We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Document information 22/02/2018 01:22
Current documents
SPC 2611
PIL 2175
Total: 4786
Submissions in the last 3 months
Updated: 917
New: 47

 

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.

Filter Results

Document Type:
PIL SPC
Status:  
New Update Retired
Wednesday, February 21, 2018
New 1, Updated 17, Retired 13, [Total 31]
  • Change to section 1 - Name of medicinal product
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
PIL retired Anusol Cream
Active Ingredients: Zinc Oxide, Bismuth Oxide, Balsam Peru
  • Product/Presentation not currently marketed
SPC retired Anusol Cream
Active Ingredients: Zinc Oxide, Bismuth Oxide, Balsam Peru
  • Presentation currently not marketed.
PIL retired Anusol HC Ointment
Active Ingredients: Zinc Oxide, Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Balsam Peru, Hydrocortisone Acetate
  • Product/Presentation not currently marketed
SPC retired Anusol HC Ointment
Active Ingredients: Zinc Oxide, Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Balsam Peru, Hydrocortisone Acetate
  • Presentation currently not marketed.
SPC retired Anusol HC Suppositories
Active Ingredients: Zinc Oxide, Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Balsam Peru, Hydrocortisone Acetate
  • Presentation currently not marketed.
PIL retired Anusol HC Suppositories
Active Ingredients: Zinc Oxide, Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Balsam Peru, Hydrocortisone Acetate
  • Product/Presentation not currently marketed
SPC retired Anusol Ointment
Active Ingredients: Zinc Oxide, Bismuth Oxide, Bismuth Subgallate, Balsam Peru
  • Presentation currently not marketed.
PIL retired Anusol Ointment
Active Ingredients: Zinc Oxide, Bismuth Oxide, Bismuth Subgallate, Balsam Peru
  • Product/Presentation not currently marketed
PIL retired Anusol Suppositories
Active Ingredients: Zinc Oxide, Bismuth Oxide, Bismuth Subgallate, Balsam Peru
  • Product/Presentation not currently marketed
SPC retired Anusol Suppositories
Active Ingredients: Zinc Oxide, Bismuth Oxide, Bismuth Subgallate, Balsam Peru
  • Presentation currently not marketed.
SPC retired Benylin Phlegm Cough Menthol
Active Ingredients: Guaifenesin
  • Presentation currently not marketed.
PIL retired Benylin Phlegm Cough Menthol
Active Ingredients: Guaifenesin
  • Product/Presentation not currently marketed
  • Correction of spelling/typing errors
  • New PIL for medicines.ie
Active Ingredients: Benzoyl Peroxide, Adapalene
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision, Correction of spelling/typing errors
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • 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 10 - Date of revision of the text
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
PIL retired Methotrexate 1 g/10 ml and 5 g/50 ml Injection
Active Ingredients: Methotrexate
  • Submitted in error
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Dexrazoxane hydrochloride
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Eculizumab
  • Correction of spelling/typing errors
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to section 10 - Date of revision of the text
  • Change to section 10 - Date of revision of the text
  • Change to section 1 - Name of medicinal product
  • 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 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • 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: Imiquimod
  • Change to section 2 - Qualitative and quantitative composition
  • 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
Tuesday, February 20, 2018
New 2, Updated 19, Retired 7, [Total 28]
Active Ingredients: Calcium Carbonate, Colecalciferol (Vitamin D3)
  • New SPC for medicines.ie
Active Ingredients: Paracetamol
  • Change to section 4.2 - Posology and method of administration
Active Ingredients: Ponatinib hydrochloride
  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
Active Ingredients: Ponatinib 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 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Active Ingredients: Alprostadil
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Active Ingredients: Lidocaine Hydrochloride, Ceftriaxone sodium
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Active Ingredients: Nalmefene hydrochloride dihydrate
  • 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, Removal of black triangle
Active Ingredients: Nalmefene hydrochloride dihydrate
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision, Removal of black triangle
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Change to section 6 - date of revision
SPC retired Stalevo 100 mg/25 mg/200 mg film-coated tablets
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Individual SPC superseded by joint SPC
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Change to section 6 - date of revision
SPC retired Stalevo 125 mg/31.25 mg/200 mg film-coated tablets
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Individual SPC superseded by joint SPC
SPC retired Stalevo 150 mg/37.5 mg/200 mg film-coated tablets
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Individual SPC superseded by joint SPC
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Change to section 6 - date of revision
SPC retired Stalevo 175 mg/43.75 mg/200 mg film-coated tablets
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Individual SPC superseded by joint SPC
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Change to section 6 - date of revision
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Change to section 6 - date of revision
SPC retired Stalevo 200 mg/50 mg/200 mg film-coated tablets
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Individual SPC superseded by joint SPC
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Change to section 6 - date of revision
SPC retired Stalevo 50 mg/12.5 mg/200 mg film-coated tablets
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Individual SPC superseded by joint SPC
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Change to section 6 - date of revision
SPC retired Stalevo 75mg/18.75mg/200 mg film-coated tablets
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Individual SPC superseded by joint SPC
Active Ingredients: Entacapone, Levodopa, Carbidopa
  • Addition of joint SPC covering all presentations
Active Ingredients: Epoprostenol Sodium
  • Change to section 6 - manufacturer
  • 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 5.2 - Pharmacokinetic properties
Monday, February 19, 2018
New 1, Updated 19, Retired 0, [Total 20]
Active Ingredients: Methylphenidate Hydrochloride
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision, Correction of spelling/typing errors
Active Ingredients: Methylphenidate Hydrochloride
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Methylphenidate Hydrochloride
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision, Correction of spelling/typing errors
Active Ingredients: Methylphenidate Hydrochloride
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Methylphenidate Hydrochloride
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ulipristal acetate
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ulipristal acetate
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
Active Ingredients: Perindopril arginine, Atorvastatin calcium trihydrate
  • New SPC for new product
Active Ingredients: Pramipexole dihydrochloride monohydrate
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Active Ingredients: Pramipexole dihydrochloride monohydrate
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
Active Ingredients: Pantoprazole sodium sesquihydrate
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - driving and using machines
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Lisdexamfetamine dimesylate
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Lisdexamfetamine dimesylate
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - interactions with other medicines, food or drink