Dexsol 2mg/5ml Oral Solution

  • Name:

    Dexsol 2mg/5ml Oral Solution

  • Company:
    info
  • Active Ingredients:

    Dexamethasone Sodium Phosphate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/05/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 3/5/2019

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Rosemont Pharmaceuticals Limited

Rosemont Pharmaceuticals Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Amlodipine 1mg/ml Oral Solution Active Ingredients Amlodipine besilate
Medicine Name Amlodipine 2mg/ml Oral Solution Active Ingredients Amlodipine besilate
Medicine Name Clonazepam Rosemont 0.5mg/5ml Oral Solution Active Ingredients Clonazepam
Medicine Name Clonazepam Rosemont 2mg/5ml Oral Solution Active Ingredients Clonazepam
Medicine Name Dexsol 2mg/5ml Oral Solution Active Ingredients Dexamethasone Sodium Phosphate
Medicine Name Gabapentin Rosemont 50mg/ml Oral Solution Active Ingredients Gabapentin
Medicine Name Metformin Hydrochloride 500mg/5ml Oral Solution Active Ingredients Metformin Hydrochloride
Medicine Name Methadone HCL Sugar Free 1mg/1ml Oral Solution Active Ingredients Methadone Hydrochloride
Medicine Name Perizam 1mg/ml Oral Suspension Active Ingredients Clobazam
Medicine Name Perizam 2mg/ml Oral Suspension Active Ingredients Clobazam
Medicine Name Quetiapine Rosemont 20mg/ml Oral Suspension Active Ingredients Quetiapine fumarate
Medicine Name Ranitidine 150mg/10ml Oral Solution Active Ingredients Ranitidine Hydrochloride
Medicine Name Tamoxifen Rosemont 10mg/5ml Oral Solution Active Ingredients Tamoxifen Citrate
1 - 0 of 13 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 7 May 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 3 May 2019 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)

Updated on 15 March 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • 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 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 15 March 2019 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 11 January 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 4.8 – Undesirable effects - how to report a side effect
  • 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

In section 4.4: updates to add visual disturbances and tumour lysis syndrome

In section 4.5: updates to add co-treatment with CYP3A inhibitors

In section 4.8: blurred vision and chorioretinopathy added

In section 10: approval date added

Updated on 11 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 10 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 January 2018 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 24 October 2017 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

In section 2: section updated in line with the QRD

In section 4.2: addition of suitability of administration via NG and PEG tube

In section 4.6: section updated in line with the QRD

In section 4.8: Reporting of suspected adverse reactions paragraph added

In section 5.1: section updated in line with the QRD

In section 6.6: instruction for administration via NG and PEG tube added

In section 10: approval date added

Updated on 12 October 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 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 11 July 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 11 July 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

In Section 2 Excipent list added.

In Section 4.1 Childhood croup added.

 

In section 4.2 childhood croup section added.

In section 4.4 significant changes to section

In section 4.5 Changes to section made.

 

In section 4.6 (Use during pregnancy and lactation) more information about administration of corticosterioids in pregnant animals added.

In section 4.8 (undesirable effects) Number of change made.

In section 5.3 (Preclinical safety data) Content amended.

In section 6.4 Light sensitivity information added.

In section 6.5 bottle size amended.

In section 10 date of text revision amended

Updated on 14 November 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Changes to therapeutic indications
  • Introduction of new pack/pack size

Updated on 14 July 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie

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 14 July 2011 PIL

Reasons for updating

  • New PIL for medicines.ie