Adverse reactions : תופעות לוואי

4.8      Undesirable effects

Adverse reactions (occurring in 1% of patients or more) from the clinical trials and post marketing are listed below.

The most commonly reported Adverse Reaction from the controlled clinical trials with Physioneal 40 was alkalosis, occurring in approximately 10% of patients. In most cases, it was based on serum bicarbonate values only and was usually not associated with clinical symptoms.

The adverse drug reactions listed in this section are given following the recommended frequency convention: 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 available data).


System Organ Class                 Preferred Term                          Frequency BLOOD AND                          Eosinophilia                            Not known LYMPHATIC SYSTEM
DISORDERS
METABOLISM AND                     Alkalosis                               Common NUTRITION                          Hypokalaemia                            Common DISORDERS                          Fluid retention                         Common Hypercalcaemia                          Common
Hypervolaemia                           Uncommon
Anorexia                                Uncommon
Dehydration                             Uncommon
Hyperglycaemia                          Uncommon
Lactic Acidosis                         Uncommon


PSYCHIATRIC                        Insomnia                                Uncommon DISORDERS
NERVOUS SYSTEM                     Dizziness                               Uncommon DISORDERS                          Headache                                Uncommon 
VASCULAR                           Hypertension                            Common DISORDERS                          Hypotension                             Uncommon RESPIRATORY,                       Dyspnoea                                Uncommon THORACIC, AND                      Cough                                   Uncommon MEDIASTINAL
DISORDERS
GASTROINTESTINAL                 Peritonitis                               Common DISORDERS                        Peritoneal membrane failure               Uncommon Abdominal pain                            Uncommon
Dyspepsia                                 Uncommon
Flatulence                                Uncommon
Nausea                                    Uncommon
Encapsulating peritoneal sclerosis        Not known
Cloudy peritoneal effluent                Not known

SKIN AND                         Angioedema                                Not known SUBCUTANEOUS                     Rash                                      Not known TISSUE DISORDERS
MUSCULOSKELETAL                Musculoskeletal pain                      Not known AND CONNECTIVE
TISSUE DISORDERS
GENERAL                        Oedema                                    Common DISORDERS AND                  Asthenia                                  Common ADMINISTRATION                 Chills                                    Uncommon SITE CONDITIONS                Facial oedema                             Uncommon Hernia                                    Uncommon
Malaise                                   Uncommon
Thirst                                    Uncommon
Pyrexia                                   Not known

INVESTIGATIONS                 Weight increased                          Common PCO2 increased                            Uncommon



Other undesirable effects of peritoneal dialysis related to the procedure: bacterial peritonitis, catheter site infection, catheter related complication.

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