Ponstan Forte 500mg Film-coated Tablets

Concurrent therapy with other plasma protein binding drugs may necessitate a modification in 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 analgesics:  Concomitant 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 increases 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 indicates that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics.  Patients taking NSAIDs and quinolones may have 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.

Concurrent therapy with other plasma protein binding drugs may necessitate a modification in 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 analgesics:  Concomitant 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 increases 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 indicates that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics.  Patients taking NSAIDs and quinolones may have 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.