September 1, 2014
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Sativex

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

DIN (Drug Identification Number)

02266121 SATIVEX 25MG/ML CBD, 27MG/ML THC BUCCAL SPRAY

How does Sativex work? What will it do for me?

This medication contains two ingredients: 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. It is used to treat pain. Although it is not known exactly how THC and CBD work to relieve nerve pain, it is thought to work by mimicking natural pain relievers called cannabinoids that are released in the body.

Tetrahydrocannabinol - cannabidiol is used, along with other medications, to relieve the muscle spasms that occur with multiple sclerosis (MS), when other medications do not provide enough relief. MS is a chronic disease that affects the brain. It is caused by the destruction of myelin, a fatty tissue that allows the nerves to conduct signals to and from the brain.

This medication may also be used in addition to other medications to reduce the nerve pain that is also associated with MS. Tetrahydrocannabinol - cannabidiol has also been used to treat moderate to severe pain in advanced cancer, when the highest doses of other pain relievers do not provide adequate pain relief.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using 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 use this medication if their doctor has not prescribed it.

How should I use Sativex?

Tetrahydrocannabinol - cannabidiol is available as a spray for the mouth. It is sprayed under the tongue or on the inside of the cheeks. The usual starting adult dose of tetrahydrocannabinol - cannabidiol is one spray 2 times a day on the first day. You should start to feel its effects in about 30 minutes. Do not spray the back of the throat or into the nose. After the first day, you may be advised to increase the dose by 1 spray every 24 hours, spacing the doses evenly. No more than 12 doses should be used over a 24 hour period.

The maintenance dose depends on each person's medical condition and individual response to the medication. The right dose is reached when you achieve acceptable pain relief with tolerable side effects. Most people require between 4 and 8 doses daily.

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.

How to prime your spray: Before using a pump spray device for the first time, it must be primed. Shake the vial gently and remove the protective cap. Hold the vial in an upright position and press firmly and quickly on the actuator 2 or 3 times, until a fine spray appears. Point the spray into a tissue, away from yourself, children, and pets when priming.

Normal use: Shake the vial gently and remove the protective cap before using. Holding the vial upright and directing it into your mouth, press firmly and quickly to release the spray under the tongue or towards the inside of the cheek. Regularly change the site that the spray is directed at to reduce irritation.

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 using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of the medication, do not worry. Tetrahydrocannabinol - cannabidiol is a medication that is taken as needed; take another dose as soon as you feel you need to for the pain.

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. Keep it out of the reach of children.

Any unused contents should be discarded after 28 days.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.





What form(s) does Sativex come in?

Each spray (100 µL) contains 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Nonmedicinal ingredients: ethanol, propylene glycol, and peppermint oil.

Who should NOT take Sativex?

Tetrahydrocannabinol - cannabidiol should not be used by anyone who:

  • is allergic to cannabinoids or to any of the ingredients of the medication
  • is a woman of child-bearing age and not using reliable contraception
  • is pregnant or breast-feeding
  • 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
  • intends to start a family while on treatment (applies to both men and women)

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