Monotrim 10mg/ml Oral Suspension

  • Name:

    Monotrim 10mg/ml Oral Suspension

  • 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: 9/5/2019

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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 9 May 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Change to Marketing Authorisation Holder

Updated on 6 March 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

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

Free text change information supplied by the pharmaceutical company

Aligned with QRD template.

Updated on 25 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 25 January 2017 SmPC

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 - 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

Section 4.4: Concomitantuse of medicinal products known to cause hyperkalaemia with trimethoprim mayresult in severe hyperkalaemia (see Section 4.5).$0$0$0$0$0$0Section 4.5: In addition to other medicinal products known to causehyperkalaemia concomitant use of spironolactone with trimethoprim may result inclinically relevant hyperkalaemia.$0$0$0$0$0Section 4.8: Side effects are updated under system organ class. No new side effects added.$0$0$0

Updated on 25 January 2017 PIL

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 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4.4: Concomitantuse of medicinal products known to cause hyperkalaemia with trimethoprim mayresult in severe hyperkalaemia (see Section 4.5).$0$0$0$0$0$0Section 4.5: In addition to other medicinal products known to causehyperkalaemia concomitant use of spironolactone with trimethoprim may result inclinically relevant hyperkalaemia.$0$0$0$0$0Section 4.8: Side effects are updated under system organ class. No new side effects added.$0$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) the 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 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) the 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 19 March 2014 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 6.3 has been changed to add in- use shelf life : Discard any remaining solution 28 days after first opening.$0Section 10 has changed with a new revision date$0

Updated on 19 March 2014 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 6.3 has been changed to add in- use shelf life : Discard any remaining solution 28 days after first opening.$0Section 10 has changed with a new revision date$0

Updated on 19 April 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

1. Treatment of respiratory and urinary tract infections:

Adults and children over 12 years: The usual dosage is 200 mg (4 teaspoonsfour 5 ml spoonfuls) twice daily for 7-10 days.

Children under 12 years:           Based on 6 mg/kg/day in two divided dosages as follows:

6 weeks to 5 months:                 25 mg (1/2 teaspoonhalf a 5 ml spoonful) twice daily for 7-10 days.

6 months to 3 years (8-15 kg):  25-50 mg (1/2-1 teaspoonhalf to one 5 ml spoonful) twice daily for 7-10 days.

4-7years (15-25 kg):                  50-75 mg (1-11/2 teaspoonsone to one-and-a-half 5 ml spoonfuls) twice daily for 7-10 days.

8-12 years (25-40 kg):               75-125 mg (11/2-21/2 teaspoonsone-and-a-half to two-and-a-half 5 ml spoonfuls) twice daily for 7-10 days.

 

The first dosage on the first day can be doubled.

 

2. Prophylaxis of recurrent urinary tract infection:

Adults and children over 12 years: The usual dose is 100 mg (2 teaspoonstwo 5 ml spoonfuls) at night.

An extra 100 mg may be taken in the morning, if necessary.

 

Children under 12 years:        2.5 mg/kg/day once daily in the evening.

 

3. Dosage in renal impairment:

 

Creatinine clearance (ml/sec)

Plasma creatinine (micromol/l)

Dosage advised

Over 0.45

men < 250

women < 175

normal

0.25–0.45

men >250 600

women >175- 400

normal for 3 days then half dose

Under 0.25

men > 600

women > 400

half normal dose

 

Trimethoprim is removed by dialysis. However, it should not be administered to dialysis patients unless plasma concentrations can be estimated regularly.

4.3 Contraindications

Hypersensitivity to trimethoprim or to any of the excipients.

Pregnancy, premature infants and neonates under 6 weeks, trimethoprim hypersensitivity, blood dyscrasias, severe renal insufficiency where blood levels cannot be monitored.

Updated on 19 April 2011 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

1. Treatment of respiratory and urinary tract infections:

Adults and children over 12 years: The usual dosage is 200 mg (4 teaspoonsfour 5 ml spoonfuls) twice daily for 7-10 days.

Children under 12 years:           Based on 6 mg/kg/day in two divided dosages as follows:

6 weeks to 5 months:                 25 mg (1/2 teaspoonhalf a 5 ml spoonful) twice daily for 7-10 days.

6 months to 3 years (8-15 kg):  25-50 mg (1/2-1 teaspoonhalf to one 5 ml spoonful) twice daily for 7-10 days.

4-7years (15-25 kg):                  50-75 mg (1-11/2 teaspoonsone to one-and-a-half 5 ml spoonfuls) twice daily for 7-10 days.

8-12 years (25-40 kg):               75-125 mg (11/2-21/2 teaspoonsone-and-a-half to two-and-a-half 5 ml spoonfuls) twice daily for 7-10 days.

 

The first dosage on the first day can be doubled.

 

2. Prophylaxis of recurrent urinary tract infection:

Adults and children over 12 years: The usual dose is 100 mg (2 teaspoonstwo 5 ml spoonfuls) at night.

An extra 100 mg may be taken in the morning, if necessary.

 

Children under 12 years:        2.5 mg/kg/day once daily in the evening.

 

3. Dosage in renal impairment:

 

Creatinine clearance (ml/sec)

Plasma creatinine (micromol/l)

Dosage advised

Over 0.45

men < 250

women < 175

normal

0.25–0.45

men >250 600

women >175- 400

normal for 3 days then half dose

Under 0.25

men > 600

women > 400

half normal dose

 

Trimethoprim is removed by dialysis. However, it should not be administered to dialysis patients unless plasma concentrations can be estimated regularly.

4.3 Contraindications

Hypersensitivity to trimethoprim or to any of the excipients.

Pregnancy, premature infants and neonates under 6 weeks, trimethoprim hypersensitivity, blood dyscrasias, severe renal insufficiency where blood levels cannot be monitored.

Updated on 22 October 2008 PIL

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

In SPC section 4.4 - added repaglinide warning
In SPC sections 4.5 and 4.8 - updated with current safety information

Updated on 22 October 2008 SmPC

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

In SPC section 4.4 - added repaglinide warning
In SPC sections 4.5 and 4.8 - updated with current safety information

Updated on 20 August 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Section 1:  Name changed from Monotrim Suspension 10 mg/ml to Monotrim 10 mg/ml Oral Suspension

 

Section 6.1:  Excipient names updated and E numbers added

 

Section 6.4: Storage conditions changed from ‘Store below 25oC’ to ‘Do not store above 25oC’

 

Section 9:  Renewal date changed

Updated on 20 August 2008 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation

Free text change information supplied by the pharmaceutical company

Section 1:  Name changed from Monotrim Suspension 10 mg/ml to Monotrim 10 mg/ml Oral Suspension

 

Section 6.1:  Excipient names updated and E numbers added

 

Section 6.4: Storage conditions changed from ‘Store below 25oC’ to ‘Do not store above 25oC’

 

Section 9:  Renewal date changed

Updated on 28 June 2007 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 28 June 2007 PIL

Reasons for updating

  • New SPC for new product