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Document information 28/08/2015 13:42
Current documents
SPC 2506
PIL 2034
Total: 4540
Submissions in the last 3 months
Updated: 1529
New: 93

 

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
28 August 2015
New 0, Updated 4, Retired 0, [Total 4]
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects
  • Change to further information section
  • Change to date of revision, Correction of spelling/typing errors
Active Ingredients: Podophyllotoxin
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability, Addition of information on reporting a side effect.
27 August 2015
New 0, Updated 24, Retired 4, [Total 28]
Active Ingredients: Tadalafil
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision, Addition of information on reporting a side effect.
PIL retired Affex Capsules 20mg
Active Ingredients: fluoxetine hydrochloride
  • PIL - Product no longer marketed in Ireland
SPC retired Affex Capsules 20mg
Active Ingredients: fluoxetine hydrochloride
  • Product no longer marketed in Ireland
Active Ingredients: Donepezil Hydrochloride
  • Change to further information section
Active Ingredients: Mupirocin calcium
  • Change of trade or active ingredient name
  • Change to date of revision
Active Ingredients: Mupirocin calcium
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision, Addition of information on reporting a side effect.
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • Change to appearance of the medicine, Addition of information on reporting a side effect.
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision, Addition of information on reporting a side effect.
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Hydrochlorothiazide, Valsartan
  • 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 4.5 - 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 5.1 - Pharmacodynamic properties
Active Ingredients: Hydrochlorothiazide, Valsartan
  • 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 4.5 - 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 5.1 - Pharmacodynamic properties
Active Ingredients: duloxetine hydrochloride
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
SPC retired Difene Ampoules 75mg/3ml
Active Ingredients: Diclofenac Sodium
  • Product no longer marketed in Ireland
PIL retired Difene Ampoules 75mg/3ml
Active Ingredients: Diclofenac Sodium
  • PIL - Product no longer marketed in Ireland
  • Change to side-effects
  • Change to side-effects
Active Ingredients: Memantine hydrochloride
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
Active Ingredients: Carbocisteine
  • Change to side-effects
  • Change to date of revision, Addition of information on reporting a side effect.
  • Change to further information section
  • Change to date of revision
Active Ingredients: Hydrocortisone, Framycetin Sulphate, Cinchocaine hydrochloride, Aesculin
  • Addition of manufacturer, Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
Active Ingredients: Sofosbuvir
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Active Ingredients: duloxetine hydrochloride
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Addition of manufacturer
26 August 2015
New 1, Updated 13, Retired 0, [Total 14]
Active Ingredients: Paclitaxel Albumin
  • Change to section 4.2 - Posology and method of administration
Active Ingredients: Valsartan, Hydrochlorothiazide
  • 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 4.5 - 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 5.1 - Pharmacodynamic properties
Active Ingredients: Hydrochlorothiazide, Valsartan
  • 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 4.5 - 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 5.1 - Pharmacodynamic properties
Active Ingredients: Hydrochlorothiazide, Valsartan
  • 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 4.5 - 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 5.1 - Pharmacodynamic properties
Active Ingredients: Betamethasone dipropionate, Calcipotriol monohydrate
Company: LEO Pharma
  • New PIL for medicines.ie
  • Change to side-effects
  • Change to date of revision, Addition of information on reporting a side effect.
Active Ingredients: Canagliflozin hemihydrate
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Canagliflozin hemihydrate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Canagliflozin hemihydrate
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Active Ingredients: Clarithromycin
  • Change to separate SPCs covering individual presentations
Active Ingredients: Saxagliptin hydrochloride , Metformin Hydrochloride
  • Change to side-effects
  • Change to date of revision
Active Ingredients: Metformin Hydrochloride, Saxagliptin hydrochloride
  • Change to side-effects
  • Change to date of revision
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Changes to therapeutic indications
  • Change of special precautions for disposal
  • Change to section 4.1 - Therapeutic indications
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text