Adverse reactions : תופעות לוואי

4.8.           Undesirable effects
Adverse drug reactions reported in clinical trials with Cortiment are presented in Table 1. Adverse drug reactions reported for the therapeutic class are presented in Table 2.
In Phase II and III clinical trials, the incidence of adverse events for Cortiment tablets, at the recommended dose of 9 mg/day, was comparable to placebo.
Most adverse events were of mild to moderate intensity and of a non-serious nature.


Adverse reactions reported are listed according to the following frequency: 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).

Table 1 Cortiment drug-related adverse reactions reported during clinical trials with more than one case (N=255)

Preferred Term of Adverse Drug Reaction
MedDRA System
Organ Classification           Common            Uncommon

Gastrointestinal         Nausea disorders                Abdominal pain         Flatulence upper
Abdominal distension
Abdominal pain
Dry mouth
Dyspepsia
Nervous System           Headache               Dizziness disorders
Psychiatric disorders    Insomnia               Mood altered

Skin and                 Acne subcutaneous disorders
General disorders and    Fatigue administration site                             Peripheral oedema conditions

Musculoskeletal and      Myalgia                Back pain connective tissue                               Muscle spasms disorders
Investigations           Blood cortisol decreased
Infections and                                  Influenza infestations
Blood and lymphatic                             Leukocytosis system disorders
Table 2 Events reported for the therapeutic class (intestinal anti-inflammatory agents, corticosteroids acting locally, budesonide)


MedDRA System Organ                            Common                    Uncommon        Rare           Very Rare Classification
Cardiac disorders                              Palpitations
Endocrine disorders                            Cushingoid                                               Growth features                                                 retardation in children*
Eye disorders                                                                            Cataract including subcapsular cataract
Glaucoma
Vision,
blurred (see also section
4.4)
Gastrointestinal disorders                     Dyspepsia
Immune system disorders                                                                                 Anaphylactic reaction
Metabolism and nutrition                       Hypokalemia disorders
Musculoskeletal and connective                 Muscle tissue disorders                               cramps
Nervous system disorders                                                 Tremor Psychiatric disorders                          Behavioural               Psychomotor     Aggression changes such              hyperactivity as                        Anxiety nervousness,
insomnia and mood swings
Depression
Reproductive system and breast                 Menstrual disorders                                      disorders
Skin and subcutaneous tissue                   Skin                                      Ecchymosis disorders                                      reactions
(urticaria,
exanthema)
* Note that Cortiment is not recommended for use in children (see 4.2) 


Most of the adverse events mentioned in this SmPC can also be expected for other treatments with glucocorticoids.
Side effects typical of systemic corticosteroids (e.g. cushingoid features and growth retardation) may occur. These side effects are dependent on the dose, treatment time, concomitant and previous corticosteroid intake and individual sensitivity.


Paediatric population

No data available.

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://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=Adver sEffectMedic@moh.gov.il