Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Gastro-intestinal disorders:
Common: dry mouth, diarrhoea, abdominal pain (including dyspepsia), nausea.
Not known: vomiting.
Central nervous system disorders and psychiatric disorders:
Common: drowsiness often transient, headache, dizziness,
Uncommon: anxiety and depression.

Liver disorders:
Uncommon: raised liver enzymes.
Hematological disorders:
Very rare: low neutrophil count.

Body as a whole:
Common: asthenia often transient, increased appetite associated with weight gain.
Very rare: allergic reactions including anaphylaxis, angioedema, generalized rash/urticaria, pruritus and hypotension.
Cardiovascular disorders:
Uncommon: hypotension, tachycardia, palpitations.
Very rare: vasovagal attack

2
Musculoskeletal disorders:
Uncommon: arthralgia and myalgia.

Description of selected adverse reactions
There were reports of bronchospasm and aggravation of asthma but in view of the high frequency of asthma in the patient population being treated, a causal relationship remains uncertain.
Treatment with certain antihistamines has been associated with QT interval prolongation increasing the risk of serious cardiac arrhythmias in susceptible subjects.
Minor changes in blood sugar and electrolytes have been observed rarely. The clinical significance of these changes in otherwise healthy individuals remains unclear. Patients at risk (diabetics, those susceptible to electrolyte imbalance and cardiac arrhythmias) should be monitored periodically.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il