Adverse reactions : תופעות לוואי

4.8.     Undesirable Effects

The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their incidence depending on the indication.
The following convention has been used for the classification of undesirable effects in terms 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, very rare <1/10,000.

Blood and lymphatic system disorders:
Very rare: Anaemia, leukopenia, thrombocytopenia.

Immune system disorders:
Rare: Anaphylaxis.
Psychiatric and nervous system disorders:
Common: Headache, dizziness.
Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma.
The above events are generally reversible and usually reported in patients with renal impairment or with other predisposing factors (see 4.4 Special Warnings and Precautions for Use).

Respiratory, thoracic and mediastinal disorders:
Rare: Dyspnoea.

Gastrointestinal disorders:
Common: Nausea, vomiting, diarrhoea, abdominal pains.
Hepato-biliary disorders:
Rare: Reversible rises in bilirubin and liver related enzymes.
Very rare: Hepatitis, jaundice.

Skin and subcutaneous tissue disorders:
Common: Pruritus, rashes (including photosensitivity).
Uncommon: Urticaria. Accelerated diffuse hair loss. Accelerated diffuse hair loss has been associated with a wide variety of disease processes and medicines, the relationship of the event to aciclovir therapy is uncertain.
Rare: Angioedema.

Renal and urinary disorders:
Rare: Increases in blood urea and creatinine.
Very rare: Acute renal failure, renal pain.
Renal pain may be associated with renal failure and crystalluria.

General disorders and administration site conditions:
Common: Fatigue, fever.
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 should also report to GSK Israel (il.safety@gsk.com)