Sativex 2.7 mg/2.5 mg oromucosal spray solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sativex 2.7 mg / 2.5 mg oromucosal spray solution

delta-9-tetrahydrocannabinol/cannabidiol

Please read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Sativex is and what it is used for
2. What you need to know before using Sativex
3. How to use Sativex
4. Possible side effects
5. How to store Sativex
6. Contents of the pack and other information

1. What Sativex is and what it is used for

What Sativex is

Sativex is an oral spray solution containing cannabis extracts known as "cannabinoids".

What it is used for

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

The term "spasticity" means an increase in "muscle tone" that causes muscles to feel more rigid or tight. This makes it more difficult than normal to move the muscles.

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

4-week trial period with Sativex

Only a specialist doctor can prescribe you to start treatment with Sativex.

• Before starting Sativex, your specialist doctor will perform a complete assessment of the severity of your spasticity to evaluate the degree of muscle stiffness and your response to other treatments.
• You will then undergo a 4-week trial period with Sativex. After this period, your specialist doctor will carry out a new assessment to determine whether Sativex has been helpful.
• You will only be able to continue receiving Sativex if you show a significant improvement in symptoms related to spasticity after these 4 weeks.

2. What you need to know before using Sativex

Do not use Sativex:

• if you are allergic to cannabis extracts or to any of the other components of this medicine (listed in section 6);
• if you or someone closely related to you has any kind of mental disorder, such as schizophrenia, psychosis, or another significant psychiatric disorder. This does not include depression due to your multiple sclerosis; or
• if you are breastfeeding.

Do not use this medicine if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist before using Sativex.

Warnings and precautions

Talk to 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 epileptic seizures (convulsions);
• if you have moderate or severe kidney problems;
• if you have moderate or severe liver problems;
• if you have a serious heart condition such as angina, previous myocardial infarction, poorly controlled 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 hot food or drinks; or
• if you have a history of drug use or substance abuse.

Both you and your partner must use reliable contraception during treatment with this medicine (see section “Pregnancy, breastfeeding and contraception (men and women)” below).

If any of the above conditions apply to you (or if you are unsure), consult your doctor or pharmacist before using Sativex.

Other medicines and Sativex

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as Sativex may interfere with the action of certain medicines. Likewise, some medicines may interfere with the action of Sativex.

Specifically, inform your doctor or pharmacist if you are taking medicines for:

• anxiety or insomnia (sedatives or hypnotics such as benzodiazepines, e.g., diazepam or triazolam; other sedatives, e.g., zopiclone, zolpidem, buspirone, St. John’s wort [a herbal preparation]);
• muscle spasms (such as baclofen);
• bacterial infections (antibiotics such as rifampicin, clarithromycin);
• epilepsy or neuropathic pain (such as phenytoin, phenobarbital, carbamazepine);
• high cholesterol (known as statins; e.g., atorvastatin or simvastatin);
• fungal infections (such as itraconazol, fluconazole and ketoconazole);
• HIV infection (e.g., ritonavir);
• certain hormonal medicines used for contraception or certain types of cancer (such as ethinylestradiol, levonorgestrel or dydrogesterone);
• anaesthesia to put you to sleep before surgery (such as propofol).

If any of the above conditions apply to you (or if you are unsure), consult your doctor or pharmacist before using Sativex.

If you visit another doctor or go to hospital, inform them about the medicines you are taking.

Use of Sativex with food, drinks and alcohol

• In general, you should avoid drinking alcohol while using Sativex, especially at the beginning of treatment or when your dose is changed. If you drink alcohol while using Sativex, be aware that taking alcohol together with Sativex may increase the effects of both (causing loss of balance or impaired reaction ability), which could increase the risk of falls and other accidents.
• You may 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• Do not use Sativex during pregnancy unless instructed by your doctor.

• Sativex may affect the effectiveness of contraceptive methods such as the “pill” or contraceptive implants. This means you should use an additional contraceptive method.

• Both you and your partner must use a reliable barrier method of contraception, such as a condom, diaphragm, or cervical cap, during treatment with this medicine and for at least 3 months after stopping treatment.

• Do not use Sativex during breastfeeding.

Driving and use of machines

• Do not drive or operate machinery when you first start taking Sativex or until you are on a stable daily dose.
• Sativex may cause drowsiness or dizziness, which may impair your judgment and ability to perform tasks requiring skill. Rarely, it may cause a brief loss of consciousness.
• Even if you are already accustomed to taking Sativex and your dose is stable, do not drive or operate machinery if Sativex causes side effects such as drowsiness or dizziness that may impair 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 medicine.

Travelling abroad with Sativex

• Before travelling abroad, you must check whether it is legal to bring this medicine into the countries you are visiting or transiting through.
• Sativex is a controlled medicine, so its legal status varies from country to country.
• Driving while being treated with Sativex may be illegal in some countries.

Sativex contains ethanol and propylene glycol

This medicine contains up to 40 mg of ethanol (alcohol) per dose. The amount of alcohol in the maximum daily dose for most people (12 sprays) is equivalent to about two teaspoons (10 ml) of beer and approximately one teaspoon (5 ml) of wine. The small amount of alcohol in this medicine does not produce any noticeable effect. This medicine contains propylene glycol, which may cause skin irritation. Each spray contains 52 mg of propylene glycol.

3. How to use Sativex

Follow exactly the instructions for administering this medicine provided in this leaflet or as directed by your doctor. If in doubt, ask your doctor or pharmacist.

