Ventolin Nebules 5mg
- Name:
Ventolin Nebules 5mg
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/01/19
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GlaxoSmithKline (Ireland) Ltd
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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 14 March 2019 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Improved presentation of SmPC
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC Section 4.4: Updated warnings section to be in line with company core information
SPC Section 4.8: Removal of text as due to duplication as text was present in SPC Section 4.4 already
SPC Section 4.1-6.5: Updated sub-headings to align with QRD template
Updated on 16 January 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 15 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 21 December 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 21 December 2015 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 5 November 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 November 2015 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3 Removal of following warning - "
Although intravenous salbutamol is used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, inhaled salbutamol preparations are not appropriate for managing premature labour. Salbutamol presentations should not be used for threatened abortion".
Section 2 and 5.2 - Correction to spelling of sulfate
Section 4.5 - additional sentence added on Caution with anaesthetic agents
Section 4.6, 4,8 and 4.9 - Formatting changes
Updated on 5 November 2015 PIL
Reasons for updating
- Change to instructions about overdose
- Change to drug interactions
- Change to date of revision
- Correction of spelling/typing errors
- Improved electronic presentation
Updated on 21 July 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 21 July 2015 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 April 2015 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 April 2015 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3 - Contraindications more clearly stated as Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Removed reference to tablets.
Section 4.4 - Paradoxical bronchodilator warning added.
Section 4.6 - Added subheading, updated fertility statement
Section 4.7 - Added statement on no negligible influence on ability to drive or operate machinery
Section 4.8 - AE reporting details updated.
Section 4.9 - Removed instructions on treatment of overdose. Added statement on lactic acidosis
Section 5.1 - Updated ATC Code
Section 5.3 - Added preclinical study data
Section 6.4 - Added protect from frost and sunlight
Section 6.6 - No special requirements for disposal
Updated on 16 April 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 21 October 2013 SmPC
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 4.1 - Therapeutic indications
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.1 -Therapeutic indications,
Section 4.4 - Special warnings and precautions for use,
Section 4.2 - Posology and method of administration
Updated on 19 October 2012 PIL
Reasons for updating
- Change to dosage and administration
Updated on 4 November 2009 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
- Change to product name
Updated on 20 April 2009 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 26 February 2009 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SUMMARY OF PRODUCT CHARACTERISTICS CHANGES (marked in Red)
1. NAME OF THE MEDICINAL PRODUCT
Ventolin Nebules 5mg/2.5ml Nebuliser Solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nebule (2.5ml of solution) contains 5.0mg salbutamol (as sulphate).
For a full list of excipients, see section 6.1
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Sodium Chloride
Dilute Sulphuric Acid (for pH adjustment)
Water for Injections
6.2 Incompatibilities
None reported.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Updated on 1 October 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 14 August 2007 SmPC
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.9 Overdose
The preferred antidote for overdosage with salbutamol is a cardioselective â-blocking agent.
Symptoms and Signs
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events (see Special Warnings and Precautions for Use and Undesirable Effects).
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Treatment
Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations).
Beta-blocking drugs should be used with caution in patients with a history of
bronchospasm.
6.6 Instructions for Use and Handling
No special requirements.
Salbutamol syrup may be diluted with Purified Water BP (50% v/v). The resulting mixture should be protected from light and used within 28 days.
A 50% v/v dilution of salbutamol syrup has been shown to be adequately preserved against microbial contamination.
Admixture of salbutamol syrup with other liquid preparation is not recommended.
Updated on 9 July 2007 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.4 Special Warnings and Precautions for Use
Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
4.8 Undesirable Effects
Unknown: Myocardial ischaemia* (see section 4.4).
* reported spontaneously in post-marketing data therefore frequency regarded as unknown
Patient Leaflet additional wording – Respiratory indication only
(Ventolin Diskus, Evohaler, Nebules, Syrup & Respirator Solution)
Tell your doctor before starting this medicine:
· If you have a history of heart disease, irregular heart rhythm or angina.
Side effects:
Although it is not known exactly how often this happens, some people may occasionally experience chest pain (due to heart problems such as angina). Tell your doctor/midwife if you develop these symptoms whilst receiving treatment with salbutamol, but do not stop using this medicine unless told to do so.
Updated on 9 July 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 6 November 2006 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and Precautions for Use
Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Adverse Reaction section). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.
4.8 Undesirable Effects
Very rare: Lactic acidosis.
Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute asthma exacerbation.
Updated on 13 January 2006 PIL
Reasons for updating
- Improved electronic presentation
Updated on 8 November 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 15 July 2005 SmPC
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 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 31 May 2005 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 8 March 2004 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)