In a first Phase 3 placebo controlled trial over a 6-week treatment period the difference from placebo reached statistical significance but the difference between treatments of 0.5 to 0.6 points on the 0-10 point NRS was of questionable clinical relevance. In a responder analysis 40% Sativex and 22% placebo responded to treatment using the criterion of greater than a 30% reduction in NRS score. Salivix Spray is used for the relief of dry mouth in those aged 6 years of age and over, including the elderly, when saliva production is weakened but potentially functioning salivary gland tissue is still the mouth. Why choose Salivix Spray? If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Cannabis causes problems for some people with their memory, thinking or mental health, or they become dependent on it. But these problems aren’t seen in people who use Sativex, despite it having THC in it. Avoid getting the spray in your eyes. If it gets in your eyes by accident rinse them as soon as possible with water.

Concomitant treatment of Sativex (4 sprays) with the CYP2C9 inhibitor fluconazole (200 mg capsule) resulted in an increase in mean THC Cmax of 22 % and mean AUC of 32 %. Exposure to the metabolite 11-OH-THC also increased by approximately 2.1-fold and 2.5-fold for Cmax and AUC respectively, indicating that fluconazole may inhibit its subsequent metabolism. The Cmax of CBD also increased by approximately 40 % but there was no significant change in AUC. There was no significant change in exposure to 7-OH-CBD either although an increase in the minor circulating metabolite of CBD, 6-OH CBD was noted (by up to 2.2-fold based on Cmax and AUC) .The clinical relevance of this drug-drug interaction is not fully understood, however care should be taken when co-administering Sativex with potent CYP2C9 inhibitors as it may lead to an increase in exposure to THC, CBD and their metabolites. Do not use the product in cases where there's no synthesis of saliva or where there are no salivary glands or where they are severely damaged. The spray can be used either with or without food. However, food can affect how much of the medicine is absorbed, so it is best to try and always use the spray at the same time in relation to food, so you get the same effect each time.

It is not fully understood how THC and CBD work in multiple sclerosis, because the disease and its cause are not fully understood. However, these cannabinoids are known to stimulate the cannabinoid receptors found at the ends of nerves in the central nervous system, including those associated with movement and control of posture. Amber medicines are considered suitable for GP prescribing following specialist initiation or recommendation. Shared Care - these medicines require specialist initiation and stabilisation. Ongoing division of responsibility for drug and disease monitoring between specialist and GP by a Shared Care Guideline (SCG). If no SCG in place status reverts to red. The oral spray contains xylitol and fluoride, which protects against tooth decay, whilst the peppermint flavour promotes fresh breath. How does it work? When Sativex is administered oromucosally, plasma levels of THC and other cannabinoids are lower compared with the levels achieved following inhalation of cannabinoids at a similar dose. A dose of 8 mg of vaporised THC extract, administered by inhalation resulted in mean plasma C max of more than 100 ng/mL within minutes of administration, with significant psychoactivity.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

Sativex oromucosal spray contains two active ingredients, tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which are known as cannabinoids. They are extracted from the leaf and flower of the Cannabis Sativa plant.

Sativex has been studied at doses of up to 48 sprays/day in controlled clinical trials of up to 19 weeks duration in more than 1500 patients with MS. In the pivotal trials to assess the efficacy and safety of Sativex for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) the primary efficacy measure was a 0 to 10 point Numeric Rating Scale (NRS) on which patients indicated the average level of their spasticity related symptoms over the last 24 hours where 0 is no spasticity and 10 is the worst possible spasticity.CBD can also affect how your liver works, so doctors would need to monitor you regularly. How do I get a prescription? If small amounts of Caphosol or NeutraSal are swallowed accidentally, no adverse effects are anticipated. Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. After 12 weeks of treatment, the mean change from baseline for Sativex-treated participants' spasticity severity NRS scores was −1.850 (SD 1.9275) and for placebo participants −1.573 (SD 2.0976). The least square mean difference between the two groups (−0.166, 95% CI −1.119, 0.787) was not statistically significant (p=0.7291).