Monotrim 200 mg Tablets *
Pharmacy Only: Prescription

  • Company:

    Chemidex Pharma Ltd
  • Status:

    No Recent Update
  • Legal 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

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 02 November 2020

File name

20201016 mono 200_1604345347.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_1603216802.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_1603216701.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 October 2020

File name

22643-2-3-SPC-6 20200911 200mg_1602503239.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_1560345513.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

  • 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$0$0$0$0$0Section 4.5: In addition to other medicinal products knownto cause hyperkalaemia concomitant use of spironolactone with trimethoprim mayresult in clinically relevant hyperkalaemia.$0$0$0$0$0Section 4.8: Side effects updated according to their system organ class. No new side effects included.$0$0$0

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

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$0$0$0$0$0Section 4.5: In addition to other medicinal products knownto cause hyperkalaemia concomitant use of spironolactone with trimethoprim mayresult in clinically relevant hyperkalaemia.$0$0$0$0$0Section 4.8: Side effects updated according to their system organ class. No new side effects included.$0$0$0

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 $0$0HPRAPharmacovigilance$0$0EarlsfortTerrace $0$0IRL- Dublin 2$0$0Tel:+353 1 6764971$0$0Fax:+353 1 6762517$0$0Website:www.hpra.ie$0$0e-mail: medsafety@hpra.ie$0$0$0$0$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 $0$0HPRAPharmacovigilance$0$0EarlsfortTerrace $0$0IRL- Dublin 2$0$0Tel:+353 1 6764971$0$0Fax:+353 1 6762517$0$0Website:www.hpra.ie$0$0e-mail: medsafety@hpra.ie$0$0$0$0$0

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

Free text change information supplied by the pharmaceutical company

None provided

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