Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Adverse drug reactions from clinical trials, spontaneous reports and literature cases are listed by MedDRA system organ class. Adverse drug reactions are ranked under heading of Preferred Term (PT) frequency, with the most frequent first. Since reactions from spontaneous reports and literature cases are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. The following convention is used: very common (≥ 1/10); common (≥ 1/100,<1/10); uncommon (≥ 1/1,000<1/100); rare (≥ 1/10,000<1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data), including isolated reports. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Infections and infestations
Uncommon:           Cystitis
Immune system disorders
Very rare:       Erythema multiforme, Stevens-Johnson syndrome, severe skin reaction
Metabolism and nutrition disorders
Rare:            Weight increased
Psychiatric disorders**
Common:           Agitation, irritability, insomnia, nervousness Nervous system disorders
Uncommon:         Dizziness*
Rare:             Sedation*
Not known:        Convulsions, Somnolence, headache

Gastrointestinal disorders
Uncommon:         Dry mouth*
Not known: Vomiting, nausea, diarrhoea
Hepatobiliary disorders
Very rare:        Hepatitis, hepatic enzymes increased
Skin and subcutaneous tissue disorders
Not known: Rash, urticaria

* Somnolence and sedation, dry mouth and dizziness may occur at the beginning of treatment, but usually disappear spontaneously with continued medication. There have been reports of nausea, vomiting, headache, convulsion, urticaria and rash.
**Symptoms of CNS stimulation, such as agitation, irritability, insomnia and nervousness have been observed particularly in children.


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/
In addition, you can report online to Padagis Israel pharmaceuticals LTD at the following address: Padagis.co.il.