BOTOX 100 Units
- Name:
BOTOX 100 Units
- Company:
Allergan Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/02/21
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Allergan Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Acular | Active Ingredients Ketorolac Trometamol |
| Medicine Name Alphagan | Active Ingredients brimonidine tartrate |
| Medicine Name Betagan Unit Dose | Active Ingredients Levobunolol hydrochloride |
| Medicine Name BOTOX 100 Units | Active Ingredients Botulinum Toxin Type A |
| Medicine Name BOTOX 200 Units | Active Ingredients Botulinum Toxin Type A |
| Medicine Name BOTOX 50 Units | Active Ingredients Botulinum Toxin Type A |
| Medicine Name Celluvisc 0.5% | Active Ingredients Carmellose sodium |
| Medicine Name Celluvisc 1.0% w/v Eye drops, solution | Active Ingredients Carmellose sodium |
| Medicine Name Combigan | Active Ingredients brimonidine tartrate, Timolol Maleate |
| Medicine Name Exocin | Active Ingredients Ofloxacin |
| Medicine Name FML | Active Ingredients Fluorometholone |
| Medicine Name Ganfort | Active Ingredients Bimatoprost, Timolol Maleate |
| Medicine Name Ganfort SD | Active Ingredients Bimatoprost, Timolol Maleate |
| Medicine Name Lacri-Lube | Active Ingredients No Active Ingredients |
| Medicine Name Liquifilm Tears | Active Ingredients Polyvinyl Alcohol |
| Medicine Name Lumigan 0.1mg/ml | Active Ingredients Bimatoprost |
| Medicine Name Ozurdex | Active Ingredients Dexamethasone |
| Medicine Name Pred Forte | Active Ingredients Prednisolone Acetate |
| Medicine Name Pred Mild | Active Ingredients Prednisolone Acetate |
| Medicine Name Refresh Ophthalmic | Active Ingredients Polyvinyl Alcohol, Povidone |
| Medicine Name Relestat 0.5 mg/ml, eye drops, solution | Active Ingredients Epinastine Hydrochloride |
| Medicine Name Vistabel | Active Ingredients Botulinum Toxin Type A |
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 11 February 2021 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 February 2021 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.1 (therapeutic indications, neurological disorders), indication updated to:
Focal spasticity of the ankle and foot in ambulant paediatric cerebral palsy patients, two years of age or older as an adjunct to rehabilitative therapy.
In section 4.2 (posology, paediatric population), no recommendation on posology can be made for indications other than paediatric focal spasticity associated with cerebral palsy. BOTOX should only be administered by physicians who are experienced in the assessment and treatment of paediatric focal spasticity and as part of a structured program of rehabilitation. For Focal spasticity of the lower limb in paediatric patients administration guidance, recommended needle size, recommended dose and diagram indicating the injection sites were added.
In section 4.8 (undesirable effects, general), clinical trial data was updated. For focal spasticity of the lower limb in paediatric patients, ligament sprain, skin abrasion were added. The frequency of muscular weakness was changed from common to uncommon. Viral infection, ear infection, somnolence, paraesthesia, myalgia, pain in extremity, asthenia, malaise, urinary incontinence and fall were removed.
In section 5.1 (pharmacodynamic properties), clinical data for focal spasticity of the upper limb in paediatric patients was added (section 5.1 only). Study data for lower limb spasticity patients was added.
In section 5.3 (preclinical safety data), study data was added.
In section 10 (date of revision of text), the revised date was updated to 21/12/2020
Updated on 27 July 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 July 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects), the adverse drug reaction eyelid oedema was added in additional information.
In section 10 (date of revision of the text), the revision date was updated to 13/07/2020.
Updated on 14 June 2019 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 3 - use in children/adolescents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 13 June 2019 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.2 (posology and method of administration), further information is provided regarding the safety and efficacy of BOTOX in the paediatric population.
In section 10 (date of the revision of the text), the revised date was updated to 07/03/2019
Updated on 22 February 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to information for healthcare professionals
Updated on 22 February 2019 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 3 (pharmaceutical form), the pharmaceutical form was expanded.
In section 4.2 (posology and method of administration), clarification was provided to reconstitute BOTOX with sterile unpreserved normal saline solution (0.9% sodium chloride solution for injection).
In section 4.8 (undesirable effects), adverse reactions listed for urinary incontinence due to neurogenic detrusor overactivity, also occured in Phase 2 clinical trials. In additional information, dry eye (associated with periocular injections) and localised muscle twitching/involuntary muscle contractions were added.
In section 6.4 (special precautions for storage), freezer temperature was updated to -5°C to -20°C.
In section 6.6 (special precautions for disposal and other handling), clarification was provided to reconstitute BOTOX with sterile unpreserved normal saline solution (0.9% sodium chloride solution for injection).
