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Document information 01/09/2014 12:11
Current documents
SPC 2388
PIL 1988
Total: 4376
Submissions in the last 3 months
Updated: 997
New: 58

 

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
01 September 2014
New 1, Updated 7, Retired 0, [Total 8]
Active Ingredients: Ibuprofen, Pseudoephedrine Hydrochloride
  • 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 5.3 - Preclinical safety data
  • Change to packaging
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications, Correction of spelling/typing errors
Active Ingredients: Sodium Fusidate
  • Change to side-effects
Active Ingredients: Fusidic Acid
  • Change to side-effects
Active Ingredients: verapamil hydrochloride
  • Addition of joint PIL covering all presentations
  • New PIL for new product
Active Ingredients: Mercaptopurine
Company: Aspen | Document History
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Change to product name
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
31 August 2014
New 0, Updated 1, Retired 0, [Total 1]
Active Ingredients: Hydrochlorothiazide, olmesartan medoxomil
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation
29 August 2014
New 2, Updated 7, Retired 2, [Total 11]
PIL retired Cetrotide 3 mg
Active Ingredients: cetrorelix acetate
Company: Merck Serono
  • PIL product / presentation discontinued
SPC retired Cetrotide 3 mg
Active Ingredients: cetrorelix acetate
Company: Merck Serono
  • SPC Product / presentation discontinued
Active Ingredients: Empagliflozin
  • New SPC for new product
Active Ingredients: Empagliflozin
  • New SPC for new product
Active Ingredients: Oxybutynin Hydrochloride
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
Active Ingredients: Meningococcal Group A, C, W135 and Y conjugate vaccine
  • Change to date of revision, Correction of spelling/typing errors
Active Ingredients: Ivabradine hydrochloride
  • Change to side-effects
  • 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 4.5 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • 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 4.5 - 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 - 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 10 - Date of revision of the text
Active Ingredients: Cobicistat
  • 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: Idarubicin Hydrochloride
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect