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Document information 01/11/2014 05:59
Current documents
SPC 2404
PIL 1993
Total: 4397
Submissions in the last 3 months
Updated: 973
New: 73

 

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
31 October 2014
New 0, Updated 14, Retired 0, [Total 14]
  • Addition of information on reporting a side effect.
Active Ingredients: Potassium Chloride, Bendroflumethiazide
  • 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 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
  • Change to date of revision, Addition of information on reporting a side effect., Correction of spelling/typing errors
  • Change to date of revision, Addition of information on reporting a side effect., Correction of spelling/typing errors
  • 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 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Lamivudine
  • Change to date of revision, Addition of information on reporting a side effect., Correction of spelling/typing errors
Active Ingredients: Lamivudine
  • 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 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Econazole Nitrate
  • Change to side-effects
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Potassium Chloride, Bendroflumethiazide
  • 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 6.6 - Special precautions for disposal and other handling
Active Ingredients: Lixisenatide
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Cisatracurium Besilate
  • 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
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision, Addition of information on reporting a side effect.
30 October 2014
New 0, Updated 13, Retired 0, [Total 13]
  • 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 4.6 - 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 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: Doxazosin mesilate
  • Improved electronic presentation
Active Ingredients: Tenecteplase
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Tenecteplase
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Sterculia, Frangula
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to section 4.2 - Posology and method of administration
  • 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: Pantoprazole sodium sesquihydrate
  • Change to date of revision
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to section 4.2 - Posology and method of administration
  • 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: Pantoprazole sodium sesquihydrate
  • Change to date of revision
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to date of revision
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
29 October 2014
New 0, Updated 26, Retired 0, [Total 26]
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
Active Ingredients: Irbesartan
  • Change to warnings or special precautions for use
Active Ingredients: Irbesartan
  • Change to warnings or special precautions for use
Active Ingredients: Irbesartan
  • Change to warnings or special precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Hydrochlorothiazide, Irbesartan
  • Change to warnings or special precautions for use
Active Ingredients: Hydrochlorothiazide, Irbesartan
  • Change to warnings or special precautions for use
Active Ingredients: Hydrochlorothiazide, Irbesartan
  • Change to warnings or special precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
Active Ingredients: Acetylsalicylic Acid, Clopidogrel hydrogen sulphate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
Active Ingredients: Leuprorelin Acetate
  • Change to, or new use for medicine
Active Ingredients: Leuprorelin Acetate
  • Change to, or new use for medicine
Active Ingredients: Leuprorelin Acetate
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
Active Ingredients: Rasburicase
  • Change to marketing authorisation holder
Active Ingredients: Rasburicase
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Metformin Hydrochloride, Linagliptin
  • 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: Metformin Hydrochloride, Linagliptin
  • 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: Tenecteplase
  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Tenecteplase
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
Active Ingredients: Neomycin Sulphate, Chlorhexidine Dihydrochloride
  • Change to Section 4.8 – Undesirable effects - how to report a side effect, Correction of spelling/typing errors
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Active Ingredients: docetaxel trihydrate
  • Change to side-effects
Active Ingredients: docetaxel trihydrate
  • Change to side-effects
  • 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