Monotrim 100 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 20 October 2020
File name
100 mono spc.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
100 mono pil.pdf
Reasons for updating
- New PIL for new product
Updated on 12 October 2020
File name
22643-2-2-SPC-6 20200911.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-1161-2-2-spc4-20190322.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)
Free text change information supplied by the pharmaceutical company
Updated MAH and PA number
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.4 - Special warnings and precautions for use
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.4 - Special warnings and precautions for use
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 about 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 about 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 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- 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
1. Sec. 2. Qualitative and Quantitative composition:
- there should be space 100 and mg and also 24 and mg
2. Sec. 3 Pharmaceutical form:
- there should be full stop after Tablet
3. Sec. 4.2 Posology and method of administration:
- there should be space between 100 and mg and also between 10 and mg/ml
- there should be full stop after first, second and third bullet point to read 1., 2., and 3.
- there should be full stop after the end of each sentence under first bullet point, "1. Treatment of respiratory and urinary tract infections"
- there should be full stop at the end of the second sentence of the second paragraph "2. Prophylaxis of recurrent urinary tract infection:"
- there should be no space between colon and second bullet point to read: "2. Prophylaxis of recurrent urinary tract infection:"
- there should be space between < and 175 and > and 400 to read Women < 175 and Women > 400 in middle column of the table under third paragraph "3. Dosage in renal impairment"
4. Sec. 4.7 Effects on ability to drive and use machines:
- there should be ful stop at the end of the sentence
5. Sec. 5.1 Pharmacodynamic properties:
- please move pneumoniae to previous line so Klebsiella pneumoniae read as one
- there should be space between coma and Streptococcus faecalis
6. Sec. 5.2 Pharmacokinetic properties:
- there should be space between 1 and hyphen and hyphen and 4 and also 20 and hyphen and hyphen and 50 to read 1 - 4 and 20 - 50
- there shouldn't be space between µ and g so it should read 1 µg
7. Sec. 6.3 Shelf life
- there should be full stop at the end of the sentence
8. Sec. 6.5 Nature and contents of container
- there should be full stop at the end of the last sentece
- there should be space 100 and mg and also 24 and mg
2. Sec. 3 Pharmaceutical form:
- there should be full stop after Tablet
3. Sec. 4.2 Posology and method of administration:
- there should be space between 100 and mg and also between 10 and mg/ml
- there should be full stop after first, second and third bullet point to read 1., 2., and 3.
- there should be full stop after the end of each sentence under first bullet point, "1. Treatment of respiratory and urinary tract infections"
- there should be full stop at the end of the second sentence of the second paragraph "2. Prophylaxis of recurrent urinary tract infection:"
- there should be no space between colon and second bullet point to read: "2. Prophylaxis of recurrent urinary tract infection:"
- there should be space between < and 175 and > and 400 to read Women < 175 and Women > 400 in middle column of the table under third paragraph "3. Dosage in renal impairment"
4. Sec. 4.7 Effects on ability to drive and use machines:
- there should be ful stop at the end of the sentence
5. Sec. 5.1 Pharmacodynamic properties:
- please move pneumoniae to previous line so Klebsiella pneumoniae read as one
- there should be space between coma and Streptococcus faecalis
6. Sec. 5.2 Pharmacokinetic properties:
- there should be space between 1 and hyphen and hyphen and 4 and also 20 and hyphen and hyphen and 50 to read 1 - 4 and 20 - 50
- there shouldn't be space between µ and g so it should read 1 µg
7. Sec. 6.3 Shelf life
- there should be full stop at the end of the sentence
8. Sec. 6.5 Nature and contents of container
- there should be full stop at the end of the last sentece
Updated on 21 July 2011
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 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
1. Sec. 2. Qualitative and Quantitative composition:
- there should be space 100 and mg and also 24 and mg
2. Sec. 3 Pharmaceutical form:
- there should be full stop after Tablet
3. Sec. 4.2 Posology and method of administration:
- there should be space between 100 and mg and also between 10 and mg/ml
- there should be full stop after first, second and third bullet point to read 1., 2., and 3.
- there should be full stop after the end of each sentence under first bullet point, "1. Treatment of respiratory and urinary tract infections"
- there should be full stop at the end of the second sentence of the second paragraph "2. Prophylaxis of recurrent urinary tract infection:"
- there should be no space between colon and second bullet point to read: "2. Prophylaxis of recurrent urinary tract infection:"
- there should be space between < and 175 and > and 400 to read Women < 175 and Women > 400 in middle column of the table under third paragraph "3. Dosage in renal impairment"
4. Sec. 4.7 Effects on ability to drive and use machines:
- there should be ful stop at the end of the sentence
5. Sec. 5.1 Pharmacodynamic properties:
- please move pneumoniae to previous line so Klebsiella pneumoniae read as one
- there should be space between coma and Streptococcus faecalis
6. Sec. 5.2 Pharmacokinetic properties:
- there should be space between 1 and hyphen and hyphen and 4 and also 20 and hyphen and hyphen and 50 to read 1 - 4 and 20 - 50
- there shouldn't be space between µ and g so it should read 1 µg
7. Sec. 6.3 Shelf life
- there should be full stop at the end of the sentence
8. Sec. 6.5 Nature and contents of container
- there should be full stop at the end of the last sentece
- there should be space 100 and mg and also 24 and mg
2. Sec. 3 Pharmaceutical form:
- there should be full stop after Tablet
3. Sec. 4.2 Posology and method of administration:
- there should be space between 100 and mg and also between 10 and mg/ml
- there should be full stop after first, second and third bullet point to read 1., 2., and 3.
- there should be full stop after the end of each sentence under first bullet point, "1. Treatment of respiratory and urinary tract infections"
- there should be full stop at the end of the second sentence of the second paragraph "2. Prophylaxis of recurrent urinary tract infection:"
- there should be no space between colon and second bullet point to read: "2. Prophylaxis of recurrent urinary tract infection:"
- there should be space between < and 175 and > and 400 to read Women < 175 and Women > 400 in middle column of the table under third paragraph "3. Dosage in renal impairment"
4. Sec. 4.7 Effects on ability to drive and use machines:
- there should be ful stop at the end of the sentence
5. Sec. 5.1 Pharmacodynamic properties:
- please move pneumoniae to previous line so Klebsiella pneumoniae read as one
- there should be space between coma and Streptococcus faecalis
6. Sec. 5.2 Pharmacokinetic properties:
- there should be space between 1 and hyphen and hyphen and 4 and also 20 and hyphen and hyphen and 50 to read 1 - 4 and 20 - 50
- there shouldn't be space between µ and g so it should read 1 µg
7. Sec. 6.3 Shelf life
- there should be full stop at the end of the sentence
8. Sec. 6.5 Nature and contents of container
- there should be full stop at the end of the last sentece
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