Ponstan 250mg Capsules *
Pharmacy Only: Prescription

  • Company:

    Chemidex Pharma Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • 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 22 July 2021

File name

IR1-1-L-x-4-20201016_1626964656.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 November 2020

File name

Ponstan spc 20201016_1604397965.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 be renewed (B)

Updated on 10 July 2020

File name

ie-spc-IR1-1-SPC-13-20200304_1594372565.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Unable to open current uploaded version

Updated on 19 June 2020

File name

ie-spc-IR1-1-SPC-13-20200304_1592575916.

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 12 June 2019

File name

ie-spc-ir1-1-spc-12-20190322_1560345625.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 be renewed (B)

Updated on 02 December 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 02 December 2015

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 - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$0Acetylsalicylic Acid added to Section 4.5 $0

Updated on 02 December 2015

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 - how to report a side effect

Free text change information supplied by the pharmaceutical company

$0Acetylsalicylic Acid added to Section 4.5 $0

Updated on 09 July 2013

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.3 (Contraindications), treatment of pain after coronary artery bypass graft (CABG) surgery have been added.

Updated on 09 July 2013

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.3 (Contraindications), treatment of pain after coronary artery bypass graft (CABG) surgery have been added.

Updated on 17 August 2012

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.1 (list of excipients), new printing ink details have been added.
In section 10 (date of revision of text), new approval date added.

Updated on 17 August 2012

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 6.1 (list of excipients), new printing ink details have been added.
In section 10 (date of revision of text), new approval date added.

Updated on 24 March 2011

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Free text change information supplied by the pharmaceutical company

4.5       Interaction with other medicinal products and other forms of interaction

 

 

Concurrent administration with other protein bound drugs may require adjustment in their dosage.

 

Anticoagulants:  NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4, Special warnings and precautions for use). Concurrent administration of mefenamic acid with oral anticoagulant drugs requires careful prothrombin time monitoring.

 

It is considered unsafe to take NSAIDs in combination with warfarin or heparin unless under direct medical supervision.

 

Lithium: A reduction in renal lithium clearance and an elevation of plasma lithium levels. Patients should be observed carefully for signs of lithium toxicity.

 

The following interactions have been reported with NSAIDs but have not necessarily been associated with Ponstan:

 

Other analgesicsConcomitant use of two or more NSAIDs (including aspirin) should be avoided (see section 4.3, Contraindications).

 

Antidepressants:  Selective serotonin re-uptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4, Special warnings and precautions for use).

 

Antihypertensives and diuretics: A reduction in antihypertensive and diuretic effect has been observed.  Diuretics can increase the risk of nephrotoxicity of NSAIDs.

 

ACE Inhibitors and angiotensin-II receptor antagonists: A reduction in antihypertensive effect and an increased risk of renal impairment especially in elderly patients. Patients should be adequately hydrated and the renal function assessed in the beginning and during concomitant therapy.

 

Aminoglycosides: Reduction in renal function in susceptible individuals, decreased elimination of aminoglycoside and increased plasma concentrations.

 

Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4,

Special warnings and precautions for use).

 

Cardiac glycosides:  NSAIDs may exacerbate cardiac failure and increase in plasma cardiac glycoside levels may occur when renal function is affected.

 

Ciclosporin:  The risk of nephrotoxicity of ciclosporin may be increased with NSAIDs.

 

Corticosteroids:  Increased risk of gastrointestinal ulceration or bleeding (see section 4.4, Special warnings and precautions for use).

 

Oral hypoglycaemic agents:  Inhibition of metabolism of sulfonylurea drugs, prolonged half-life and increased risk of hypoglycaemia.

 

Mifepristone:  NSAIDs should not be taken for 8-12 days after mifepristone administration, NSAIDs can reduce the effects of mifepristone.

 

Methotrexate:  Elimination can be reduced resulting in increased plasma levels.

