Sativex | Delta-9-tetrahydrocannabinol and cannabidiol uses, dose and side effects

Sativex is used to relieve symptoms related to muscle stiffness, also called spasticity, in multiple sclerosis (MS). Spasticity means that the “muscle tension” is elevated, which makes the muscles feel more stiff or stiff. This means that it is more difficult than normal to use muscles. Sativex is used because other medicines have not helped your muscle stiffness.

Your 4-week trial of Sativex
Only a specialist should start your treatment with Sativex.

Before you start using Sativex, your specialist doctor will assess to see how severe your muscle stiffness is and how well other treatments have helped you.
You will then undergo a 4-week trial period, after which your specialist doctor will make another assessment to see if Sativex helps you.
Only if your symptoms related to muscle stiffness have significantly improved after these 4 weeks, should you continue treatment with Sativex.

What you need to know before using Sativex

Do not use Sativex

if you are allergic to cannabis extract or any of the other ingredients of this medicine (listed in section 6).
if you or a close relative has mental health problems such as schizophrenia, psychosis, or any other serious mental illness. Depression caused by multiple sclerosis is not included.
if you are breastfeeding.

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 cautions

Talk to your doctor or pharmacist before using Sativex:

if you are pregnant or planning to become pregnant
if you are under 18 years of age
if you have epilepsy or regular seizures
if you have kidney problems
if you have moderate to severe liver problems
if you have severe heart problems such as angina, have ever had a heart attack, have poorly controlled high blood pressure, or have problems with heart rate or heart rate
if you are older, especially if you have problems with everyday activities such as cooking hot food and hot drinks
if you have previously abused drugs or other substances.

Whether you are a man or a woman, you must use a reliable contraceptive during treatment with Sativex (see also “Pregnancy, breastfeeding, and contraception (men and women)” below).

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 taking, have recently taken, or might take any other medicines. This is because Sativex can affect the effectiveness of other medicines. Other medicines may also affect the effect of Sativex.

Be especially careful to tell your doctor or pharmacist if you are taking any of the following medicines:

anxiety or sleep problems (sedative/sedative, which includes benzodiazepines such as diazepam or triazolam, other sedatives such as zopiclone, zolpidem, buspirone, St. John’s wort (an herbal medicine))
muscle cramps (such as baclofen)
bacterial infections ( antibiotics such as rifampicin, and clarithromycin)
epilepsy or nerve pain (such as phenytoin, phenobarbital, carbamazepine)
high cholesterol (statins such as atorvastatin or simvastatin )
fungal infections (such as itraconazole, fluconazole and ketoconazole )
HIV infection (such as ritonavir)
blood thinners (coumarins such as warfarin )
heart problems ( beta-blockers such as bisoprolol, and propranolol)
corticosteroids for the treatment of inflammation (such as hydrocortisone, beclomethasone, and prednisolone )
certain hormonal drugs used as contraceptives or in certain types of cancer (such as Ethinyl estradiol, levonorgestrel, or dydrogesterone)
anesthetics used for anesthesia or muscle relaxation before surgery (such as propofol).

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 different doctors or are hospitalized, tell them which medicines you are taking.

Sativex with food, drink, and alcohol

Generally, alcoholic beverages should be avoided while using Sativex. This is especially important at the beginning of treatment and when the dose is changed. If you drink alcohol during treatment with Sativex, be aware that using Sativex with alcohol may increase the effects of both (such as impaired balance and reactivity), which may 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 breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Sativex during pregnancy unless your doctor has advised you to do so.
Sativex can affect the effects of hormonal contraceptives such as birth control pills or implants. This means that you should also use another type of contraceptive. Whether you are male or female, you must use a reliable barrier contraceptive such as a condom or diaphragm while using Sativex. Continue to use contraception for at least 3 months after stopping treatment.
Do not use Sativex while breastfeeding.

