Serevent Evohaler

  • Name:

    Serevent Evohaler

  • Company:
    info
  • Active Ingredients:

    Salmeterol Xinafoate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/07/15

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Summary of Product Characteristics last updated on medicines.ie: 21/7/2015
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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 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 21 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

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 20 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 July 2015 PIL

Reasons for updating

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

Updated on 26 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 26 March 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 - Change to Marketing Authorisation Holder

Updated on 15 September 2014 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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

To update section 4.2 (Posology and administration) of the SmPC), with a consequential change to the leaflet, in order to align with Company Core Data Sheet as follows:
Update to priming instructions for the use of Serevent Evohaler, following an EMA mandate that marketing authorisation holders (MAHs) review dossiers for currently authorised metered dose inhalers (MDIs), to ensure that storage orientation studies have been performed in line with the Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products (CHMP/QWP/49313/2005) and update product labelling if necessary.

Updated on 12 September 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 29 April 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

·         Section 4.4: removal of non-core safety text in the Warnings and Precautions section.

·         Section 4.8 and 4.4: relocating of the paradoxical bronchospasm and pharmacological side effects of beta2-agonist wording from the Adverse Reactions section to the Warnings and Precautions section.

 

·         Section 4.6: update to pregnancy data

 

·         Section 4.8: Update to Adverse Event Reporting information

 

 

·         Section 4.9: update to overdosage guidance treatment.

Updated on 29 April 2014 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 21 August 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

 

The management of asthma should normally follow a stepwise programme and patient response should be monitored clinically and by lung function tests.

 

Salmeterol should not be used (and is not sufficient) as the first treatment for asthma.

 

Salmeterol is not a replacement for oral or inhaled corticosteroids in asthma.  Its use is complementary to them.  Asthmatic Ppatients must be warned not to stop steroid therapy and not to reduce it without medical advice even if they feel better on salmeterol.

 

Salmeterol should not be used to treat acute asthma symptoms for which a fast and short-acting inhaled bronchodilator is required.  Patients should be advised to have their medicinal product to be used for the relief of acute asthma symptoms available at all times.

 

Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control.  The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective or more inhalations than usual are required.  In this situation the patient should be assessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroid or a course of oral corticosteroid).  Severe exacerbations of asthma must be treated in the normal way.

 

Although Serevent may be introduced as add-on therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, patients should not be initiated on Serevent during an acute severe asthma exacerbation, or if they have significantly worsening or acutely deteriorating asthma.

 

Serious asthma-related adverse events and exacerbations may occur during treatment with Serevent.  Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Serevent.

 

Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment.  Consideration should be given to increasing corticosteroid therapy.  Under these circumstances daily peak flow monitoring may be advisable.  For maintenance treatment of asthma salmeterol should be given in combination with inhaled or oral corticosteroids.  Long-acting bronchodilators should not be the only or the main treatment in maintenance asthma therapy (see Section 4.1).

 

Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Serevent.  Regular review of patients as treatment is stepped down is important.  The lowest effective dose of Serevent should be used.

 

Salmeterol should be administered with caution in patients with thyrotoxicosis.

 

There have been very rare reports of increases in blood glucose levels (see Section 4.8) and this should be considered when prescribing to patients with a history of diabetes mellitus.

 

Cardiovascular effects, such as increases in systolic blood pressure and heart rate, may occasionally be seen with all sympathomimetic drugs, especially at higher than therapeutic doses.  For this reason, salmeterol should be used with caution in patients with pre-existing cardiovascular disease.

 

Potentially serious hypokalaemia may result from β2 agonist therapy.  Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics.  Serum potassium levels should be monitored in such situations.

 

Data from a large clinical trial (the Salmeterol Multi-Center Asthma Research Trial, SMART) suggested African-American patients were at increased risk of serious respiratory-related events or deaths when using salmeterol compared with placebo (see section 5.1).  It is not known if this was due to pharmacogenetic or other factors.  Patients of black African or Afro-Caribbean ancestry should therefore be asked to continue treatment but to seek medical advice if asthma symptoms remained uncontrolled or worsen whilst using Serevent.

