Salofalk 4g/60ml Enema

  • Name:

    Salofalk 4g/60ml Enema

  • Company:
    info
  • Active Ingredients:

    Mesalazine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/11/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 6/11/2019

Click on this link to Download PDF directly

DR. FALK PHARMA GMBH

Company Products

Medicine NameActive Ingredients
Medicine Name Budenofalk 2mg/dose rectal foam Active Ingredients Budesonide
Medicine Name Budenofalk 3mg gastro-resistant capsules Active Ingredients Budesonide
Medicine Name Budenofalk 9mg gastro-resistant granules Active Ingredients Budesonide
Medicine Name Salofalk 1.5g gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Salofalk 1000mg gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Salofalk 1g Suppositories Active Ingredients Mesalazine
Medicine Name Salofalk 1g/Actuation Rectal Foam Active Ingredients Mesalazine
Medicine Name Salofalk 250mg gastro-resistant tablets Active Ingredients Mesalazine
Medicine Name Salofalk 250mg Suppositories Active Ingredients Mesalazine
Medicine Name Salofalk 3g Gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Salofalk 4g/60ml Enema Active Ingredients Mesalazine
Medicine Name Salofalk 500mg gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Ursofalk 250mg Hard Capsules Active Ingredients Ursodeoxycholic Acid
Medicine Name Ursofalk 250mg/5ml Suspension Active Ingredients Ursodeoxycholic Acid
Medicine Name Ursofalk 500mg film-coated tablets Active Ingredients Ursodeoxycholic Acid
1 - 0 of 15 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 6 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Warning and possible adr relating to nephrolithiasis

Updated on 6 November 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Warning and possible adr relating to nephrolithiasis

Updated on 1 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 1 December 2017 SmPC

Reasons for updating

  • 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

Addition of side effect according to PRAC recommendations

Updated on 29 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 November 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 6 July 2017 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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

Changed to No special store conditions needed. $0$0$0$0$0$0

Updated on 23 June 2017 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 3 June 2015 SmPC

Reasons for updating

  • 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 4.5 - 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 - how to report a side effect
  • 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

All QRD template updates or minor admin, spelling, corrections/changes

Updated on 29 May 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 7 August 2013 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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

Store condition changed from store below 25C to store below 30C.

Updated on 2 August 2013 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 7 March 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

4.3 Contraindications - removed contraindications relating to ulcers and haemorrhagic diathesis
4.5 Interactions - removed majority of contraindications.  Added contraindications relating to thioguanine and warfarin.
4.8 Undesirable effects - added effects under "cardiac disorders", Respiratory, thoracic and mediastinal disorders" and "gastrointestinal disorders"
4.9 Overdose - new advice
10  Approved Feb 2012

Updated on 5 March 2012 PIL

Reasons for updating

  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 1 August 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change due to user-testing of patient information

Updated on 18 May 2011 SmPC

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

This SmPC has been updated in full to be in line with more up-to-date information available for the recently approved 1g Suppository.

Updated on 12 May 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4 - Clinical particulars
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 1:  Added ‘4g/60ml’ to name and throughout corrected ‘4g/60g’ to ‘4g/60ml’.

Section 2:  Added ‘60g= 60ml’; added ‘Excipients:  Sodium Benzoate and Potassium metabisulphite’

Section 3:  Added ‘Enema’ to the form
Section 4.8:  Added peripheral neuropathy and reversible oligospermia

Section 5.3:  Added standard text:  Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Section 6.1:  Corrected Sodium bisulphate to Sodium metabisulphite

Section 6.6:  Added ‘shake well before use’

Section 10:  Changed to April 2010

Updated on 6 May 2010 PIL

Reasons for updating

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

Updated on 26 July 2007 SmPC

Reasons for updating

  • 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

Addition of cholestatic hepatitis to section 4.8.

Updated on 14 November 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 October 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

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