Driving and using machines

You must not drive or use any tools or machines when starting treatment with Sativex until a stable daily dose has been established and you know how Sativex affects you.
Sativex can cause drowsiness and dizziness, which can lead to impaired judgment and affect the ability to perform tasks that require sharpened attention. Isolated cases of short-term unconsciousness have also been reported.
Once you get used to Sativex and your dosage is stable, you should still not drive or use any tools or machines if Sativex causes effects such as drowsiness or dizziness, which may impair your ability to perform such activities. If you are not sure how to react to Sativex, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Talk to your doctor or pharmacist if you are not sure if it is safe for you to drive while taking this medicine.

Traveling abroad with Sativex

Before traveling abroad, make sure that you are taking this medicine with you. This includes all countries you will be traveling through.

Sativex is a controlled drug and its legal status may vary between countries.
Driving while using Sativex may be illegal in some countries.

Sativex contains alcohol and propylene glycol

Sativex contains about 50% v / v ethanol (alcohol), ie up to 40 mg per dose . The amount of alcohol in the maximum dose one for most people (12 sprays/day) corresponds to about two teaspoons (10 ml) of beer and about one teaspoon (5 ml) of wine. This product may be harmful to those suffering from alcoholism.
Sativex contains propylene glycol, which may irritate.

How to use Sativex

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Use Sativex only in the mouth – on the inside of the cheek or under the tongue.

You can take Sativex with or without food, but taking Sativex with food can affect the amount of medicine absorbed into your body. You should try, as far as possible, to always take Sativex in the same way as food intake, so that you get the same effect every time.

To open the spray bottle to use it

Remove the package from the refrigerator (see section 5 for important information on how to store Sativex).
Write down the date you opened the spray bottle on the booklet label on the package leaflet. Attach the label to the spray bottle so you can check the date. Do not use the spray for more than 6 weeks (42 days) after opening it.
Lightly shake the spray bottle before use.
Remove the protective cover.
Hold the spray bottle between your thumb and middle finger. Put your index finger on the spray head.
Hold the spray bottle upright and then practice spraying in a paper towel 2 or 3 times until there is a nice and even shower. These showers prepare the pump and ensure that it works properly.
The spray is now ready to use. You do not need to do any more preparatory showers until you open a new spray bottle.

Practice spraying in a paper towel 2 or 3 times until there is a nice and even shower.

Using the spray

Hold the spray bottle between your thumb and middle finger. Put your index finger on the spray head.
Hold the spray bottle upright and aim it in your mouth. Aim the spray head under the tongue or towards the inside of the cheek. Vary the place in the mouth that you spray against each time. This prevents discomfort from occurring in one place.
Press the spray head down hard. Spray only once at a time, even if you feel that only a small amount came.
Replace the protective cap.

Hold the spray bottle upright and spray into your mouth.

If you happen to get eye spray, rinse immediately with water.

Do not inhale the spray.
Do not spray near children or pets.
Do not use the spray near open flames or heat sources.

To figure out how much to use

The number of sprays per day is individual. Everyone needs different numbers of sprays to get the best relaxing effect on muscle stiffness, with the least number of side effects.

When you start using Sativex, you must follow the days and times listed in the table below until you achieve the best number of sprays for you.
Stop increasing the number of sprays when you have reached the number that suits you best. This can take from just a few days up to 2 weeks. Try to use that number of sprays every day. Then you can distribute the sprays evenly throughout the day.
Do not spray more than one spray at a time. Allow at least 15 minutes between sprays.
Do not exert yourself during the first days when you start using Sativex but wait until you know how the medicine affects you.
If you start to experience side effects (usual dizziness), take one less spray every day until you experience the best relief of the symptoms with the least possible side effects.
Once you have achieved the best number of sprays for you, try to use that number every day. Then you can distribute the sprays evenly throughout the day, in a way that suits you. There must continue to be at least 15 minutes between sprays.

