Common adverse reactions 1

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

Adverse events with a plausible relationship to Sativex, from placebo-controlled trials in patients with MS. Some of these adverse events may be part of the underlying condition.
MedDRa SOCVery Common ≥ 1/10Common ≥ 1/100 to < 1/10Uncommon ≥ /1000 to < 1/100
Infections and infestations  Pharyngitis
Metabolism and nutrition disorders Anorexia (including appetite decreased); appetite increased 
Psychiatric disorders Depression; disorientation; dissociation; euphoric moodHallucination (unspecified, auditory, visual); illusion; paranoia; suicidal ideation; delusional perception*
Nervous system disordersDizzinessAmnesia; balance disorder; disturbance in attention; dysarthria; dysgeusia; lethargy; memory impairment somnolenceSyncope
Eye disorders Vision blurred 
Ear and labyrinth disorders Vertigo 
Cardiac disorders  Palpitations; tachycardia
Vascular disorders  Hypertension
Respiratory, thoracic and mediastinal disorders  Throat irritation
Gastrointestinal disorders Constipation; diarrhoea; dry mouth; glossodynia; mouth ulceration; nausea; oral discomfort; oral pain; vomitingAbdominal pain (upper); oral mucosal discolouration*; oral mucosal disorder; oral mucosal exfoliation*; stomatitis; tooth discolouration
General disorders and administration site conditionsFatigueApplication site pain; asthenia; feeling abnormal; feeling drunk; malaiseApplication site irritation
Injury, poisoning and procedural complaints Fall 
* Reported in long-term open-label studies

Drug interactions 1

However care should be taken with hypnotics, sedatives and drugs with potential sedating effects as there may be an additive effect on sedation and muscle relaxing effects.

Also, although there has been no greater rate of adverse events in patients already taking anti-spasticity agents when they also take Sativex, care should be taken when co-administering Sativex with anti-spasticity agents, since a reduction in muscle tone and power may occur, leading to a greater risk of falls.

Refer to the SmPC for details of interactions with other medicinal products and other forms of interaction.

Abuse potential 1

In a study designed to identify its abuse potential, Sativex at a dose of four sprays taken at one time did not differ significantly from placebo.

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