Product Information for the Patient

Sativex 2.7 mg / 2.5 mg Oral Solution for Mouth Spray

Delta-9-tetrahydrocannabinol/cannabidiol

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information.See section 4.

What is Sativex

Sativex is a buccal spray solution that contains cannabis extracts (designated as “cannabinoids”).

What is it used for

Sativex is used in multiple sclerosis (MS) to improve symptoms related to muscle stiffness, also known as “spasticity”.

The term “spasticity” means that there is an increase in “muscle tone” that makes muscles feel stiffer or more rigid. This results in more difficulty than normal in moving muscles.

Sativex is used when other medications have not helped to improve muscle stiffness.

4-week trial period with Sativex

Only a specialist doctor can prescribe Sativex treatment.

• Before starting to use Sativex, your specialist doctor will perform a complete evaluation of the severity of your spasticity to assess the degree of muscle stiffness and your response to other treatments.
• Next, you will undergo a 4-week trial period with Sativex. After this, your specialist doctor will perform a new evaluation to determine if Sativex is helpful.
• You can only continue to receive Sativex if you show a significant improvement in symptoms related to spasticity after these 4 weeks.

Do not use Sativex:

• If you are allergic to cannabis extracts or any of the other components of this medication (listed in Section 6).
• If you or someone directly related to you suffers from any type of mental disorder, such as schizophrenia, psychosis, or other significant psychiatric disorders. This does not include depression due to multiple sclerosis.
• If you are breastfeeding.

Do not use this medication if you present any of the circumstances mentioned above. In case of doubt, consult your doctor or pharmacist before using Sativex.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Sativex:

• If you are pregnant or trying to become pregnant.
• If you are under 18 years of age.
• If you have epilepsy or frequent seizures (convulsions).
• If you have kidney problems.
• If you have moderate or severe liver problems.
• If you have a serious heart problem such as angina, previous myocardial infarction, uncontrolled high blood pressure, or any disorder related to heart rate or rhythm.
• If you are elderly, especially if you have difficulty performing daily activities such as preparing food and hot drinks.
• If you have a history of drug use or substance abuse.

Both you and your partner should use reliable contraceptive methods during the use of this medication (see the section "Pregnancy, breastfeeding, and contraception (men and women)" below).

If you present any of the circumstances mentioned above (or are unsure), consult your doctor or pharmacist before using Sativex.

Using Sativex with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, as Sativex may interact with the action of some medications. Similarly, some medications may interact with the action of Sativex.

Specifically, inform your doctor or pharmacist if you are using medications for:

• anxiety or insomnia (sedatives or hypnotics such as benzodiazepines, for example, diazepam or triazolam; other sedatives, for example, zopiclone, zolpidem, buspirone, St. John's Wort (a plant-based preparation)
• muscle spasms (such as baclofen)
• bacterial infections (antibiotics such as rifampicin, clarithromycin)
• epilepsy or nerve pain (such as phenytoin, phenobarbital, carbamazepine)
• high cholesterol (known as statins; for example, atorvastatin or simvastatin)
• fungal infections (such as itraconazole, fluconazole, and ketoconazole)
• HIV infection (for example, ritonavir)
• blood thinners (known as anticoagulants; for example, warfarin)
• heart problems (known as beta-blockers; for example, bisoprolol, propranolol)
• corticosteroids for inflammation (such as hydrocortisone, beclometasone, prednisolone)
• some hormonal medications used for contraception or certain types of cancer (such as ethinylestradiol, levonorgestrel, or dienogest)
• anesthesia for sleeping and relaxing muscles before surgery (such as propofol)

If you present any of the circumstances mentioned above (or are unsure), consult your doctor or pharmacist before using Sativex.

In case of visiting another doctor or going to a hospital, inform them of the medications you are using.

Using Sativex with food, drinks, and alcohol

• Generally, you should avoid consuming alcoholic beverages during the use of Sativex, especially at the beginning of treatment or when changing the dose. If you consume alcoholic beverages during the use of Sativex, be aware that the concurrent ingestion of alcohol and Sativex may increase the effects of both (causing loss of balance or alteration of response ability), which may increase the risk of falls and other accidents.
• You can use Sativex with or without food (see Section 3. "How to use Sativex").

