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Pulmicort Turbohaler 100

  • Name:

    Pulmicort Turbohaler 100

  • Company:
    info
  • Active Ingredients:

    Budesonide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/11/19

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Summary of Product Characteristics last updated on medicines.ie: 23/1/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

Company Products

Medicine NameActive Ingredients
Medicine Name Alvesco 160 micrograms pressurised inhalation,solution Active Ingredients Ciclesonide
Medicine Name Alvesco 80 micrograms pressurised inhalation,solution Active Ingredients Ciclesonide
Medicine Name Arimidex Active Ingredients Anastrozole
Medicine Name Atacand 8mg 16mg Tablets Active Ingredients Candesartan Cilexetil
Medicine Name Atacand Plus 16/12.5mg Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
Medicine Name Bricanyl Turbohaler Active Ingredients Terbutaline sulfate
Medicine Name Brilique 60 mg film-coated tablets Active Ingredients Ticagrelor
Medicine Name Brilique 90 mg film coated tablets Active Ingredients Ticagrelor
Medicine Name Brilique 90 mg Orodispersible Tablets Active Ingredients Ticagrelor
Medicine Name Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen Active Ingredients Exenatide
Medicine Name Byetta 5 micrograms solution for injection, prefilled pen. Byetta 10 micrograms solution for injection, prefilled pen Active Ingredients Exenatide
Medicine Name Casodex 50mg Tablets Active Ingredients Bicalutamide
Medicine Name Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets Active Ingredients Rosuvastatin Calcium
Medicine Name Daxas 250 mcg Film-Coated Tablets Active Ingredients roflumilast
Medicine Name Daxas 500 mcg Film-coated Tablets Active Ingredients roflumilast
Medicine Name Fasenra 30 mg solution for injection in pre filled syringe Active Ingredients Benralizumab
Medicine Name Faslodex Active Ingredients Fulvestrant
Medicine Name Forxiga 10 mg Film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name Forxiga 5 mg film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name IMFINZI 50 mg/mL concentrate for solution for infusion Active Ingredients durvalumab
Medicine Name IRESSA 250 mg film-coated tablets Active Ingredients gefitinib
Medicine Name Komboglyze 2.5mg-1000mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Komboglyze 2.5mg-850mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Losec MUPS 10mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
Medicine Name Losec MUPS 20mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
1 - 0 of 54 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 November 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 24 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 23 January 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 – Marketing Authorisation Holder details updated

Section 8 – Marketing Authorisation numbers updated

Section 10 – date of revision updated

Updated on 24 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 July 2017 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 4.8 - 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 – Updated information relating to the risk of increased systemic corticosteroid side effects with CYP3A inhibitors. Addition of warning on visual disturbance including ‘central serous chorioretinopathy’.
Section 4.5 – Updated information relating to the risk of increased systemic corticosteroid side effects with CYP3A inhibitors.
Section 4.8 – Addition of ‘vision, blurred’ to ADR table
Section 10 – Date of revision of text

Updated on 20 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 September 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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
  • 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 4.2 Editorial changes to reflect the QRD template

Section 4.4 Addition of information relating to pneumonia in patients with COPD

Section 4.6 Updated information relating to pregnancy

Section 4.8 Updated ADR table and statement beneath table. Also updated information relating to adverse effects seen in clinical trials.

Section 10 Updated revision date

Updated on 20 September 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 11 November 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 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 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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 2 editorial changes-aligned to lated QRD template
- Section 4.2 editorial changes-aligned to lated QRD template

- Section 4.3 editorial changes- aligned to lated QRD template

- Section 4.4 editorial changes- aligned to lated QRD template

- Section 4.5 editorial changes- aligned to lated QRD template

- Section 4.6 editorial changes- aligned to lated QRD template

- Section 4.7 editorial changes- aligned to lated QRD template

-Section 4.8 editorial changes- aligned to lated QRD template. Addition of ADR reoporting statement

- section 4.9 editorial changes- aligned to lated QRD template

- Section 5.1 editorial changes- aligned to lated QRD template and CDS update to the wording on growth

-Section 6.6 editorial changes- aligned to lated QRD template

-Section 9 editorial changes- aligned to lated QRD template

-Section 10 date of revision of text updated

Updated on 7 November 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 30 September 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability

Updated on 21 May 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.4 – Update to list of systemic effects
- Section 4.8 – Update to rare side effects

 

-Section 4.2 Posology and method of administration
-Section 4.4 Special warnings and precautions for use
-Section 4.4 Special warnings and precautions for use
-Section 4.5 Interaction with other medicinal products and other forms of interaction
- Section 4.6 Pregnancy and lactation
-Section 4.7 Effects on ability to drive and use machines
-Section 4.8 Undesirable effects
-Section 4.9 Overdose
- Section 5.1 Pharmacodynamic properties
- Section 5.2 Pharmacokinetic properties
-Section 10 Update to date of revision

Updated on 17 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration

Updated on 2 February 2012 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 30 January 2012 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to side-effects
  • Change to date of revision

Updated on 23 December 2010 PIL

Reasons for updating

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

Updated on 23 April 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 18 August 2008 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 11 April 2005 PIL

Reasons for updating

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

Updated on 5 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie