What form does Sativex come in?
Each spray (100 µL) contains 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD), together with nonmedicinal ingredients ethanol, propylene glycol and peppermint oil.
How is Sativex used?
Sativex is sprayed under the tongue or on the inside of the cheeks. It shouldn’t be sprayed on the back of the throat or into the nose. After spraying, it takes about 30 minutes for effects to be felt. The usual starting dose is one spray two times a day on the first day. After the first day, doctors may advise increasing the dose by one spray every 24 hours, but no more than 12 doses should be used over a 24-hour period.
Maintenance doses depend on each person’s medical condition and individual response to the drug. The right dose is reached when a balance is achieved between acceptable pain relief with tolerable side effects. Most people require between four and eight doses daily.
Body weight, other medical conditions and other medications can affect the dose of medications a person needs. Sativex is a medication that is taken as needed.
What are the side effects of Sativex?
Side effects are mild to moderate, consisting mainly of either application site reactions in the mouth—dry mouth, stinging, or intoxication—dizziness, disorientation or impaired memory. Diarrhea has also been reported.
These side effects have been reported by at least one percent of people taking this medication. Many of these side effects can be managed; some may go away on their own over time.
• burning sensation in the mouth
• dry mouth
• soreness or stinging sensation in mouth
• unusual taste in the mouth
• sore throat
• flushing
• forgetfulness or poor concentration
• tiredness
• dizziness
• nausea
• mood changes
• trouble sleeping
• weakness
• headache
• abdominal pain
• constipation
• diarrhea
• vomiting
• increased appetite
If you experience new symptoms after beginning Sativex, report this to your doctor. Ask your doctor or pharmacist for advice on how to manage side effects that are severe or bothersome.
More serious side effects:
Most of these side effects don’t happen very often—but they could lead to serious problems. Check with your doctor as soon as possible, if any of the following side effects occur:
• anxiety
• blurred vision
• confusion
• fainting
• falls, or difficulty with balance
• hallucinations (seeing, hearing, or feeling things that are not there) or strange ideas
• intoxication (a feeling of being drunk; e.g., difficulty paying attention, dizziness, sleepiness, disorientation, changes in mood, a feeling of unreality, or a feeling of general happiness or a “high,” such as easy laughter or heightened awareness)
• loss of appetite
• mouth sores
• rapid heartbeat
• severe dizziness
• severe tiredness
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
Stop taking the medication and seek immediate medical attention if any of the following occur:
• blood in the urine
• inability to urinate, bladder pain, or abdominal pain
• signs of a severe allergic reactions (e.g., hives; difficulty breathing; or swelling of the tongue, face, mouth, or throat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Who can use Sativex?
In Canada, New Zealand and some European countries, patients over 18 years old with multiple sclerosis can be treated with Sativex. There are no special precautions for use in elderly patients, but frequent review by the clinician is recommended.
Who should NOT take Sativex?
Sativex should not be used by anyone who:
• is allergic to cannabinoids, propylene glycol, ethanol or peppermint oil
• is under 18 years old
• has a history of schizophrenia or other psychotic disorders
• has serious heart disease, such as ischemic heart disease, irregular heartbeat or rhythm, poorly controlled blood pressure, or severe heart failure
• is a woman of child-bearing age and not using reliable contraception
• is pregnant or breast-feeding
• intends to start a family while on treatment (applies to both men and women)
• has significant hepatic or renal impairment
Sativex may interact with any of the following:
• alcohol
• amphetamines (e.g., dexamphetamine)
• antihistamines (e.g., cetirizine, dimenhydrinate, diphenhydramine, hydroxyzine)
• antipsychotic medications (e.g., olanzepine, quetiapine, risperidone)
• atropine
• barbiturates (e.g., phenobarbital, butalbital)
• benzodiazepines (e.g., clonazepam, diazepam, lorazepam)
• benztropine
• bupropion
• carbamazepine
• cocaine
• cyclobenzaprine
• disulfiram
• MAO inhibitors (e.g, tranylcypromine, phenelzine, moclobemide)
• marijuana or smoked cannabis
• methotrimeprazine
• opioid narcotic medications (e.g., morphine, codeine, fentanyl)
• oxybutynin
• oxymetazoline
• phenytoin
• pseudoephedrine
• salbutamol
• salmeterol
• scopolamine
• selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)
• theophylline
• tiotropium
• tricyclic antidepressants (e.g., amitriptyline, desipramine)
• vigabatrin
• zopiclone
If you are taking any of these medications, speak with your doctor or pharmacist. An interaction between two medications does not always mean that you must stop taking one of them. Your doctor will advise you on how any drug interactions should be managed.