… ypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur (see section 4.5).
Renal impairment as renal function may deteriorate (see section 4.3 and 4.8).
Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.
Hepatic dysfunction (see section 4.3 and 4.8).
Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration to control symptoms (see GI and cardiovas …
Identical in all 7 labels. Surrounding text shown from Haleon UK Trading Limited.
… ay be diminished. Tricyclic antidepressants: Effect of pseudoephedrine may be diminished or enhanced. Digitalis, chinidine or tricyclic antidepressants: Increased frequency of arrhythmia.
Concomitant use of ibuprofen with : Possible Reaction Other NSAIDs: The concomitant administration of several NSAIDs may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect. The concomitant use of ibuprofen with other NSAIDs should therefore be avoided (see sections 4.3 and 4.4). Digoxin: The concomitant use of RobiCold Sinus Relief with digoxin preparations may increase serum levels of these medicinal products. A check of serum-digoxin is not as a rule required on correct use (maximum over 5 days). Corticosteroids: Corticosteroids as these may increase the risk of adverse reactions, especially of the gastrointestinal tract (gastrointestinal; ulceration or bleeding) (see section 4.3). Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4). Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1). Anticoagulants: (e.g.: warfarin, ticlopidine, clopidogrel, tirofiban, eptifibatide, abciximab, iloprost) NSAIDs as ibuprofen may enhance the effect of anti-coagulants (see section 4.4). Phenytoin: The concomitant use of RobiCold Sinus Relief with phenytoin preparations may increase serum levels of these medicinal products. A check of serum-phenytoin levels is not as a rule required on correct use (maximum over 5 days). Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4). Lithium: The concomitant use of RobiCold Sinus Relief with lithium preparations may increase serum levels of these medicinal products. A check of serum-lithium is not as a rule required on correct use (maximum over 5 days). Probenecid and sulfinpyrazone: Medicinal products that contain probenecid or sulfinpyrazone may delay the excretion of ibuprofen. Diuretics, ACE inhibitors, betareceptor-blockers and angiotensin-II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive medicinal products. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor, betareceptor-blockers or angiotensin-II antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Potassium sparing diuretics: The concomitant administration of RobiCold Sinus Relief and potassium-sparing diuretics may lead to hyperkalaemia (check of serum potassium is recommended). Methotrexate: The administration of RobiCold Sinus Relief within 24 hours before or after administration of methotrexate may lead to elevated concentrations of methotrexate and an increase in its toxic effect. Ciclosporin: The risk of a kidney-damaging effect due to ciclosporin is increased through the concomitant administration of certain nonsteroidal antiinflammatory drugs. This effect also cannot be ruled out for a combination of ciclosporin with ibuprofen. Tacrolimus: The risk of nephrotoxicity is increased if the two medicinal products are administered concomitantly. Zidovudine: There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen. Sulfonylureas: Clinical investigations have shown interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (sulfonylureas). Although interactions between ibuprofen and sulfonylureas have not been described to date, a check of blood-glucose values is recommended as a precaution on concomitant intake. Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. Heparins; Gingko biloba: Increased risk of bleeding. Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone Antacids: Certain antacids may increase the gastrointestinal absorption of Ibuprofen. This is considered to be of clinical relevance particularly during long-term use of Ibuprofen. Aminoglycosides: Reduction in renal function in susceptible individuals decreased elimination of aminoglycosides and increased plasma concentrations.