PACKAGE LEAFLET: INFORMATION FOR THE USER
BOTOX®
100 Allergan units,
Powder for solution for injection
Botulinum toxin type A
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What BOTOX is and what it is used for
- 2. Before you use BOTOX
- 3. How to use BOTOX
- 4. Possible side effects
- 5. How to store BOTOX
- 6. Further information
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1. WHAT BOTOX IS AND WHAT IT IS USED FOR
What BOTOX is
BOTOX is a muscle relaxant that is injected into the muscles or deep into the skin. It works by partially blocking the nerve impulses to any muscles that have been injected and reduces excessive contractions of these muscles.
When injected into the skin, BOTOX works on sweat glands to reduce the amount of sweat produced.
What BOTOX is used for
In adults, BOTOX is used to control:
- persistent muscle spasms in the eyelid and face;
- persistent muscle spasms in the neck and shoulders;
- persistent muscle spasms in the wrist and hand of patients who have suffered a stroke;
- excessive sweating of the armpits that affects the activities of daily living, when other local treatments do not help.
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.
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2. BEFORE YOU USE BOTOX
Do NOT use BOTOX
- if you are allergic (hypersensitive) to botulinum toxin type A or any of the other ingredients of BOTOX;
- if you have an infection at the proposed site of injection.
Take special care with BOTOX
Tell your doctor if you:
- have had any problems with injections (such as fainting) in the past;
- have inflammation in the muscles or skin area where your doctor plans to inject;
- have significant weakness or wasting of the muscles which your doctor plans to inject;
- have ever had problems with swallowing or food or liquid accidentally going into your lungs, especially if you will be treated for persistent muscle spasms in the neck and shoulders;
- suffer from any other muscle problems or chronic diseases affecting your muscles (such as myasthenia gravis or Eaton Lambert Syndrome);
- suffer from certain diseases affecting your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy);
- have an eye disease called closed-angle glaucoma (high pressure in the eye) or were told you are at risk for developing this type of glaucoma;
- have had any surgery that may have in some way changed the muscle to be injected.
After you have been given BOTOX
Contact your doctor and seek medical attention immediately if you experience any of the following:
- difficulty in breathing, swallowing, or speaking;
- hives, swelling including swelling of the face or throat, wheezing, feeling faint and shortness of breath (possible symptoms of severe allergic reaction).
If you are given BOTOX too often or the dose is too high, your body may start producing some antibodies, which can reduce the effect of BOTOX.
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.
BOTOX contains human albumin which comes from human blood. As with any medicine which is created from human blood there is a possibility of passing on infections. To reduce this risk, blood donors are chosen very carefully. Furthermore, BOTOX is made in a way that should remove or destroy viruses.
It is unlikely that this medicine will improve the range of motion of joints where the surrounding muscle has lost its ability to stretch.
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.
Taking other medicines
Tell your doctor or pharmacist if:
- you are using any antibiotics (used to treat infections) or muscle relaxants. Some of these medicines may increase the effect of BOTOX.
- you have recently been injected with a medicine containing botulinum toxin (the active substance of BOTOX), as this may increase the effect of BOTOX too much.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
The use of BOTOX during pregnancy is not recommended, unless clearly necessary.
BOTOX is not recommended in breast-feeding women.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
BOTOX may cause dizziness, sleepiness, tiredness or problems with your vision. If you experience any of these effects, do not drive or use any machines. If you are not sure, ask your doctor for advice.
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3. HOW TO USE BOTOX
BOTOX must only be injected by healthcare professionals with specific skills on how to use the medicine.
Method and route of administration
BOTOX is injected into your muscles (intramuscularly) or into the skin (intradermally). It is injected directly into the affected area of your body; your doctor will usually inject BOTOX into several sites within each affected area.
General information about dosage
- The number of injections per muscle and the dose vary depending on the indications. Therefore, your doctor will decide how much, how often, and in which muscle(s) BOTOX will be given to you. It is recommended that your doctor uses the lowest effective dose.
- Dosages for the elderly are the same as for other adults.
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:
For persistent muscle spasms of the eyelid and face
Dosage
In the first treatment session, your doctor may give multiple injections in the affected muscles with 1.25 to 2.5 Units of BOTOX into each injection site.
The maximum dose for the first treatment session is 25 Units per affected area (for example per eye). For the following treatment sessions, the total maximum dose can be increased up to 100 Units, if needed.
Duration of treatment effect
You will usually see an improvement within 3 days after the injection.
The maximum effect is usually seen 1 to 2 weeks after treatment.
