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Hypersensitivity to olsalazine or other salicylates or any other of the excipients.
There is no experience of the use of olsalazine in patients with significant renal impairment. Olsalazine is contra-indicated in patients with significant renal impairment.
It is recommended to monitor patients with impaired kidney or liver function.
Patients suffering from severe allergy or asthma should be observed for signs of worsening of these conditions.
Serious blood dyscrasias have been reported very rarely with olsalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is a suspicion or evidence of a blood dyscrasia.
The coadministration of salicylates and low molecular weight heparins or heparinoids may result in an increased risk of bleeding, more specifically hematomas following neuraxial anesthesia. Salicylates should be discontinued prior to the initiation of a low molecular weight heparin or heparinoid. If this is not possible, it is recommended to monitor patients closely for bleeding.
Increased prothrombin time in patients taking concomitant warfarin has been reported.
The coadministration of olsalazine and 6-mercaptopurine or thioguanine may result in an increased risk of myelosuppression. If coadministered with 6-mercaptopurine, it is recommended to use the lowest possible doses of each drug and to monitor the patient, especially for leukopenia. In case of coadministration with thioguanine, careful monitoring of blood counts is recommended.
It is recommended not to give salicylates for six weeks after the varicella vaccine to avoid a possible increased risk of developing Reye’s syndrome.
Pregnancy:
Olsalazine has been shown to produce fetal developmental toxicity as indicated by reduced fetal weights, retarded ossifications and immaturity of the fetal visceral organs when given during organogenesis to pregnant rats in doses 5 to 20 times the human dose (100 to 400 mg/kg).
There are no adequate and well-controlled studies in pregnant women. Olsalazine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
There is a reported risk of stillborn or pre-term birth but with no substantial risk of malformation.
Lactation:
Small amounts of the active metabolite of olsalazine (5-ASA) may pass into breast milk. Harmful infant effects (diarrhea) have been reported when 5-ASA was used during breastfeeding. Unless the benefit of the treatment outweighs the risks, olsalazine should not be taken by breast-feeding women, or patients should be advised to discontinue breastfeeding if using olsalazine.
On the basis of the pharmacodynamic profile and reported adverse events, olsalazine does not appear to produce any effects on ability to drive and use machines.
The most common side effect is diarrhoea which is usually transient.
In addition, the following undesirable effects have been reported:
General disorders and administration site conditions : headache, pyrexia
Blood and lymphatic system disorders : aplastic anaemia, eosinophilia, haemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Gastrointestinal disorders : abdominal pain upper, diarrhoea, dyspepsia, nausea, pancreatitis, vomiting
Hepatobiliary disorders : hepatic enzyme increased, hepatitis, increased bilirubin, pancreatitis
Skin and subcutaneous tissue disorders : alopecia, angioneurotic oedema, photosensitivity reaction, pruritus, rash, urticaria, paraesthesia
Cardiac disorders : myocarditis, palpitations, pericarditis, tachycardia
Renal and urinary disorders : interstitial nephritis
Respiratory, thoracic and mediastinal disorders : dyspnoea, interstitial lung disease
Musculoskeletal and connective tissue disorders : arthralgia, myalgia
Nervous system disorders : dizziness, paraesthesia
Psychiatric disorders: depression
Eye disorders : vision blurred
The knowledge of overdosage is limited. Possible overdose symptoms include nausea, vomiting and diarrhoea. It is recommended to check hematology, acid-base, electrolyte, liver and kidney status, and to provide supportive treatment. There is no specific antidote to Dipentum.
As a salicylate, interference in biochemical and other tests characteristic of salicylates may occur.