 

Probenecid:  Reduction in metabolism and elimination of NSAIDs and metabolites.

 

Quinolone antibiotics:  Animal data indicated that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics.  Patients taking NSAIDs and quinolone may have an increased risk of developing convulsions.

 

Tacrolimus:  Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

 

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemaophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Updated on 24 March 2011

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.5       Interaction with other medicinal products and other forms of interaction

 

 

Concurrent administration with other protein bound drugs may require adjustment in their dosage.

 

Anticoagulants:  NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4, Special warnings and precautions for use). Concurrent administration of mefenamic acid with oral anticoagulant drugs requires careful prothrombin time monitoring.

 

It is considered unsafe to take NSAIDs in combination with warfarin or heparin unless under direct medical supervision.

 

Lithium: A reduction in renal lithium clearance and an elevation of plasma lithium levels. Patients should be observed carefully for signs of lithium toxicity.

 

The following interactions have been reported with NSAIDs but have not necessarily been associated with Ponstan:

 

Other analgesicsConcomitant use of two or more NSAIDs (including aspirin) should be avoided (see section 4.3, Contraindications).

 

Antidepressants:  Selective serotonin re-uptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4, Special warnings and precautions for use).

 

Antihypertensives and diuretics: A reduction in antihypertensive and diuretic effect has been observed.  Diuretics can increase the risk of nephrotoxicity of NSAIDs.

 

ACE Inhibitors and angiotensin-II receptor antagonists: A reduction in antihypertensive effect and an increased risk of renal impairment especially in elderly patients. Patients should be adequately hydrated and the renal function assessed in the beginning and during concomitant therapy.

 

Aminoglycosides: Reduction in renal function in susceptible individuals, decreased elimination of aminoglycoside and increased plasma concentrations.

 

Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4,

Special warnings and precautions for use).

 

Cardiac glycosides:  NSAIDs may exacerbate cardiac failure and increase in plasma cardiac glycoside levels may occur when renal function is affected.

 

Ciclosporin:  The risk of nephrotoxicity of ciclosporin may be increased with NSAIDs.

 

Corticosteroids:  Increased risk of gastrointestinal ulceration or bleeding (see section 4.4, Special warnings and precautions for use).

 

Oral hypoglycaemic agents:  Inhibition of metabolism of sulfonylurea drugs, prolonged half-life and increased risk of hypoglycaemia.

 

Mifepristone:  NSAIDs should not be taken for 8-12 days after mifepristone administration, NSAIDs can reduce the effects of mifepristone.

 

Methotrexate:  Elimination can be reduced resulting in increased plasma levels.

 

Probenecid:  Reduction in metabolism and elimination of NSAIDs and metabolites.

 

Quinolone antibiotics:  Animal data indicated that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics.  Patients taking NSAIDs and quinolone may have an increased risk of developing convulsions.

 

Tacrolimus:  Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

 

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemaophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Updated on 04 August 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use - addition of


In patients who are known or suspected to be poor CYP2C9 metabolisers based on previous history/experience with other CYP2C9 substrates, mefenamic acid should be administered with caution as they may have abnormally high plasma levels due to reduced metabolic clearance (see section 5.2).

Section 5.2 Pharmacokinetics properties - amendment to

Absorption and distribution

 

Mefenamic acid is absorbed from the gastrointestinal tract.  Peak levels of 10 mg/l occur two hours after the administration of a 1g oral dose to adults.

 

Metabolism

 

Mefenamic acid is predominantly metabolised by cytochrome P450 enzyme CYP2C9 in the liver, first to a 3 hydroxymethyl derivative (metabolite I) and then a 3 carboxyl derivative (metabolite II).  Both metabolites undergo secondary conjugation to form glucuronides.

 

Therefore in patients who are known or suspected to be poor CYP2C9 metabolisers based

on previous history/experience with other CYP2C9 substrates, mefenamic acid should be

administered with caution as they may have abnormally high plasma levels due to

reduced metabolic clearance.