Pregnancy, breastfeeding, and contraception (men and women)

• If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use Sativex during pregnancy, unless your doctor tells you to.Sativex may affect the effectiveness of contraceptive methods, such as "the pill" or contraceptive implants. This means that you should use an additional contraceptive method.

• Both you and your partner should use a reliable barrier contraceptive method, such as a condom, diaphragm, or cervical cap, during the use of this medication and for at least 3 months after stopping treatment.

• Do not use Sativex during breastfeeding.

Driving and operating machinery

• Do not drive or operate machinery when starting to take Sativex or until you are taking a stable daily dose.
• Sativex may cause drowsiness or dizziness, which may alter your ability to judge and perform tasks requiring skill. In rare cases, it may cause a brief loss of consciousness.
• Although you may be more accustomed to taking Sativex and your dose is stable, do not drive or operate machinery if Sativex causes effects such as drowsiness or dizziness that may alter your ability to perform these tasks. If you are unsure, do not drive or operate machinery.

Consult your doctor or pharmacist if you are unsure whether it is safe to drive while taking this medication.

Traveling abroad with Sativex

• Before traveling abroad, you must check if it is legal to introduce this medication into the countries you visit and pass through.
• Sativex is a controlled medication, so its legal status will vary depending on the country.
• Driving during Sativex treatment may be illegal in some countries.

Sativex contains ethanol and propylene glycol

• This medication contains up to 40 mg of ethanol (alcohol) per spray. The amount of alcohol in the maximum daily dose for most people (12 sprays) is equivalent to about two tablespoons (10 ml) of beer and approximately one tablespoon (5 ml) of wine.The small amount of alcohol in this medication will have no notable effect.The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.
• This medication contains 52 mg of propylene glycol in each spray. Propylene glycol may cause skin irritation.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Sativex is only for buccal use: on the inner cheek or under the tongue.

• You can use Sativex with or without food. However, using Sativex with food may affect the amount of medication absorbed by the body. Try to use Sativex in the same way in relation to food, so you will always get the same effect.

Opening the aerosol and preparing for use

1. Remove the aerosol from the refrigerator (see section 5. Storage of Sativex).
2. Note the date of opening the aerosol on the adhesive label provided at the end of the leaflet. Once opened, do not use the aerosol for more than 6 weeks (42 days).
3. Gently shake the aerosol container before use.
4. Remove the protective cap.
5. Place the aerosol between your thumb and index finger, and support the nozzle with your index finger.
6. Hold the container in a vertical position, then perform 2 or 3 actuations on a paper tissue until a fine spray appears. These actuations serve to "prepare" the pump and ensure it is working correctly.
7. The aerosol is now ready for use. You do not need to perform any further preparation actuations until you open a new aerosol container.

Using the aerosol

1. Place the aerosol between your thumb and index finger, and support the nozzle with your index finger.

2. Hold it in a vertical position and direct it towards your mouth. Place the nozzle under your tongue or towards the inner cheek. Vary the application site of the sprays to avoid any discomfort in one area.

3. Press the nozzle firmly. Do not perform more than one spray at a time, even if you think the amount sprayed is small.

4. Replace the protective cap.

In case of accidental spray in the eyes, rinse them immediately with water.

Determining the required dose

The number of sprays you need per day depends solely on you. Each person needs a different number of sprays to get the maximum relief from muscle stiffness with the fewest side effects.

• When starting treatment with Sativex, you should follow the days and hours indicated in the table provided below to determine the optimal number of sprays for you.
• Stop increasing the sprays when you have determined the optimal number of sprays for you.This may take a few days to 2 weeks. Perform the same number of sprays each day. Distribute the sprays uniformly throughout the day.
• Do not perform more than one spray at a time. Always leave at least 15 minutes between each spray.
• Do not make excessive efforts during the first days of use of Sativex until you know how it affects you.
• If you start to notice side effects (usually dizziness), perform one spray less each day until you achieve the maximum relief of symptoms with the fewest side effects.
• Once you have determined the optimal number of sprays for you, perform the same number of sprays each day. Distribute the sprays uniformly throughout the day, according to your needs. However, always leave at least 15 minutes between each spray.

Do not take more than 12 sprays per day, unless your doctor tells you to.

If you use more Sativex than you should

If you accidentally use a higher dose than usual, you may:

• see or hear things that do not exist (hallucinations)
• feel dizziness, drowsiness, or confusion
• notice changes in heart rate

Inform your doctor or pharmacist if you have used more Sativex than you should. You can also contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Sativex

• If you forgot a dose, apply a spray as soon as possible or when you feel you need a spray.
• Do not apply two sprays at once to compensate for a missed dose.

How to know if the aerosol is almost empty

Once you have performed the 3 preparation sprays, the aerosol contains 90 measured sprays. When the aerosol starts to run out, the sound of the spray may change. The spray may also have a different taste. This is because the aerosol is almost empty. When this happens, you should open a new aerosol container.

If you interrupt treatment with Sativex

If you decide to interrupt treatment with Sativex for any reason, inform your doctor or pharmacist. If you interrupt treatment suddenly, you may experience temporary effects on sleep, appetite, or mood. Muscle stiffness usually returns gradually when treatment with Sativex is interrupted.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Sativex can cause side effects, although not everyone will experience them.

Stop taking this medicine and consult your doctor or go directly to the hospital if

you experience any of the following serious side effects; you will be monitored

until the symptoms disappear:

• Seeing or hearing things that do not exist (hallucinations)

• Belief in false ideas

• Feeling that others are against you

• Thoughts of suicide

• Feeling depressed or confused

• Feeling overexcited or loss of contact with reality

The following side effects are more frequent when starting treatment. In most cases, they are quite mild and usually disappear 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 you use the medicine again, use the number of sprays with which you did not feel the side effects.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Very common (affects more than 1 in 10 people)

• Feeling dizzy or tired

Common (affects less than 1 in 10 people)

• Memory or concentration problems
• Drowsiness or drowsiness
• Blurred vision
• Difficulty speaking
• Increased or decreased appetite
• Alteration of taste or dry mouth
• Constipation or diarrhea
• Nausea or vomiting sensation
• Oral problems, including burning, pain, or mouth ulcers
• Lack of energy, feeling weak or general discomfort
• Abnormal sensation or feeling of intoxication
• Loss of balance or falls

Rare (affects less than 1 in 100 people)

• Fainting
• Changes in heart rate, pulse frequency, or blood pressure
• Throat pain or irritation
• Abdominal pain
• Alteration of mouth or tooth color
• Irritation at the Sativex spray site
• Redness or inflammation of the mouth or peeling of its interior. Do not continue spraying in these areas.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• No use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Before use, store the Sativex packaging in an upright position, inside its case, in the refrigerator (between 2?C and 8?C). If not stored in the refrigerator, it will become unstable and lose its desired effect.
• Once opened, store Sativex in an upright position at a temperature below 25?C.
• Do not use Sativex once opened for more than 42days.
• Medications should not be disposed of through drains or trash.Deposit the packaging and medications that you no longer need at the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Sativex

• The active principles are cannabis extracts. 1 ml contains 38-44 mg and 35-42 mg of two extracts ofCannabis sativa L.,leaf and flower, corresponding to 27 mg/ml of delta‑9‑tetrahydrocannabinol (THC) and 25 mg/ml of cannabidiol (CBD). Each 100 microliter spray contains 2.7 mg of THC and 2.5 mg of CBD.

• The other components are ethanol, propylene glycol, and peppermint essence.

Appearance of the product and contents of the container

Sativex is a yellow/brown liquid inside a 10 ml glass container equipped with a spray pump. The pump is protected with a plastic cap.

The number of sprays measured in the container is 90 (after the 3 sprays of preparation).

Sativex is available in boxes containing 3 spray containers.

Marketing Authorization Holder

Jazz Pharmaceuticals Ireland Ltd

5th Floor

Waterloo Exchange

Waterloo Road

Dublin

D04E5W7

Ireland

Responsible for Manufacturing

Jazz Pharmaceuticals Netherlands B.V.

Smallepad 32, 3811MG, Amersfoort, Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Almirall, S.A.

General Mitre, 151 08022 Barcelona, Spain

Telephone: 932913000

Email: [email protected]

Last review date of this leaflet: 11/2024

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/