Adverse reactions : תופעות לוואי

4.8   Undesirable effects

For this product there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending on the dose received and also when given in combination with other therapeutic agents.
The following convention has been utilised for the classification of frequency: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data).

Body System                                                 Side effects Neoplasms benign, malignant           Common                Acute secondary haematologic and unspecified (including cysts                            malignancies (especially leukaemia and and polyps)                                                 myelodysplastic syndrome), particularly after long term treatment.
Blood and lymphatic system            Very common           Leukopenia, neutropenia, disorders                                                   thrombocytopenia, pancytopenia or bone marrow suppression1.
Common                Anaemia.
Very rare             Irreversible bone marrow failure.
Immune system disorders               Rare                  Hypersensitivity such as urticaria and angioneurotic oedema following initial or subsequent dosing.
(See Skin and subcutaneous tissue disorders).
Nervous system disorders              Common                Convulsions in children with nephrotic syndrome.
Rare                  Convulsions2, partial and/or generalised in children and adults receiving therapeutic daily doses or high pulse dosing regimens of chlorambucil.
Very rare             Movement disorders including tremor,
muscle twitching and myoclonus in the absence of convulsions. Peripheral neuropathy.
Respiratory, thoracic and             Very rare             Interstitial pulmonary fibrosis3, mediastinal disorders                                       interstitial pneumonia.

Gastrointestinal disorders            Common                Gastro-intestinal disorders such as nausea and vomiting, diarrhoea and mouth ulceration.
Hepatobiliary disorders               Rare                  Hepatoxicity, jaundice.
Skin and subcutaneous tissue          Uncommon              Rash.
disorders                             Rare                  Stevens-Johnson syndrome, toxic epidermal necrolysis. 4 (see Immune system disorders).
Renal and urinary disorders           Very rare             Sterile cystitis.
Reproductive system and breast        Not known             Amenorrhoea, azoospermia.
disorders
General disorders and                 Rare                  Pyrexia.
administration site conditions
1. Although bone marrow suppression frequently occurs, it is usually reversible if Chlorambucil is withdrawn early enough.
2. Patients with a history of seizure disorder may be particularly susceptible.
3. Severe interstitial pulmonary fibrosis has occasionally been reported in patients with chronic lymphocytic leukaemia on long-term Chlorambucil therapy. However, this may be reversible on withdrawal of Chlorambucil.
4. Skin rash has been reported to progress to serious conditions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

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
Additionally, you can also report to Padagis via the following address: Padagis.co.il