Keral 25mg Film-Coated Tablets *

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 04 June 2021

File name

ie-spc Keral 25mg Tabs Sodium Warning Approved May 21_1622817003.pdf

Reasons for updating

  • 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

Section 4.4 Excipient warning typo corrected from previous version  

Updated on 25 May 2021

File name

ie-spc Keral 25mg Tabs Sodium Warning Approved May 21_1621971258.pdf

Reasons for updating

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

Section 4.4 - Sodium Excipient content warnings added

Section 4.8 - HPRA reporting details updated

Section 10 - Date of revision updated 

Updated on 25 May 2021

File name

ie-leaflet Keral 25mg Tabs Sodium Warning Clean Approved May 21_1621971147.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Change to Section 2 - Sodium Excipient Warning added

Change to Section 4 - HPRA reporting details updated

Change to other sources of information - Added United Kingdom (Northern Ireland)

Change to Section 6 - Date of revision updated

Updated on 05 September 2019

File name

ie-leaflet Keral 25mg clean 22-8-19_1567692405.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Free text change information supplied by the pharmaceutical company

Addition of new blister packaging with no special storage conditions.

Updated on 05 September 2019

File name

ie-spc Keral 25 mg tabs clean 22-8-19_1567692168.pdf

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Addition of new blister packaging with a 3 year shelf life and no special storage conditions.

Updated on 01 August 2019

File name

ie-leaflet Keral 25mg clean 10-4-18.pdf

Reasons for updating

  • XPIL Created

Updated on 01 August 2019

File name

ie-spc_Keral_25_mg_tabs_clean_10-4-18_1564670738.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

File format updated to pdf

Updated on 17 May 2018

File name

ie-spc_Keral_25_mg_tabs_clean_10-4-18.docx

Reasons for updating

  • 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
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Update to the SmPC to align to the current QRD template.

Also to update section 4.5 Interactions including updated warning for mifepristone.  Tenofovir, deferasirox and pemetrexed added.

Updated on 13 May 2018

File name

ie-leaflet Keral 25mg clean 10-4-18.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 19 May 2015

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 4.4 - Special warnings and precautions for use
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

The main changes are to update the SmPC as follows:
4.2.       Posology and method of administration
Renal dysfunction: Mild renal dysfunction has changed from "creatinine clearance 50-80 ml/min" to "creatinine clearance 60-89 ml/min"
Moderate to severe renal dysfunction has changed from "creatinine clearance <50 ml/min" to "creatinine clearance <59 ml/min"

4.3.       Contraindications

The following contraindications have been added:
- known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates
- patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)"
The contraindication in case of history of gastrointestinal ulceration/bleeding is now better specified as "patient with active peptic ulcer/gastrointestinal haemorrhage, or any history of gastrointestinal bleeding, ulceration or perforation";
The levels of severe renal dysfunction have been better specified:
-patients with moderate to severe renal dysfunction is now specified as "creatinine clearance <59ml/min)"

4.4 Special warnings and precautions for use

The paragraph has been organized in sub sections (Gastrointestinal safety, Renal Safety, Liver safety, Cardiovascular and cerebrovascular safety,Skin reactions, Other information; Paediatric population) where the information already present in the previous SmPC have been reported. 
The following information has been added:
Renal Safety
Adequate fluid intake should be ensured during treatment to prevent dehydration and possibly associated increased renal toxicity.
Older patients are more likely to be suffering from impaired renal function (see section 4.2).
Other information
Particular caution is required in patients with:
- congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria)
- dehydration
- directly after major surgery
If the physician considers long-term dexketoprofen therapy to be necessary, hepatic and renal function and the bloodcount should be regularly checked.
Severe acute hypersensitivity reactions (anaphylactic shock, for example) have been observed on very rare occasions. Treatment must be discontinued at the first signs of severe hypersensitivity reactions following intake of Keral. Depending on the symptoms, any medically required procedures must be initiated by specialist healthcare professionals.
Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicinal product can cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3).
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of Keral in case of varicella.
KERAL should be administered with caution to patients suffering from haematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disease.
As other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases.

Updated on 19 May 2015

Reasons for updating

  • New SPC for new product

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

Updated on 19 May 2015

File name

PIL_7912_889.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 May 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 12 August 2011

Reasons for updating

  • 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 10 - Date of revision of the text
  • Change to improve clarity and readability
  • Section 4.5 Interactions: information regarding interaction with aminoglycosides has been included.
  • Section 4.8 Undesirable effects: hepatitis, laryngeal oedema and acute renal failure have been included; hepatocellular damage and angioneurotic oedema have been replaced by hepatocellular injury and angioedema, respectively.
  • Minor discrepancies between the SmPC of the film-coated tablets and the solution for injection have been amended.

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

Free text change information supplied by the pharmaceutical company


  • Section 4.5 Interactions: information regarding interaction with aminoglycosides has been included.
  • Section 4.8 Undesirable effects: hepatitis, laryngeal oedema and acute renal failure have been included; hepatocellular damage and angioneurotic oedema have been replaced by hepatocellular injury and angioedema, respectively.
  • Minor discrepancies between the SmPC of the film-coated tablets and the solution for injection have been amended.

Updated on 09 August 2011

Reasons for updating

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

Updated on 28 September 2009

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 18 November 2008

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 12 July 2007

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

The SmPC changes are to update the cardiovascular, gastrointestinal, skin and fertility warnings.
 Sections 4.2, 4.4, 4.5, 4.8 & 10 have been updated.   

Updated on 12 July 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 20 March 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • 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

The changes have been made following licence renewal.

Updated on 20 March 2007

Reasons for updating

  • Change of active ingredient
  • Change to packaging
  • Change of inactive ingredient
  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to side-effects

Updated on 29 March 2005

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 29 March 2005

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to side-effects
  • Change to drug interactions

Updated on 10 August 2004

Reasons for updating

  • New SPC for new product

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

Updated on 05 August 2004

Reasons for updating

  • New PIL for new product