Adverse reactions : תופעות לוואי

4.8.   Undesirable effects
Summary of the safety profile
In general, the adverse reactions of digoxin are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect.

Hence, adverse reactions are less common when digoxin is used within the recommended dose range or therapeutic serum concentration range and when there is careful attention to concurrent medications and conditions.

Tabulated list of adverse reactions
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as:
Very common ≥ 1/10
Common ≥ 1/100 and < 1/10
Uncommon ≥ 1/1000 and < 1/100
Rare ≥ 1/10,000 and < 1/1000
Very rare < 1/10,000, including isolated reports.

Very common, common and uncommon events were generally determined from clinical trial data.
The incidence in placebo was taken into account. Adverse drug reactions identified through post- marketing surveillance were considered to be rare or very rare (including isolated reports).

System Organ Class                   Frequency      Side effects

Blood and lymphatic system           Very rare      Thrombocytopaenia disorders
Metabolism and nutrition disorders   Very rare       Decreased appetite Psychiatric disorders                Uncommon       Depression
Very rare      Psychotic disorder, apathy, confusional state
Nervous system disorders             Common         Nervous system disorder, dizziness Very rare      Headache
Eye disorders                        Common         Visual impairment (blurred vision or xanthopsia) Cardiac disorders                    Common         Arrhythmia, conduction disorder, bigeminy, trigeminy, PR prolongation, sinus bradycardia
Very rare      Supraventricular tachyarrhythmia, atrial tachycardia (with or without block),
supraventricular tachycardia (nodal arrhythmia),
ventricular arrhythmia, ventricular extrasystoles,
electrocardiogram ST segment depression
Gastrointestinal disorders           Common         Nausea, vomiting, diarrhoea Very rare      Intestinal ischaemia, gastrointestinal necrosis
Skin and subcutaneous tissue         Common         Rash* disorders
Reproductive system and breast       Very rare      Gynaecomastia* disorders
General disorders and administration Very rare      Fatigue, malaise, asthenia site conditions

*See “Description of selected adverse reactions”

Description of selected adverse reactions
Skin and subcutaneous tissue disorders
Skin rashes of urticarial or scarlatiniform character may be accompanied by pronounced eosinophilia.

Reproductive system and breast disorders
Gynaecomastia can occur with long term administration.

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 http://sideeffects.health.gov.il Additionally, you can also report to Padagis via the following address: Padagis.co.il