Adverse reactions : תופעות לוואי

4.8 Undesirable Effects
Summary of safety profile
The most commonly reported adverse reactions are hypokalaemia, hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions and maculopapular rashes.

Tabulated summary of adverse reactions
The following undesirable effects have been observed with indapamide during treatment ranked under the following frequency:
Very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100); rare (> 1/10000, < 1/1000), very rare (> 1/100000, < 1/10000), not known (cannot be estimated from the available data).
MedDRA                      Undesirable Effects               Frequency System Organ Class
Blood and the             Agranulocytosis                            Very rare lymphatic System          Aplastic anaemia                           Very rare Disorders                 Haemolytic anaemia                         Very rare Leucopenia                                 Very rare
Thrombocytopenia                           Very rare
Metabolism and            Hypokalaemia (see section 4.4)             Common Nutrition Disorders       Hyponatraemia (see section 4.4)            Uncommon Hypochloraemia                             Rare
Hypomagnesaemia                            Rare
Hypercalcaemia                             Very rare
Nervous System            Vertigo                                    Rare disorders                 Fatigue                                    Rare Headache                                   Rare
Paraesthesia                               Rare
Syncope                                    Not known
Eye disorders             Myopia                                     Not known Blurred vision                             Not known
Visual impairment                          Not known
Acute angle-closure glaucoma               Not known
Choroidal effusion                         Not known
Cardiac Disorders         Arrhythmia                                 Very rare Torsade de pointes (potentially fatal)     Not known
(see sections 4.4 and 4.5)
Vascular Disorders        Hypotension                                Very rare Gastrointestinal          Vomiting                                   Uncommon Disorders                 Nausea                                     Rare Constipation                               Rare
Dry mouth                                  Rare
Pancreatitis                               Very rare
Hepatobiliary Disorders   Abnormal hepatic function                  Very rare Possibility of onset of hepatic            Not known encephalopathy in case of hepatic insufficiency (see sections 4.3 and 4.4)
Skin and Subcutaneous     Hypersensitivity reactions                 Common Tissue Disorder           Maculopapular rashes                       Common Purpura                                    Uncommon
Angioedema                                 Very rare
Urticaria                                  Very rare
Toxic epidermal necrolysis                 Very rare
Stevens-Johnson Syndrome                   Very rare
Possible worsening of pre-existing         Not known acute disseminated lupus erythematosus
Photosensitivity reactions (see section    Not known
4.4)
Renal and Urinary         Renal failure                              Very rare Disorders
Musculoskeletal              Muscle spasms                             Not known and Connective               Muscular weakness                         Not known Tissue Disorders             Myalgia                                   Not known Rhabdomyolysis                            Not known
Reproductive                 Erectile dysfunction                      Uncommon System and Breast
Disorders
Investigations               Electrocardiogram QT prolonged (see       Not known sections 4.4 and 4.5)
Blood glucose increased (see section      Not known
4.4)
Blood uric acid increased (see section    Not known
4.4)
Elevated liver enzyme levels              Not known


Description of selected adverse reactions
During phase II and III studies comparing indapamide 1.5mg and 2.5mg, plasma potassium analysis showed a dose-dependent effect of indapamide: - Indapamide 1.5mg: Plasma potassium <3.4 mmol/l was seen in 10% of patients and <3.2 mmol/l in 4% of patients after 4 to 6 weeks treatment.
After 12 weeks treatment, the mean fall in plasma potassium was 0.23 mmol/l.
- Indapamide 2.5mg: Plasma potassium <3.4 mmol/l was seen in 25% of patients and <3.2 mmol/l in 10% of patients after 4 to 6 weeks treatment.
After 12 weeks treatment, the mean fall in plasma potassium was 0.41 mmol/l.

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/