Medication Guide App

SATIVEX OROMUCOSAL SPRAY

Active substance: DELTA(9)-TETRAHYDROCANNABINOL

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PE0018.V4

Each 100 microlitre spray contains
2.7 mg delta-9-tetrahydrocannabinol
and 2.5 mg cannabidiol

Package leaflet: Information for the patient

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

Back Cover

Front Cover

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 is 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.

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. . . . . . . . . . . . . . . . . . . . . . 7
4. Possible side effects. . . . . . . . . . . . . . . . . . . . 12
5. How to store Sativex. . . . . . . . . . . . . . . . . . . . 14
6. Contents of the pack and other information. . 15

1

Inside Front Cover

1 What Sativex is and what it is used for
1.

2. Before you use Sativex
2 What you need to know before you use Sativex

What Sativex is

Do not use Sativex:if:
Sativex

Sativex is a mouth spray which contains cannabis
extracts called cannabinoids.

• If you are allergic to cannabis extracts or any of
• You are allergic (hypersensitive) to cannabis
the otheror any of the of thisingredients of Sativex
extracts ingredients other medicine (listed in
Section 6).
(listed in Section 6).

What Sativex is used for

• If you or anyone directly related to you has any
• 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.

Sativex is used to improve symptoms related to
muscle stiffness also called spasticity in multiple
sclerosis (MS). Spasticity means there is an increase
in ‘muscle tone’ which makes the muscles feel more
stiff or rigid. In other words, when the muscle is
moved, there is more resistance to this movement
than there normally would be.
Sativex is used when other medicines have not
worked to relieve your muscle stiffness.

Your 4 week trial of Sativex
Only a specialist physician can start you on treatment
with Sativex. The specialist will assess you from time
to time to see if you should carry on taking it.
• Before you start using Sativex your specialist

doctor will conduct a thorough assessment of how
bad your spasticity is and how it has responded to
other treatments.
• You will then have a 4 week trial of Sativex after

which your specialist 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.
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PE0018V2-383782_P1.indd 2-3

• If you are breast-feeding.
• 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.

Warnings and precautions
Take special care with Sativex
Talk to with your doctor or pharmacist before using
Check your doctor or pharmacist before using
Sativex:if:
Sativex
• If you are pregnant or plan to become pregnant.
• 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,
contraception’, below).
• If you are under 18 years of age.
• You are under 18 years of age.
• If you have epilepsy or regular fits (seizures).
• You have epilepsy or regular fits (seizures).
If any of the above apply to you (or you are not
sure), talk to your doctor or pharmacist before using
Sativex.

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Warnings and precautions - continued
Talk to your doctor or pharmacist before using Sativex:
• 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 have liver or kidney problems.
• 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.

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.

4

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.

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, 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
doing this for at least 3 months after your treatment
has stopped.
• Do not use Sativex while breast-feeding.
If you are pregnant or breast-feeding always ask your
doctor for advice before taking any medicine.

5

Driving and using machines
• You must not drive or use machinery when
Driving and using machines
you first start to take Sativex and until you are
established on a stable daily dose.
• You must not drive or use machinery when
• you firstmay cause you to feel sleepy or dizzy,
Sativex start to take Sativex and until you are
established impair your judgment and performance
which may on a stable daily dose.
of skilled tasks. It has also rarely been reported
• Sativex may cause you to feel sleepy or dizzy, to
which a brief loss of consciousness. performance
cause may impair your judgment and
• of skilled tasks. It has also rarely been reported to
Once you are more used to taking Sativex and
cause a briefstable, you should still not drive or
your dose is loss of consciousness.
• Once you are more used causes effects such as
use machinery if Sativex to taking Sativex and
your dose is stable, youthat could impair youror
sleepiness or dizziness should still not drive
use machinery if Sativextasks. If you are such as
ability to perform these causes effects not sure,
sleepiness or dizziness machines. impair your
do not drive or operate that could
ability to perform these tasks. If you are not sure,
Foreign drive orwith Sativex
do not travel operate machines.
• Check that it is legal for you to take this medicine
Foreign travel with Sativex
into any countries you are travelling to and
• Check that it is legal for youthrough.this medicine
countries you are travelling to take Sativex is
into any countries and its legal status will vary
a Controlled Drug you are travelling to and
countries countries.
between you are travelling through. Sativex is
a Controlled Drug and its legal status will vary
• Driving while taking Sativex might be illegal in
between countries.
some countries.
• Driving while taking Sativex might be illegal in
Important information about some of the
some countries.

