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Document information 23/11/2017 18:48
Current documents
SPC 2630
PIL 2189
Total: 4819
Submissions in the last 3 months
Updated: 791
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
23 November 2017
New 2, Updated 14, Retired 7, [Total 23]
SPC retired Actonel 30mg film coated tablets
Active Ingredients: Risedronate Sodium
  • Retired from medicines.ie
SPC retired Actonel Combi film-coated tablets
Active Ingredients: Calcium Carbonate, Risedronate Sodium
  • Retired from medicines.ie
SPC retired Actonel Plus Ca & D Film-Coated Tablets & Effervescent Granules
Active Ingredients: Calcium Carbonate, Risedronate Sodium, Colecalciferol (Vitamin D3)
  • Retired from medicines.ie
  • Change to section 1 - what the product is used for
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to section 1 - what the product is used for
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • 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 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision, Correction of spelling/typing errors, Improved presentation of PIL
  • 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 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision, Correction of spelling/typing errors, Improved presentation of PIL
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
SPC retired Didronel 200mg Tablets
Active Ingredients: Etidronate Disodium
  • Retired from medicines.ie
PIL retired Didronel PMO
Active Ingredients: Etidronate Disodium
  • Retired from medicines.ie
SPC retired Didronel PMO
Active Ingredients: Etidronate Disodium
  • Retired from medicines.ie
Active Ingredients: Dasabuvir sodium monohydrate
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
SPC retired Intrinsa 300 micrograms/24 hours transdermal patch
Active Ingredients: Testosterone
  • Retired from medicines.ie
Active Ingredients: Carfilzomib
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Carfilzomib
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
Active Ingredients: Piperacillin sodium , Tazobactam sodium
Company: Hospira UK Ltd
  • New SPC for medicines.ie
Active Ingredients: Piperacillin sodium , Tazobactam sodium
Company: Hospira UK Ltd
  • New SPC for medicines.ie
  • 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 - excipient warnings
  • Change to section 6 - date of revision
Active Ingredients: Acetylsalicylic Acid, Ramipril, Atorvastatin calcium trihydrate
  • Change to other sources of information section
Active Ingredients: Ritonavir, Ombitasvir, Paritaprevir
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Active Ingredients: Sodium oxybate
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • 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
22 November 2017
New 1, Updated 16, Retired 16, [Total 33]
Active Ingredients: Glimepiride
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 10 - Date of revision of the text
Active Ingredients: Glimepiride
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 10 - Date of revision of the text
Active Ingredients: Botulinum Toxin Type A
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
PIL retired Bisodol Antacid chewable Tablets
Active Ingredients: Calcium Carbonate, Sodium Hydrogen Carbonate, Light Magnesium Carbonate
  • Retired from medicines.ie
SPC retired Bisodol Antacid Chewable Tablets
Active Ingredients: Calcium Carbonate, Sodium Hydrogen Carbonate, Light Magnesium Carbonate
  • Retired from medicines.ie
PIL retired Bisodol Extra Strong Mint Tablets
Active Ingredients: Calcium Carbonate, Sodium Hydrogen Carbonate, Magnesium Carbonate
  • Retired from medicines.ie
SPC retired Bisodol Extra Strong Mint Tablets
Active Ingredients: Calcium Carbonate, Sodium Hydrogen Carbonate, Light Magnesium Carbonate
  • Retired from medicines.ie
Active Ingredients: Bumetanide
  • Change to section 2 - use in children and adolescents
  • Change to section 6 - date of revision, Joint PIL superseded by individual PILs
Active Ingredients: Bumetanide
Company: LEO Pharma
  • New individual PIL (was previously included in a combined PIL)
SPC retired Colobreathe
Active Ingredients: Colistimethate Sodium
  • Retired from medicines.ie
PIL retired Colobreathe
Active Ingredients: Colistimethate Sodium
  • Retired from medicines.ie
SPC retired Colomycin Injection
Active Ingredients: Colistimethate Sodium
  • Retired from medicines.ie
PIL retired Colomycin Injection
Active Ingredients: Colistimethate Sodium
  • Retired from medicines.ie
PIL retired Effico Tonic
Active Ingredients: Caffeine, Nicotinamide, Thiamine Hydrochloride (Vitamin B1), Compound Gentian Infusion
  • Retired from medicines.ie
SPC retired Exorex Lotion
Active Ingredients: Coal Tar Solution
  • Retired from medicines.ie
PIL retired Exorex Lotion
Active Ingredients: Coal Tar Solution
  • Retired from medicines.ie
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
SPC retired Infacol
Active Ingredients: Simethicone
  • Retired from medicines.ie
PIL retired Infacol
Active Ingredients: Simethicone
  • Retired from medicines.ie
Active Ingredients: pregabalin
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Improved presentation of PIL
Active Ingredients: Botulinum Toxin Type B
  • Change to section 6 - date of revision
  • Change to MA holder contact details, Improved presentation of PIL
Active Ingredients: Ziconotide acetate
  • Change to section 6 - date of revision
  • Change to MA holder contact details, Improved presentation of PIL
Active Ingredients: Betahistine dihydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Active Ingredients: Betahistine dihydrochloride
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Active Ingredients: Zolpidem tartrate
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
SPC retired Sudocrem Antiseptic Healing Cream
Active Ingredients: Zinc Oxide, Benzyl Benzoate, Benzyl Alcohol, Benzyl Cinnamate, wool fat
  • Retired from medicines.ie
Active Ingredients: Budesonide, Formoterol fumarate 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
Active Ingredients: Budesonide, Formoterol fumarate 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
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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
SPC retired Veno's Expectorant
Active Ingredients: Guaifenesin, Liquid Glucose, Treacle
  • Retired from medicines.ie
SPC retired Veno's Honey and Lemon
Active Ingredients: Ammonium Chloride, Ipecacuanha Liquid Extract, Liquid Glucose, Honey, Lemon Juice
  • Retired from medicines.ie
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
21 November 2017
New 4, Updated 20, Retired 0, [Total 24]
Active Ingredients: Glimepiride
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Botulinum Toxin Type A
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Bumetanide
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Bumetanide
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Dasabuvir sodium monohydrate
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to section 1 - Name of medicinal product
  • 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 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
Active Ingredients: Telmisartan
  • Change to section 2 - what you need to know - warnings and precautions
  • 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 - date of revision
  • Change to other sources of information section
  • Change to MA holder contact details, Correction of spelling/typing errors, Improved presentation of PIL
Active Ingredients: Telmisartan
  • Change to section 2 - what you need to know - warnings and precautions
  • 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 - date of revision
  • Change to other sources of information section
  • Change to MA holder contact details, Correction of spelling/typing errors, Improved presentation of PIL
Active Ingredients: Telmisartan
  • Change to section 2 - what you need to know - warnings and precautions
  • 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 - date of revision
  • Change to other sources of information section
  • Change to MA holder contact details, Correction of spelling/typing errors, Improved presentation of PIL
  • 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 5.2 - Pharmacokinetic properties
Active Ingredients: Piperacillin sodium , Tazobactam sodium
Company: Hospira UK Ltd
  • New PIL for medicines.ie
Active Ingredients: Piperacillin sodium , Tazobactam sodium
Company: Hospira UK Ltd
  • New PIL for medicines.ie
Active Ingredients: Budesonide, Formoterol fumarate 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
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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
Active Ingredients: Guselkumab
  • New SPC for new product
Active Ingredients: Guselkumab
  • New PIL for new product
  • Change to section 3 - how to take/use
Active Ingredients: Insulin degludec
  • Change to section 3 - how to take/use
Active Ingredients: Paracetamol, Codeine Phosphate Hemihydrate
  • 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 4.5 - 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Paracetamol, Codeine Phosphate Hemihydrate
  • 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 4.4 - 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Active Ingredients: Ritonavir, Ombitasvir, Paritaprevir
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
Active Ingredients: Abiraterone Acetate
  • 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 10 - Date of revision of the text