Updated on 27 December 2018 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 21 December 2018 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 28 February 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 28 February 2017 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- BLADDER DISORDERS, Overactive Bladder - duration of response updated (based on clinical data from completion of urology studies)
- BLADDER DISORDERS, Urinary incontinence due to NDO - duration of response updated (based on clinical data from completion of urology studies)
- harmonisation of the terminology for saline diluent - term "sterile unpreserved normal saline (0.9% sodium chloride for injection) used
In section 4.8 (Undesirable effects)
-BLADDER DISORDERS, Overactive Bladder - correction of the system organ class for the preferred term "residual urine volume" (editorial change, no change to the actual ADR profile)
- BLADDER DISORDERS, Urinary incontinence due to NDO - clinical safety data for Botox 100 U dose in the treatment of NDO for non-catheterising MS patients with NDO with regard to adverse reactions, MS exacerbation annualised rate
In section 5.1 (Pharmacodynamic Properties)
- Pharmacodynamic effect - additional information regarding sensory mechanism of action
- BLADDER DISORDERS, Overactive Bladder - duration of response updated (based on clinical data from completion of urology studies)
- BLADDER DISORDERS, Overactive Bladder - incidence of neutralising anti-drug antibody (based on clinical data from completion of urology studies)
- BLADDER DISORDERS, Overactive Bladder, Urinary incontinence due to NDO - duration of response updated (based on clinical data from completion of urology studies)
- BLADDER DISORDERS, Overactive Bladder, Urinary incontinence due to NDO - incidence of neutralising anti-drug antibody (based on clinical data from completion of urology studies)
- BLADDER DISORDERS, Overactive Bladder, Urinary incontinence due to NDO - efficacy of Botox 100 U dose in the treatment of NDO for non-catheterising (based on clinical data from completion of urology studies)
In section 6.6 (Special precautions for disposal and other handling) - harmonisation of the terminology for saline diluent - term "sterile unpreserved normal saline (0.9% sodium chloride for injection) used
In section 10 (Date of revision of the text) - date of revision of the text is February 2017.
Updated on 27 February 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 27 February 2017 PIL
Reasons for updating
- Change to section 3 - duration of treatment
- Change to section 6 - date of revision
Updated on 15 February 2016 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.2 (Posology and method of administration) - inclusion of specific muscle (zygomaticus major, orbicularis oris) representing lower facial muscles
In section 4.4 (Special warnings and precautions for use) - patients specified as: adult and paediatric patients; removal of word "report" to avoid using it twice in one sentence, unnecessarily.
In section 6.3 (Shelf Life) - update of the wording regarding in-use storage for the reconstitution of the product in line with the standard wording from the note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution (CPMP/QWP/159/96corr).
In section 10 (Date of revision of the text) - the date of revision of text is January 2016.
Updated on 12 February 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to dosage and administration
Updated on 13 November 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 14 October 2014 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
To update SmPC, PIL and labels in line with CCDS 16.1 & CSP 5.0.
Updated on 24 September 2014 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of information on alternative format leaflets
Updated on 4 June 2014 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 28 May 2014 PIL
Reasons for updating
- Changes to therapeutic indications
Updated on 21 February 2014 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 7 February 2014 PIL
Reasons for updating
- Change to date of revision
Updated on 20 December 2013 PIL
Reasons for updating
- Change to packaging
- Change to date of revision
Updated on 27 June 2013 PIL
Reasons for updating
- Addition of joint PIL covering all presentations
Updated on 29 January 2013 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of new indication;
Idiopathic overactive bladder with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medication.
With consequential updates to sections 4.2, 4.3, 4.4, 4.8, 5.1, 6.6 and 10.
Updated on 24 January 2013 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
Updated on 27 November 2012 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 added:
The safety and effectiveness of BOTOX in the treatment of upper limb spasticity associated with stroke has not been established in children and adolescents under 18 years of age.
Section 4.4 added:
Serious adverse events including fatal outcomes have been reported in patients who had received off-label injections of BOTOX directly into salivary glands, the oro-lingual-pharyngeal region, oesophagus and stomach. Some patients had pre-existing dysphagia or significant debility.
and:
Pneumothorax associated with injection procedure has been reported following the administration of BOTOX near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.
and:
Paediatric Use
The safety and efficacy of Botox in indications other than those described for the paediatric population in section 4.1 has not been established. Post-marketing reports of possible distant spread of toxin have been very rarely reported in paediatric patients with comorbidities, predominantly with cerebral palsy. In general the dose used in these cases was in excess of that recommended (see section 4.8).
There have been rare spontaneous reports of death sometimes associated with aspiration pneumonia in children with severe cerebral palsy after treatment with botulinum toxin, including following off-label use (e.g. neck area). Extreme caution should be exercised when treating paediatric patients who have significant neurologic debility, dysphagia, or have a recent history of aspiration pneumonia or lung disease. Treatment in patients with poor underlying health status should be administered only if the potential benefit to the individual patient is considered to outweigh the risks.
Section 4.8 Additional Information updated to include:
constipation, denervation/ muscle atrophy; respiratory depression and/or respiratory failure; aspiration pneumonia; strabismus; peripheral neuropathy;
Section 4.9 added:
Excessive doses may produce local, or distant, generalised and profound neuromuscular paralysis.
If the respiratory muscles become paralysed or sufficiently weakened, intubation and assisted respiration will be required until recovery takes place and may involve the need for a tracheostomy and prolonged mechanical ventilation in addition to other general supportive care.
Updated on 21 November 2012 PIL
Reasons for updating
- Change to side-effects
- Change to dosage and administration
Updated on 6 January 2012 SPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 December 2011 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 30 November 2011 PIL
Reasons for updating
- New PIL for medicines.ie
- Individual presentations superseded by joint PIL