ingredients of Sativex
Sativex contains ethanol and propylene glycol

Sativex contains about 50% v/v of ethanol (alcohol)
• Sativex40 mg per dose.50% v/v of ethanol (alcohol)
i.e. up to contains about
i.e. up to 40 mg per dose. The amount of alcohol
• in the maximum daily dose for most people dose
The amount of alcohol in the maximum daily
for sprays) is about sprays) is about the same
(12 most people (12 the same as found in two as
found in two teaspoons (10 ml) of beer and about
teaspoons (10 ml) of beer and about one teaspoon
one teaspoon This of wine. This product can
(5 ml) of wine.(5 ml)product can be harmful for be
harmful for those suffering from
those suffering from alcoholism. alcoholism.
• Sativex contains propylene glycol which may cause
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irritation.
PE0018V2-383782_P1.indd 6-7

6

• Sativex contains propylene glycol which may cause
irritation.

3 How to use Sativex
3.
Always use this medicine exactly as described told
Sativex exactly as your doctor has in this
leaflet or should check with your you. Check with your
you. You as your doctor has told doctor or pharmacist
doctorare pharmacist if you are not sure.
if you or 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.

Opening your spray and getting it ready to use
1 Take your spray out of the refrigerator (see Section 5
1
for important information on storing Sativex).
2 Write the date that you open your spray on the
2
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).
(42 days).
3 Shake the spray container gently before use.
3 Shake the spray container gently before use.
4 Remove the protective cap.
4 Remove the protective cap.
5 Hold the spray between your thumb and second
5 Hold the spray between your thumb and second
finger. Put your first finger on the nozzle.
finger. Put your first finger on the
nozzle.
6 Holding it upright, practise spraying into a tissue 2 or
6 3 times until a fine practise
Holding it upright, spray appears.
These sprays a tissue 2 or 3 times
spraying into prime the pump and
ensurefine spray appears. These
until a it is working properly.
sprays prime the ready and ensure
7 The spray is now pump to use.
it is will not properly.
You workingneed to do any more
priming sprays until you open a
7
new spray container.
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14/04/2011 14:29

Using your spray

Working out how much to use

1 Hold the spray between your
thumb and second finger. Put your
first finger on the nozzle.

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.

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.

• 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.

4 Replace the protective cap.

• Do not use more than one spray at a time. Always
leave at least 15 minutes between sprays.

If you get spray in your eyes by accident, wash them
as soon as possible with water.

• Do not over-exert yourself during the first couple of
days of using Sativex until you know how it affects
you.

• Do not breathe in the spray.
• Do not spray near children or pets.
• Do not use the spray near naked flames or heat
sources.

8

• 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.

9

If you use more Sativex than you should

Number of sprays
Day

Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
Day 8
Day 9
Day 10
Day 11
Day 12
Day 13
Day 14

Morning
sprays

Evening
sprays

(between
waking-up
and 12 noon)

(between 4pm
and bedtime)

0
0
0
0
1
1
1
2
2
3
3
4
4
5

1
1
2
2
2
3
4
4
5
5
6
6
7
7

Total
sprays
each day

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.

1
1
2
2
3
4
5
6
7
8
9
10
11
12

If you need more relief from your muscle stiffness
after Day 10, continue to add one spray each day
either in the morning or evening. For example, on
Day 11 you would use nine sprays and on Day 12
you would use ten sprays.

• 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.

If you stop using Sativex
If for any reason you decide to stop using Sativex,
you should let your doctor or pharmacist know.

You should not use more than 12 sprays in one
day, unless your doctor tells you to.

10

11

IfIf you stop using Sativex continued
you stop using Sativex - - continued
If If you stop taking your medicine suddenly your sleep,
you stop taking your medicine suddenly your sleep,
appetite or feelings might be affected for a a short
appetite or feelings might be affected for short
time. Your muscle stiffness usually comes back
time. Your muscle stiffness usually comes back
gradually if if you stop using Sativex.
gradually you stop using Sativex.
If If you have any further questions on the use of this
you have any further questions on the use of this
product, ask your doctor or pharmacist.
product, ask your doctor or pharmacist.

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

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

Common
Common
(affecting less than 1 1 in 10 people)
(affecting less than in 10 people)
• •Feeling depressed or confused.
Feeling depressed or confused.
• •Feeling over-excited or losing touch with reality.
Feeling over-excited or losing touch with reality.
• •Problems with your memory or having trouble
Problems with your memory or having trouble
concentrating.
concentrating.
12
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PE0018V2-383782_P1.indd 12-13

• •Feeling sleepy or giddy.
Feeling sleepy or giddy.
• •Blurred vision.
Blurred vision.
• •Difficulty speaking.
Difficulty speaking.
• •Eating more or less than usual.
Eating more or less than usual.
• •Changed sense ofof taste or a dry mouth.
Changed sense taste or a dry mouth.
• •Constipation or diarrhoea.
Constipation or diarrhoea.
• •Feeling or being sick.
Feeling or being sick.
• •Mouth problems, including burning, pain or mouth
Mouth problems, including burning, pain or mouth
ulcers.
ulcers.
• •Lack ofof energy or feeling weak or generally unwell.
Lack energy or feeling weak or generally unwell.
• •Feeling abnormal or drunk.
Feeling abnormal or drunk.
• •Loss ofof balance or falling over.
Loss balance or falling over.

Uncommon
Uncommon
(affecting less than 1 1 in 100 people)
(affecting less than in 100 people)
• •Seeing or hearing things that are not there
Seeing or hearing things that are not there
(hallucinations).
(hallucinations).
• •Believing ideas that are not true.
Believing ideas that are not true.
• •Feeling that other people are against you.
Feeling that other people are against you.
• •Thoughts ofof suicide.
Thoughts suicide.
• Fainting.
• Fainting.
• •Changes inin pulse rate, heart rate or blood pressure.
Changes pulse rate, heart rate or blood pressure.
• •Sore throat or throat irritation.
Sore throat or throat irritation.
• •Tummy pain.
Tummy pain.
• •Mouth or teeth changing colour.
Mouth or teeth changing colour.
• •Irritation where Sativex isis sprayed.
Irritation where Sativex sprayed.
• •Red and swollen mouth or peeling inside it.it. Do not
Red and swollen mouth or peeling inside Do not
keep spraying onto these areas.
keep spraying onto these areas.
If If any of any side effects getsto your doctoryou notice
you get the
talk serious, or if or
pharmacist. This includes any side leaflet, please tell in
any side effects not listed in this effects not listed your
this leaflet. pharmacist.
doctor or
13
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14/04/2011 14:29

5.
5 How to store Sativex

6. Content of the pack
6 Further information and other information

• Keep this of the reach and the sightchildren. of
out medicine out of sight of and reach

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

What Sativex contains

14
PE0018V2-383782_P1.indd 14-15

• 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,
are ethanol, propylene glycol

and peppermint and
propylene glycol oil. peppermint oil.

What Sativex looks like and contents of the pack
Sativex is provided as a yellow/brown liquid in sprayml
liquid in a 10 ml glass a 10
container with a pump. The pump. The pump with a
glass spray container with a pump is protectedis
plastic cap.
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 3 spray containers in each carton.

15
14/04/2011 14:29

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.

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 563116
e-mail: medical.information@bayer.co.uk
This leaflet was last revised in 08/2012

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/

16

Inside Back Cover

GW Pharma

Colours used:

Sativex® UK Patient Leaflet

Black +15% + 10% tints

PE0018.V4.1

Pantone 2622 ( + Vignette)

-

Pantone 2955 ( + Vignette)

90 x 140 mm

Keyline (Does not print)

7pt
20
UK
English
Elkie Bramall
Five
25/09/2012
Artwork Job No: 426894

Pharma code

n/a

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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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