Sandimmun 25mg Soft Capsules

  • Name:

    Sandimmun 25mg Soft Capsules

  • Company:
    info
  • Active Ingredients:

    Ciclosporin

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/01/19

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Summary of Product Characteristics last updated on medicines.ie: 9/8/2018

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Novartis Ireland Limited

Novartis Ireland Limited

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Medicine Name Atriance 5 mg/ml solution for infusion Active Ingredients Nelarabine
Medicine Name Azarga 10mg/ml + 5mg/ml eye drops, suspension Active Ingredients Brinzolamide, Timolol Maleate
Medicine Name Azopt 10mg/ml eye drops suspension Active Ingredients Brinzolamide
Medicine Name Cataflam 50 mg Coated Tablets Active Ingredients Diclofenac Potassium
Medicine Name Certican Tablets Active Ingredients Everolimus
Medicine Name CILOXAN 3 mg/ml ear drops, solution Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Co-Diovan 160 mg/12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 160mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 80mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Cosentyx 150 mg solution for injection in pre-filled pen Active Ingredients secukinumab
Medicine Name Desferal 500mg Vials Active Ingredients Desferrioxamine Mesylate
Medicine Name Diovan 160 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 320mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 3mg/ml Oral Solution Active Ingredients Valsartan
Medicine Name Diovan 40 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 80 mg film-coated tablets Active Ingredients Valsartan
Medicine Name DuoTrav Eye Drops Solution Active Ingredients Timolol Maleate, Travoprost
Medicine Name Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets Active Ingredients Sacubitril, Valsartan
Medicine Name Estradot Transdermal Patches Active Ingredients Estradiol Hemihydrate
Medicine Name Eucreas 50mg / 850mg and 50mg / 1000mg film-coated tablets Active Ingredients Metformin Hydrochloride, Vildagliptin
1 - 0 of 116 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 23 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 9 August 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 September 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 September 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 25 June 2015 SmPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 has been revised to update the sorbitol warning
Section 4.8 has been updated to include "pain of lower extremities" as an adverse event of unknown frequency.

Updated on 25 June 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 29 September 2014 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The entire SmPC has been revised after approval of Article 30 referral during which the text has been harmonised across all EU countries.

Updated on 24 September 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 8 January 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 23 November 2012 SmPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 has been updated to include paragraph about conversion between oral forms of ciclosporin.

Sections 4.4 and 4.8 have been updated to specifically describe PML and BK virus nephropathy in the general statement on infections in patients receiving immunosuppressive therapies.

Section 5.1 has beeen updated to include a sentence about the use of ciclosporing in liver transplant patients HCV+ and HCV-. 

Updated on 19 September 2012 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Numerous changes made to SmPC following licence renewal assessment by the IMB.

Updated on 17 April 2007 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 26 October 2006 SmPC

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to Section 4.1 (Therapeutic Indications), Section 4.2 (Posology and Method of Administration), Section 4.4 (Special Warnings and Precautions for Use), Section 4.5 (Interactions with other Medicaments and other forms of Interaction,) Section 4.6 (Pregnancy and Lactation), Section 4.9 (Overdose), Section 5.1(Pharmacodynamic Properties), Section 5.2 (Pharmacokinetic Properties) and, Section 5.3 (Preclinical Safety Data) following an update to the company core data sheet

Updated on 23 June 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 May 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie