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THC + CBD oromucosal spray Pregnancy: Should not be used during pregnancy unless the potential risks to the foetus and/or embryo are considered to be outweighed by the benefit of treatment. Contraindicated during breast-feeding. Men and women of childbearing potential should take reliable contraceptive precautions for the duration of therapy and for three months after discontinuation; patients on hormonal contraceptives should use an additional alternative non-hormonal or reliable barrier method during therapy. No effect on fertility was seen in rodent fertility studies, although independent animal research found that cannabinoids affected spermatogenesis.

Cannabis extract

Brand names: Sativex (nabiximols)

Cannabis-based extracts are unlicensed or specially licensed preparations sometimes used under specialist supervision for certain refractory conditions such as treatment-resistant epilepsy or spasticity.

Adult dose

Dose: Moderate-to-severe spasticity in multiple sclerosis that has responded inadequately to other anti-spasticity medication, as an add-on to the patient's current anti-spasticity medication — adults: titrate from 1 spray, increasing by 1 spray per day, until optimum symptom relief is achieved; the median dose in multiple sclerosis clinical trials was 8 sprays per day and the maximum is 12 sprays per day
Route: Oromucosal use only. The spray container should be shaken before use and the spray directed at different sites on the oromucosal surface, changing the application site each time the product is used. Administration should be standardised as far as possible in relation to food intake to minimise variability of bioavailability in the individual patient
Frequency: During titration, split between a morning dose taken at any time between waking and midday and an afternoon/evening dose taken at any time between 4 pm and bedtime; once the optimum dose has been achieved patients may spread the doses throughout the day according to individual response and tolerability. There should be at least a 15-minute gap between sprays
Max: 12 sprays per day — the SPC states patients 'may continue to gradually increase the dose by 1 spray per day, up to a maximum of 12 sprays per day' and that 'Doses of greater than 12 sprays per day are not recommended.' This is the ceiling for the same multiple sclerosis spasticity indication as the dose above. NOTE: the milligram content of a spray is not quoted in this bundle, so no mg figure is given here
Treatment must be initiated and supervised by a physician with specialist expertise in treating this patient population, and Sativex is intended to be used in addition to the patient's current anti-spasticity medication. TITRATION TABLE, verbatim day by day (morning sprays / evening sprays / total per day): day 1 = 0/1/1; day 2 = 0/1/1; day 3 = 0/2/2; day 4 = 0/2/2; day 5 = 1/2/3; day 6 = 1/3/4; day 7 = 1/4/5; day 8 = 2/4/6; day 9 = 2/5/7; day 10 = 3/5/8; day 11 = 3/6/9; day 12 = 4/6/10; day 13 = 4/7/11; day 14 = 5/7/12. Patients should be advised that it might take up to 2 weeks to find the optimal dose and that undesirable effects, most commonly dizziness, can occur during this time; these are usually mild and resolve in a few days, but physicians should consider maintaining the current dose, reducing it, or interrupting treatment at least temporarily depending on seriousness and intensity. MAINTENANCE: patients are advised to maintain the optimum dose achieved; re-titration upwards or downwards may be appropriate if the severity of the condition changes, concomitant medication changes, or troublesome adverse reactions develop. TRIAL OF THERAPY: a thorough evaluation of the severity of spasticity-related symptoms and of the response to standard anti-spasticity medication should be performed before initiation; response should be reviewed after four weeks and treatment stopped if a clinically significant improvement in spasticity-related symptoms is not seen — in the clinical trials this was defined as at least a 20% improvement on a 0-10 patient-reported numeric rating scale. The value of long-term treatment should be re-evaluated periodically. Starting or stopping some concomitant medicinal products may require a new dose titration. ELDERLY: no specific studies have been carried out, although patients up to 90 years of age have been included in clinical trials; elderly patients may be more prone to develop some CNS adverse reactions.

Paediatric dose

Route: Not applicable — not recommended below 18 years of age
Frequency: Not applicable
NO PAEDIATRIC DOSE IS PUBLISHED BECAUSE THE SPC RECOMMENDS AGAINST USE. Verbatim: 'Sativex is not recommended for use in children or adolescents below 18 years of age. A randomised placebo-controlled trial was performed in children and adolescents with cerebral palsy or traumatic central nervous system injury and its results regarding efficacy were negative.' dosePerKg is null — this product is not dosed by weight in any age group, and no paediatric figure may be derived from the adult titration.

