Ventolin Evohaler
*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-ventolinevohaleriss6draft1-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 26 January 2024
File name
ie-pl-ventolinevohaleriss4draft1-MASTER.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 21 September 2021
File name
ie-spc-ventolinevohalerissue5draft1-working_copy-clean-meds.ie.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 September 2021
File name
ie-pl-ventolinevohalerissue3draft1-working_copy-clean-meds.ie.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
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 06 November 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 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
File name
PIL_9902_869.pdf
Reasons for updating
- New PIL for new product
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 16 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
- 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. 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 - Corrected the AE Frequency of 'tremor and headache' from 'uncommon' to 'common' 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 and instructions to replace mouthpiece
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 07 July 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- 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
2. Qualitative and Quantitative Composition
Each metered dose contains 100 micrograms of Salbutamol (as sulphate)
For a full list of excipients see 6.1
6.1 List of Excipients
Norflurane (Hydroflouralkane ( 1,1,1,2-Tetrafluoroethane, HFA) 134a)
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product. Instructions for Use and Handling
Patients should be carefully instructed in the correct use of the inhaler.
Updated on 10 October 2007
Reasons for updating
- Change of manufacturer
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 07 February 2007
Reasons for updating
- Change to dosage and administration
Updated on 06 February 2007
Reasons for updating
- 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
4.2 Posology and method of administration
Testing your inhaler
Before using for the first time remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, and release two puffs into the air to make sure that it works. If it has not been used for several days shake it well and release one puff into the air to make sure that it works.
Using your inhaler
Remove the mouthpiece cover by gently squeezing the sides of the cover.
Check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.
Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.
Hold the inhaler upright between fingers and thumb with your thumb on the base, below the mouthpiece.
Breathe out as far as is comfortable and then place the mouthpiece in your mouth between your teeth and close your lips around it but do not bite it.
Just after starting to breathe in through your mouth press down on the top of the inhaler to release salbutamol while still breathing in steadily and deeply.
While holding your breath, take the inhaler from your mouth and take your finger from the top of the inhaler. Continue holding your breath for as long as is comfortable.
If you are to take further puffs keep the inhaler upright and wait about half a minute before repeating stages 3 to 7.
Replace the mouthpiece cover by firmly pushing and snapping the cap into position.
IMPORTANT
Do not rush Stages 5, 6 and 7. It is important that you start to breathe in as slowly as possible just before operating your inhaler.
Practise in front of a mirror for the first few times. If you see 'mist' coming from the top of the inhaler or the sides of your mouth you should start again from stage 2.
If your doctor has been given you different instructions for using your inhaler, please follow them carefully. Tell your doctor if you have any difficulties.
Cleaning
Your inhaler should be cleaned at least once a week.
Remove the metal canister from the plastic casing of the inhaler and remove the mouthpiece cover.
Rinse the actuator thoroughly under warm running water.
Dry the actuator THOROUGHLY inside and out.
Replace the metal canister and mouthpiece cover.
DO NOT PUT THE METAL CANISTER INTO WATER.
Updated on 25 October 2005
Reasons for updating
- Change to side-effects
- Change to dosage and administration
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 May 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 December 2003
Reasons for updating
- 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 30 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)