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Ventolin Diskus

  • Name:

    Ventolin Diskus

  • Company:
    info
  • Active Ingredients:

    Salbutamol sulfate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/11/15

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Summary of Product Characteristics last updated on medicines.ie: 14/5/2018
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 136 items.Total: Infinity pages

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 May 2018 SmPC

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 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 PIL

Reasons for updating

  • New PIL for new product

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 4.6 - 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 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

Update to MA holder contact details - Address change

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

Section 7 - removal of trading as Allen and Hanbury from Marketing Authorisation Holder.

Updated on 20 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.1 - Simplified indication statement.
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 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.
  • Improved electronic presentation

Updated on 3 September 2013 SmPC

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

Changes to:

Section 4.1 -Therapeutic indications,
Section 4.2 - Posology and method of administration

Updated on 30 August 2013 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 10 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 28 August 2007 PIL

Reasons for updating

  • Change to instructions about overdose

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

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 23 March 2007 SmPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 11 January 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 July 2005 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 December 2003 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)