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BOTULINUM TOXIN TYPE A 500 UNITS POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CLOSTRIDIUM BOTULINUM TYPE A TOXIN - HAEMAGGLUTININ COMPLEX / CLOSTRIDIUM BOTULINUM TYPE A TOXIN - HAEMAGGLUTININ COMPLEX

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Botulinum Toxin Type A®
500 units
Powder for solution for injection
Clostridium botulinum type A toxin-haemagglutinin complex
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 further questions, ask your doctor, pharmacist or nurse.
 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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Botulinum Toxin Type A is and what it is used for
2.
What you need to know before you are given Botulinum Toxin Type A
3.
How Botulinum Toxin Type A is given
4.
Possible side effects
5.
How to store Botulinum Toxin Type A
6.
Contents of the pack and other information

1.

What Botulinum Toxin Type A is and what it is used for

Botulinum Toxin Type A contains the active substance Clostridium botulinum type A toxinhaemagglutinin complex.
What Botulinum Toxin Type A is used for:
Adults:
Botulinum Toxin Type A is used in adults to treat muscle spasms:
 Around the eyes
 In the face
 In the neck
 In the arm and shoulders
 In the leg.
Botulinum Toxin Type A is also used in adults for:
 The temporary improvement in the appearance of moderate to severe glabellar lines (the vertical
frown lines between the eyebrows) and lateral canthal lines (crow’s feet lines), in patients under
65 years of age
 Hyperhidrosis. This is a condition where there is excess sweating of the armpits, which interferes
with daily living.
Children
Botulinum Toxin Type A is used in children (aged two years or older) with cerebral palsy to treat muscle
spasms in the legs, to improve their walking.

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How Botulinum Toxin Type A works:
Botulinum Toxin Type A contains a toxin produced by the bacterium Clostridium botulinum. It works by
stopping your muscles contracting. It does this by stopping the release of a chemical which acts between
the nerves and muscles that makes the muscles contract. This helps to reduce abnormal muscle
contractions known as spasms.
Botulinum Toxin Type A can also be used to prevent the muscles, which cause frown lines and crow’s
feet lines, from contracting. This muscle relaxation is temporary and gradually wears off. Some people
are distressed when lines appear on their face.

2.

What you need to know before you are given Botulinum Toxin Type A

Do not use Botulinum Toxin Type A:
If you are allergic to botulinum toxin type A or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions:
There are increased risks of having Botulinum Toxin Type A injections under any of these circumstances.
Talk to your doctor, pharmacist or nurse before using Botulinum Toxin Type A if:
 You have problems swallowing
 You have any history of bronchitis, pneumonia or problems with breathing
 You have had an allergic reaction to a botulinum toxin in the past
 You have other problems or diseases that affect your muscles e.g. myasthenia gravis
 You bleed easily
 You have an infection where the injection is given or if that area is swollen
 You have had surgery on your face, or are likely to undergo facial surgery or other types of
surgery soon (if you are considering treatment for glabellar lines or lateral canthal lines)
 You had no significant improvement of your lines after your last treatment (if you are considering
treatment for glabellar lines or lateral canthal lines).
Children and adolescents:
For the treatment of spasticity associated with cerebral palsy in children, Botulinum Toxin Type A should
only be used in children 2 years of age or over.
Botulinum Toxin Type A is not indicated, for the treatment of glabellar lines and lateral canthal lines, in
patients under the age of 18 years.
Other medicines and Botulinum Toxin Type A:
Please tell your doctor if you are taking any antibiotics for an infection (e.g. aminoglycosides such as
gentamicin or amikacin) or muscle relaxing drugs. Some of these medicines may increase the effect of
Botulinum Toxin Type A.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility:
Botulinum Toxin Type A is not recommended during pregnancy, unless clearly necessary.

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Botulinum Toxin Type A is not recommended in breast-feeding women.
Botulinum Toxin Type A may affect fertility, when given at high doses.
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 taking this medicine.
Driving and using machines:
Botulinum Toxin Type A may cause muscle weakness or problems with your vision.
If you experience any of these effects, do not drive or use any machines.

3.