When the effect starts to wear off, you can have the treatment again if needed, but not more often than every 3 months.
For persistent muscle spasms of the neck and shoulders
Dosage
Your doctor may give multiple injections in the affected muscles with up to 50 Units of BOTOX into each injection site.
The maximum dose for the first treatment session is 200 Units.
Duration of treatment effect
When the effect starts to wear off, you can have the treatment again if needed, normally not more often than every 12 weeks.
For persistent muscle spasms in the wrist and hand of patients who have had a stroke
Dosage
Your doctor may give multiple injections in the affected muscles. The dose and number of injections will vary depending on a number of factors, including your needs, the muscles to be injected, the size of the muscles, severity of spasms, etc.
Duration of treatment effect
You will usually see an improvement within the first 2 weeks after the injection.
The maximum effect is usually seen about 4 to 6 weeks after treatment.
When the effect starts to wear off, you can have the treatment again if needed, but not more often than every 12 weeks.
For excessive sweating of the armpits
Dosage
Your doctor will give multiple injections with a total of 50 Units of BOTOX in each armpit.
Duration of treatment effect
You will usually see an improvement within the first week after injection.
On average the effect usually lasts 4-7 months after the first injection.
When the effect starts to wear off, you can have the treatment again if needed.
For persistent muscle spasms in the legs of children who have cerebral palsy
Dosage
The doctor may give multiple injections in the affected muscles. The dose will depend on the weight of your child.
Duration of treatment effect
The improvement usually appears within the first 2 weeks after the injection.
When the effect starts to wear off, further treatment is possible, but not more often than every 2 months.
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 days.
If you have received too much BOTOX, you may have any of the following symptoms and you must contact your doctor immediately. He/she will decide if you have to go to hospital:
- difficulty in breathing, swallowing or speaking due to muscle paralysis;
- food or liquid accidentally going into your lungs which might cause pneumonia (infection of the lungs) due to muscle paralysis.
- drooping of the eyelids, double vision;
- generalised weakness.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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4. POSSIBLE SIDE EFFECTS
If you have any difficulty in breathing, swallowing or speaking after receiving BOTOX, contact your doctor immediately.
If you experience hives, swelling including swelling of the face or throat, wheezing, feeling faint and shortness of breath, contact your doctor immediately.
Like all medicines, BOTOX can cause side effects, although not everybody gets them. In general, side effects occur within the first few days following injection and last only for a short time. In rare cases, they may last for several months or longer.
The side effects are classified into the following categories, depending on how often they occur:
| Very common |
occur in more than 1 out of 10 people who use the medicine |
| Common |
occur in less than 1 out of 10 people but more than 1 out of 100 people who use the medicine |
| Uncommon |
occur in less than 1 out of 100 people but more than 1 out of 1,000 people who use the medicine |
| Rare |
occur in less than 1 out of 1,000 people but more than 1 out of 10,000 people who use the medicine |
| Very rare |
occur in less than 1 out of 10,000 people who use the medicine |
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Below are lists of side effects which vary depending on the part of the body where BOTOX is injected:
Injections in the eyelid and face
Very common side effect:
Common side effects:
- swelling of the face;
- mild inflammation of the cornea (transparent outer covering of the eye);
- difficulty in completely closing the eye;
- overflow of tears;
- irritation;
- dry eyes and sensitivity to light.
Uncommon side effects:
- dizziness;
- difficulties in seeing clearly;
- blurred vision;
- double vision;
- tiredness;
- inflammation of the cornea (transparent outer covering of the eye);
- weakness of the face muscles;
- droop of the muscles on one side of the face;
- rash;
- abnormal turning of the eyelids outwards or inwards.
Rare side effect:
Very rare side effect:
- ulcer of the cornea (transparent outer covering of the eye).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Injections in the neck and shoulder
Very common side effects:
- difficulty in swallowing;
- pain;
- muscle weakness.
Common side effects:
- dizziness;
- flu syndrome;
- sleepiness;
- muscle cramps;
- decreased skin sensation;
- feeling of weakness;
- feeling generally unwell;
- feeling sick;
- headache;
- stiff or sore muscles;
- swelling and irritation inside the nose (rhinitis);
- blocked or runny nose, cough, sore throat, tickle or irritation in the throat;
- dry mouth.
Uncommon side effects:
- shortness of breath;
- double vision;
- fever;
- drooping of the eyelid;
- changes in your voice.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Injections in the wrist and hand of patients who have had a stroke
Common side effects:
- muscle weakness;
- muscle cramps;
- bruising and bleeding under the skin causing red patches (ecchymosis or purpura);
- bleeding or burning where the injection was given;
- pain in the hand and fingers.
