Adverse reactions : תופעות לוואי

4.8 Undesirable effects
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.

Not known (cannot be estimated from available data)

System organ class                        Frequency                        Undesirable effects Infections and infestations               Not known                        Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections,
recurrence of dormant tuberculosis (see section
4.4).
Neoplasms benign, malignant and          Not known                         Kaposi's sarcoma has been reported to occur in unspecified (including cysts and polyps)                                   patients receiving corticosteroid therapy.
Discontinuation of corticosteroids may result in clinical remission.
Blood and lymphatic system disorders      Not known                        Leukocytosis Immune system disorders                   Not known                        Hypersensitivity including anaphylaxis has been reported.
Endocrine disorders                       Not known                        Suppression of the HPA axis.
Cushingoid.
Impaired carbohydrate intolerance with increased requirement for anti-diabetic therapy,
manifestation of latent diabetes mellitus.
Metabolism and nutrition disorders        Not known                        Sodium and water retention, hypokalaemia, hypokalaemic alkalosis, increased appetite,
negative protein and calcium balance.
Psychiatric disordersa                    Not known                        Euphoric mood, psychological dependence, depressed mood, insomnia, aggravation of
schizophrenia.
Nervous system disorders                  Not known                     Dizziness, headache.
Aggravation of epilepsy.
Eye disorders                             Not known                     Glaucoma, papilloedema, posterior subcapsular cataracts, central serous chorioretinopathy,
exophthalmos, corneal or scleral thinning,
exacerbation of ophthalmic viral or fungal diseases.
and vision, blurred
Ear and labyrinth disorders               Not known                     Vertigo Cardiac disorders                         Not known                     Myocardial rupture following recent myocardial infarction.
Congestive cardiac failure (in susceptible patients).
Vascular disorders                        Not known                     Hypertension, embolism.
Respiratory, thoracic and mediastinal     Not known                     Hiccups disorders
Gastrointestinal disorders                Not known                     Dyspepsia, nausea, vomiting, abdominal distension, abdominal pain, diarrhoea,
oesophageal ulceration, candidiasis, pancreatitis acute.
Peptic ulceration with perforation and haemorrhage.
Skin and subcutaneous tissue disorders Not known                        Skin Atrophy, skin striae, acne, telangiectasia, hyperhidrosis, rash, pruritus, urticaria, hirsutism.
Musculoskeletal and connective tissue     Not known                     Myopathy, osteoporosis, vertebral and long disorders                                                               bone fractures, avascular osteonecrosis, myalgia.
Renal and urinary disorders               Not known                     Scleroderma renal crisisb Reproductive system and breast            Not known                     Menstruation irregular, amenorrhoea.
disorders
General disorders and administration      Not known                     Impaired healing, malaise.
site conditions
Investigations                            Not known                     Weight increased.
Injury, poisoning and procedural             Not known                    Tendon rupture, contusion (bruising).
complications a) A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. 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 b) 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%)

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.
Paediatric population:

Increased intracranial pressure with papilloedema in children (pseudotumour cerebri) -usually after treatment withdrawal.
Growth retardation in infancy, childhood and adolescence.


Reporting of suspected adverse reactions
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.