Dose adjustments

Renal

No data with multiple dosing are available in subjects with renal impairment. Lower daily doses may be needed in patients with moderate or severe renal impairment because of increased exposures observed in a severe renal impairment study. Frequent clinical evaluation by a clinician is recommended. The SPC gives no numerical reduced dose.

Hepatic

No data with multiple dosing are available in subjects with hepatic impairment. Can be administered to patients with mild hepatic impairment without any dose adjustment. Administration to patients with moderate or severe hepatic impairment is not advised, due to the lack of information on the potential for accumulation of THC and CBD with chronic dosing. Frequent clinical evaluation by a clinician is recommended.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to cannabinoids or to any of the excipients
  • Any known or suspected history or family history of schizophrenia, or other psychotic illness
  • History of severe personality disorder or other significant psychiatric disorder other than depression associated with the underlying condition
  • Breast feeding — in view of the considerable levels of cannabinoids likely in maternal breast milk and the potential adverse developmental effects in infants

Side effects

  • Very common: dizziness, occurring mainly during the initial titration period
  • Very common: fatigue
  • Common: somnolence, disturbance in attention, balance disorder, dysgeusia, lethargy, dysarthria, memory impairment, amnesia, syncope
  • Common: disorientation, euphoric mood, depressed mood, depression, dissociation
  • Common: vertigo, vision blurred
  • Common: nausea, diarrhoea, dry mouth, vomiting, constipation, oral pain, mouth ulceration, oral discomfort, glossodynia, tooth discolouration, upper abdominal pain, oral disorder
  • Common: decreased appetite, muscular weakness, throat irritation, pharyngitis
  • Common: application site pain, asthenia, feeling abnormal, feeling drunk, malaise, fall
  • Uncommon: hallucination (unspecified, auditory, visual), paranoia, suicidal ideation, illusion, delusional perception
  • Uncommon: palpitations, tachycardia, hypertension
  • Uncommon: oral mucosal discolouration, oral mucosal exfoliation, stomatitis, application site irritation, increased appetite
  • This list is taken from the tabulated section 4.8 of the quoted SPC and reflects placebo-controlled and open-label trials in patients with multiple sclerosis

Monitoring

  • Pulse rate and blood pressure — alterations have been observed following initial dose introduction, so caution during initial dose titration is essential; fainting episodes have been observed and use is not recommended in patients with serious cardiovascular disease
  • Neuropsychiatric state — anxiety, illusions, changes in mood and paranoid ideas have been reported; if disorientation or confusion, hallucinations, delusional beliefs, transient psychotic reactions or suicidal ideation occur, stop immediately and monitor the patient until symptoms have completely resolved
  • Risk of falls — spasticity may be reduced beyond the muscle strength available to maintain posture or gait; warn patients of a possible additive effect with muscle relaxants such as baclofen and benzodiazepines
  • Caution in patients with a history of epilepsy or recurrent seizures
  • Oromucosal application site — change the application site with each use
  • Contraception in women of childbearing potential — highly effective contraception is required, and hormonal contraceptive effectiveness may be reduced, so an additional method should be used during therapy and for three months after discontinuation
  • History of substance abuse — such patients may be more prone to abuse this product
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

Effects derive chiefly from cannabinoids such as cannabidiol and tetrahydrocannabinol acting on the endocannabinoid system and other neuronal pathways, with the contribution of each constituent varying by preparation.

Prescribing in practice

  • Prescribing of unlicensed cannabis-based products should be initiated only by specialists on the General Medical Council specialist register, in line with national guidance.
  • Tetrahydrocannabinol-containing preparations can cause psychoactive effects, sedation and impaired cognition, and have abuse potential.
  • Product composition and quality vary between preparations, so equivalence between products cannot be assumed.

Monitoring

Monitor clinical response, psychiatric and cognitive effects, and tolerability, with review against the specific preparation's specialist recommendations.

Counselling the patient

  • These products should be taken only as directed by the specialist team.
  • Avoid driving or operating machinery if experiencing drowsiness or impaired concentration.
  • Report mood changes, hallucinations or excessive sedation.

Evidence & guidelines

Evidence remains limited for most indications; NICE advises specialist-led prescribing and notes that robust trial data are restricted to particular cannabinoid products.

Reference: NICE NG144; ABN MS spasticity; SmPC; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Pathways