Seretide Evohaler

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/04/18

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 4/6/2019

Click on this link to Download PDF directly

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 4 June 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Update to Section 4.2 and Section 5.2 due to Article 46 update

Updated on 5 November 2018 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 4.5: Formatting update to correct typographical error relating to the sub-section for CYP3A4 inhibitors

Updated on 1 October 2018 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 5.1: Formatting error to correct typographical error relating to the SMART study.

Updated on 6 April 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 April 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 April 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 4.4: Added statement for warnings and precautions to include visual disturbances
Section 4.8: Updated side effects to include blurred vision

Updated on 6 April 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 1 February 2018 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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

-Sections 4.6, 5.1 and 5.3 of the SmPCs - revision of the Pregnancy and Lactation and Clinical Studies sections of the SmPCs based upon new epidemiology data
-Sections 4.4 and 5.1 of the SmPCs - addition of results of Paediatric Studies
Section 4.5 of the SmPC - incorporation of the PRAC recommendations for the interaction of corticosteroids with cobicistat-containing products

Updated on 1 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 1 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 February 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

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

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

Updated on 6 May 2015 PIL

Reasons for updating

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

Updated on 5 May 2015 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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 5.1 - update to ATC code
Section 7 – Update of the information on the MAH due to change from A&H to GSK trading style

Updated on 28 April 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic 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 4.8 – Addition of Oesophageal candidiasis as new adverse event with the frequency “rare”

Section 5.1 – Update to details on asthma studies due to alignment of wording with the definitions in the study of ‘well controlled’ and ‘total control’ of asthma

 

Updated on 27 April 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 8 December 2014 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic 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 5.1 – Update ATC level name (Pharmacotherapeutic group)

Updated on 5 December 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to dosage and administration
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 3 September 2013 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

Changes to:

 

 

Section 4.4 - Special warnings and precautions for use,
Section 4.8 - Undesirable effects

 

Updated on 30 August 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 24 April 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 24 April 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.4: Deleted the following warning: 'Care should be taken when transferring patients to Seretide therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy'.

Section 4.8: Updated the 'rare' side effect 'Sleep disorders and behavioural changes, including psychomotor hyperactivity and irritability (predominantly in children)' to specify 'psychomotor' hyperactivity. Added the 'uncommon' side effect 'Angina pectoris'.

Updated on 13 August 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 13 August 2012 SmPC

Reasons for updating

  • 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

Change to Section 4.8

Updated on 1 June 2012 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

Changes to:

Section 4.4 - Special warnings and precautions for use,
Section 4.8 - Undesirable effects

Updated on 1 June 2012 PIL

Reasons for updating

  • Change of manufacturer
  • Change to, or new use for medicine
  • Change to side-effects

Updated on 16 September 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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

 

4.4     Special warnings and precautions for use

 

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

 

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.

 

Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Children and adolescents <16years taking high doses of fluticasone propionate (typically ³ 1000mcg/day) may be at particular risk. Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000mcg. Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection or any rapid reduction in dosage. Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

 

SUMMARY OF PRODUCT CHARACTERISTICS

 

4.4     Special warnings and precautions for use

 

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

 

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.

 

Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Children and adolescents <16years taking high doses of fluticasone propionate (typically ³ 1000mcg/day) may be at particular risk. Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000mcg. Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection or any rapid reduction in dosage. Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

 

 

4.4     Special warnings and precautions for use

(cont‘d)

 

……

 

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).

 

 

 

4.4     Special warnings and precautions for use

(cont‘d)

 

…..

 

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).

 

Paediatric Population

 

Children and adolescents <16years taking high doses of fluticasone propionate (typically ³ 1000mcg/day) may be at particular risk. Systemic effects may occur, particularly at high doses prescribed for long periods. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, acute adrenal crisis and growth retardation in children and adolescents.

 

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored. The dose of inhaled corticosteroid should be reduced to the lowest dose at which effective control of asthma is maintained.

 

 

4.6     Pregnancy and lactation

 

There are insufficient data on the use of salmeterol and fluticasone propionate during pregnancy and lactation in man to assess the possible harmful effects. In animal studies foetal abnormalities occur after administration of beta-2-adrenoreceptor agonists and glucocorticosteroids (see section 5.3).

 

Administration of Seretide to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.

 

The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.

 

There are no data available for human breast milk. Both salmeterol and fluticasone propionate are excreted into breast milk in rats. Administration of Seretide to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

 

4.6     Fertility, pregnancy and lactation

 

Fertility

 

There are no data in humans. However, animal studies showed no effects of salmeterol or fluticasone propionate on fertility.

 

Pregnancy

 

A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of salmeterol and fluticasone propionate. Animal studies have shown reproductive toxicity after administration of beta-2-adrenoreceptor agonists and glucocorticosteroids (see section 5.3).

 

There are insufficient data on the use of salmeterol and fluticasone propionate during pregnancy and lactation in man to assess the possible harmful effects. In animal studies foetal abnormalities occur after administration of beta-2-adrenoreceptor agonists and glucocorticosteroids (see section 5.3).

