Tetrahydrocannabinol and Cannabidiol Overview

(TET ra hye droe can NAB e nol & can nab e DYE ol)

Sativex®

Analgesic, Miscellaneous

• This medicine may be habit-forming; avoid long-term use. Tell healthcare provider if you have a history of drug or alcohol abuse. May cause serious heart-related side effects. Tell healthcare provider if you have any heart disease.

• This medicine may cause fast heartbeats, blood pressure changes, dizziness, mood changes, or a change in thinking clearly and logically.

• Talk with healthcare provider if you have seizures or have ever had seizures.

• If you have an allergy to tetrahydrocannabinol, cannabidiol, or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you have any of the following conditions: Heart disease, schizophrenia, severe kidney disease, or severe liver disease.

• If you are a male patient with a sexual partner who plans on becoming pregnant at any time while you are being treated.

• If you are pregnant or may be pregnant.

• If you are breast-feeding.

• Tetrahydrocannabinol and cannabidiol work through the brain to relieve pain and spasms.

• Do not spray near an open flame.

• Shake well before use.

• Do not apply spray to irritated mouth.

• Prime pump by squeezing it 2-3 times.

• Spray into mouth below the tongue or on the inside of the cheeks.

• Do not spray the back of the throat.

• Move site in the mouth with each spray.

• Take a missed dose as soon as possible.

• If it is almost time for the next dose, skip the missed dose and return to your regular schedule.

• Do not take a double dose or extra doses.

• Many times this medicine is taken on an as needed basis.

• Change in condition being treated. Is it better, worse, or about the same?

• Dry mouth may cause an increase in cavities. Take good care of your teeth. See a dentist regularly.

• Follow up with healthcare provider.

• Store unopened vials in a refrigerator. Do not freeze.

• Store opened vials at room temperature. Throw away any unused portion after 1 month.

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Most medicines can be thrown away in household trash after mixing with coffee grounds or kitty litter and sealing in a plastic bag.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.

Created: 2006-10-13 11:49:39.0

Modified: 2010-05-06 15:12:02.0

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