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. with nutrition disorders                                           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; vision, blurred (see also section 4.4)
Gastrointestinal          Common                              Dyspepsia 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
Uncommon                            Psychomotor hyperactivity,
anxiety


Rare                                Aggression


Skin and                  Common                              Allergic exanthema, petechiae, subcutaneous tissue                                           delayed wound healing, disorders                                                     contact dermatitis Rare                                Ecchymosis
Vascular disorders        Very rare                           Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)
General disorders         Common                              Burning in the rectum and pain and administration        Very rare                           Fatigue, malaise site conditions

The following adverse reactions were additionally reported in clinical studies with Budeson rectal foam (frequency: uncommon): increased appetite, increase in erythrocyte sedimentation rate, leucocytosis, nausea, abdominal pain, flatulence, paraesthesias in the abdominal region, anal fissure, aphthous stomatitis, frequent urge to defecate, rectal bleeding, increase in transaminases (GOT, GPT), increase in parameters of cholestasis (GGT,AP), increase in amylase, change in cortisol, urinary tract infection, dizziness, disturbances of smell, insomnia, increased sweating, asthenia, increase in body weight.

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.

Some of the adverse events were reported after long-term use of orally administered budesonide.

Due to its local action, the risk of adverse reactions of Budeson rectal foam is generally lower than when taking systemically acting glucocorticosteroids.

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/