Ventolin Evohaler

  • Name:

    Ventolin Evohaler

  • 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

Company Products

Medicine NameActive Ingredients
Medicine Name Amoxil Paediatric Suspension Active Ingredients Amoxicillin trihydrate
Medicine Name Amoxil Vial for Injection 500mg Active Ingredients Amoxicillin sodium
Medicine Name ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed Active Ingredients Umeclidinium bromide, Vilanterol trifenatate
Medicine Name Augmentin 250 mg/125 mg film-coated tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 500mg/125mg Film-coated Tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 875/125mg Film Coated tablets Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin DUO Suspension 400/57mg Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin Intravenous 1.2g Active Ingredients Amoxicillin sodium, Potassium clavulanate
Medicine Name Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name AVAMYS 27.5 micrograms/spray nasal spray suspension Active Ingredients Fluticasone furoate
Medicine Name Avodart Soft Capsules 0.5mg Active Ingredients Dutasteride
Medicine Name Babyhaler Active Ingredients No Active Ingredients
Medicine Name Bactroban Nasal Ointment Active Ingredients Mupirocin calcium
Medicine Name Bactroban Ointment Active Ingredients Mupirocin
Medicine Name Becotide Evohaler 100 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 250 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 50 Active Ingredients Beclometasone Dipropionate
Medicine Name Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion Active Ingredients Belimumab
Medicine Name Betnovate C 0.1% / 3% w/w Cream Active Ingredients Betamethasone Valerate, Clioquinol
Medicine Name Betnovate Cream 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Ointment 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Cream Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Ointment Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Scalp Application 0.1% w/v Cutaneous Solution Active Ingredients Betamethasone Valerate
1 - 0 of 138 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 6 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 6 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

  • New PIL for new product

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 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 21 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

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 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
  • 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. 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 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 7 July 2010 SmPC

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 PIL

Reasons for updating

  • Change of manufacturer

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 7 February 2007 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 6 February 2007 SmPC

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to dosage and administration

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 May 2005 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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