 

Administration of Seretide to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.

 

The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.

 

Lactation

 

There are no data available for human breast milk. Both salmeterol and fluticasone propionate are excreted into breast milk in rats. Administration of Seretide to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

It is unknown whether salmeterol and fluticasone propionate/metabolites are excreted in human milk.

 

Studies have shown that salmeterol and fluticasone propionate, and their metabolites, are excreted into the milk of lactating rats.

 

A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue Seretide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

 

Updated on 18 February 2011 PIL

Reasons for updating

  • Change to storage instructions

Updated on 6 January 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

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

 

……………….etc

 

There are no data available for use of Seretide inhaler in children aged under 4 years.

 

Children <12 years old may have difficulties synchronising aerosol actuation with inspiration of breath. Use of a spacer device with Seretide inhaler is recommended in patients who find it have, or are likely to have difficulties to synchronise aerosol coordinate actuation with inspiration of breath.  A recent clinical study has shown that paediatric patients using a spacer achieved exposure similar to adults not using spacer and paediatric patients using Diskus, confirming that spacers compensate for poor inhaler technique (see Section 5.2).

 

Either the Volumatic or AeroChamber Plus spacer device can be used (depending on National Guidance).  Limited data are available that demonstrate an increase in systemic exposure when the AeroChamber Plus spacer device is used compared with the Volumatic spacer device (see section 4.4).

 

………………….etc

 

5.2     Pharmacokinetic properties

 

………………….etc

 

The renal clearance of fluticasone propionate is negligible.  Less than 5% of the dose is excreted in urine, mainly as metabolites.  The main part of the dose is excreted as faeces as metabolites and unchanged drug.

 

Paediatric population

The effect of 21 days of treatment with Seretide Inhaler 25/50 microgram (2 inhalations twice daily with or without a spacer) or Seretide Diskus 50/100 microgram (1 inhalation twice daily) was evaluated in 31 children aged 4 to 11 years with mild asthma.  Systemic exposure to fluticasone propionate was similar for Seretide Inhaler with spacer (107pg hr/mL [95% CI: 45.7, 252.2]) and Seretide Diskus (138pg hr/mL [95% CI: 69.3, 273.2]), but lower for Seretide Inhaler (24pg hr/mL [95% CI: 9.6, 60.2]).  Systemic exposure to salmeterol was similar for Seretide Inhaler, Seretide Inhaler with spacer, and Seretide Diskus (126 pg hr/mL [95% CI: 70, 225], 103 pg hr/mL [95% CI: 54, 200], and 110 pg hr/mL [95% CI: 55, 219], respectively).

 

 

 

Additional change throughout document

 The abbreviation ‘mcg’ has been replaced with the word ‘microgram’

Updated on 13 May 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

1.       NAME OF THE MEDICINAL PRODUCT

 

Seretide 50 Evohaler 25 microgram/50 microgram/dose pressurised inhalation, suspension.

 

Seretide 125 Evohaler 25 microgram/125 microgram/dose pressurised inhalation, suspension.

 

Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised inhalation, suspension.

 

4.8         Undesirable effects

 

As Seretide contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.

 

Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (³1/100 and <1/10), uncommon (³1/1000 and <1/100), rare (³1/10,000 to <1/1000), and very rare (<1/10,000) including isolated reports. Very common, common and uncommon events were derived from clinical trial data. The incidence in placebo was not taken into account. Very rare events were derived from post-marketing spontaneous data.

 

NOTE:

The changes to this table relate purely to sequence and layout issues.

There are no changes to the adverse events and/or frequency. 

System Organ Class

Adverse Event

Frequency

Infections & Infestations

 

 

 

 

Cardiac Disorders

Candidiasis of the mouth and throat

 

Pneumonia

Bronchitis

 

Palpitations

Tachycardia

Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles).

 

Common

 

Common1,3

 

Common1,3

 

Common

Uncommon

Very Rare

Immune System Disorders

 

 

 

 

 

 

 

 

Nervous System Disorders

Hypersensitivity reactions with the following manifestations:

Cutaneous hypersensitivity reactions

Angioedema (mainly facial and oropharyngeal oedema), Respiratory symptoms (dyspnoea and/or bronchospasm), Anaphylactic reactions including anaphylactic shock

 

Headache


Tremor

 

 




Uncommon

Very Rare

 

 

 

 

*Very Common

Common

Endocrine Disorders

 

 

 

Eye Disorders

Cushing’s syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density

Cataract, Glaucoma

 

Very Rare4

 

 

 

 

Very Rare

Metabolism & Nutrition Disorders

 

 

Respiratory, Thoracic & Mediastinal Disorders

Hypokalaemia

 

Hyperglycaemia

Nasopharyngitis


Throat irritation

Hoarseness/dysphonia

Sinusitis

Paradoxical bronchospasm

 

Common3

 

Very Rare4

 

**#Very Common

Common

Common

*#Common


Very Rare

Psychiatric Disorders

 

 

Skin and subcutaneous tissue disorders

 

Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children)

 

Contusions

 

Very Rare

 

 

 

*#Common

Nervous System Disorders

 

 

Musculoskeletal & Connective Tissue Disorders

Headache

Tremor

 

Muscle cramps

Traumatic fractures

Arthralgia

Myalgia

 

Very Common1

Common

 

Common

*#Common

Very Rare

Very Rare

Eye Disorders

 

Endocrine Disorders

 

Cataract, Glaucoma

 

Cushing’s syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density

Very Rare4

 

Very Rare

 

Cardiac Disorders

 

 

 

 

 

 

Metabolism & Nutrition Disorders

 

Palpitations

Tachycardia

Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles).