How Botulinum Toxin Type A is given

Your doctor will choose your dose of medicine and decide how often you need treatment. This will
depend on what you are being treated for.
A vial of Botulinum Toxin Type A should be used only for you and only for a single treatment session.
For treatment of muscle spasms in your arm and shoulder:
The dose of Botulinum Toxin Type A will usually be between 500 and 1000 units divided between the
affected arm and shoulder muscles. Your muscle spasms should normally improve within 1 week.
Injections will usually be given about every 12 to 16 weeks.
For treatment of muscle spasms in your leg:
The dose of Botulinum Toxin Type A will usually be 1500 units and should not exceed this dose. The
doctor may divide the amount between the affected leg muscles.
Injections will usually be given about every 12 to 16 weeks.
For treatment of muscle spasms in your arm and leg:
If you need to receive injections in your arm and leg in the same treatment session, your doctor may
divide the dose between your arm and leg in line with the approved dose recommendations, but the
overall dose must not exceed 1500 units.
For treatment of muscle spasms in your neck:
The first dose of Botulinum Toxin Type A will usually be 500 units divided into a number of places in the
neck, probably into 2 or 3 of the neck muscles most affected by the condition. A smaller amount may be
given to very underweight or elderly patients. Your muscle spasms should improve within 1 week.
Further injections (250 - 1000 units) will be given about every 16 weeks depending on how long the
effect lasts or as required to maintain a response, but not more frequently than every 12 weeks. The
maximum dose should not exceed 1000 units.
For treatment of muscle spasm around your eyes:
The first injection will usually be 40 units per eye. The medicine will be injected just under the skin at
various sites around the eye. If only one eye is affected, the doctor will only give injections of Botulinum
Toxin Type A around this eye. Injections will be given about every 12 weeks depending on how long the
effects last. On the next visits, the amount of Botulinum Toxin Type A given may be increased to a
maximum of 120 units per eye.

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For treatment of muscle spasm in your face:
The doctor will give you injections on the side of your face that is affected. The first injection will usually
be 120 units. Injections will be given about every 12 weeks depending on how long the effects last. Your
next injections of Botulinum Toxin Type A may be reduced to 80 or 60 units.
For treatment of muscle spasms in the legs of children with cerebral palsy:
Children over 2 years: The dose is decided by your doctor. Botulinum Toxin Type A is injected into the
affected muscles of the legs. The dose must not be higher than 1000 units or 30 units/kg at a given
treatment session. Your doctor will repeat the treatment approximately every 16 - 22 weeks or as needed,
but no more frequently than every 12 weeks.
For temporary improvement of glabellar lines and/or lateral canthal lines:
Botulinum Toxin Type A should only be administered by physicians with appropriate qualifications and
expertise in this treatment and having the required equipment.
Your doctor will prepare and give the injections. A vial of Botulinum Toxin Type A should be used only
for you and only for a single treatment session.
The recommended dose is:
 For glabellar lines: 50 units, injected as 10 units at each of 5 injection sites in your forehead in
the area above your nose and eyebrows.
 For lateral canthal lines: 60 units, injected as 10 units at each of 6 injection sites in both crow’s
feet regions.
The units used for different botulinum toxin products are not the same. Botulinum Toxin Type A units are
not interchangeable with other botulinum toxin products.
The effect of the treatment should be noticeable within a few days after injection. The interval between
treatments with Botulinum Toxin Type A will be decided by your doctor. You should not have treatment
more often than every 12 weeks.
For treatment of excessive sweating of your armpits:
The first dose will usually be 100 units per armpit. The doctor may divide this amount between the
affected areas. Your symptoms should usually improve within 2 weeks and the effect can last for up to
approximately 48 weeks. The amount of the next dose your doctor gives you, and when you will be given
a further injection will depend on how you respond. The minimum time between treatments is 12 weeks.
The maximum dose you should be given is 200 units per armpit.
If you are given more Botulinum Toxin Type A than you need
If you are given more Botulinum Toxin Type A than you need, muscles other than the ones that were
injected may begin to feel weak. This may not happen straight away. If this does happen, speak to your
doctor immediately. Seek urgent medical help if you have difficulty breathing, swallowing or speaking.
If you forget an injection of Botulinum Toxin Type A
Nothing will happen if an injection is missed other than some of the spasm or muscle stiffness may return.
Tell your doctor and he will decide when the next injection is needed.
If you stop taking Botulinum Toxin Type A
Your muscle spasms will return to the way they were before treatment.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Botulinum
Toxin Type A may in rare cases cause side effects away from its site of injection.
Seek urgent medical help if:
 You have any problems swallowing, breathing or with your speech or you have worsened muscle
weakness.
 You develop difficulty in breathing with or without swelling of the face, lips, tongue and/or
throat, redness of the skin or an itchy lumpy rash (urticaria). This may mean you are having an
allergic reaction to Botulinum Toxin Type A.
Some side effects may occur in any patient treated with Botulinum Toxin Type A whilst other side effects
may depend on the condition being treated.
Make sure you read all the sections that apply to you.
Treatment of any condition (all patients):
Common: may affect up to 1 in 10 people
 Bruising, or pain around the site where the injection was given
 Generalised weakness
 Tiredness
 Flu-like symptoms.
Uncommon: may affect up to 1 in 100 people
 Itching.
Rare: may affect up to 1 in 1,000 people
 Skin rashes
 Sudden severe pain and weakness in shoulder and/or arm (neuralgic amyotrophy).
Treatment of muscle spasms in the arm and shoulder:
Common: may affect up to 1 in 10 people
 Muscle weakness
 Musculoskeletal pain.
Uncommon: may affect up to 1 in 100 people
 Difficulty in swallowing
 Pain in the hands and fingers.
Treatment of muscle spasms in the leg:
Common: may affect up to 1 in 10 people
 Difficulty in swallowing
 Leg muscle weakness
 Muscle pain
 Fall.
Treatment of muscle spasms in the eyes or face:
Very common: may affect more than 1 in 10 people
 Drooping of the upper eyelid.
Common: may affect up to 1 in 10 people
 Double vision

