Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following frequency conventions are used in the evaluation of undesirable effects:
 very common: (≥ 1/10) common: (≥ 1/100 to < 1/10) uncommon: (≥ 1/1,000 to < 1/100) rare: (≥ 1/10,000 to < 1/1,000) very rare: (<1/10,000) not known (cannot be estimated from the available data)

System organ class      Frequency according to           Adverse reaction MedDRA convention
Metabolism and          Common                           Cushing’s syndrome: e.g.
nutrition disorders                                      with moon face, truncal obesity, reduced glucose tolerance, diabetes mellitus,
hypertension, sodium retention with oedema,
increased potassium excretion, inactivity or atrophy of the adrenal cortex,
red striae, steroid acne,
disturbance of sex hormone secretion (e.g. amenorrhoea,
hirsutism, impotence)


Very rare                        Growth retardation in children
Eye disorders           Rare                            Glaucoma, cataract, blurred vision (see also section 4.4)

Gastrointestinal        Common                           Dyspepsia, abdominal pain disorders               Uncommon                         Duodenal or gastric ulcer Rare                             Pancreatitis
Very rare                        Constipation
Immune system           Common                           Increased risk of infection disorders
Musculoskeletal and     Common                           Muscle and joint pain, muscle connective tissue                                        weakness and twitching, disorders                                                osteoporosis 
Rare                             Osteonecrosis
Nervous system          Common                           Headache disorders

Very rare                        Pseudotumor cerebri including papilloedema in adolescents
Psychiatric disorders   Common                          Depression, irritability, euphoria



System organ class        Frequency according to         Adverse reaction MedDRA convention
Uncommon                      Psychomotor hyperactivity,
anxiety


Rare                           Aggression
Skin and                  Common                         Allergic exanthema, subcutaneous tissue                                      petechiae, delayed wound disorders                                                healing, contact dermatitis 
Rare                           Ecchymosis
Vascular disorders        Very rare                      Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)

General disorders         Very rare                      Fatigue, malaise and administration site conditions


Most of the adverse events mentioned in this SmPC can also be expected for treatments with other glucocorticosteroids.

Occasionally, adverse events may occur which are typical for systemic glucocorticosteroids. These adverse events 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 adverse events is lower with oral Budeson than with oral treatment of equivalent dosages of prednisolone.

An exacerbation or the reappearance of extra-intestinal manifestations (especially affecting skin and joints) can occur on switching a patient from systemically acting glucocorticosteroids to the locally acting budesonide.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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/