 

Concomitant use of systemic ketoconazole significantly increases systemic exposure to salmeterol.  This may lead to an increase in the incidence of systemic effects (e.g. prolongation in the QTc interval and palpitations).  Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should therefore be avoided unless the benefits outweigh the potentially increased risk of systemic side effects of salmeterol treatment (see section 4.5).

 

Patients should be instructed in the proper use of their inhaler and their technique checked to ensure optimum delivery of the inhaled medicinal product to the lungs.

 

As systemic absorption is largely through the lungs, the use of a spacer plus metered dose inhaler may vary the delivery to the lungs.  It should be noted that this could potentially lead to an increase in the risk of systemic adverse effects so that dose adjustment may be necessary.

 

Updated on 14 August 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 18 February 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 10 December 2010 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

4.5     Interaction with other medicinal products and other forms of interaction

 

Beta-adrenergic blockers may weaken or antagonise the effect of salmeterol.  Both non-selective and selective beta-blockers should be avoided unless there are compelling reasons for their use.

 

………………..etc

 

Moderate CYP 3A4 inhibitors

Co-administration of erythromycin (500mg orally three times a day) and salmeterol (50µg inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (Cmax mean ratio was 1.40) (1.4-fold Cmax and 1.2-fold AUC).  Co-administration with erythromycin was not associated with any serious adverse effects.

Updated on 26 February 2010 PIL

Reasons for updating

  • Change to instructions about overdose

Updated on 22 February 2010 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

 

4.5   Interaction with other medicinal products and other forms of interaction

Beta-adrenergic blockers may weaken or antagonise the effect of salmeterol. Both non-selective and selective beta-blockers should be avoided in patients with asthma unless there are compelling reasons for their use.

Updated on 7 April 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions

Updated on 25 February 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

New text highlighted in red:

 

4.4     Special warnings and precautions for use

 

 

Concomitant use of systemic ketoconazole significantly increases systemic exposure to salmeterol.  This may lead to an increase in the incidence of systemic effects (e.g. prolongation in the QTc interval and palpitations).  Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should therefore be avoided unless the benefits outweigh the potentially increased risk of systemic side effects of salmeterol treatment (see section 4.5).

 

 

4.5     Interaction with other medicinal products and other forms of interaction

 

Both non-selective and selective beta-blockers should be avoided in patients with asthma unless there are compelling reasons for their use.

 

Potentially serious hypokalaemia may result from 2 agonist therapy.  Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.

 

Potent CYP3A4 inhibitors

Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 mcg inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4-fold Cmax and 15-fold AUC).  This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see Section 4.4).

 

Clinically significant effects were not seen on blood pressure, heart rate, blood glucose and blood potassium levels.  Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing.

 

The concomitant administration of ketoconazole should be avoided, unless the benefits outweigh the potentially increased risk of systemic side effects of salmeterol treatment.  There is likely to be a similar risk of interaction with other potent CYP3A4 inhibitors (e.g. itraconazole, telithromycin, ritonavir).

 

Moderate CYP 3A4 inhibitors

Co-administration of erythromycin (500mg orally three times a day) and salmeterol (50g inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (Cmax mean ratio was 1.40).  Co-administration with erythromycin was not associated with any serious adverse effects.

 

Updated on 9 January 2009 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Addition of TORCH study results to section 5.1 of Serevent Evohaler SPC

Updated on 4 July 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 23 June 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

 

1.NAME OF THE MEDICINAL PRODUCT

 

mg has been changes to micrograms

 

4.2       Posology and method of administration

 

Addition of practical instructions for Evohaler use

 

5.2       Pharmacokinetic properties

Fluticasone propionate:

 

The following line changed from:

The absolute bioavailability of inhaled fluticasone propionate in healthy subjects varies between approximately 10-30 % of the nominal dose depending on the inhalation device used. 