Uncommon side effects:
- depression;
- a fall in blood pressure on standing up which causes dizziness, light headedness or fainting;
- feeling of dizziness or “spinning” (vertigo);
- lack of coordination of movements;
- loss of memory;
- general weakness;
- pain;
- joint pain or inflammation;
- decreased skin sensation;
- numbness;
- swelling of the extremities such as the hands and feet;
- inflammation of the skin (dermatitis);
- headache;
- feeling generally unwell;
- feeling sick;
- increased sensitivity where the injection was given;
- rash;
- numbness around the mouth;
- difficulty in sleeping (insomnia);
- itching.
Some of these uncommon side effects may also be related to your disease.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Injections for excessive sweating of the armpits
Common side effects:
- hot flushes;
- increased sweating at sites other than the armpit;
- reactions and pain where the injection was given;
- headache.
Uncommon side effects:
- muscle weakness;
- feeling of weakness;
- muscle pain;
- pain in the extremities, such as the hands and fingers;
- problem with the joints;
- feeling sick;
- swelling or pain where the injection was given;
- itching.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Injections in the legs of children with cerebral palsy
Very common side effects:
- viral infection;
- ear infection.
Common side effects:
- sleepiness;
- muscle weakness;
- problems with walking;
- numbness;
- muscle pain;
- urinary incontinence (not being able to control when you empty your bladder);
- feeling generally unwell;
- rash.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
General information about other side effects
Side effects related to the spread of BOTOX far away from the site of injection have been reported very rarely and include
- muscle weakness;
- difficulty in swallowing or food or liquid accidentally going into the lungs that might caused pneumonia.
The difficulty in swallowing may range from mild to severe and in some cases you may need treatment. In rare cases, people have died because of swallowing difficulties.
Side effects affecting the heart have been rarely reported:
- irregular heartbeat;
- heart attacks.
Some of these people have died. However, some of these patients were already suffering from heart complaints.
Serious or immediate allergic reactions have been rarely reported, including
- hives;
- swelling including swelling of the face or throat;
- wheezing;
- feeling faint;
- shortness of breath.
There have been very rare reports of
- glaucoma (high pressure in the eye).
There have been reports of
- seizures or convulsions after treatment with BOTOX, particularly in patients who have previously experienced these symptoms. These effects occurred mainly when BOTOX was used for the treatment of persistent muscle spasms in the legs of children with cerebral palsy.
As with any injection, you may suffer from injection related side effects:
- pain or bruising where the injection is given;
- a drop in blood pressure or fainting may be caused by needle-related pain and/or anxiety .
After injection of BOTOX patients have also suffered
- fever and flu-like symptoms.
The following list describes additional side effects reported for BOTOX, in any disease, since it has been marketed:
- allergic reaction;
- chronic disease affecting the muscles (myasthenia gravis);
- blurred vision;
- fainting;
- pain/numbness/or weakness starting from the spine;
- paralysis of the face;
- difficulty moving the arm and shoulder;
- decreased skin sensation;
- muscles pain;
- abdominal pain;
- diarrhoea, vomiting, loss of appetite;
- fever;
- different types of red blotchy skin rashes;
- feeling generally unwell;
- speech problems;
- itching;
- excessive sweating;
- decreased hearing;
- noises in the ear.
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.
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5. HOW TO STORE BOTOX
Keep out of the reach and sight of children.
Store in a refrigerator (2°C – 8°C), or store in a freezer (at or below -5°C).
After the solution is made up, immediate use of the solution is recommended; however it can be stored for up to 24 hours in a refrigerator (2°C – 8°C).
Your doctor should not use BOTOX after the expiry date which is stated on the label after ‘EXP’.
The expiry date refers to the last day of that month.
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6. FURTHER INFORMATION
What BOTOX contains
- The active substance is: Botulinum toxin type A from Clostridium botulinum;
- The other ingredients are human albumin and sodium chloride.
What BOTOX looks like and content of the pack
BOTOX is presented as a white powder in a transparent glass vial. Prior to injection, the product must be dissolved in a sterile saline solution.
Each vial contains 100 Allergan Units of botulinum toxin type A.
Each pack contains 1, 2, 3 or 6 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Allergan Ltd.
Marlow International
The Parkway
Marlow
Bucks
SL7 1YL
UK
Manufacturer:
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
This medicinal product is authorised in the Member States of the EEA under the following name: BOTOX
Austria, Belgium, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Slovak Republic, United Kingdom
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This leaflet was last approved in 29/05/2008