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
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Inside Front Cover
1 What Sativex is and what it is used for 1.
What Sativex is
Sativex is a mouth spray which contains cannabis extracts called cannabinoids.
2. Before you use Sativex 2 What you need to know before you use Sativex
Do not use Sativex:if: Sativex
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). 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. 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.
What Sativex is used for
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.
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.
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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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.
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).
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.
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.
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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.
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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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 6 irritation.
PE0018V2-383782_P1.indd 6-7
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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.
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. 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.
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Number of sprays Day Morning sprays
(between waking-up and 12 noon)
If you use more Sativex than you should
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. Feel your heart rate change. Please tell your doctor or pharmacist if you used more Sativex than you should.
Evening sprays
(between 4pm and bedtime)
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
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
1 1 2 2 3 4 5 6 7 8 9 10 11 12
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 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. You should not use more than 12 sprays in one day, unless your doctor tells you to.
If you stop using Sativex
If for any reason you decide to stop using Sativex, you should let your doctor or pharmacist know.
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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.
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
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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.
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5. 5 How to store Sativex
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 (2C to 8C). If it is not carton in Store unopened Sativex upright in itsstored in a refrigerator it will to 8C). If it is not stored in a a refrigerator (2Cbecome unstable and is unlikely to work. refrigerator it will become unstable and is unlikely to work. Store opened Sativex in an upright position below 25C. Store opened Sativex in an upright position below 25C. 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.
6. Content of the pack 6 Further information 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, 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 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 3 spray containers in each carton.
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Marketing Authorisation Holder and Manufacturer
GW Pharma Limited, Salisbury, Wiltshire UK, SP4 0JQ
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
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://drugs.homeoffice.gov.uk/drugs-laws/licensing/ personal/
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 02/2012
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Inside Back Cover
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.
What Sativex is
Sativex is a mouth spray which contains cannabis extracts called cannabinoids.
2. Before you use Sativex 2 What you need to know before you use Sativex
Do not use Sativex:if: Sativex
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). 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. 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.
What Sativex is used for
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.
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.
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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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.
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).
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.
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.
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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.
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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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 6 irritation.
PE0018V2-383782_P1.indd 6-7
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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.
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. 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.
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Number of sprays Day Morning sprays
(between waking-up and 12 noon)
If you use more Sativex than you should
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. Feel your heart rate change. Please tell your doctor or pharmacist if you used more Sativex than you should.
Evening sprays
(between 4pm and bedtime)
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
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
1 1 2 2 3 4 5 6 7 8 9 10 11 12
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 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. You should not use more than 12 sprays in one day, unless your doctor tells you to.
If you stop using Sativex
If for any reason you decide to stop using Sativex, you should let your doctor or pharmacist know.
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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.
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
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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.
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5. 5 How to store Sativex
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 (2C to 8C). If it is not carton in Store unopened Sativex upright in itsstored in a refrigerator it will to 8C). If it is not stored in a a refrigerator (2Cbecome unstable and is unlikely to work. refrigerator it will become unstable and is unlikely to work. Store opened Sativex in an upright position below 25C. Store opened Sativex in an upright position below 25C. 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.
6. Content of the pack 6 Further information 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, 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 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 3 spray containers in each carton.
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Marketing Authorisation Holder and Manufacturer
GW Pharma Limited, Salisbury, Wiltshire UK, SP4 0JQ
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
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://drugs.homeoffice.gov.uk/drugs-laws/licensing/ personal/
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 02/2012
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Inside Back Cover
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
