Brand Name

Sativex

Common Name

delta-9-tetrahydrocannabinol (THC) - cannabidiol (CBD)

How does this medication work? What will it do for me?

Tetrahydrocannabinol - cannabidiol contains two ingredients used to treat pain: tetrahydrocannabinol (THC) and cannabidiol (CBD). These ingredients belong to the family of medications known as cannabinoids and are extracted from the Cannabis sativa (hemp) plant.

Tetrahydrocannabinol - cannabidiol is used, along with other medications, to relieve the nerve pain that occurs with multiple sclerosis (MS). MS is a chronic disease that affects the brain. It is caused by the destruction of myelin, which is a fatty tissue that allows the nerves to conduct signals to and from the brain. This medication is thought to work by mimicking natural pain relievers released in our body called cannabinoids. However, it is not known exactly how THC and CBD work to relieve nerve pain.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

Tetrahydrocannabinol - cannabidiol is available as a spray for the mouth. It is sprayed under the tongue or on the inside of the cheeks. You should start to feel its effects in about 30 minutes. Do not spray the back of the throat or into the nose.

You can determine the dose that best suits you according to the pain relief you experience from taking tetrahydrocannabinol - cannabidiol.

The usual starting adult dose is one spray every four hours to a maximum of four sprays on the first day. You may need much less than this to control your pain. If your pain is not relieved, increase your dose gradually by a few sprays each day until you achieve acceptable pain relief. The right dose is reached when you achieve acceptable pain relief with tolerable side effects.

Space out your doses evenly throughout the day, or adjust the timing of the dose depending on how you feel. If you experience side effects that you cannot tolerate, try reducing your dose or increasing the time between each dose.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Shake the bottle gently before use. Store unopened bottles in the refrigerator. Do not freeze. Keep away from sources of heat such as direct sunlight or flames (as the product is flammable). Opened bottles may be stored at room temperature. Any unused contents should be discarded after 28 days.

What form(s) does this medication come in?

Each buccal spray contains delta-9-tetrahydrocannabinol 27 mg per mL (from Tetranabinex - Cannabis sativa L. extract) and cannabidiol 25 mg per mL (from Nabidiolex - Cannabis sativa L. extract). Nonmedicinal ingredients: ethanol anhydrous, peppermint oil and propylene glycol.

Who should NOT take this medication?

This medication should not be used by anyone who:

• is allergic to cannabinoids, propylene glycol, ethanol, or peppermint oil
• has significant liver or kidney disease
• has serious heart disease, such as ischemic heart disease, irregular heartbeat or rhythm, poorly controlled blood pressure, or severe heart failure
• has a history of schizophrenia or any other psychotic disorder
• is under 18 years old
• is a woman of child-bearing age and not using reliable contraception
• intends to start a family while on treatment (applies to both men and women)
• is pregnant or breast-feeding

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• cough
• diarrhea
• dizziness
• dry mouth
• forgetfulness, poor concentration
• headache
• increased appetite
• mood changes
• nausea
• sore throat
• soreness or stinging sensation in mouth
• thirst
• tiredness
• unusual taste in the mouth
• vomiting
• weakness

Check with your doctor as soon as possible if any of the following side effects occur:

• confusion
• falls, or difficulty with balance
• hallucinations or strange ideas
• intoxication (a feeling of being drunk, difficulty paying attention, dizziness, sleepiness, disorientation, changes in mood, a feeling of unreality, or a feeling of general happiness or a "high" [easy laughter, heightened awareness])
• rapid heartbeat
• severe dizziness
• severe tiredness

Stop taking the medication and seek immediate medical attention if any of the following occur:

• fainting

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.

Are there any other precautions or warnings for this medication?

Be sure to inform your doctor of all your medical conditions before you begin taking a medication. Some conditions can affect how you should take this medication.

Dependence: This medication can cause physical and psychological dependence and has the potential to be abused. Your condition and treatment should be closely monitored by your doctor.

Drowsiness/reduced alertness: This medication can impair mental and physical abilities. Do not drive, operate heavy machinery, or engage in activities that require mental alertness when using this medication.

Heart problems: This medication may cause low blood pressure and increase your heart rate. It can also cause postural hypotension, which is a drop in blood pressure when changing position. People may experience lightheadedness when getting up from a sitting or lying position. It should not be used by people with severe heart problems such as an irregular heart rate or rhythm, ischemic heart disease (caused by restricted blood-flow to the heart), poorly controlled high blood pressure, or heart failure.

Intoxication: One of the active ingredients in tetrahydrocannabinol - cannabidiol is THC. THC can have many effects on the central nervous system. It can impair memory, mental performance, and the ability to control behaviour. It can also change a person's mood and alter their sense of reality and time. THC can interfere with physical ability to carry out tasks and cause fainting. These reactions tend to occur with larger doses or when the medication is used more frequently in the day. They may improve when the dose is lowered, when the medication is used less frequently, or when it is stopped.

Medical conditions: Talk to your doctor or pharmacist if you have any of the following medical conditions:

• epilepsy
• liver, kidney, or heart disease
• schizophrenia or depression
• irregular heart beat or rhythm, including a fast or slow pulse
• high blood pressure
• an addiction to drugs or alcohol

Psychiatric disorders: Depressed mood has been reported in 5% of people taking tetrahydrocannabinol - cannabidiol. It should not be used by people with a history of schizophrenia or psychosis. It should be used cautiously by people taking medications for psychiatric disorders.

Seizure disorders: The effects of this medication on people with epilepsy are unknown. This medication should be used with caution when treating people with epilepsy.

Substance abuse disorders: This medication should be used cautiously by people with a history of substance abuse disorders, including alcohol abuse or dependence. It is not recommended for people with addictions.

Pregnancy: This medication should not be used by women who are pregnant or intend to start a family. This medication must be used with reliable contraception during treatment and for three months after stopping it.

Breast-feeding: It is not known if this medication passes into breast milk. Breast-feeding mothers should not use this medication.

Children: Children under 18 years old should not use this medication.

Seniors: The safety and effectiveness of this medication have not been established for seniors. Seniors using this medication should be monitored closely by their doctor.

What other drugs could interact with this medication?

The following medications may affect how tetrahydrocannabinol - cannabidiol works or increase the risk of side effects:

• alcohol
• marijuana or smoked cannabis
• opioids (e.g., morphine, codeine, fentanyl)
• sedatives or hypnotics (e.g., barbiturates, diazepam, zopiclone)

The following medications may be affected by tetrahydrocannabinol - cannabidiol or increase the risk of side effects:

• amitriptyline

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

By:  Medbroadcast. Canada