase in pulse rate).

or healthcare practitioner if at any time ecause it is possible that you may need ical trials, approximately one fifth of

o completely empty their bladder after e third of patients not using a catheter use a catheter after treatment.

ration of Effect

ms in the elbow, wrist and hand n two years and older with

ent usually appears within the first

ms in the hand, arm and shoulder

ually see an improvement within the n. The maximum effect is usually treatment.

ms in the ankle and foot of

ct starts to wear off, you can have , but not more often than every

ms of the eyelid and face, you will within 3 days after the injection and seen after 1 to 2 weeks.

Package leaflet: Information for the

BOTOX^®

user

50 Allergan Units, 100 Allergan Units, 200 Allergan Units, Powder for Solution for Botulinum toxin type A

Injection

The fo medic

Pleas Chara inform

llowing information is intended fo al or healthcare professionals onl

e refer to the Summary of Product cteristics for complete prescribing ation for BOTOX.

r y:

For all in Side effe administr which in and/or si the mech reported probably comorbid including with high Patients t

dications:

cts related to spread of toxin distant from the site of ation have been reported, sometimes resulting in d some cases was associated with dysphagia, pneum gnificant debility.The symptoms are consistent with anism of action of botulinum toxin and have been hours to weeks after injection.The risk of symptom greatest in patients who have underlying conditions ities that would predispose them to these symptom children and adults treated for spasticity, and are tr doses.

reated with therapeutic doses may also experience

eath, onia

s is

and s,

eated

exaggera Pneumot reported Caution i particula Serious a reported BOTOX d region, o dysphagi There ha associat

ted muscle weakness.

horax associated with injection procedure has been following administration of BOTOX near the thorax. s warranted when injecting in proximity to the lung, rly the apices or other vulnerable anatomic structure dverse events including fatal outcomes have been in patients who had received off-label injections of irectly into salivary glands, the oro-lingual-pharyng esophagus and stomach. Some patients had pre-ex a or significant debility.

ve been rare spontaneous reports of death sometim ed with aspiration pneumonia in children with severe

s.

eal

isting

es

cerebral following exercise neurolog aspiratio Treatmen administ consider Refer to t informati

Reconst

palsy after treatment with botulinum toxin, including off-label use (e.g. neck area). Extreme caution sho d when treating paediatric patients who have signific ic debility, dysphagia, or have a recent history of n pneumonia or lung disease.

t in patients with poor underlying health status shou ered only if the potential benefit to the individual pat ed to outweigh the risks.

he Summary of Product Characteristics for complet on for BOTOX.

itution of the medicinal product:

uld be ant

ld be ient is

e

It is good preparati The expo with alco

Reconstit (0.9% so of diluent

Dilution size for

practice to perform vial reconstitution and syringe on over plastic-lined paper towels to catch any spill sed portion of the rubber septum of the vial is clean hol (70%) prior to insertion of the needle.

ute BOTOX only with sterile unpreserved normal sali dium chloride for injection). Draw up an appropriate a (see dilution table or instructions below) into a syring

age.

ed

ne

mount e.

vial

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

50 unit vial

100 unit vial

200 unit v

ial

f

terile ved

line dium or

)

t vial

Resultin (Units p 0.1 ml)

20 Units

g dose er

Amount of

diluent (sterile unpreserved normal saline (0.9% sodium chloride for injection))

added in

a 50 unit vial

Amount of

diluent (sterile unpreserved normal saline (0.9% sodium chloride for injection))

added in

a 100 unit vial

Amount o diluent (s unpreser normal sa (0.9% so chloride f injection) added in a 200 uni

0.25 ml

0.5 ml

1 ml

10 Units 5 Units 4 Units 2.5 Unit 1.25 Un

Since BO agitation,

0.5 ml

1 ml

2 ml

1 ml

2 ml

4 ml

1.25 ml

2.5 ml

5 ml

s

2 ml

4 ml

8 ml

its

4 ml

8 ml

N/A

TOX is denatured by bubbling or similar vigorous inject the diluent gently into the vial. Discard the via

l

if a vacuu

m does not pull the diluent into the vial. Reconstitut

ed

BOTOX i

s a clear colourless to slightly yellow solution free of

particulat inspecte reconstit (2°C - 8° From a m immediat condition normally

e matter. The reconstituted solution should be visua d for clarity and absence of particles prior to use.W uted in the vial, BOTOX may be stored in a refrigera C) for up to 24 hours prior to use.

