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Document information 22/05/2017 16:36
Current documents
SPC 2615
PIL 2158
Total: 4773
Submissions in the last 3 months
Updated: 954
New: 62

 

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
22 May 2017
New 0, Updated 26, Retired 5, [Total 31]
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.2 - Posology and method of administration
Active Ingredients: Hydrocortisone Acetate
  • 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
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
Active Ingredients: Ispaghula Husk, Mebeverine Hydochloride
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
Active Ingredients: human papillomavirus vaccine
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • 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 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: ropinirole hydrochloride
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: ropinirole hydrochloride
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: ropinirole hydrochloride
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: ropinirole hydrochloride
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zidovudine
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Active Ingredients: Amylmetacresol, 2, 4-Dichlorobenzyl alcohol
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Amylmetacresol, Dichlorobenzyl alcohol
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Amylmetacresol, 2, 4-Dichlorobenzyl alcohol
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Vitamin C, Amylmetacresol, 2, 4-Dichlorobenzyl alcohol
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Amylmetacresol, 2, 4-Dichlorobenzyl alcohol
  • Change to section 5.1 - Pharmacodynamic properties
Active Ingredients: Amylmetacresol, 2, 4-Dichlorobenzyl alcohol
  • Change to section 5.1 - Pharmacodynamic properties
PIL retired Tegretol Suppositories
Active Ingredients: Carbamazepine
  • Transfer of Marketing Authorisation licence
SPC retired Tegretol Suppositories 125 mg
Active Ingredients: Carbamazepine
  • Transfer of marketing authorisation holder
SPC retired Tegretol Suppositories 250 mg
Active Ingredients: Carbamazepine
  • Transfer of marketing authorisation holder
SPC retired Xenical 120mg Hard Capsules
Active Ingredients: Orlistat
  • Transfer of marketing authorisation holder
PIL retired Xenical 120mg Hard Capsules
Active Ingredients: Orlistat
  • Transfer of Marketing Authorisation licence
Active Ingredients: Lisinopril dihydrate
  • 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 10 - Date of revision of the text
19 May 2017
New 0, Updated 11, Retired 1, [Total 12]
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision
Active Ingredients: Budesonide
  • 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 2 - what you need to know - warnings and precautions
  • Change to information for healthcare professionals
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to information for healthcare professionals
Active Ingredients: Human Normal Immunoglobulin
  • Change to section 6.4 - Special precautions for storage
Active Ingredients: Brinzolamide, brimonidine tartrate
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
SPC retired Tresiba 200 units/mL Pre-filled Pen (FlexTouch)
Active Ingredients: Insulin degludec
  • Individual SPC superseded by joint SPC
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
Active Ingredients: Insulin degludec
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
18 May 2017
New 0, Updated 22, Retired 4, [Total 26]
Active Ingredients: Budesonide
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • 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
PIL retired Diflucan 10 mg/ml & 40 mg/ml powder for oral suspension
Active Ingredients: Fluconazole
  • Submitted in error
PIL retired Diflucan 2mg/ml Solution for Infusion
Active Ingredients: Fluconazole
  • Submitted in error
PIL retired Diflucan 50mg, 200mg Capsules
Active Ingredients: Fluconazole
  • Submitted in error
PIL retired DIFLUCAN CAPSULES 150MG
Active Ingredients: Fluconazole
  • Submitted in error
  • 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: Betamethasone dipropionate, Calcipotriol monohydrate
  • Correction of spelling/typing errors
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
Active Ingredients: Apraclonidine Hydrochloride
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
Active Ingredients: Apraclonidine Hydrochloride
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 4 - possible side effects
  • Change to section 4 - possible side effects
Active Ingredients: Human Normal Immunoglobulin
  • Change to section 5 - how to store or dispose
  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • 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 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • 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 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
Active Ingredients: Tiotropium bromide monohydrate
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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 first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision, Improved presentation of PIL
  • Change to section 6 - manufacturer
Active Ingredients: Rivaroxaban
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Rivaroxaban
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Rivaroxaban
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Active Ingredients: Lisinopril dihydrate
  • 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 6 - marketing authorisation holder
  • Change to section 6 - date of revision