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Document information 19/12/2014 20:13
Current documents
SPC 2423
PIL 1990
Total: 4413
Submissions in the last 3 months
Updated: 990
New: 67

 

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
19 December 2014
New 0, Updated 20, Retired 0, [Total 20]
Active Ingredients: Amikacin Sulphate
  • Change to date of revision, Addition of information on reporting a side effect.
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision, Improved electronic presentation
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Valproic Acid, Sodium Valproate
  • 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 10 - Date of revision of the text
Active Ingredients: Valproic Acid, Sodium Valproate
  • 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 10 - Date of revision of the text
Active Ingredients: Telaprevir
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 section 4.6 - Pregnancy and lactation
Active Ingredients: Methoxy polyethylene glycol-epoetin beta
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Ketoconazole
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
Active Ingredients: Ketoconazole
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ketoconazole
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Active Ingredients: Romiplostim
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Alfacalcidol
  • Correction of spelling/typing errors
  • 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
Active Ingredients: Testosterone undecanoate
  • 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: Zolpidem tartrate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Addition of information on reporting a side effect.
Active Ingredients: Mebendazole
  • Addition of information on reporting a side effect.
18 December 2014
New 0, Updated 25, Retired 0, [Total 25]
Active Ingredients: Lorazepam
  • Change of manufacturer
  • Change to date of revision
Active Ingredients: Levobunolol hydrochloride
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Sodium Valproate
  • 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 10 - Date of revision of the text
Active Ingredients: Valproic Acid, Sodium Valproate
  • 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 10 - Date of revision of the text
Active Ingredients: Ofloxacin
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Active Ingredients: Frovatriptan succinate monohydrate
  • Change of contraindications
  • Change to storage instructions, Addition of information on reporting a side effect.
Active Ingredients: Telaprevir
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Paracetamol, Tramadol Hydrochloride
  • 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 10 - Date of revision of the text
Active Ingredients: Paracetamol, Tramadol Hydrochloride
  • Change to side-effects
Active Ingredients: Paracetamol, Tramadol Hydrochloride
  • 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 10 - Date of revision of the text
Active Ingredients: Paracetamol, Tramadol Hydrochloride
  • Change to side-effects
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • 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 section 10 - Date of revision of the text
Active Ingredients: No Active Ingredients
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 section 10 - Date of revision of the text
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Hydrochlorothiazide, olmesartan medoxomil
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Hydrochlorothiazide, olmesartan medoxomil
  • 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 section 10 - Date of revision of the text
Active Ingredients: Hydrochlorothiazide, olmesartan medoxomil
  • 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 section 10 - Date of revision of the text
Active Ingredients: Hydrochlorothiazide, olmesartan medoxomil
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
Active Ingredients: Testosterone undecanoate
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change due to harmonisation of PIL
Active Ingredients: Hydrocortisone sodium succinate
  • 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 5.3 - Preclinical safety data
Active Ingredients: Tiotropium bromide monohydrate
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
17 December 2014
New 1, Updated 26, Retired 1, [Total 28]
  • 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
Active Ingredients: Spironolactone
  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to, or new use for medicine
  • Change to date of revision
PIL retired Condyline Cutaneous Solution 0.5 % w/v
Active Ingredients: Podophyllotoxin
  • PIL Submitted in error
Active Ingredients: White Soft Paraffin, Light Liquid Paraffin, Anhydrous Lanolin
  • Change to section 4.2 - Posology and method of administration
Active Ingredients: Ertapenem
  • Change to side-effects
  • Change to information about pregnancy or lactation
Active Ingredients: Granisetron hydrochloride
  • 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 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: Granisetron hydrochloride
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Granisetron hydrochloride
  • 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 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: Granisetron hydrochloride
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: No Active Ingredients
  • Change to side-effects
Active Ingredients: Terbinafine hydrochloride
  • Change of manufacturer
  • Change to date of revision
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
Active Ingredients: Pyridostigmine Bromide
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • New individual SPC (was previously included in combined SPC)
  • Discontinuation of one or more strengths, Correction of spelling/typing errors
  • Discontinuation of one or more strengths, Correction of spelling/typing errors
Active Ingredients: Ketoconazole
  • Change to date of revision
  • Change to dosage and administration
Active Ingredients: Ketoconazole
  • Change to dosage and administration
Active Ingredients: Ketoconazole
  • Change to date of revision
  • Change to dosage and administration
Active Ingredients: Propantheline bromide
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Active Ingredients: Bedaquiline fumarate
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Potassium Chloride
  • Change to packaging
Active Ingredients: Dextran70, Hypromellose
  • 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 warnings or special precautions for use