icrobiological point of view, the product should be u ely. If not used immediately, in-use storage times an s prior to use are the responsibility of the user and not be longer than 24 hours at 2°C - 8°C.

lly

hen

tor

sed d

would

Dilution instructions for treatment of due to overactive bladder:

It is recommended that a 100 Unit or used for convenience of reconstituti

Should you need to use a 200 Unit vial, re BOTOX with 8 ml of sterile unpreserved no chloride for injection) and mix gently. Dr a 10 ml syringe. Complete the reconstitutio unpreserved normal saline (0.9% sodium c 10 ml syringe and mix gently. This will result

urinary incontinence

two 50 Unit vials are on.

constitute a 200 Unit vial of rmal saline (0.9% sodium aw 4 ml from the vial into n by adding 6 ml of sterile hloride for injection) into the in a 10 ml syringe containing

a total of 100 Units of reconstituted BOTOX reconstitution in the syringe. Dispose of any

Or, reconstitute a 100 Unit vial of BOTO unpreserved normal saline (0.9% sodiu and mix gently. Draw the 10 ml from the This will result in a 10 ml syringe contain reconstituted BOTOX. Use immediately syringe. Dispose of any unused saline.

Or reconstitute two 50 Unit vials of BOT

. Use immediately after unused saline.

X with 10 ml of sterile m chloride for injection) vial into a 10 ml syringe. ing a total of 100 Units of after reconstitution in the

OX, each with 5 ml of sterile

unpreserved normal saline (0.9% sodium and mix each vial gently. Draw the 5 ml fr 10 ml syringe.This will result in a single 1 a total of 100 Units of reconstituted BOTO reconstitution in the syringe. Dispose of a

This product is for single use only and a product should be disposed of.

Dilution instructions for treatment of due to neurogenic detrusor overacti It is recommended that a 200 Unit or used for convenience of reconstituti

chloride for injection) om each vial into a single 0 ml syringe containing X. Use immediately after ny unused saline.

ny unused reconstituted

urinary incontinence vity:

two 100 Unit vials are on

Reconstitute a 200 Unit vial of BOTOX unpreserved normal saline (0.9% sodiu and mix gently. Draw 2 ml from the vial i syringes. Complete the reconstitution by unpreserved normal saline (0.9% sodiu into each of the 10 ml syringes, and mix in three 10 ml syringes containing a tota reconstituted BOTOX. Use immediately syringe. Dispose of any unused saline.

Or, reconstitute two 100 Unit vials of B of sterile unpreserved normal saline (0.9

with 6 ml of sterile

m chloride for injection) nto each of three 10 ml adding 8 ml of sterile m chloride for injection) gently.This will result l of 200 Units of

after reconstitution in the

OTOX, each with 6 ml % sodium chloride for

injection) and mix the vials gently. Draw each of two 10 ml syringes. Draw the re into a third 10 ml syringe. Complete the 6 ml of sterile unpreserved normal salin for injection) into each of the 10 ml syrin will result in three 10 ml syringes contain reconstituted BOTOX. Use immediately syringe. Dispose of any unused saline.

Should you need to use 50 Unit vials, re vials of BOTOX, each with 3 ml of steril saline (0.9% sodium chloride for injectio

4 ml from each vial into maining 2 ml from each vial reconstitution by adding e (0.9% sodium chloride ges, and mix gently.This ing a total of 200 Units of after reconstitution in the

constitute four 50 Unit e unpreserved normal

1. n) and mix the vials gently.

