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SATIVEX OROMUCOSAL SPRAY

Active substance: DELTA(9)-TETRAHYDROCANNABINOL

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PE0018.V6

(delta-9-tetrahydrocannabinol and cannabidiol)

Package leaflet: Information for the patient

Sativex® is a registered trade mark of GW Pharma Ltd.
a

Package leaflet: Information for the patient

Sativex® Oromucosal Spray
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4
What is in this leaflet:

Page

1. What Sativex is and what it is used for. . . . . . . . 2
2. What you need to know before you use Sativex. 3
3. How to use Sativex. . . . . . . . . . . . . . . . . . . . . . . . 9
4. Possible side effects. . . . . . . . . . . . . . . . . . . . . . 15
5. How to store Sativex. . . . . . . . . . . . . . . . . . . . . . 18
6. Contents of the pack and other information. . . 19
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1. What Sativex is and what it is used for
What Sativex is
Sativex is a mouth spray which contains cannabis extracts called
cannabinoids.
What Sativex is used for
Sativex is used in multiple sclerosis (MS) to improve symptoms
related to muscle stiffness. This is also called “spasticity”.
Spasticity means there is an increase in ‘muscle tone’ which makes
the muscles feel more stiff or rigid. This means it is more difficult
than normal to move the muscle.
Sativex is used when other medicines have not helped your muscle
stiffness.
Your 4 week trial of Sativex
Only a specialist doctor can start you on treatment with Sativex.
• Before you start using Sativex your specialist doctor will do an
assessment. This is to see how bad your muscle stiffness is.
They will look at how well other treatments have worked.

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• You will then have a 4 week trial of Sativex. After this, your
specialist doctor will do another assessment to see whether
Sativex is helping you.
• Only if you have shown a significant improvement in your
spasticity related symptoms after these 4 weeks should you
continue to be treated with Sativex.

2. What you need to know before you use Sativex
Do not use Sativex:
• If you are allergic to cannabis extracts or any of the other
ingredients of this medicine (listed in section 6).
• If you or anyone directly related to you has any mental health
problems such as schizophrenia, psychosis or other significant
psychiatric disorder. This does not include depression due to
your multiple sclerosis.
• If you are breast-feeding.
Do not use this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before using
Sativex.

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Warnings and precautions
Talk to your doctor or pharmacist before using Sativex:
• If you are pregnant or plan to become pregnant.
• Whether male or female you must use a reliable contraceptive
method while using this medicine (see also “Pregnancy,
breast-feeding and contraception (men and women)”, below).
• If you are under 18 years of age.
• If you have epilepsy or regular fits (seizures).
• If you have liver or kidney problems.
• If you have a serious heart problem such as angina, a previous heart
attack, poorly controlled high blood pressure or a problem with your
heart rate or heart beat.
• If you are elderly, especially if you have problems doing everyday
activities such as making hot food and drinks.
• If you have previously abused any drug or substance.
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before using Sativex.

4

Other medicines and Sativex
Tell your doctor or pharmacist if you are using or have recently used
or might use any other medicines. This is because Sativex may affect
the way some other medicines work. Also, some other medicines can
affect the way Sativex works.
In particular, tell your doctor or pharmacist if you are using any of
the following medicines:
• Medicines that reduce anxiety (sedatives) or make you sleep
better (hypnotics). These medicines may increase the side
effects of Sativex and may increase the risks of falls and other
accidents.
• Medicines to relax your muscles such as baclofen or diazepam.
This is because taking Sativex with these medicines may
increase the risk of you falling over.
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before using Sativex.
If you see a different doctor or go into hospital, let them know all
the medicines you are using.

5

Sativex with food, drink and alcohol
• In general, alcoholic beverages should be avoided whilst using
Sativex especially at the beginning of treatment or when
changing dose. If you do drink alcohol while using Sativex,
be aware that using Sativex and alcohol together may increase
their effects (such as loss of balance or ability to respond quickly)
which could increase the risk of falls and other accidents.
• You can use Sativex with or without food (but see section 3
below “How to use Sativex”).
Pregnancy, breast-feeding and contraception (men and
women)
• If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before using this medicine.
• Do not use Sativex during pregnancy, unless advised to by your
doctor.
• Whether male or female you must use a reliable contraceptive
method while using this medicine. Keep using it for at least
3 months after your treatment has stopped.
• Do not use Sativex while breast-feeding.
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If you are pregnant or breast-feeding always ask your doctor for
advice before taking any medicine.
Driving and using machines
• You must not drive or use machinery when you first start to take
Sativex and until you are established on a stable daily dose.
• Sativex may cause you to feel sleepy or dizzy, which may impair
your judgement and performance of skilled tasks. It has also
rarely been reported to cause a brief loss of consciousness.
• Once you are more used to taking Sativex and your dose is
stable, you should still not drive or use machinery if Sativex
causes effects such as sleepiness or dizziness that could impair
your ability to perform these tasks. If you are not sure, do not
drive or operate machines.
The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
• Do not drive while taking this medicine until you know how it
affects you.
• It is an offence to drive if this medicine affects your ability to
drive.