	Number of sprays
Day	Morning(between waking up and noon)	Evening(between 4 pm and bedtime)	Total number of sprays each day
Day 1	0	1	1
Day 2	0	1	1
Day 3	0	2	2
Day 4	0	2	2
Day 5	1	2	3
Day 6	1	3	4
Day 7	1	4	5
Day 8	2	4	6
Day 9	2	5	7
Day 10	3	5	8
Day 11	3	6	9
Day 12	4	6	10
Day 13	4	7	11
Day 14	5	7	12
Do not use more than 12 sprays on the same day without your doctor’s instructions.

If you use more Sativex than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.

If you happen to use a larger amount of the medicine than you usually do, you may:

See or hear things that do not exist (hallucinations).
Feeling dizzy, sleepy, or confused.
Feels that heart rate increases or decreases.

If you forget to use Sativex

If you have forgotten a spray, take a spray when you come to this or as soon as you need it.
Do not take 2 sprays at a time to compensate for a missed spray.

How to know that your spray bottle is almost empty

After 3 preparatory showers, your bottle contains up to 90 dosed sprays. When the spray bottle starts to empty, the sound of the spray itself may change. You may also find that the spray feels different in your mouth. This is because your spray bottle is almost empty. When this happens, open a new spray bottle.

If you stop using Sativex

If for any reason you decide to stop using Sativex, you should inform your doctor or pharmacist. If you suddenly stop using the medicine, your sleep, appetite or emotions may be affected for a short time. Usually, your muscle stiffness will gradually return if you stop using Sativex.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and contact a doctor or go to the hospital immediately if you get any of the following serious side effects, as you need to be monitored until the symptoms disappear:

Seeing or hearing things that do not exist (hallucinations)
Believing in ideas that are not true
A feeling that other people are against one
Suicidal thoughts
Depression or confusion
Excitement or loss of grounding in reality.

The likelihood of the following side effects is greatest when you start treatment. The side effects are usually mild and subside within a few days.

If you experience any of the following side effects, use fewer sprays or stop using Sativex until you feel normal again.
When resuming the use of the medicine, return to the number of sprays that did not cause these unwanted side effects.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

Very common (affects more than 1 user in 10)

Dizziness
Fatigue

Common (affects less than 1 user in 10)

Memory problem
Concentration problems
Drowsiness, feeling of being dizzy
Dimsyn
Speech difficulties
Bigger or smaller appetite than usual
Taste changes
Dry mouth
Constipation
Diarrhea
Nausea, vomiting
Mouth problems, including a burning or painful sensation, or blisters in the mouth
Lack of energy, the feeling of weakness, feelings of discomfort
A feeling of being abnormal or intoxicated
Balance disorders, tendency to fall over

Uncommon (affects less than 1 user in 100)

Fainting
Change in heart rate, heart rate or blood pressure
Sore throat, throat irritation
Stomach pain
Color changes in the mouth or on teeth
Irritation where Sativex has been sprayed
Red and swollen mouth or flaky skin in the mouth. Do not continue to spray in these areas.

How to store Sativex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Store the unopened spray bottle upright in the outer carton of the refrigerator (2 ° C to 8 ° C). If not refrigerated, the medicine may lose its effect.
The store opened the spray bottle upright below 25 ° C. Do not use Sativex after packing for 42 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the packaging and other information

Content declaration

The active substances are cannabis extract (from Cannabis sativa L.) named delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Each 100 microliter spray dose contains 2.7 mg THC and 2.5 mg CBD.
The other ingredients are ethanol, propylene glycol, and peppermint oil.

What the medicine looks like and the contents of the pack

Sativex is a yellow-brown solution in 10 ml glass spray bottles with a pump. The pump is protected by a plastic lid.

The number of dosed sprays in the bottle is up to 90 sprays (after 3 preparatory showers).

Pack sizes: 1, 2, 3, 4, 5, 6, 10 or 12 spray bottles in each carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

GW Pharma (International) BV, Databankweg 26, 3821AL Amersfoort, The Netherlands

Manufacturer

GW Pharma Limited, Histon, Cambridge UK, CB24 9BZ, UK