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Document information 23/11/2014 15:49
Current documents
SPC 2403
PIL 1990
Total: 4393
Submissions in the last 3 months
Updated: 987
New: 63

 

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
21 November 2014
New 1, Updated 17, Retired 1, [Total 19]
  • Change to side-effects
  • Change to side-effects
Active Ingredients: Reboxetine
  • Change to side-effects
  • Change to date of revision
Active Ingredients: sitagliptin phosphate monohydrate
  • Change to section 4.4 - Special warnings and precautions for use
Active Ingredients: Ethinyloestradiol, Gestodene
  • Change to appearance of the medicine
  • Change to name of manufacturer, Correction of spelling/typing errors
Active Ingredients: Pramipexole dihydrochloride monohydrate
  • Change to date of revision
  • Change to MA holder contact details, Addition of information on reporting a side effect.
  • 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
  • Change of contraindications, Addition of information on reporting a side effect.
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to side-effects
  • Change to date of revision, Correction of spelling/typing errors
  • Change to side-effects
  • Change to date of revision, Correction of spelling/typing errors
  • Change to side-effects
  • Change to date of revision, Correction of spelling/typing errors
  • Change to side-effects
  • Change to date of revision, Correction of spelling/typing errors
Active Ingredients: Lenalidomide
  • Addition of separate PILs covering individual presentations
Active Ingredients: Lenalidomide
Company: Celgene Ltd
  • New individual PIL (was previously included in a combined PIL)
  • Change to side-effects
  • Change to date of revision
PIL retired Tritace 10mg Tablets
Active Ingredients: Ramipril
Company: SANOFI
  • Individual presentations superseded by joint PIL
Active Ingredients: Ramipril
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to further information section
20 November 2014
New 0, Updated 19, Retired 0, [Total 19]
Active Ingredients: Risedronate Sodium
  • Change of active ingredient
  • Change to date of revision
Active Ingredients: Risedronate Sodium
  • Change of active ingredient
  • Change to date of revision
Active Ingredients: Calcium Carbonate, Risedronate Sodium
  • Change of active ingredient
  • Change to date of revision
  • Change of active ingredient
  • Change to date of revision
Active Ingredients: Calcium Carbonate, Risedronate Sodium, Colecalciferol (Vitamin D3)
  • Change of active ingredient
  • Change to date of revision
Active Ingredients: Anastrozole
  • Change to section 3 - Pharmaceutical form
  • 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: Calcium Carbonate, Sodium Hydrogen Carbonate, Light Magnesium Carbonate
  • 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 10 - Date of revision of the text
Active Ingredients: Calcium Carbonate
  • Change to further information section
Active Ingredients: Calcium Carbonate, Colecalciferol (Vitamin D3)
  • Change to further information section
  • 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 10 - Date of revision of the text
Active Ingredients: Azilsartan medoxomil potassium
  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details, Addition of information on reporting a side effect.
Active Ingredients: Corifollitropin Alfa
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
Active Ingredients: sitagliptin phosphate monohydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
Active Ingredients: sitagliptin phosphate monohydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
Active Ingredients: sitagliptin phosphate monohydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
Active Ingredients: 90% Omega-3 acid ethyl esters
  • Change of inactive ingredient, Addition of information on reporting a side effect.
  • Change to date of revision
  • Change to dosage and administration
  • Change to MA holder contact details
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change to side-effects, Correction of spelling/typing errors
Active Ingredients: Cetirizine Dihydrochloride
  • Change to section 4.2 - Posology and method of administration
19 November 2014
New 1, Updated 10, Retired 0, [Total 11]
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
Active Ingredients: Diclofenac Sodium
  • Change to dosage and administration
  • Change to side-effects
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Change to side-effects
  • Change to dosage and administration
  • Change to improve clarity and readability
Active Ingredients: Gentamicin Sulphate, Hydrocortisone Acetate
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Active Ingredients: Sofosbuvir, Ledipasvir
  • New PIL for new product, New PIL for medicines.ie
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Filgrastim
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Filgrastim
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Felodipine, Ramipril
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Active Ingredients: Cyclizine lactate
  • Change to section 1 - Name of medicinal product
  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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 6.3 - 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text