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• However, you would not be committing an offence if:
o 
The medicine has been prescribed to treat a medical or dental
problem and
o 
You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine
and
o  was not affecting your ability to drive safely
It
Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.

Sativex contains ethanol and propylene glycol
• Sativex contains about 50% v/v of ethanol (alcohol) i.e. up to
40 mg per dose. The amount of alcohol in the maximum daily
dose for most people (12 sprays) is about the same as found in
two teaspoons (10 ml) of beer and about one teaspoon (5 ml)
of wine. This product can be harmful for those suffering from
alcoholism.
• Sativex contains propylene glycol which may cause irritation.
Symptoms of irritation are pain, itchiness, dry cough, sore throat.

Foreign travel with Sativex
Before going abroad, check that it is legal for you to take this
medicine. This includes any countries you are travelling through.

3. How to use Sativex

• Sativex is a controlled drug and its legal status will vary between
countries.
• Driving while taking Sativex might be illegal in some countries.
• Please refer to page no 9 for additional information on foreign
travel.

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Always use this medicine exactly as described in this leaflet or as
your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
Only use Sativex in your mouth – on the inside of your cheek or
under your tongue.
• You can take Sativex with or without food. However, taking
Sativex with food can affect the amount your body takes in.
You should try, as far as possible, to take Sativex the same way
in relation to food each time, so you get the same effect each
time.
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Opening your spray and getting it ready to use
1. Take your spray out of the refrigerator
(see section 5 for important information on
Storing Sativex).
2. Write the date that you open your spray on
the sticker provided in the box. Stick the
sticker on the spray so that you can check
the date. Do not use the spray after it has
been open for more than 6 weeks
(42 days).
3. Shake the spray container gently before use.
4. Remove the protective cap.
5. Hold the spray between your thumb and second finger. Put your
first finger on the nozzle.
6. Hold the spray upright, then practice spraying into a tissue
2 or 3 times until a fine spray appears. These sprays “prime”
the pump and make sure it is working properly.
7. The spray is now ready to use. You will not need to do any more
priming sprays until you open a new spray container.

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Using your spray
1. Hold the spray between your thumb and
second finger. Put your first finger on the
nozzle.
2. Hold it upright and point into your mouth.
Point the nozzle under your tongue or onto
the inside of your cheek. Change the area in
your mouth where you spray each time.
This helps to stop any discomfort in one
place.
3. Press the nozzle down firmly. Do not take more than one spray at
a time, even if you feel that you only got a small amount of spray.
4. Replace the protective cap.
If you get spray in your eyes by accident, wash them as soon as
possible with water.
• Do not breathe in the spray.
• Do not spray near children or pets.
• Do not use the spray near naked flames or heat sources.

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Working out how much to use
The number of sprays you need each day depends
on you as an individual. Each person needs a different number of
sprays to give them the best relief from their muscle stiffness,
with the fewest unwanted effects.

Number of sprays
Evening

• When you first start using Sativex, you need to follow the days
and times in the following table until you find the best number of
sprays for you.
• Stop increasing your sprays when you find the best number
of sprays for you. This may only take a few days or it may take
up to 2 weeks. Aim to use this number of sprays each day.
You can then spread your sprays evenly over the whole day.
• Do not use more than one spray at a time.
Always leave at least 15 minutes between sprays.
• Do not over-exert yourself during the first couple of days of using
Sativex until you know how it affects you.
• If you start to feel unwanted effects (usually dizziness) use one
less spray each day until you find the best symptom relief with
the fewest unwanted effects.
• When you find the best number of sprays for you,
aim to use this number each day. You can then spread your sprays
out evenly over the whole day, in a way that suits you. Still leave at
least 15 minutes between sprays.

Total
sprays
each day
0
1
Day 1
1
0
1
Day 2
1
0
2
Day 3
2
0
2
Day 4
2
1
2
Day 5
3
1
3
Day 6
4
1
4
Day 7
5
2
4
Day 8
6
2
5
Day 9
7
3
5
Day 10
8
3
6
Day 11
9
4
6
Day 12
10
4
7
Day 13
11
5
7
Day 14
12
Do not use more than 12 sprays in one day, unless your doctor
tells you to.

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Morning

(between waking-up
and 12 noon)

(between 4 pm and
bedtime)

If you use more Sativex than you should
If you accidentally use more of this medicine than you normally do
you may:





See or hear things that are not there (hallucinations).
Feel dizzy, sleepy or confused.
Feel your heart rate change.
Please tell your doctor or pharmacist if you used more Sativex
than you should.

If you forget to use Sativex
• If you forget a dose, use a spray as soon as you remember or
when you feel you need a spray.
• Do not use 2 sprays at the same time to make up for a missed
spray.
Knowing if your spray is nearly empty
After the 3 priming sprays, your spray contains up to 90 measured
sprays. When the spray is becoming empty, the noise of the spray
action may change. You may also find the spray feels different in
your mouth. This is because your spray is nearly empty. When this
happens you should open a new spray container.
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If you stop using Sativex
If for any reason you decide to stop using Sativex, tell your doctor
or pharmacist. If you stop using your 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.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them. These are more likely when you start
your treatment. In most cases side effects are quite mild and they
generally wear off within a few days, please use less sprays or stop
using Sativex until you feel normal again. When you start using the
medicine again, go back to the number of sprays where you did not
feel these unwanted effects.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.

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If you get any of the following side effects please stop taking the
medicine and contact your doctor:











Difficulty speaking.
Blurred vision.
Problems with your memory or having trouble concentrating.
Feeling over excited or losing touch with reality.
Feeling depressed or confused.
Seeing or hearing things that are not there (hallucinations).
Believing ideas that are not true.
Feeling that other people are against you.
Thoughts of suicide.
Changes in pulse rate, heart rate or blood pressure.








Constipation or diarrhoea.
Feeling or being sick.
Mouth problems, including burning, pain or mouth ulcers.
Lack of energy or feeling weak or generally unwell.
Feeling abnormal or drunk.
Loss of balance or falling over.

Very common (affecting more than 1 in 10 people)
• Feeling dizzy or tired.

Uncommon (affecting less than 1 in 100 people)
• Fainting.
• Sore throat or throat irritation.
• Tummy pain.
• Mouth or teeth changing colour.
• Irritation where Sativex is sprayed.
• Red and swollen mouth or peeling inside it. Do not keep spraying
onto these areas.

Common (affecting less than 1 in 10 people)
• Feeling sleepy or giddy.
• Eating more or less than usual.
• Changed sense of taste or a dry mouth.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via United Kingdom Yellow
Card Scheme - Website: www.mhra.gov.uk/yellowcard

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By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Sativex
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date shown on the product
packaging. The expiry date refers to the last day of that month.
• Store unopened Sativex upright in its carton in a refrigerator
(2°C to 8°C). If it is not stored in a refrigerator it will become
unstable and is unlikely to work.
• Store opened Sativex in an upright position below 25°C.
• Do not use Sativex after it has been open for 42 days.
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the
environment.

6. Content of the pack and other information
What Sativex contains
• The active substances are cannabis extracts. Each millilitre (ml)
contains 38-44 mg and 35-42 mg of two extracts (as soft
extracts) from Cannabis sativa L., leaf and flower, corresponding
to 27 mg/ml delta-9-tetrahydrocannabinol (THC) and 25 mg/ml
cannabidiol (CBD). Each 100 microlitre spray contains 2.7 mg
THC and 2.5 mg CBD.
• The other ingredients (excipients) are ethanol, propylene glycol
and peppermint oil.
What Sativex looks like and contents of the pack
Sativex is a yellow/brown liquid in a 10 ml glass spray container
with a pump. The pump is protected with a plastic cap.
The number of measured sprays in the container is up to 90 sprays
(after 3 priming sprays).
Sativex is packed as single, 2, 3, 4, 5, 6, 10 or 12 spray containers
in each carton.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer
GW Pharma Limited, Salisbury, Wiltshire UK, SP4 0JQ
Foreign travel with Sativex
Check that it is legal for you to take this medicine into any countries
you are travelling to and countries you are travelling through.
Sativex is a Controlled Drug and therefore its legal status will vary
between countries.
Driving while taking Sativex might be illegal in some countries.
When you leave the United Kingdom, you will not need a Home
Office licence if you are travelling for less than three months or
carrying no more than three months supply of medicine.
However, you will need to carry a letter from your doctor that has
your name, address and date of birth on it. It will need to show
outward and return dates of travel, the countries you are visiting
and the medicine you are carrying. It will need to detail the strength
of the medicine and the total amount you have with you.

When you travel abroad, contact the Embassy/Consulate/High
Commission of the country you are travelling to for the rules for
that country concerning Controlled Drugs. Information on these is
given at: http://homeoffice.gov.uk/drugs/licensing/personal/
Other formats
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Sativex Oromucosal Spray
Reference number: 18024/0009
Distributed in the UK by Bayer plc, Bayer House, Strawberry Hill,
Newbury, Berkshire, RG14 1JA.
For further medical information on how to use Sativex please contact:
Telephone: +44 (0) 1635 563000
e-mail: medical.information@bayer.co.uk
This leaflet was last revised in 11/2014
Sativex® is a registered trade mark of GW Pharma Ltd.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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