Monotrim 200 mg Tablets
*Company:
Chemidex Pharma LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 November 2020
File name
20201016 mono 200.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 October 2020
File name
200 pil.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 October 2020
File name
200 pil.pdf
Reasons for updating
- New PIL for new product
Updated on 12 October 2020
File name
22643-2-3-SPC-6 20200911 200mg.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 June 2019
File name
ie-spc-1161-2-3-spc-4-20190322.pdf
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 not be renewed (A)
Updated on 27 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 January 2017
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4: Concomitant use of medicinal products known tocause hyperkalaemia with trimethoprim may result in severe hyperkalaemia (seeSection 4.5).$0
Updated on 27 January 2017
Reasons for updating
- 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
Free text change information supplied by the pharmaceutical company
Section 4.4: Concomitant use of medicinal products known tocause hyperkalaemia with trimethoprim may result in severe hyperkalaemia (seeSection 4.5).$0
Updated on 17 June 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) statement how to report side effects has been added:$0$0Reportingsuspected adverse reactions after authorisation of the medicinal product isimportant. It allows continued monitoring of the benefit/risk balance of themedicinal product. Healthcare professionals are asked to report any suspectedadverse reactions via
Updated on 17 June 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) statement how to report side effects has been added:$0$0Reportingsuspected adverse reactions after authorisation of the medicinal product isimportant. It allows continued monitoring of the benefit/risk balance of themedicinal product. Healthcare professionals are asked to report any suspectedadverse reactions via
Updated on 21 July 2011
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In section 4.5 (Interaction with other medicinal products and other forms of interaction), a colon (:) has been in the first paragraph between anticonvulsants and Trimethoprim. It now reads "Folate antagonists and anticonvulsants: Trimethoprim..."
- In section 5.1 (Pharmacodynamic properties), a space has been added to read now Pseudomonas aeruginosa.
- In section 6.5 (Nature and contents of container) a full stop (.) has been added at the end of the paragraph.
Updated on 21 July 2011
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
- In section 4.5 (Interaction with other medicinal products and other forms of interaction), a colon (:) has been in the first paragraph between anticonvulsants and Trimethoprim. It now reads "Folate antagonists and anticonvulsants: Trimethoprim..."
- In section 5.1 (Pharmacodynamic properties), a space has been added to read now Pseudomonas aeruginosa.
- In section 6.5 (Nature and contents of container) a full stop (.) has been added at the end of the paragraph.
Updated on 09 October 2009
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
None provided
Updated on 09 October 2009
Reasons for updating
- New SPC for medicines.ie
Free text change information supplied by the pharmaceutical company
None provided