 

To : The absolute bioavailability of a single dose of inhaled fluticasone propionate in healthy subjects varies between approximately 5-11% of the nominal dose depending on the inhalation device used. 

 

 6.4      Special precautions for storage

 

The following line has been added:

Replace the mouthpiece cover firmly and snap it into position.

Updated on 31 August 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 August 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

4.2 Posology and method of administration

Serevent Evohaler is for inhalation use only.

Serevent Evohaler should be used regularly. The full benefits of treatment will be apparent after several doses of the medicinal product. As there may be adverse reactions associated with excessive dosing with this class of medicinal product, the dosage or frequency of administration should only be increased on medical advice.

 

Recommended Doses:

Asthma

Adults and adolescents 12 years and older:

Two actuations of 25 micrograms salmeterol twice daily.

In asthma patients with more severe airways obstruction up to four inhalations of 25 micrograms of salmeterol twice daily may be of benefit.

Children aged 4 years and older:

Two actuations of 25 micrograms salmeterol twice daily.

Children below 4 years of age:

Serevent Evohaler is not recommended for use in children below four years of age due to insufficient data on safety and efficacy.

 

COPD

 

Adults: Two actuations of 25 micrograms salmeterol twice daily.

Children: There is no relevant indication for use of Serevent Evohaler in children.

 

Special patient groups:

There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available on the use of Serevent Evohaler in patients with hepatic impairment.

INSTRUCTIONS FOR USE:

Patients should be carefully instructed in the proper use of their inhaler (see Patient Information Leaflet).

 

Patients should remove the mouthpiece cover by gently squeezing the sides of the cover. and check the mouthpiece inside and putside to see that it is clean.

Patients should check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.

Patients should shake the inhaler well. to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed. Before using for the first time or if the inhaler has not been used for a week patients should release one puff into the air to make sure that it works.

Patients should hold the inhaler upright between fingers and thumb with their thumb on the base, below the mouthpiece.

Patients should breathe out as far as is comfortable and then place the mouthpiece in their mouth between their teeth and close their lips around it. Patients should be instructed not to bite the mouthpiece.

Just after starting to breathe in through their mouth patients should press down on the top of the inhaler to release salmeterol while still breathing in steadily and deeply.

While holding their breath, patients should take the inhaler from their mouth and take their finger from the top of the inhaler. They should continue holding their breath for as long as is comfortable.

If patients are going to take a further puff, they should keep the inhaler upright and wait about half a minute before repeating steps 2 3 to 6 7.

After use patients should always replace the mouthpiece cover to keep out dust and fluff.

Patients should replace Tthe mouthpiece cover is replaced by firmly pushing and snapping the cap into position.

 

Important:

 

Patients should not rush stages 4, 5 5, 6 and 7 6. It is important that they start to breathe in as slowly as possible just before operating their inhaler.

 

Patients should practise in front of a mirror for the first few times. If they see "mist" coming from the top of their inhaler or the sides of their mouth they should start again from stage 2.

 

Serevent Evohaler should be used with a Volumatic spacer device by patients who find it difficult to synchronise aerosol actuation with inspiration of breath which is often the case for children and the elderly.

 

Cleaning:

 

The inhaler should be cleaned at least once a week by:

1. Removing the mouthpiece cover.

2. Wiping the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.

3. Replacing the mouthpiece cover.

The canister must not be removed from the plastic casing when cleaning the inhaler.

PATIENTS MUST NOT PUT THE METAL CANISTER INTO WATER.

 

 

6.4 Special precautions for storage

 

Replace the mouthpiece cover firmly and snap it into position.

 

Do not store above 30 C.

 

The canister contains a pressurised liquid. Do not expose to temperatures higher than 50oC. Do not pierce the canister.

 

Pressurised container. Do not expose to temperatures higher than 50C. Do not puncture, break or burn even when apparently empty.

 

 

6.6 Special precautions for disposal and other handling

 

No special requirements.

Updated on 13 April 2007 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 12 April 2007 PIL

Reasons for updating

  • New PIL for new product