Botulinum Toxin Type A Powder For Solution For Injection
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. Y ou 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 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 use 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 toxin-haemagglutinin complex.
What Botulinum Toxin Type A is used for:
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.
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.
Botulinum Toxin Type A can also be used to prevent the muscles, which cause frown lines, from contracting. This muscle relaxation is temporary and gradually wears off. Some people are distressed when lines appear on their face. Botulinum Toxin Type A can be used in adults under 65 years to temporarily improve the appearance of any moderate to severe glabellar lines (these are the vertical frown lines between the eyebrows).
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.
2. What you need to know before you use Botulinum Toxin Type A Do not use Botulinum Toxin Type A:
• If you are allergic to Clostridium 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)
• You had no significant improvement of your lines after your last treatment (if you are considering treatment for glabellar lines).
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 and breast-feeding:
Botulinum Toxin Type A is not recommended during pregnancy, unless clearly necessary.
Botulinum Toxin Type A 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 taking this medicine.
Use in children:
Botulinum Toxin Type A should not be used in children younger than 2 years of age. Botulinum Toxin Type A is not suitable for the treatment of glabellar lines in patients under the age of 18.
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.
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 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.
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:
The first dose of Botulinum Toxin Type A will be 20 units for each kg of the child’s body weight divided between both lower leg muscles. If only one leg is affected by spasms, the doctor will only give injections of 10 units per kg in this leg. Injections will be given about every 12 to 16 weeks. The dose your doctor gives the child could change depending on how they respond. The maximum dose should not exceed 1000 units.
For temporary improvement of glabellar 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 50 units, injected as 10 units at each of 5 injection sites in your forehead in the area above your nose and eyebrows.
The units used for different botulinum toxin products are not the same.
The effect of the treatment on the severity of your glabellar lines should be noticeable in 2 to 3 days. 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.
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.
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
• Fatigue
• 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.
Uncommon: may affect up to 1 in 100 people
• Difficulty in swallowing
• Tiredness.
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
• 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 children with muscle spasms in the leg:
Common: may affect up to 1 in 10 people
• Weakness of the leg muscles. This may change the way you walk or make you fall over more
• Muscle pain
• Urinary incontinence
• Diarrhoea.
Temporary improvement of glabellar lines:
Very common: may affect more than 1 in 10 people
• 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
• 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).
Usually these side effects, after treatment for glabellar lines, have occurred within the first week following injections and did not last long. They were usually mild to moderate in severity.
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.
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).
Botulinum Toxin Type A also contains 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 white powder in a glass vial. It comes in pack sizes of 1 or 2 vials, although not all pack sizes may be marketed.
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 August 2016.
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