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 11/12/2016 02:18
Current documents
SPC 2595
PIL 2142
Total: 4737
Submissions in the last 3 months
Updated: 885
New: 68

 

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
09 December 2016
New 0, Updated 13, Retired 0, [Total 13]
  • Change to Section 1 - what the product is
  • 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 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to Section 1 - what the product is
  • 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 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to Section 1 - what the product is
  • 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 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to Section 1 - what the product is
  • 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 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Sofosbuvir, Velpatasvir
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Active Ingredients: Sofosbuvir, Ledipasvir
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Active Ingredients: Tapentadol hydrochloride
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Active Ingredients: Tapentadol hydrochloride
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Active Ingredients: Tapentadol hydrochloride
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Active Ingredients: Tapentadol hydrochloride
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Active Ingredients: Indacaterol maleate , Glycopyrronium bromide
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
08 December 2016
New 1, Updated 13, Retired 2, [Total 16]
Active Ingredients: Sofosbuvir, Velpatasvir
  • Change to section 2 - what you need to know - warnings and precautions
Active Ingredients: Imatinib mesilate
  • Addition of joint SPC covering all presentations
SPC retired Glivec 100mg Film-Coated Tablets
Active Ingredients: Imatinib mesilate
  • Individual SPC superseded by joint SPC
SPC retired Glivec 400mg Film-Coated Tablets
Active Ingredients: Imatinib mesilate
  • Individual SPC superseded by joint SPC
Active Ingredients: Sofosbuvir, Ledipasvir
  • Change to section 2 - what you need to know - warnings and precautions
Active Ingredients: Influenza vaccine (surface antigen, inactivated)
  • Change to section 6 - date of revision
Active Ingredients: Oxybutynin Hydrochloride
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Levonorgestrel
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Sofosbuvir
  • Change to section 2 - what you need to know - warnings and precautions
Active Ingredients: Mebendazole
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • 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
07 December 2016
New 0, Updated 14, Retired 0, [Total 14]
Active Ingredients: Calcipotriol
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Oxybutynin Hydrochloride
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Levonorgestrel
  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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
Active Ingredients: Ivabradine hydrochloride
  • Change to section 4 - possible side effects
Active Ingredients: Pantoprazole sodium sesquihydrate
  • 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 4.4 - 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 4.9 - 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 10 - Date of revision of the text
Active Ingredients: Pantoprazole sodium sesquihydrate
  • 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 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
Active Ingredients: Pantoprazole sodium sesquihydrate
  • 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 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4 - possible side effects
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision