We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Document information 28/05/2015 04:50
Current documents
SPC 2458
PIL 2003
Total: 4461
Submissions in the last 3 months
Updated: 1196
New: 61

 

What's New

These are the latest new, updated and retired (removed) Summaries of Product Characteristics (known as SPCs or SmPCs) and Patient Information Leaflets (known as PILs, Package Leaflets or PLs) on medicines.ie. More help.

Filter Results

Document Type:
PIL SPC
Status:  
New Update Retired
27 May 2015
New 1, Updated 18, Retired 0, [Total 19]
Active Ingredients: Terbutaline Sulphate
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Sodium Dihydrogen Phosphate Dihydrate, Disodium Phosphate Dodecahydrate
  • New PIL for medicines.ie
Active Ingredients: Perampanel
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change due to user-testing of patient information
Active Ingredients: Carbamazepine
  • Change due to user-testing of patient information
Active Ingredients: Carbamazepine
  • Change due to user-testing of patient information
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Allopurinol
Company: Aspen | Document History
  • Change to further information section
  • Change to date of revision
26 May 2015
New 3, Updated 41, Retired 2, [Total 46]
Active Ingredients: Clomipramine hydrochloride
  • 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
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
Active Ingredients: Clomipramine hydrochloride
  • 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
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
Active Ingredients: Mesalazine
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Chlorphenamine Maleate
  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder
Active Ingredients: Sodium Picosulphate, Citric Acid (Anhydrous), Magnesium Oxide Light
  • New SPC for medicines.ie
Active Ingredients: Desmopressin Acetate
  • Change to product name
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Diclofenac Sodium
  • Change to date of revision, Addition of manufacturer
  • Change to section 1 - Name of medicinal product
  • 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 4.3 - 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 4.8 - 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 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • 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
  • Change to section 1 - Name of medicinal product
  • 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 4.3 - 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 4.8 - 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • 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
  • Change to section 1 - Name of medicinal product
  • 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 4.3 - 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 4.8 - 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • 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
Active Ingredients: Sodium Dihydrogen Phosphate Dihydrate, Disodium Phosphate Dodecahydrate
  • New SPC for medicines.ie
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
Active Ingredients: Paracetamol, Codeine Phosphate Hemihydrate
Company: Galen Ireland
  • New PIL for medicines.ie
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - 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 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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
Active Ingredients: Hydrocortisone 17-Butyrate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Active Ingredients: Hydrocortisone 17-Butyrate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Active Ingredients: Hydrocortisone 17-Butyrate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Active Ingredients: Memantine hydrochloride
  • Correction of spelling/typing errors
Active Ingredients: Desmopressin Acetate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Desmopressin Acetate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
SPC retired Orfadin 10mg Capsules
Active Ingredients: Nitisinone
  • Joint SPC superseded by SPCs for individual presentations
SPC retired Orfadin 5mg Capsules
Active Ingredients: Nitisinone
  • Joint SPC superseded by SPCs for individual presentations
Active Ingredients: Nitisinone
  • 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 4.1 - Therapeutic indications
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC
Active Ingredients: Nicotinamide, Thiamine Hydrochloride (Vitamin B1), Pyridoxine Hydrochloride (Vitamin B6), Ascorbic acid, Anhydrous glucose, Riboflavin sodium phosphate (Vitamin B2)
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Mesalazine
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Propantheline bromide
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to information about pregnancy or lactation
  • Change to date of revision, Correction of spelling/typing errors
Active Ingredients: Zidovudine
  • Change to information about pregnancy or lactation
  • Change to date of revision, Correction of spelling/typing errors
Active Ingredients: Zidovudine
  • Change to information about pregnancy or lactation
  • Change to date of revision, Correction of spelling/typing errors
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Interferon Alfa-2a
  • Change to date of revision, Introduction of new pack/pack size
Active Ingredients: Methylprednisolone sodium succinate
  • Improved electronic presentation
Active Ingredients: Methylprednisolone sodium succinate
  • Improved electronic presentation
Active Ingredients: Methylprednisolone sodium succinate
  • Improved electronic presentation
Active Ingredients: oseltamivir phosphate
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to side-effects
Active Ingredients: Erythromycin, Zinc acetate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
25 May 2015
New 0, Updated 8, Retired 0, [Total 8]
Active Ingredients: Levodopa, Carbidopa Monohydrate
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Leuprorelin Acetate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Leuprorelin Acetate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Leuprorelin Acetate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Sodium Picosulphate, Citric Acid (Anhydrous), Magnesium Oxide Light
  • Change to Section 4.8 – Undesirable effects - how to report a side effect