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 21/08/2017 23:55
Current documents
SPC 2644
PIL 2186
Total: 4830
Submissions in the last 3 months
Updated: 1027
New: 93

 

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
21 August 2017
New 2, Updated 9, Retired 1, [Total 12]
Active Ingredients: Atovaquone, Proguanil Hydrochloride
  • Change to Section 1 - what the product is
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • 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, Correction of spelling/typing errors
  • 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, Correction of spelling/typing errors
  • 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, Correction of spelling/typing errors
  • 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, Correction of spelling/typing errors
  • 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, Correction of spelling/typing errors
  • New SPC for medicines.ie
Active Ingredients: Methotrexate disodium
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Meloxicam
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Active Ingredients: Meloxicam
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Active Ingredients: Paracetamol, Codeine Phosphate Hemihydrate, Caffeine
  • New SPC for new product
PIL retired Tavager 250 mg & 500 mg film-coated tablets
Active Ingredients: Levofloxacin hemihydrate
  • Joint PIL superseded by individual PILs,Licence withdrawn
18 August 2017
New 4, Updated 22, Retired 1, [Total 27]
Active Ingredients: Quinapril hydrochloride
  • 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
Active Ingredients: Quinapril hydrochloride
  • 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 6 - date of revision
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Dexamethasone Sodium Phosphate
Company: Hospira UK Ltd
  • New SPC for medicines.ie
Active Ingredients: Rilpivirine Hydrochloride
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text, Removal of black triangle
  • New SPC for medicines.ie
Active Ingredients: Calcium Folinate
Company: Hospira UK Ltd
  • New SPC for medicines.ie
SPC retired Intelence 200 mg tablets
Active Ingredients: Etravirine
  • Individual SPC superseded by joint SPC
  • 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 4.3 - 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
Active Ingredients: Esomeprazole magnesium trihydrate
  • Change to section 6 - date of revision, Improved presentation of PIL
  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • 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: Simeprevir sodium
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • 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 10 - Date of revision of the text
  • Change to section 10 - Date of revision of the text
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Active Ingredients: Fosphenytoin Sodium
  • Change to section 4 - how to report a side effect
Active Ingredients: Calcium Carbonate, Magnesium carbonate, heavy
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Bedaquiline fumarate
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Paracetamol, Caffeine, Codeine Phosphate Hemihydrate
  • New PIL for new product
Active Ingredients: Telmisartan, Amlodipine besilate
  • Improved presentation of PIL
Active Ingredients: Telmisartan, Amlodipine besilate
  • Improved presentation of PIL
Active Ingredients: Telmisartan, Amlodipine besilate
  • Improved presentation of PIL
Active Ingredients: Alprostadil
  • Change to section 3 - how to take/use
Active Ingredients: Alprostadil
  • Change to section 4.2 - Posology and method of administration
Active Ingredients: Lercanidipine Hydrochloride
  • 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 4.5 - 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 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Lercanidipine Hydrochloride
  • 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 4.7 - Effects on ability to drive and use machines
  • 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 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
17 August 2017
New 4, Updated 9, Retired 0, [Total 13]
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Dexamethasone Sodium Phosphate
Company: Hospira UK Ltd
  • New PIL for medicines.ie
  • New PIL for medicines.ie
Active Ingredients: Calcium Folinate
Company: Hospira UK Ltd
  • New PIL for medicines.ie
  • New PIL for medicines.ie
  • Improved presentation of PIL
  • 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 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
Active Ingredients: Metformin Hydrochloride, Empagliflozin
  • Improved presentation of PIL
Active Ingredients: Anagrelide hydrochloride
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to section 4.1 - Therapeutic indications
Active Ingredients: Idelalisib
  • Change to section 6.3 - Shelf life
Active Ingredients: Idelalisib
  • Change to section 6.3 - Shelf life