Keral 25 mg granules for oral solution *

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 03 December 2019

File name

ie-leaflet Keral 25 clean 10-9-19_1575373731.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Update to replace the excipient 'sucrose powder with silica' with 'sucrose' 

Updated on 03 December 2019

File name

ie-spc Keral 25 mg granules approved clean 10-9-19_1575373631.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • 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

Update to replace the excipient 'sucrose powder with silica' with 'sucrose' 

Updated on 01 August 2019

File name

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

Reasons for updating

  • XPIL Created

Updated on 01 August 2019

File name

ie-spc_Keral_25_mg_granules_approved_clean_10-4-18_1564670605.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_granules_approved_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 25 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 08 March 2016

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

The changes are as follows:

  • Section 4.4 Special warnings and precautions for use
    introduction of a warning related to the content of sucrose, for patients with diabetes mellitus.
  • Administrative changes according to the latest QRD template and SmPC guideline

Updated on 08 March 2016

Reasons for updating

  • New SPC for new product

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

Updated on 08 March 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 08 March 2016

File name

PIL_15366_93.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 June 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Change of special precautions for disposal
  • Addition of information on reporting a side effect.

Updated on 30 June 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 4.5 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Sections 2, 4.2 4.3, 4.4, 4.5, 4.6, 4.8 4.9, 6.6 of the SmPC.  The main changes are shown in bold text below:

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION:

Excipients with known effect:

Sucrose with colloidal silica: 2.40- 2.44 g respectively

 

4.2.       Posology and method of administration:

Renal dysfunction:

The initial dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (creatinine clearance 59 - 89 ml / min) (see section 4.4). Keral should not be used in patients with moderate to severe renal dysfunction (creatinine clearance <59 ml / min) (see section 4.3).

 

"Children and adolescents" has been changed to "Paediatric population".

 

The following paragraph has been moved from section 6.6:

Method of administration

Dissolve the whole contents of each sachet in a glass of water; shake/ stir well to help to dissolve. The obtained solution should be immediately ingested after reconstitution.

Concomitant administration with food delays the absorption rate of the drug (see Pharmacokinetic Properties), thus in case of acute pain it is recommended that administration is at least 15 minutes before meals

 

4.3.       Contraindications:

 

·    "angioneurotic oedema" is now described as "angioedema";

·    hystory of peptic ulcer/gastrointestinal bleeding is now described as" patient with active peptic ulcer/gastrointestinal haemorrhage,or any history of gastrointestinal bleeding, ulceration or perforation";

·   "severe renal dysfunction" is now specified as  "creatinine clearance <59 ml/min";

·    severely impaired hepatic function is now described as "Child-Pugh score 10-15".

 

The sentence "Patients with less than 18 years of age" has been removed: as information on paediatric use is included in sections 4.2 and 4.4.  

 

4.4.    Special warnings and special precautions for use

 

Other information

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).

 

4.5.    Interactions with other medicinal products and other forms of interaction

Inadvisable combinations: Other NSAIDs, (including cyclooxygenase-2 selective inhibitors)

 

4.6.       Fertility, pregnancy and lactation

KERAL is contraindicated during third trimester of pregnancy and lactation (see section 4.3).

 

4.8.    Undesirable effects.

The frequency of some previously reported undesirable effects has been updated:

 

·         laryngeal oedema : rare (previously reported as "not known"):

·         hepatocellular injury : rare (previously reported as "very rare");

·         acute renal failure : rare (previously reported as "not known").

 

 

4.9.    Overdose

The symptomatology following overdose is not known. Similar medicinal products have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, headache) disorders

 

6.6      Special precautions for disposal

Information on the method of administration has been moved to section 4.2.

 

 

Updated on 09 September 2014

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision
  • Change to dosage and administration

Updated on 17 September 2013

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

The following sentence has been added to section 6.6:

Any unused medicinal product or waste material should be disposed of in accordance with local requirements

Updated on 11 May 2012

Reasons for updating

  • New PIL for new product

Updated on 10 May 2012

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided