Ventolin Diskus
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 26 January 2024
File name
ie-spc-ventolindiskusiss6draft1-MASTER.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 January 2022
File name
ie-spc-ventolindiskusiss5draft2-working_copy-clean-meds.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 January 2022
File name
ie-pl-ventolindiskusiss4draft1-working_copy-clean-meds.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - how to report a side effect
Updated on 19 February 2021
File name
ie-pl-ventolindiskusiss3draft1-clean-MEDS.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 May 2018
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 November 2015
File name
PIL_9903_372.pdf
Reasons for updating
- New PIL for new product
Updated on 05 November 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 November 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- 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 4.6, 4,8 and 4.9 - Formatting changes
Updated on 05 November 2015
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
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 21 July 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 27 April 2015
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 20 April 2015
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
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. Due to the excipient Lactose monohydrate, added ‘patients with a severe milk-protein allergy’.
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 15 April 2015
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.
- Improved electronic presentation
Updated on 03 September 2013
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
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 4.2 - Posology and method of administration
Updated on 30 August 2013
Reasons for updating
- Change to, or new use for medicine
Updated on 10 November 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 28 August 2007
Reasons for updating
- Change to instructions about overdose
Updated on 14 August 2007
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 09 July 2007
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 09 July 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 23 March 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each blister contains 200 micrograms of salbutamol (as sulphate).
Excipients: Lactose monohydrate 12.26 mg/blister
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White powder.
Updated on 12 March 2007
Reasons for updating
- Improved electronic presentation
Updated on 11 January 2006
Reasons for updating
- Improved electronic presentation
Updated on 15 July 2005
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 12 December 2003
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 6.1 - List of excipients
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)