Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Nausea can commonly occur on initial treatment and occasionally skin rash can occur. Duodenitis and severe colitis have been reported. Neurological deterioration can occur at the start of the treatment.

Tabulated list of adverse reactions
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies are defined as: 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 4
known (cannot be estimated from the available data).

MedDRA- system organ class database                  Adverse reaction Blood and lymphatic system disorders:                Uncommon: Anaemia Uncommon: Aplastic anaemia
Uncommon: Sideroblastic anaemia
Nervous system disorders:                            Uncommon: Dystonia Uncommon: Tremor
Not known: Dysarthria
Not known: Muscle rigidity
Not known: Neurological deterioration
Immune system disorders:                             Not known: Lupus-like syndrome
Not known: Lupus nephritis
Gastrointestinal disorders:                          Common: Nausea
Not known: Colitis
Not known: Duodenitis
Skin and subcutaneous tissue disorders:              Uncommon: Rash

Description of selected adverse reactions
There have been reports of neurological deterioration at the start of treatment in Wilson’s disease patients treated with copper chelators including trientine, with symptoms of, for example, dystonia, rigidity, tremor and dysarthria (see section 4.2).

Paediatric population
Clinical trials with Cufence including a limited number of children in the age range of 5 to 17 years at the start of treatment indicate that frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

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