July 29, 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

What side effects are possible with Sativex?

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. Many of these side effects can be managed, and some may go away on their own over time.

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.

  • abdominal pain
  • burning sensation in the mouth
  • constipation
  • diarrhea
  • dizziness
  • dry mouth
  • flushing
  • forgetfulness or poor concentration
  • headache
  • increased appetite
  • mood changes
  • nausea
  • sore throat
  • soreness or stinging sensation in mouth
  • tiredness
  • trouble sleeping
  • unusual taste in the mouth
  • vomiting
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

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.





Are there any other precautions or warnings for Sativex?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bladder outflow obstruction: This medication can cause the inability to urinate in people who have medical problems that obstruct the flow of urine from the bladder (e.g., enlarged prostate, prostate cancer). People with a history of bladder outflow obstruction should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: This medication can impair mental and physical abilities. You should avoid driving, operating heavy machinery, or engaging in activities that require mental alertness when using this medication.

Heart problems: This medication may cause low blood pressure and increase your heart rate. You may experience lightheadedness when getting up from a sitting or lying down position (postural hypotension). 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 should not use this medication. People with a history of heart disease or blood pressure problems should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Intoxication: One of the active ingredients in this medication is tetrahydrocannabinol (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. Talk to your doctor if you have any concerns about using this medication.

Kidney disease: People with kidney disease or reduced kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. While taking this medication, your doctor may order blood tests to check how well your kidneys are working.

Liver disease: People with liver disease or reduced liver function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. While taking this medication, your doctor may order blood tests to check how well your liver is working.

Psychiatric disorders: Depressed mood has been reported people taking tetrahydrocannabinol - cannabidiol. People with a history of schizophrenia or psychosis should not use this medication. People taking medications for psychiatric disorders should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report any signs of depression (in sleep, decreased interest in activities, thoughts of suicide ) or other psychiatric changes (mood swings, hallucinations, anxiety) to your doctor as soon as possible.

Seizure disorders: This medication may cause seizures, especially when higher doses are used or when taken with other medications such as:

  • cyclobenzaprine
  • neuroleptics (e.g., haloperidol, quetiapine, olanzapine, resperidone)
  • opioids (e.g., morphine, codeine, oxycodone)
  • promethazine
  • selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)
  • tricyclic antidepressants (TCAs; e.g., amitriptyline, imipramine)

The risk of seizures is also higher for people with epilepsy, a history of seizures, or who are at risk of seizures (e.g., people with head trauma). People with a history of seizure disorders should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Substance abuse disorders: This medication is not recommended for people with addictions as it can cause physical and psychological dependence and has the potential to be abused. People with a history of substance abuse disorders, including alcohol abuse or dependence, should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used by women who are pregnant or intend to start a family. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking tetrahydrocannabinol - cannabidiol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. This medication should not be used in children under 18 years age.

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 Sativex?

There may be an interaction between tetrahydrocannabinol - cannabidiol and 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. 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.

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