  

Elimination

 

Fifty two percent of a dose is recovered from the urine, 6% as mefenamic acid, 25% as metabolite I and 21% as metabolite II.  Assay stools over a 3 day period accounted for 10-20% of the dose chiefly as unconjugated metabolite II.

The plasma levels of unconjugated mefenamic acid decline with half life of approximately two hours.

 

Updated on 04 August 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use - addition of


In patients who are known or suspected to be poor CYP2C9 metabolisers based on previous history/experience with other CYP2C9 substrates, mefenamic acid should be administered with caution as they may have abnormally high plasma levels due to reduced metabolic clearance (see section 5.2).

Section 5.2 Pharmacokinetics properties - amendment to

Absorption and distribution

 

Mefenamic acid is absorbed from the gastrointestinal tract.  Peak levels of 10 mg/l occur two hours after the administration of a 1g oral dose to adults.

 

Metabolism

 

Mefenamic acid is predominantly metabolised by cytochrome P450 enzyme CYP2C9 in the liver, first to a 3 hydroxymethyl derivative (metabolite I) and then a 3 carboxyl derivative (metabolite II).  Both metabolites undergo secondary conjugation to form glucuronides.

 

Therefore in patients who are known or suspected to be poor CYP2C9 metabolisers based

on previous history/experience with other CYP2C9 substrates, mefenamic acid should be

administered with caution as they may have abnormally high plasma levels due to

reduced metabolic clearance.

  

Elimination

 

Fifty two percent of a dose is recovered from the urine, 6% as mefenamic acid, 25% as metabolite I and 21% as metabolite II.  Assay stools over a 3 day period accounted for 10-20% of the dose chiefly as unconjugated metabolite II.

The plasma levels of unconjugated mefenamic acid decline with half life of approximately two hours.

 

Updated on 13 August 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

 

4.2         Added  - ‘with or after food’

4.3         Concomitant NSAID use added

4.4         Warnings updated re. SLE, smoking and alcohol use

4.5         Updated to align with NSAID class interactions i.e. ACE inhibitors, angiotensin-II-receptor antagonists & tacrolimus

4.7         Fatigue and visual disturbances added

4.8         Section reorganised according to guidleines

            Class neurological and hypersensitivity effects added

            Other PT terms added: bone marrow hyperplasia, decreased haematocrit, leukopenia, neutropenia, anaemia, blurred      vision, eye irritation, reversible loss of colour vision, ear pain, convulsions (usually in overdose), insomnia, anorexia, hyponatraemia, mild hepatotoxicity, hepatitis, hepatorenal syndrome, colitis, enterocolitis, steatorrhoea, nervousness, perspiration, pyrexia, multi-organ failure, photosensitivity.

 

6.4        Change to: Do not store above 25oC

 

Updated on 13 August 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

4.2         Added  - ‘with or after food’

4.3         Concomitant NSAID use added

4.4         Warnings updated re. SLE, smoking and alcohol use

4.5         Updated to align with NSAID class interactions i.e. ACE inhibitors, angiotensin-II-receptor antagonists & tacrolimus

4.7         Fatigue and visual disturbances added

4.8         Section reorganised according to guidleines

            Class neurological and hypersensitivity effects added

            Other PT terms added: bone marrow hyperplasia, decreased haematocrit, leukopenia, neutropenia, anaemia, blurred      vision, eye irritation, reversible loss of colour vision, ear pain, convulsions (usually in overdose), insomnia, anorexia, hyponatraemia, mild hepatotoxicity, hepatitis, hepatorenal syndrome, colitis, enterocolitis, steatorrhoea, nervousness, perspiration, pyrexia, multi-organ failure, photosensitivity.

 

6.4        Change to: Do not store above 25oC

 

Updated on 11 July 2007

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 July 2007

Reasons for updating

  • New SPC for medicines.ie