Draw 3 ml from the first vial and 1 ml fro one 10 ml syringe. Draw 3 ml from the th the fourth vial into a second 10 ml syring 2 ml from the second and fourth vials int Complete the reconstitution by adding 6 normal saline (0.9% sodium chloride for three 10 ml syringes, and mix gently. Thi syringes containing a total of 200 Units Use immediately after reconstitution in t unused saline.

This product is for single use only and a

m the second vial into ird vial and 1 ml from e. Draw the remaining

o a third 10 ml syringe. ml of sterile unpreserved injection) into each of the s will result in three 10 ml of reconstituted BOTOX. he syringe. Dispose of any

ny unused solution should

be discarded.

Procedure to follow for safe disposa

l of vials, syringes and

materials used

For safe disposal, unused vials should be

reconstituted with a small

amount of water and then autoclaved. An

y used vials, syringes,

and spillages etc. should be autoclaved,

or the residual BOTOX

inactivated using dilute hypochlorite solu

tion (0.5%) for 5 minutes.

Identification of the product

In order to verify receipt of actual BOTO look for a tamper-evident seal that conta Allergan logo on the top and bottom flap and a holographic film on the vial label. I examine the vial under a desk lamp or fl Rotating the vial back and forth between horizontal lines of rainbow colour on the name “Allergan” appears within the rainb

X product from Allergan, ins a translucent silver s of the BOTOX cartons n order to see this film, uorescent light source. your fingers, look for label and confirm that the ow lines.

Do not use the prod additional informati

• the horizontal lin

  not present on th

• the tamper-evid

  of the carton

• the translucent s

  visible or has a b prohibition sign)

  uct and contact your local AbbVie office for on if:

  es of rainbow colour or the word “Allergan” are e vial label

  ent seal is not intact and present on both ends

  ilver Allergan logo on the seal is not clearly lack circle with a diagonal line through it (i.e.,

Additionally, Allerga BOTOX vial label, w the product you hav and placed in your Note that once you the word “USED” wi assurance that you manufactured by Al

n has created detachable stickers on the hich include the lot number and expiry date of e received.These stickers can be peeled off patient’s clinical file for traceability purposes. remove the sticker off the BOTOX vial label, ll show, which is to provide you with further are using an authentic BOTOX product lergan.

20096920 BOTOX^®

For persistent muscle spasms of th will usually see an improvement within The maximum effect is usually seen ab

For leakage of urine due to overactiv an improvement within 2 weeks after the find the effect lasts approximately 6-7 m

For leakage of urine due to bladder spinal cord injury or multiple scler

e neck and shoulders, you 2 weeks after the injection. out 6 weeks after treatment.

e bladder, you will usually see injection. Typically patients onths after the injection.

problems associated with osis, you will usually see an

Below are lists of the body where B serious, or if you please tell your d

Injections for in the elbow,

Common U

w

improvement within 2 weeks after the i find the effect lasts approximately 9-10

For excessive sweating of the arm improvement within the first week afte effect usually lasts 4-7 months after th

For vertical lines between the eyeb frown, you will usually see an improv treatment, the maximum effect being injection.The treatment effect has be

njection. Typically patients months after the injection.

pits, you will usually see an r injection. On average the e first injection.

rows seen at maximum

ement within 1 week after observed 5 to 6 weeks after en demonstrated for up to

Injections for in the ankle a

Common

Uncommon

4 months after injection.

For fan-shaped lines from the corn at maximum smile you will usually s within 1 week after treatment. The trea demonstrated for an average of 4 mo

For forehead lines seen at maximu will usually see an improvement withi The treatment effect has been demon 4 months after injection.

er of the eyes seen

ee an improvement

tment effect has been nths after injection.

m eyebrow elevation you n 1 week after treatment. strated for an average of

There have been associated with a cerebral palsy aft

Injections in th

Common

If you have received more BOT

The signs of too much BOTOX may n days after the injection. Should you sw accidentally injected, you should see practitioner who might keep you unde several weeks.

