Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Data reported under this section originate from post authorization and spontaneous reporting, therefore estimation of frequency of adverse reaction could not be established.
The incidence of predictable undesirable effects, including hypothalamo-pituitary- adrenal (HPA) suppression, correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment (see Section 4.4).
The following side effects may be associated with the long-term systemic use of corticosteroids.
Infections and Infestations
Infection susceptibility increased, opportunistic infection, latent tuberculosis (see section 4.4).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma (see section 4.4).
Blood and lymphatic system disorders
Leukocytosis.
Immune system disorders
Hypersensitivity, anaphylactic reaction.
Endocrine disorders
Suppression of the HPA axis.
Cushingoid.
Carbohydrate intolerance, diabetes mellitus exacerbated.
Metabolism and nutrition disorders
Sodium retention, fluid retention, hypokalaemia, hypokalaemic alkalosis, increased appetite, electrolyte imbalance, protein total abnormal
Psychiatric disorders
Dependence.
Affective disorder: irritability, euphoric mood, depressed mood, affect lability, suicidal ideation.
Psychotic disorder: mania, delusions, hallucinations, schizophrenia aggravated.
Abnormal behavior, anxiety, sleep disorder.
Cognitive disorder: confusion, amnesia.
A wide range of psychiatric reactions including the above mentioned reactions, are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
Nervous system disorders
Dizziness, headache, epilepsy aggravated.
Intracranial pressure increased, papilloedema, epilepsy.
Eye disorders
Glaucoma, papilloedema, posterior subcapsular cataract, chorioretinopathy, vision, blurred (see also section 4.4), exophthalmos, corneal thinning, scleral thinning, eye infection viral, eye infection fungal.
Ear and labyrinth disorders
Vertigo
Cardiac disorders
Myocardial rupture (post infarct), cardiac failure congestive.
Frequency “not known”: Bradycardia*
Vascular disorders
Hypertension, embolism.
Respiratory, thoracic and mediastinal disorders
Hiccups.
Gastrointestinal disorders
Dyspepsia, nausea, vomiting, abdominal distension, abdominal pain, diarrhoea, oesophageal ulcer, candidiasis, pancreatitis acute.
Peptic ulcer haemorrhage, peptic ulcer perforation.
Skin and subcutaneous tissue disorders
Skin atrophy, skin striae, acne, telangiectasia, hyperhidrosis, rash, pruritus, urticaria, hirsutism, Stevens-Johnson syndrome.
Musculoskeletal and connective tissue disorders
Myopathy, osteoporosis, multiple spinal fractures, osteonecrosis, myalgia.
Renal and urinary disorders
Scleroderma renal crisis.
Amongst the different subpopulations the occurrence of scleroderma renal crisis varies. The highest risk has been reported in patients with diffuse systemic sclerosis.
The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%).
Reproductive system and breast disorders
Menstruation irregular, amenorrhoea.
Congenital, familial and genetic disorders
Porphyria
General disorders and administration site conditions
Impaired healing, malaise.
Investigations
Weight increased, intraocular pressure increased.
Injury, poisoning and procedural complications
Tendon rupture, contusion.
Withdrawal Symptoms
Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (See Section 4.4).
A 'withdrawal syndrome' may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.
In some instances, withdrawal symptoms may involve or resemble a clinical relapse of the disease for which the patient has been undergoing treatment.
Other effects that may occur during withdrawal or change of corticosteroid therapy include benign intracranial hypertension with headache and vomiting and papilloedema caused by cerebral oedema.
Latent rhinitis or eczema may be unmasked.
Pediatric population
The following side effects have been reported in the pediatric population.
Growth retardation in infancy, childhood and adolescence.
Intracranial pressure increased with papilloedema (pseudo tumour cerebri) after treatment withdrawal.
For psychiatric reactions in children, refer to the paragraph “Psychiatric disorders”.
*Following high doses
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form : https://sideeffects.health.gov.il
Additionally, you should also report to Kamada Ltd. to email address: pharmacovigilance@kamada.com