 

Hypokalaemia

 

Hyperglycaemia

Common

Uncommon

Very Rare

 

 

Common

 

Very Rare

 

 

Respiratory, Thoracic & Mediastinal Disorders

 

 

 

 

 

 

 

Infections & Infestations

 

Nasopharyngitis


Throat irritation

Hoarseness/dysphonia

Sinusitis

Paradoxical bronchospasm

 

Candidiasis of the mouth and throat

 

Pneumonia

Bronchitis

 

Very Common2,3

Common

Common

Common1,3


Very Rare4

 

Common

 

*#Common

 

*#Common

 

Skin and subcutaneous tissue disorders

 

Immune System Disorders

 

 

Contusions

 

 

 

Hypersensitivity reactions with the following manifestations:

Cutaneous hypersensitivity reactions

Angioedema (mainly facial and oropharyngeal oedema), Respiratory symptoms (dyspnoea and/or bronchospasm), Anaphylactic reactions including anaphylactic shock

 

Common1,3

 

 

 

 

 

 

Uncommon

Very Rare

Musculoskeletal & Connective Tissue Disorders

 

 

 

 

 

Psychiatric Disorders

 

Muscle cramps

Traumatic fractures

Arthralgia

Myalgia

 

Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children)

 

Common

Common1,3

Very Rare

Very Rare

 

Very Rare

 

1.    Reported commonly in placebo

2.    Reported very commonly in placebo

3.    Reported over 3 years in a COPD study

4.    See section 4.4

 

Description of selected adverse reactions

 

The pharmacological side effects of beta-2-agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.

 

Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after using the product. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Seretide Diskus.

 

Pneumonia was reported in studies of patients with COPD (see section 5.1)

 

Paediatric population

 

Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, and growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma (see section 4.4). Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability.

 

There have been very rare reports of hyperglycaemia (see section 4.4).

 

As with other inhalation therapy, paradoxical broncospasm may occur (see section 4.4).

 

Updated on 18 March 2010 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

6.3     Shelf life

 

        1 year 2 years

Updated on 16 November 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

SUMMARY OF PRODUCT CHARACTERISTICS

 

4.4   Special warnings and precautions for use

 

…..

 

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 Seretide.

 

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 unless there are compelling reasons for their use.

 

Concomitant use of other beta-adrenergic containing drugs can have a potentially additive effect.

 

Fluticasone Propionate

 

Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.

 

In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg b.i.d. increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations. Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected. Cases of Cushing’s syndrome and adrenal suppression have been reported. The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.

 

In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%. This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone. Co-treatment with other potent CYP3A inhibitors, such as itraconazole, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic side-effects. Caution is recommended and long-term treatment with such drugs should if possible be avoided.


Salmeterol

 

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 (50mcg inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC).  Co-administration with erythromycin was not associated with any serious adverse effects.

Updated on 10 November 2009 PIL

Reasons for updating

  • Change to drug interactions

Updated on 13 October 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company



On the search pages of Med.ie The active ingredient is stated as Salbutamol it should state

 Salmeterol .

Updated on 5 May 2009 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 27 April 2009 PIL

Reasons for updating

  • Change to name of manufacturer
  • Change to date of revision

Updated on 3 July 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 5.2 - Pharmacokinetic 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

Typo changes

 

4.2  Posology and method of administration

Typo changes

 

Changes to “Instructions for Use”

 

5.2       Pharmacokinetic properties

 

Changed from   “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.

 

To “  Changed from “The absolute bioavailability of a single dose of inhaled fluticasone propionate in healthy subjects varies between approximately 10-30% of the nominal dose depending on the inhalation device used

 

6.4       Special precautions for storage

 

Addition of the following line ”Replace the mouthpiece cover firmly and snap it into position.”

 

 

Updated on 19 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 5.2 - Pharmacokinetic 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

 

4.2     Posology and method of administration
Addition of information regarding the practical use of the evohaler

5.2     Pharmacokinetic properties

The absolute bioavailability of a single dose of inhaled fluticasone propionate in healthy subjects changed from 10-30% to. 5-11%.

6.4     Special precautions for storage

Addition of the following line “Replace the mouthpiece cover firmly and snap it into position”

Updated on 10 June 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of trade or active ingredient name

Updated on 20 September 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 11 September 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 October 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 27 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie