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 24/04/2017 02:22
Current documents
SPC 2620
PIL 2168
Total: 4788
Submissions in the last 3 months
Updated: 901
New: 75

 

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 April 2017
New 0, Updated 8, Retired 0, [Total 8]
Active Ingredients: Bosutinib monohydrate
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
Active Ingredients: Cyproterone Acetate, Ethinylestradiol
  • Change to section 10 - Date of revision of the text, Removal of black triangle
Active Ingredients: Digoxin
Company: Aspen | Document History
  • Change to section 1 - what the product is used for
  • 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Active Ingredients: Thiamine Hydrochloride (Vitamin B1), Calcium glycerophosphate, Potassium glycerophosphate, Manganese glycerophosphate, Sodium glycerophosphate
  • Change to section 6 - date of revision
  • Change to MA holder contact details
  • 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
Active Ingredients: Zopiclone
  • 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 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
Active Ingredients: Azithromycin dihydrate
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.4 - Special warnings and precautions for use
20 April 2017
New 0, Updated 13, Retired 2, [Total 15]
Active Ingredients: Amoxicillin trihydrate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Amoxicillin trihydrate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Budesonide, Formoterol fumarate dihydrate
  • Change to section 2 - interactions with other medicines, food or drink
Active Ingredients: Budesonide, Formoterol fumarate dihydrate
  • Change to section 2 - interactions with other medicines, food or drink
Active Ingredients: Budesonide, Formeterol fumarate dihydrate
  • Change to section 2 - interactions with other medicines, food or drink
Active Ingredients: Dorzolamide Hydrochloride, Timolol Maleate
  • Change to section 2 - Qualitative and quantitative composition
  • 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 first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ferric carboxymaltose
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Sodium Amidotrizoate, Meglumine Amidotrizoate
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
PIL retired Inspra 25mg & 50mg Film-Coated Tablets
Active Ingredients: Eplerenone
  • Submitted in error
Active Ingredients: Digoxin
Company: Aspen | Document History
  • 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 4.8 - 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Medroxyprogesterone Acetate, Conjugated oestrogens
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
PIL retired Refludan
Active Ingredients: Lepirudin
Company: Celgene Ltd
  • Product/presentation discontinued
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Azithromycin dihydrate
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
Active Ingredients: Azithromycin dihydrate
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
19 April 2017
New 0, Updated 17, Retired 1, [Total 18]
Active Ingredients: Methylphenidate Hydrochloride
  • Correction of spelling/typing errors
Active Ingredients: Methylphenidate Hydrochloride
  • Correction of spelling/typing errors
Active Ingredients: Methylphenidate Hydrochloride
  • Correction of spelling/typing errors
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Digoxin
Company: Aspen | Document History
  • 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 4.8 - 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 10 - Date of revision of the text
Active Ingredients: Digoxin
Company: Aspen | Document History
  • 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 10 - Date of revision of the text
Active Ingredients: Ethinylestradiol, Desogestrel
  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ethinylestradiol, Desogestrel
  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Mesalazine
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
SPC retired Premique 0.625mg /2.5mg Coated Tablets
Active Ingredients: Medroxyprogesterone Acetate
  • SPC submitted in error
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Phenol, Halogenated phenols
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text