Keral 25 mg granules for oral solution
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 10 May 2023
File name
ie-spc Keral 25 mg granules for OS clean Approved May 23.pdf
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 and 5.2 - deletion of reference to a 12.5mg dose.
Section 10 - date of revision updated
Updated on 13 April 2023
File name
ie-spc Keral 25 mg granules Clean Approved April 23.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 4.6 - Information on pregnancy updated
Section 10 - Date of revision updated
Updated on 13 April 2023
File name
ie-leaflet Keral 25mg granules Clean Approved April 23.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Pregnancy warnings and information section updated
Section 6 - Date of revision updated
Updated on 20 January 2022
File name
ie-spc Keral 25 mg granules clean - Approved Jan 22.pdf
Reasons for updating
- 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 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 - "dysfunction" replaced with "impairment"
Section 4.3 - "dysfunction" replaced with "impairment"
Section 4.4 - new section added - "Masking of symptoms of underlying infections" and other minor amends
Section 4.6 - "dysfunction" replaced with "impairment"
Section 10 - Date of revision updated
Updated on 20 January 2022
File name
ie-leaflet Keral 25mg granules clean - Approved Jan 22.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 2 - warnings and precautions - information on infections added
Section 3 - How to take Keral - Dosing information updated and information on infections added
Other information - product name in other countries updated
Section 10 - date of revision updated
Updated on 03 December 2019
File name
ie-leaflet Keral 25 clean 10-9-19.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.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.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
File name
PIL_15366_93.pdf
Reasons for updating
- New PIL for new product
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 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
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
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 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 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
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)