If you have received too much BOTOX the following symptoms and you must healthcare practitioner immediately. H to go to hospital:

OX than you should

ot appear for several

allow BOTOX or have it your doctor or healthcare r observation for

, you may have any of contact your doctor or e/she will decide if you have

Injections in th

Common

Injections in t

Very Common

• muscle weakness which could be

  of injection;

• difficulty in breathing, swallowing o

  paralysis;

• food or liquid accidentally going into

  cause pneumonia (infection of the l

• drooping of the eyelids, double vis
• generalised weakness.

If you have any further questions on th your doctor or pharmacist or healthca

local or distant from the site

r speaking due to muscle

your lungs which might ungs) due to muscle paralysis; ion;

e use of this product, ask re practitioner.

4. Possible side effects

If you have any difficulty in breathi after receiving BOTOX, contact you

If you experience hives, swelling in face or throat, wheezing, feeling fa breath, contact your doctor immed

Like all medicines, this medicine can

ng, swallowing or speaking r doctor immediately.

cluding swelling of the int and shortness of iately.

cause side effects, although

Rare

Very rare

not everybody gets them. In general, first few days following injection. They usually last only for a short time, months and in rare cases, longer.

As expected for any injection procedu swelling and/or bruising may be asso

The side effects are classified into the depending on how often they occur:

side effects occur within the

but they may last for several

re, pain/burning/stinging, ciated with the injection.

following categories,

Injections in t

Very Common

Common

Very common may affect more than

Common may affect up to 1 in

Uncommon may affect up to 1 in

Rare may affect up to 1 in

Very rare may affect up to 1 in

Not known cannot be estimated

1 in 10 people

10 people

100 people

1,000 people

10,000 people

from the available data

side OTO notic octor

child wrist

effects which vary depending on the part of X is injected. If any of the side effects gets e any side effects not listed in this leaflet, or pharmacist or healthcare practitioner.

ren with persistent muscle spasms and hand

r respiratory tract infection, nausea, muscle ness, pain where the injection was given.

ppe eak

child nd fo

ren with persistent muscle spasms ot

Stretching or tearing of ligaments, shallow wound to the skin,

Problems with walking, pain where the injection was given

Rash

Muscle weakness

•

•

•

•

rare spira er tre

e ha

spontaneous reports of death sometimes tion pneumonia in children with severe atment with BOTOX.

nd, arm and shoulder of adult patients

Pain in the hand and fingers

Nausea

Swelling of the extremities such as the hands and feet

Tiredness

Muscle weakness

•

•

•

•

•

e an

kle and foot of adult patients

Rash

Joint pain or inflammation, stiff or sore muscles, muscle weakness

Swelling of the extremities such as the hands and feet

Fall

yelid and face for muscle spasms

Drooping of the eyelid

•

•

•

•

he e

•

Common

•

•

•

•

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

Uncommon

•

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

he n

eck and shoulder

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)

Uncommon

•

•

•

Shortness of breath, changes in voice Double vision, drooping of the eyelid Fever

Injections in the head and neck to prev in patients who suffer from chronic mig

Common • Increase in headache, mi

worsening of migraine

• Weakness of the face mu
• Drooping of the eyelid
• Rash, itching
• Pain where the injection

• Muscle weakness, neck p

  ent headache raine

  graine and

  scles

  was given

  ain, muscle pain

  or cramp, muscle stiffnes Uncommon • Difficulty in swallowing

• Swollen eyelid
• Skin pain
• Jaw pain

Not known • Mephisto sign (raising of th

Injections in the bladder wall for overac

s or tightness

e outer eyebrows)

tive bladder

with leakage of urine

Very common • Urinary tract infection, pa

after the injection*

inful urination

Common • Inability to empty the blad

retention), incomplete em bladder, frequent daytime

• Bacteria or white blood c *This side effect is related to the injection proced

  der (urinary ptying of the urination

  ells in the urine

  ure.

Injections in the bladder wall of paedia

tric patients for

leakage of urine due to overactive blad

der

Common Urinary tract infection, painful ur

the injection*, pain in the urethra carries urine from urinary bladd

ination after (the tube that er out of your

body)*, abdominal pain, lower a

*This side effect is only related to the injection pr

bdominal pain

ocedure.

Injections in the bladder wall of adult p

atients for

leakage of urine due to bladder proble

ms associated

with spinal cord injury or multiple scler

osis

Very common • Urinary tract infection (in

patients)

• Inability to empty the blad

  retention; see section 3)

  about half the

  der (urinary

Common

• Muscle spasm
• Bulge in the bladder wall (bl

The following side effects have in multiple sclerosis:

• Difficulty in sleeping (inso

• Tiredness, problems with

  disturbance)

• Constipation
• Muscle weakness, fall

The following side effects are re injection procedure:

adder diverticulum)

only be reported

mnia)

walking (gait

lated to the

• Blood in the urine after th

• Uncontrolled reflex reacti

  (profuse sweating, throbb increase in pulse rate) arou injection (autonomic dysrefl

Injections in the bladder wall of paediatric

e injection

on of the body ing headache or nd the time of the exia; see section 3)

patients for

leakage of urine due to bladder problems

associated

with spina bifida, spinal cord injury or tra

nsverse myelitis

Very Common Bacteria in the urine Common Urinary tract infection, white b

lood cells in the

urine, blood in the urine after

Injections for excessive sweating of the

the injection

armpits

Very common • Pain where the injectio Common • Headache, numbness

• Hot flushes

• Increased sweating at

  the armpit, abnormal s lump under the skin

• Hair loss

• Pain in the extremities,

  n was given

  sites other than kin odour, itching,

  such as the

  hands and fingers

• Pain, reaction where th

  was given such as swe burning or increased s Uncommon • Muscle weakness, mus

  problem with the joints

• Feeling weak

• Feeling sick

  e injection

  lling, bleeding, ensitivity

  cle pain,

  Injections for facial lin

  Possible Side Effects

  • Headache

  • Numbness

    es in adults

    Injection in the forehead for vertical lines

    Injections in th lines from the c eyes, when trea without vertical the eyebrows s

    e fan-shaped orner of the ted with or lines between een at frown

    Injections in the forehead line vertical lines between the eye seen at frown when treated wi without the fan-shaped lines f the corner of the eyes

    s and brows th or rom

    Common

    n/a

    Common

    Common

    n/a

    n/a

  • Drooping of the eyelid

    Common

    n/a

    Common

    1

  • Feeling sick

    Common

    n/a

    n/a

  • Localised muscle weak

    ness

    Common

    n/a

    n/a

  • Face pain, injection site

    bruising under the skin, irritation

    swelling,

    injection site

    Common

    n/a

    n/a

  • Skin redness

    Common

    n/a

    n/a

  • Skin tightness

    Common

    n/a

    Common

  • Injection site haematom

    a*

    n/a

    Common

    Common

  • Injection site bruising*

    n/a

    n/a

    Common

  • Infection

    Uncommon

    n/a

    n/a

  • Anxiety

    Uncommon

    n/a

    n/a

  • Dizziness

    Uncommon

    n/a

    n/a

  • Inflammation of the eyel

    visual disturbance, blurr

    id, eye pain, ed vision

    Uncommon

    n/a

    n/a

  • Swelling (face, around t

    sensitivity to light, dry s

    he eyes), skin kin, itching

    Uncommon

    n/a

    n/a

  • Eyelid swelling

  • Dry mouth

    Uncommon Uncommon

    Uncommon n/a

    n/a n/a

  • Muscle twitching

    Uncommon

    n/a

    n/a

  • Mephisto sign (raising of t

    he outer eyebrows)

    Uncommon

    n/a

    Common

  • Fever, flu manifestation

    s, feeling weak

    Uncommon

    n/a

    n/a

  • Injection site bleeding*

    n/a

    Uncommon

    n/a

  • Injection site pain

    Common

    Uncommon*

    Uncommon*

  • Injection site tingling or

    numbness

    n/a

    Uncommon

    n/a

  • Drooping eyebrow²

    n/a

    n/a

    Common

n/a - not reported as possib

le side effect

*Some of these side effects

may also be related to the injection procedure.

1.The median time to onset

of drooping eyelid was 9 days following treatment

2.The median time to onset

of drooping eyebrow was 5 days following treatmen

t

Affectin

• dec
• nois
• feeli

Affectin

• hea

Affectin

• aspi

  acci

• brea rary improvement in vertical w and neck seen at maximum

ficulty swallowing

eakness in the lower part of the face

out other side effects

additional side effects reported for ce it has been marketed:

g the ears

reased hearing

es in the ear

ng of dizziness or “spinning” (vertigo)

g the cardiovascular system

rt problems including irregular heartbeat and heart a g the respiratory system

ration pneumonia (lung inflammation caused by dentally breathing in food, drink, saliva or vomit) thing problems, respiratory depression and/or resp

ttack iratory failu

Affectin

• abd
• diar
• dry
• diffi
• feeli

Affectin

• hair

• droo

  re

  g the gastrointestinal system ominal pain

  rhoea, constipation

  mouth

  culty swallowing

  ng sick, vomiting

  g the skin

  loss, loss of eyebrows/eyelashes ping eyebrow

• diffe
• exce
• itchi
• rash

Affectin

• mus

  inje

• loca

Affectin

• feeli

  rent types of red blotchy skin rashes

  ssive sweating

  ng

  g muscles

  cles pain, loss of nerve supply to/shrinkage of cted muscle

  lised muscle twitching/involuntary muscle contracti

  g the body

  ng generally unwell

  ons

• feve

Report

If you g any pos report s www.m the Go

r

ing of side effects

et any side effects, talk to your doctor. This includes sible side effects not listed in this leaflet.You can al ide effects directly via Yellow Card Scheme, Websit hra.gov.uk/yellowcard or search for MHRA Yellow C ogle Play or Apple Pay Store.

so e:

ard in

Injections for the tempo bands connecting the ja contraction

Uncommon • Dif

• W

General information ab

The following list describes BOTOX, in any disease, sin

Affecting the immune syste

m

• sudden allergic reaction

  s, 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 syste

m

• nerve damage (brachial

  plexopathy)

• slurred speech, speech

  problems

• weakness or drooping of

  the muscles on one side of the face

• decreased skin sensatio

  n

• 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 weak

  ness starting from the spine

• seizures, fainting

Affecting the eyes

• increase in eye pressure
• drooping eyelid

• difficulty in completely cl

  osing the eye

• strabismus (squint)
• blurred vision
• visual disturbance
• dry eye

• swelling of the eyelid

  By reporting side effects you can help the safety of this medicine.

5. How to store BOTOX

Keep out of the sight and reach of chil Store in a refrigerator (2°C - 8°C), or sto

provide more information on dren.

re in a freezer (-5°C to -20°C).

After the solution is made up, immedia recommended; however it can be store a refrigerator (2°C - 8°C).

Your doctor or healthcare practitioner s the expiry date which is stated on the l date refers to the last day of that mont

6. Contents of the pack an

te use of the solution is d for up to 24 hours in hould not use BOTOX after abel after ‘EXP’.The expiry h.

d other information

What BOTOX contains

• The active substance is: Botulinum

  Clostridium botulinum.

• The other ingredients are human al

What BOTOX looks like and con

BOTOX is presented as a thin white po to see on the bottom of a transparent g the product must be dissolved in steril (0.9% sodium chloride for injection). Each vial contains either 50, 100 or 20

toxin type A from bumin and sodium chloride.

tent of the pack wder that may be difficult lass vial. Prior to injection, e unpreserved normal saline

0 Allergan Units of botulinum toxin type A.

Each pack contains 1, 2, 3 or 6 vials. N

ot all pack sizes may be marketed.

Marketing Authorisation Holder

and Manufacturer

Marketing Authorisation Holder: AbbVie Ltd.

Maidenhead

SL6 4UB

UK

Manufacturer:

Allergan Pharmaceuticals Ireland Castlebar Road

Westport

County Mayo

Ireland

This leaflet was last revised in Decemb

er 2025.