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Document information 04/05/2015 22:07
Current documents
SPC 2453
PIL 1998
Total: 4451
Submissions in the last 3 months
Updated: 1077
New: 66

 

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.

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Document Type:
PIL SPC
Status:  
New Update Retired
04 May 2015
New 0, Updated 1, Retired 0, [Total 1]
Active Ingredients: Cyclizine Hydrochloride
  • 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 - Clinical particulars
  • 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 4.7 - 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 - Pharmacological properties
  • 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 - Pharmaceutical particulars
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
01 May 2015
New 1, Updated 26, Retired 0, [Total 27]
Active Ingredients: Everolimus
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Acetylsalicylic acid (Aspirin)
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: Budesonide
  • New SPC for new product
Active Ingredients: Perindopril, Amlodipine, Indapamide
  • 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 5.1 - Pharmacodynamic properties
Active Ingredients: Medroxyprogesterone Acetate
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Sodium Valproate
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation, Addition of black triangle
Active Ingredients: Valproic Acid, Sodium Valproate
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation, Addition of black triangle
Active Ingredients: Valproic Acid, Sodium Valproate
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation, Addition of black triangle
Active Ingredients: Sodium Valproate
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation, Addition of black triangle
Active Ingredients: Sodium Valproate
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation, Addition of black triangle
Active Ingredients: Sodium Valproate
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation, Addition of black triangle
Active Ingredients: Sodium Valproate
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation, Addition of black triangle
Active Ingredients: Estradiol Hemihydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Alendronate Sodium Trihydrate
  • 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 4.6 - 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 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 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Active Ingredients: Mecasermin
  • Change to side-effects, Addition of manufacturer
Active Ingredients: Trazodone Hydrochloride
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Trazodone Hydrochloride
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Mycophenolate sodium
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects
  • 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 5.2 - Pharmacokinetic properties
  • 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 date of revision
  • Change to marketing authorisation holder
Active Ingredients: Dolutegravir sodium
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision, Correction of spelling/typing errors
Active Ingredients: Anagrelide hydrochloride
  • Change to date of revision
  • Change to MA holder contact details
30 April 2015
New 0, Updated 20, Retired 1, [Total 21]
Active Ingredients: Clotrimazole
  • Improved electronic presentation
  • 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 5.1 - Pharmacodynamic properties
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • 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 5.1 - Pharmacodynamic properties
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • 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 5.1 - Pharmacodynamic properties
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
Active Ingredients: Alendronate Sodium Trihydrate
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to dosage and administration
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Simethicone, Loperamide Hydrochloride
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Ethinyloestradiol, Desogestrel
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Hydrochlorothiazide, Nebivolol hydrochloride
  • Change to side-effects
  • Change to drug interactions
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Hydrochlorothiazide, Nebivolol hydrochloride
  • 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: Gabapentin
  • Change to side-effects, Correction of spelling/typing errors
  • Change to side-effects
  • 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to further information section
SPC retired Ritalin LA Prolonged Release Capsules 20mg, 30mg and 40mg
Active Ingredients: Methylphenidate Hydrochloride
  • Joint SPC superseded by SPCs for individual presentations
Active Ingredients: Methylphenidate Hydrochloride
  • Change to warnings or special precautions for use, Addition of information on reporting a side effect.
Active Ingredients: sildenafil citrate
  • Change to date of revision, Introduction of new pack/pack size
Active Ingredients: Idelalisib
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Idelalisib
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text