Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The Sativex clinical program has so far involved over 1500 patients with MS in placebo controlled trials and long-term open label studies in which some patients used up to 48 sprays per day.

The most commonly reported adverse reactions in the first four weeks of exposure were dizziness, which occurs mainly during the initial titration period, and fatigue. These reactions are usually mild to moderate and resolve within a few days even if treatment is continued (see section 4.2). When the recommended dose titration schedule was used, the incidence of dizziness and fatigue in the first four weeks was much reduced.

The frequency of adverse events with a plausible relationship to Sativex, from placebo controlled trials in patients with MS, according to System Organ Classes (SOC) are given below (some of these adverse events may be part of the underlying condition).

MedDRa SOC                Very Common Common                                   Uncommon  1/10       1/100 to  1/10                         1/1000 to  1/100 Infections and pharyngitis infestations
Metabolism and                              anorexia (including appetite nutrition disorders                         decreased), appetite increased hallucination (unspecified,
depression, disorientation,        auditory, visual), illusion,
Psychiatric disorders dissociation, euphoric mood,       paranoia, suicidal ideation,
delusional perception* amnesia, balance disorder,
disturbance in attention,
Nervous system dizziness         dysarthria, dysgeusia,      syncope disorders lethargy, memory impairment somnolence
Eye disorders                               vision blurred
Ear and labyrinth vertigo disorders
Cardiac disorders                                                              palpitations, tachycardia 
Vascular disorders                                                             hypertension Respiratory, thoracic and mediastinal                                                                throat irritation disorders constipation, diarrhoea, dry       abdominal pain (upper), oral mouth, glossodynia, mouth          mucosal discolouration*, oral
Gastrointestinal ulceration, nausea, oral           mucosal disorder, oral mucosal disorders discomfort, oral pain,             exfoliation*, stomatitis, tooth vomiting                           discolouration
General disorders and                       application site pain, asthenia, fatigue administration site                         feeling abnormal, feeling          application site irritation conditions                                  drunk, malaise
Injury, poisoning and fall procedural complaints

* reported in long-term open-label studies:
A single case of ventricular bigeminy has been reported though this was in the context of acute nut allergy.

See also sections 4.4, 4.5 and 4.7.

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/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com