Cannabinoids (Sativex)

How does it work?

Sativex oromucosal spray contains two active ingredients, tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which are known as cannabinoids. They are extracted from the leaf and flower of the Cannabis Sativa plant.

Sativex spray is used to help improve the symptoms of muscle tightening (spasticity) in people with multiple sclerosis (MS).

It is not fully understood how THC and CBD work in multiple sclerosis, because the disease and its cause are not fully understood. However, these cannabinoids are known to stimulate the cannabinoid receptors found at the ends of nerves in the central nervous system, including those associated with movement and control of posture.

The effect of the cannabinoids is to reduce limb stiffness and related pain and improve movement.

The medicine is sprayed under the tongue or onto the inside of your cheek. It is absorbed into the bloodstream through the rich supply of blood vessels in these areas.

What is it used for?

  • To help improve moderate to severe symptoms of multiple sclerosis, such as stiffness and spasms, that are caused by muscle tightening (spasticity).

Sativex spray is used in addition to other medicines for people who have had an inadequate response to other muscle relaxant medicines and who show a significant improvement in symptoms after an initial four week trial period.

Treatment with this medicine can only be started by specialists in multiple sclerosis.

How do I use and store the spray?

  • It is important that you carefully follow the instructions you have been given with this medicine. The number of sprays you use each day should be gradually increased when you first start using the medicine. Everyone using this medicine will need a slightly different dose and it can take up to two weeks until you reach the optimum dose for you. When you first start treatment you may experience side effects such as dizziness, but these are usually mild and improve in a few days. You should follow the instructions given by your doctor.
  • Each time you use the spray make sure you use a different area of the mouth. This helps to prevent discomfort and irritation developing in one place.
  • Do not breathe in the spray.
  • Avoid getting the spray in your eyes. If it gets in your eyes by accident rinse them as soon as possible with water.
  • Avoid using the spray near children, pets, naked flames or heat sources.
  • • Sativex spray should be stored upright in a refrigerator at 2 to 8°C until opened. Once opened it can be kept and used at room temperature. It should be kept upright and away from heat and direct sunlight. The opened spray must not be used for longer than six weeks (42 days). Write the date that you open your spray on the sticker provided in the box and stick it on the spray so that you know when it was opened. Any medicine left after six weeks should be disposed of carefully, preferably by returning to your pharmacist.

Warning!

  • This medicine may cause drowsiness and dizziness and can also cause some people to faint. It can also affect your concentration and judgement. You should not drive, operate machinery or perform other potentially hazardous activities until you know how this medicine affects you and are sure you can perform such activities safely.
  • If you drink alcohol while using this medicine it may have an additional effect on your co-ordination, concentration and ability to respond quickly.
  • Sativex spray is a controlled drug, so its legal status will vary between countries. Before taking this medicine abroad you should check its legal status in the countries you are travelling through and to. You should also be aware that it may not be legal to use this medicine when driving in some countries.
  • It is important that both men and women use a reliable contraception method whilst using this medicine and for at least three months after stopping treatment.
  • This medicine contains a small amount of alcohol that is insignificant for most people. However, if you have been told to avoid alcohol completely you should talk to your doctor about this.
  • If you stop taking this medicine suddenly your sleep, appetite or feelings might be affected for a short time. Your muscle stiffness usually comes back gradually if you stop using Sativex.

Use with caution in

  • Elderly people.
  • History of epilepsy or recurrent seizures.
  • People with a history of drug abuse.
  • Decreased kidney function.
  • Decreased liver function.
  • People with serious cardiovascular disease, such as angina or a history of heart attack.

Not to be used in

  • People with symptoms of, or a history of schizophrenia or other psychotic illness.
  • People with a history of severe personality disorders.
  • People with symptoms of, or a history of other serious psychiatric illness (not including depression due to your MS).
  • People with a family history of significant psychiatric illness, such as schizophrenia, psychosis or personality disorders.
  • Breastfeeding.
  • Sativex spray is not recommended for children and adolescents under 18 years of age, as it has not been studied in this age group.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless the potential benefits outweigh the potential risks to the developing baby.
  • Women who could get pregnant should use effective contraception to avoid pregnancy during treatment, and for at least three months after they stop treatment. Men using this medicine whose partner could get pregnant must use a condom during their treatment and for at least three months after they stop treatment.
  • This medicine passes into breast milk and could have adverse effects on a nursing infant. It must not be used by mothers who are breastfeeding.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

  • Dizziness.
  • Fatigue.

Common (affect between 1 in 10 and 1 in 100 people)

  • Increase or decrease in appetite.
  • Disturbances of the gut, such as constipation, diarrhoea, nausea and vomiting.
  • Pain at site of application in the mouth.
  • Pain in the tongue.
  • Changes in the mouth, such as ulcers, pain, dry mouth and change in taste.
  • Depression.
  • Feeling disorientated.
  • Feeling lethargic or sleepy.
  • Confusion.
  • Feeling abnormal or drunk.
  • Weakness or loss of strength (asthenia).
  • A general feeling of being unwell (malaise).
  • Loss of balance and falling over.
  • Blurred vision.
  • Spinning sensation.
  • A state of well-being, optimism and cheerfulness (euphoria).
  • Concentration or memory difficulties.
  • Speech difficulties.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

  • Inflammation of the throat (pharyngitis).
  • Throat irritation.
  • Discoloration of teeth and mouth.
  • Inflammation of the lining of the mouth (stomatitis).
  • Redness and peeling of skin inside the mouth.
  • Abdominal pain.
  • Hallucinations, paranoia, delusions or suicidal thoughts. (Stop taking this medicine and tell your doctor straight away if you experience any of these effects.)
  • Fainting.
  • Awareness of your heartbeat (palpitations).
  • Increased heart rate (tachycardia).
  • High blood pressure (hypertension).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

There may be an increased risk of drowsiness and sedation if this medicine is taken with any of the following (which can also cause drowsiness):

  • alcohol
  • antipsychotics, eg chlorpromazine, clozapine
  • barbiturates, eg phenobarbital
  • benzodiazepines, eg temazepam
  • MAOI antidepressants, eg phenelzine
  • sedating antihistamines, eg chlorphenamine
  • sleeping tablets, eg zopiclone
  • strong opioid painkillers, eg morphine, codeine, dihydrocodeine
  • tricyclic antidepressants, eg amitriptyline.

Using other muscle relaxant medicines, such as baclofen and diazepam together with Sativex spray can result in decreased muscle tone and power. This may affect balance and movement which can increase the risk of falls.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK that contain delta-9 tetrahydrocannabinol and cannabidiol as the active ingredients.