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 Swelling of the eyelid
 Facial muscle weakness
 Dry eyes or more tears than usual.
Uncommon: may affect up to 1 in 100 people
 Facial paralysis.
Rare: may affect up to 1 in 1,000 people
 Difficulty in moving the eye
 Edge of the eyelid turning in towards the eyeball (entropion).
Treatment of muscle spasms in the neck:
Very common: may affect more than 1 in 10 people
 Muscle weakness
 Difficulty in swallowing. This side effect may be expected to resolve within 2 to 4 weeks
 Dry mouth.
Common: may affect up to 1 in 10 people
 Headache
 Dizziness
 Blurred vision or other problems in seeing clearly
 Weakness of face muscles
 Stiff muscles
 Shortness of breath
 A change to the tone of the voice
 Neck pain, muscle pain, pain in the hands and fingers.
Uncommon: may affect up to 1 in 100 people
 Loss of muscle tissue
 Jaw problems
 Drooping of the upper eyelid
 Double vision
 Nausea.
Rare: may effect up to 1 in 1,000 people
 Lung inflammation caused by accidentally breathing in food, drink, saliva or vomit (aspiration
pneumonia).
Treatment of muscle spasms in the legs of children with cerebral palsy:
Common: may affect up to 1 in 10 people
 Muscle pain
 Muscle weakness
 Urinary incontinence
 Influenza-like illness
 Pain, redness, bruising at the injection site
 Abnormal walking
 Tiredness
 Fall.
Uncommon:
 Loss of strength and weakness.
Temporary improvement of glabellar lines:
Very common: may affect more than 1 in 10 people

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Redness, swelling, irritation, rash, itching, tingling, pain, discomfort, stinging or bruising at the
site of injection
 Headache.
Common: may affect up to 1 in 10 people
 Tired eyes or dim vision, drooping of the upper eyelid, swelling of the eyelid, watering eyes, dry
eye, twitching of muscles around the eyes
 Temporary facial paralysis.
Uncommon: may affect up to 1 in 100 people
 Impaired, blurred or double vision
 Dizziness
 Eye movement disorder.
Rare: may affect up to 1 in 1,000 people
 Itchy and lumpy rash (hives).
Temporary improvement of lateral canthal lines:
Common: may affect up to 1 in 10 people
 Headache
 Temporary facial paralysis
 Swelling of the eyelid
 Drooping of the upper eyelid
 Bruising, itching and swelling around the eyes.
Usually these side effects, after treatment for glabellar lines or lateral canthal lines, have occurred within
the first week following injections and did not last long. They were usually mild to moderate in severity.
Treatment of excessive sweating of the armpits:
Common: may affect up to 1 in 10 people
 Increased sweating in other parts of the body (compensatory sweating).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
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 Botulinum Toxin Type A

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after ‘EXP’. The expiry date
refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Chemical and physical in-use stability has been demonstrated for the reconstituted solution for 24 hours
in a refrigerator (2°C - 8°C). After the solution is made up, unless the method of reconstitution precludes
the risk of microbial contamination, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user.

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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Botulinum Toxin Type A contains
The active constituent of Botulinum Toxin Type A is Clostridium botulinum type A toxin-haemagglutinin
complex (500 units).
The other excipients in Botulinum Toxin Type A are human albumin and lactose.
Before it is injected, Botulinum Toxin Type A will be dissolved in sodium chloride for injection (a
solution of salt).
What Botulinum Toxin Type A looks like and contents of the pack
Botulinum Toxin Type A is a powder for solution for injection. It appears as a white powder in a glass
vial. It comes in pack sizes of 1 or 2 vials, although not all pack sizes may be marketed.
Botulinum Toxin Type A is also available in 300 unit vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK.
Manufacturer:
Ipsen Biopharm Limited, Ash Road, Wrexham Industrial Estate, Wrexham LL13 9UF.
Is this leaflet hard to see or read? Please phone +44 (0) 1753 627777 and ask for help.
This leaflet was last revised in June 2017.

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--------------------------------------------------------------------------------------------------------------------------------------DETACH HERE AND GIVE INFORMATION TO PATIENT---------------

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Expand Transcript

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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