Undesirable Effects. In clinical studies very common adverse reactions included abdominal bloating, abdominal pain and nausea. Common side effects included vomiting, headache and dizziness. These adverse reactions are generally transient and subside rapidly. There have been reports of generalised tonic-clonic and/or loss of consciousness associated with use of the active ingredient in patients with no prior history of seizures. Cases of seizure were associated with electrolyte abnormalities (e.g. hyponatraemia, hypokalaemia, hypochloraemia, hypocalcaemia, hypomagnesaemia) and low serum osmolality.
Undesirable Effects. Occasionally side effects may occur which are typical for systemically acting glucocorticosteroids. These side effects depend on the dosage, the period of treatment, concomitant or previous treatment with other glucocorticosteroids and the individual sensitivity. Interference with the immune response (e.g. increase in risk of infections). An exacerbation or the reappearance of extraintestinal manifestations (especially affecting skin and joints) can occur on switching a patient from the systemically acting glucocorticosteroids to the locally acting budesonide. Xxxxxxx’x syndrome: moon-face, truncal obesity, reduced glucose tolerance, diabetes mellitus, sodium retention with oedema formation, increased excretion of potassium, inactivity or atrophy of the adrenal cortex, growth retardation in children, disturbance of sex hormone secretion (e.g. amenorrhoea, hirsutism, impotence) depression, irritability, euphoria in isolated cases (< 1/10,000): pseudotumor cerebri (including papilloedema) in adolescents. glaucoma, cataract hypertension, increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy) stomach complaints, duodenal ulcer, pancreatitis, constipation allergic exanthema, red striae, petechiae, ecchymoses, steroid acne, delayed wound healing. Due to the sorbic acid content local skin reactions may occur, e.g. contact dermatitis. aseptic necrosis of bone (femur and head of the humerus), diffuse muscle pain and weakness, osteoporosis. Tiredness, malaise. Some of the undesired effects were reported after long-term use of orally administered budesonide. Due to its local action, the risk of unwanted effects of Budenofalk® 2mg rectal foam is generally lower than when taking systemically acting glucocorticoids.]
Undesirable Effects. The following undesirable effects and frequencies of Budenofalk 3 mg have been spontaneously reported: • Metabolism and nutritional disorders: oedema of legs, Xxxxxxx’x syndrome. • Nervous system disorders: Pseudotumor cerebri (including papilloedema) in adolescents. • Gastrointestinal disorders: Constipation. • Musculoskeletal, connective tissue and bone disorders: diffuse muscle pain and weakness, osteoporosis. • General disorders: tiredness, malaise. Some of the undesired effects were reported after long-term use. Occasionally side effects may occur which are typical for systemic glucocorticosteroids. These side effects depend on the dosage, the period of treatment, concomitant or previous treatment with other glucocorticosteroids and the individual sensitivity. Clinical studies showed that the frequency of glucocorticosteroid associated side effects is lower with Budenofalk 3 mg (approx. by half) than with oral treatment of equivalent dosages of prednisolone. Interference with the immune response (e.g. increase in risk of infections). An exacerbation or the reappearance of extraintestinal manifestations (especially affecting skin and joints) can occur on switching a patient from the systemically acting glucocorticosteroids to the locally acting budesonide.
Undesirable Effects. […] Haematocrit increased, Red blood cell count increased, Haemoglobin increased Frequency common. […]
Undesirable Effects. The following list should not be considered exhaustive. For further documented ADRs and details of likelihood etc, see Summary of Product Characteristics or BNF. Methotrexate has been shown to be teratogenic to humans. In women of child-bearing age, any existing pregnancy must be excluded with certainty by taking appropriate measures, e.g. pregnancy test, prior to initiating therapy. Patients of a sexually mature age (women and men) must use effective contraception during treatment with methotrexate and at least 6 months thereafter. Nausea – very common Use of antiemetics where necessary, discuss with specialist team Stomatitis – very common Oral Ulcers – common Prophylactic folic acid 5mg should be given up to 6 times per week (avoid on day of methotrexate) discuss with specialist team if occurs Elevated transaminases – very common If ALT, AST >100u/L then withhold and discuss with specialist team. Thrombocytopenia, leucopenia, anaemia, eosinophilia If WCC <3.5x109/L or Neutrophils<1.6x109/L or Platelets<140x109/L or unexplained eosinophilia >0.5x109/L then withhold and discuss with specialist team MCV If MCV >105fl then withhold and discuss with specialist team. Dyspnoea – new or increasing or dry cough Withhold and discuss urgently with specialist team Severe sore throat or abnormal bruising Immediate FBC and withhold until result of FBC available Baseline investigation should have been completed for the initiation of oral methotrexate. If patient has not been on oral methotrexate then :- FBC,U&E’s,LFT’s and CXR (unless previous CXR within 6 months). Pulmonary function tests in selected patients (see BSR guidelines). The following monitoring is to be undertaken in Primary Care FBC 2 weekly until dose stable for 6 weeks then when on stable dose – monthly for 3 months then thereafter at least every 12 weeks. For dose adjustments – 2 weekly until dose stable for 6 weeks then revert to previous schedule. If on concomitant leflunomide treatment then monthly monitoring required. WCC Neutrophils Platelets Eosinophils MCV WCC<3.5x109/L Neutrophils<1.6x109/L Platelets<140x109/L Unexplained eosinophilia - eosinophils >0.5x109/L MCV>105fl Withhold and discuss with specialist team U&E’s Mild to moderate Creatinine increased by >30% in one year, or eGFR decreased to <50ml/min Withhold and discuss with specialist team. Please weigh patient and report weight when seeking advice for accurate calculation of creatinine clearance. LFT’s ALT AST Albumin ALT,AST >100u/L Une...
