Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), 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).
Blood and lymphatic system disorders:
Uncommon: red blood cell count decreased, white blood cell count decreased and platelet count decreased. These changes are usually mild.

Immune system disorders:
Very rare: antinuclear antibody increased with and without systemic inflammation 
Psychiatric disorders:
Rare: hallucination, depression, confusional state, anxiety, amnesia, insomnia, nervousness 
Nervous system disorders:
Very common: giddiness, dizziness and light headedness which are usually transient 
Rare: During long term therapy a few cases of neuropathy peripheral, paraesthesia and ataxia have been reported. Rare instances of dyskinesia have been reported, which have improved on withdrawal of Tambocor tablets therapy. Hypoaesthesia, hyperhidrosis, syncope, tremor, somnolence, headache, and convulsion.

Eye disorders:
Very common: visual impairment, such as diplopia and vision blurred. These are usually transient and disappear upon continuing or reducing the dosage.
Very rare: corneal deposits

Ear and labyrinth disorders:
Rare: tinnitus, vertigo

Cardiac disorders:
Common: Proarrhythmia (most likely in patients with structural heart disease and/or significant left ventricular impairment).
Uncommon: Patients with atrial flutter can develop a 1:1 AV conduction with increased heart rate. These effects are most common following the use of the injection for acute conversion. This effect is usually short lived and abates quickly following cessation of therapy.
Not known: atrioventricular block-second-degree and atrioventricular block third degree, cardiac arrest, bradycardia, cardiac failure/ cardiac failure congestive, chest pain, hypotension, myocardial infarction, palpitations, sinus pause or arrest and tachycardia (AT or VT) or ventricular fibrillation. Demasking of a pre-existing Brugada syndrome. Dose-related increases in PR and QRS intervals may occur (see section 4.4). Altered pacing threshold (see section 4.4).

Vascular disorders
Rare: flushing

Respiratory, thoracic and mediastinal disorders:
Common: dyspnoea
Rare: pneumonitis
Not known: pulmonary fibrosis, insterstitial lung disease
Gastrointestinal disorders:
Uncommon: nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhoea, dyspepsia, flatulence
Very rare: dry mouth, taste disorders

Hepatobiliary disorders:
Rare: hepatic enzymes increased with and without jaundice. So far this has always been reversible on stopping treatment.
Not known: hepatic dysfunction

Skin and subcutaneous tissue disorders:
Uncommon: dermatitis allergic, including rash, alopecia
Rare: serious urticaria
Very rare: photosensitivity reaction

Musculoskeletal and connective tissue disorders
Very rare: arthralgia and myalgia
Reproductive system and breast disorders
Very rare: impotence

General disorders and administration site conditions:
Common: asthenia, fatigue, pyrexia, oedema

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.