Monotrim 100 mg Tablets

  • Name:

    Monotrim 100 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Trimethoprim

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Summary of Product Characteristics last updated on medicines.ie: 12/6/2019

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Chemidex Pharma Ltd

chemidex

Company Products

Medicine NameActive Ingredients
Medicine Name Monotrim 100 mg Tablets Active Ingredients Trimethoprim
Medicine Name Monotrim 10mg/ml Oral Suspension Active Ingredients Trimethoprim
Medicine Name Monotrim 200 mg Tablets Active Ingredients Trimethoprim
Medicine Name Ponstan 250mg Capsules Active Ingredients Mefenamic Acid
Medicine Name Ponstan Forte 500mg Film-coated Tablets Active Ingredients Mefenamic Acid
1 - 0 of 5 items.Total: Infinity pages

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 12 June 2019 SmPC

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 PIL

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$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 arranged according to their system organ class. No new side effects added. $0$0$0

Updated on 27 January 2017 SmPC

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$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 arranged according to their system organ class. No new side effects added. $0$0$0

Updated on 27 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 17 June 2015 PIL

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 $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

Updated on 17 June 2015 SmPC

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 $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

Updated on 21 July 2011 PIL

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

Updated on 21 July 2011 SmPC

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

Updated on 9 October 2009 PIL

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 9 October 2009 SmPC

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