BOTOX 200 ALLERGAN UNITS POWDER FOR SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

BOTOX has been shown to significantly reduce the frequency of days with headache and to improve the quality of life of patients suffering from chronic migraine. After two treatment sessions, approximately 47% of patients had a 50% or greater reduction from baseline in the number of days with headache they experienced.

if you have an eye disease called closed-angle glaucoma (high pressure in the eye) or were told you are at risk for developing this type of glaucoma;

if you will have an operation soon;

if you are taking any blood thinning medicine.

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

BOTOX® 3) When injected into the bladder wall, BOTOX works on

the bladder muscle to reduce leakage of urine (urinary

50 Allergan Units, Powder for Solution for Injection incontinence) and control the following conditions in adults:

After you have been given BOTOX

You or your caregiver should contact your doctor and seek medical attention immediately if you experience any of the

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

overactive bladder with leakage of urine , the sudden urge to empty your bladder and needing to go to the toilet more than usual;

leakage of urine due to bladder problems associated with spinal cord injury or multiple sclerosis.

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.

In patients who have not managed to control overactive bladder with leakage of urine with medicines called anticholinergics,

If you have any further questions, ask your doctor or pharmacist or healthcare practitioner.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist or healthcare practitioner. This includes any possible side effects not listed in this leaflet. See section 4.

BOTOX has been shown to reduce leakage of urine from an average of about 5 episodes per day down to 2 after 12 weeks. 27% of patients had no leakage of urine at all.

In patients with bladder problems associated with spinal cord

following:

• difficulty in breathing, swallowing, or speaking;
• hives, swelling including swelling of the face or throat, wheezing, feeling faint and shortness of breath (possible symptoms of severe allergic reaction).

If you have been treated for vertical and/or fan-shaped and/or forehead lines, please inform your doctor or healthcare practitioner if you see no significant improvement of your lines one month after your first course of treatment.

Pregnancy and breast-feeding

The use of BOTOX is not recommended during pregnancy and in women of childbearing potential not using contraception. BOTOX is not recommended in breast-feeding women.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist or

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 or healthcare practitioner for advice.

What is in this leaflet

• 1. What BOTOX is and what it is used for

• 2. What you need to know before you use BOTOX

• 3. How to use BOTOX

• 4. Possible side effects

• 5. How to store BOTOX

• 6. Contents of the pack and other information

injury or multiple sclerosis who have not managed to control leakage of urine with medicines called anticholinergics, BOTOX has been shown to reduce leakage of urine, from an average of about 30 episodes per week down to 10 after 6 weeks. 37% of patients had no leakage of urine at all.

• 4) In adults, BOTOX can be injected deep into the skin and can work on sweat glands to reduce excessive sweating of the armpits , which affects the activities of daily living when other local treatments do not help.

• 5) BOTOX is used for the temporary improvement in the appearance of:

• Vertical lines between the eyebrows seen at maximum frown and/or
• Fan-shaped lines from the corner of the eyes seen at

General precautions

As with any injection, it is possible for the procedure to result in infection, pain, swelling, burning and stinging, increased sensitivity, tenderness, redness, and/or bleeding/bruising at the site of injection.

Side effects possibly related to the spread of toxin distant from the site of administration have been reported with botulinum toxin (e.g. muscle weakness, difficulty swallowing or unwanted food or liquid in the airways). This is a particular risk for patients with an underlying illness that makes them susceptible to these symptoms.

aximum smile and/or,

BOTOX contains Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”

• Forehead lines seen at maximum raised eyebrows, When the severity of the facial lines has an important

If you are given BOTOX too often or the dose is too high, you may experience muscle weakness and side effects related to the spread of toxin, or your body may start producing some antibodies, which can reduce the effect of BOTOX. To limit this risk, the interval between two treatments must not be less than two or three months depending on the indication.

Method and route of administration

BOTOX is injected into your muscles (intramuscularly), into the bladder wall via a specific instrument (cystoscope) to inject into the bladder or into the skin (intradermally). It is injected directly into the affected area of your body; your doctor or healthcare practitioner will usually inject BOTOX into several sites within each affected area.

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The following information is intended for mediCal or healthcare professionals only:

Please refer to the Summary of Product Characteristics for complete prescribing information for BOTOX.

"“For alUndications:

Side effects related to spread of toxin distant from the site of administration have been reported, sometimes resulting in death, which in some cases was associated with dysphagia, pneumonia and/or significant debility. The symptoms are consistent with the mechanism of action of botulinum toxin and have been

reported | hours to weeks after injection. The risk of symptoms is probably greatest in patients who have underlying conditions and

comorbidities that would predispose them to these symptoms,

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hological impact in adult patients.

When BOTOX is used in the treatment of a condition that it is not listed in this leaflet, it could result in serious reactions, particularly

type A and is injected into eit deep into the skin. It works b

ther the muscles, the bladder wall or y partially blocking the nerve impulses

to any muscles that have been injected and reduces excessive contractions of these muscles. In the case of chronic migraine, it is thought that BOTOX blocks pain signals, which indirectly block the development of a migraine.

When injected into the skin, BOTOX works on sweat glands to reduce the amount of sweat produced.

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BOTOX ®

Print Colors

Black

PMS 285

Non-Print Colors

Keyline

For leakage of urine due to bladder problems associated with spinal cord injury or multiple sclerosis, you will usually see an improvement within 2 weeks after the injection. Typically patients find the effect lasts approximately 9- 10 months after the injection.

For excessive sweating of the armpits , you will usually see an improvement within the first week after injection. On average the effect usually lasts 4–7 months after the first injection.

. For vertical lines between the eyebrows seen at maximum frown, you will usually see an improvement within 1 week after treatment, the maximum effect being observed 5 to 6 weeks after injection. The treatment effect has been demonstrated for up to 4 months after injection.

Injections for children with persistent muscle spasms in the ankle and foot

Injections in the neck and shoulder

Injections for excessive sweating of the armpits

Common

------Uncommon--

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

। For forehead lines seen at maximum eyebrow elevation you will usually see an improvement within 1 week after treatment. The treatment effect has been demonstrated for an average of 4 months after injection.

• 1 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 or healthcare practitioner who might keep you under observation for several weeks.

If you have received too much BOTOX, you may have any of the following symptoms and you must contact your doctor or healthcare practitioner immediately. He/she will decide if you have to go to hospital:

• muscle weakness which could be local or distant from the site of injection;
• difficulty in breathing, swallowing or speaking due to muscle paralysis;
• food or liquid accidentally going into your lungs which might cause pneumonia (infection of the lungs) due to muscle paralysis; r»__drooping of the eyelids double vision;_________­________

pg y ,;

• generalised weakness.

If you have any further questions on the use of this product, ask your doctor or pharmacist or healthcare practitioner.

If you have any difficulty in breathin g, 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, this medicine can cause side effects, although not everybody gets them. In general, side effects occur within the first few days following injection.

They usually last only for a short time, but they may last for several months and in rare cases, longer.

j As expected for any injection procedure, pain/burning/stin­ging, swelling and/or bruising may be associated with the injection.

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

Below are lists of side effects which vary depending on the part of the body where BOTOX is injected. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or healthcare practitioner.

Perforation

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

Problems with walking, pain where the injection was given

Rash

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

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

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

Injections in the ankle and foot of adult patients who have had a stroke

different types of red blotchy skin rashes excessive sweating

itching

rash

Affecting muscles

• muscles pain, loss of nerve supply to/shrinkage of injected muscle
• localised muscle twitching/invo­luntary muscle contractions

Affecting the body

• feeling generally unwell
• fever

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

J-

*This side effect is related to the injection procedure.

Injections in the bladder wall of adult patients for leakage of urine due to bladder problems associated with spinal cord injury or multiple sclerosis

1“

J-

Injections in the bladder wall of paediatric patients for leakage of urine due to bladder problems associated with spina bifida, spinal cord injury or transverse myelitis

n/a – not reported as possible 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 treatment

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Store in a refrigerator (2°C – 8°C), or store in a freezer

(-5°C to –20°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

Your doctor or healthcare practitioner 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.

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 thin white powder that may be difficult to see on the bottom of a transparent glass vial. Prior to injection, the product must be dissolved in sterile unpreserved normal saline (0.9% sodium chloride for injection).

Each vial contains either 50, 100 or 200 Allergan Units of botulinum toxin type A.

Each pack contains 1, 2, 3 or 6 vials. Not all pack sizes may be marketed.

General information about other side effects

nerve damage (brachial plexopathy)

slurred speech, speech problems

weakness or drooping of the muscles on one side of the face decreased skin sensation

muscle weakness

chronic disease affecting the muscles (myasthenia gravis)

difficulty moving the arm and shoulder

• numbness, tingling and pain in hands and feet
• pain/numbness/or weakness starting from the spine
• seizures, fainting

Affecting the eyes

• increase in eye pressure
• drooping eyelid
• difficulty in completely closing the eye

and Manufacturer

Affecting the respiratory system

• aspiration pneumonia (lung inflammation caused by accidentally breathing in food, drink, saliva or vomit)
• breathing problems, respiratory depression and/or respiratory failure

Affecting the gastrointestinal system

This leaflet was last revised in February 2022.

abdominal pain hoea, constipation

diar

dry mouth difficulty swallowing feeling sick, vomiting

Affecting the skin

• hair loss, loss of eyebrows

• drooping eyebrow