Sativex is for oral use only: on the inside of the cheek or under the tongue.

You may use Sativex with or without food. However, using Sativex with food may affect the amount of medicine absorbed by the body. Whenever possible, try to use Sativex in the same way in relation to meals, so that you always obtain the same effect.

Opening the spray and preparing it for use

1. Remove the spray from the refrigerator (see section 5 for important information on the storage of Sativex).
2. Record the date you opened the spray on the adhesive label provided on the reverse of the leaflet. Attach the adhesive label to the spray so that you can refer to the date. Once opened, do not use the spray for longer than 6 weeks (42 days).
3. Gently shake the spray container before use.
4. Remove the protective cap.
5. Hold the spray with your thumb and ring finger, placing your index finger on the nozzle.
6. Hold the container upright and prime the pump by spraying 2 or 3 times onto a tissue until a fine mist appears. These sprays are intended to "prime" the pump and ensure it is working correctly.
7. The spray is now ready for use. You do not need to repeat priming sprays unless you are opening a new spray container.

Using the spray

1. Hold the spray with your thumb and ring finger, placing your index finger on the nozzle.
2. Hold it upright and direct it towards your mouth. Aim the nozzle under the tongue or against the inside of the cheek. Vary the site of application to avoid irritation or discomfort in one area.
3. Press down firmly on the nozzle. Do not administer more than one spray at a time, even if it seems that only a small amount was sprayed.
4. Replace the protective cap.

If accidental spraying into the eyes occurs, rinse them immediately with water.

• Do not inhale the product.
• Do not apply the product in the presence of children or animals.
• Do not use the spray near open flames or sources of heat.

Determining the required dose

The number of sprays you need per day depends entirely on you. Each person requires a different number of sprays to achieve the greatest relief from muscle stiffness with the fewest adverse effects.

• When starting treatment with Sativex, you should follow the days and times indicated in the table provided later to determine the optimal number of sprays for you.
• Stop increasing the number of sprays once you have determined your optimal dose. This may take from a few days up to 2 weeks. Once determined, use this same number of sprays every day. Distribute the sprays evenly throughout the day.
• Do not administer more than one spray at a time. Always wait at least 15 minutes between sprays.
• Avoid excessive physical exertion during the first few days of using Sativex, until you know how it affects you.
• If you begin to experience adverse effects (usually dizziness), reduce the number of sprays by one per day until you achieve the greatest symptom relief with the fewest adverse effects.

Do not administer more than 12 sprays per day unless your doctor instructs you otherwise.

If you use more Sativex than you should

If you accidentally use more medicine than usual, you may:

• see or hear things that are not real (hallucinations).
• feel dizzy, drowsy, or confused.
• notice changes in heart rate.

If you have used more Sativex than you should, inform your doctor or pharmacist. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount used.

If you forget to use Sativex

• If you miss a dose, administer one spray as soon as possible or when you feel you need a spray.
• Do not administer 2 sprays consecutively to make up for a missed dose.

How to know if the spray is nearly empty

After the initial 3 priming sprays, the spray device contains 90 measured sprays. When the spray begins to run low, the sound of spraying may change. You may also notice a different taste with the spray. This indicates that the spray is nearly empty. When this occurs, you should open a new container.

If you stop using Sativex

If for any reason you decide to stop treatment with Sativex, inform your doctor or pharmacist. If you stop treatment suddenly, you may experience, for a short period of time, disturbances in sleep, appetite, or mood. Generally, muscle stiffness gradually returns after stopping treatment with Sativex.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking this medicine and consult your doctor or go directly to hospital if you experience any of the following serious adverse effects; you will be monitored until symptoms resolve:

• seeing or hearing things that are not there (hallucinations);
• belief in false ideas;
• feeling that others are against you;
• thoughts of suicide;
• feeling depressed or confused; or
• feeling overexcited or losing touch with reality.

The following adverse effects are more common when starting treatment. In most cases, they are mild and usually disappear after a few days.

• If you experience any of the following adverse effects, use fewer sprays or stop using Sativex until you feel normal again.
• When you resume using the medicine, use the number of sprays that did not cause adverse effects.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are effects not listed 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 dizziness,
• blurred vision,
• difficulty speaking,
• increased or decreased appetite,
• altered sense of taste or dry mouth,
• constipation or diarrhoea,
• feeling nauseous or vomiting,
• mouth disorders, including burning, pain or mouth ulcers,
• lack of energy, feeling weak or generally unwell,
• unusual or drunken feeling, and
• loss of balance or falls.

Uncommon (affects less than 1 in 100 people)

• fainting,
• changes in pulse rate, heart rate or blood pressure,
• sore throat or throat irritation,
• abdominal pain,
• changes in the colour of mouth or teeth,
• irritation at the site of Sativex spraying, and
• redness or inflammation of the mouth or peeling of its inner lining. Do not continue spraying in these areas.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sativex

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• Before use, store the Sativex container upright inside its carton in the refrigerator (between 2°C and 8°C). If not stored in the refrigerator, it will become unstable and lose its intended effect.
• After opening, store Sativex upright at a temperature not exceeding 25°C.
• Do not use Sativex for more than 42 days after first opening.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sativex

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

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

Appearance of the product and contents of the pack

Sativex is a yellowish/brown liquid contained in a 10 ml glass bottle equipped with a spray pump. The pump is protected by a plastic cap.

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

Sativex is available in cartons containing 3 spray devices.

Marketing Authorisation Holder

CNX Therapeutics Ireland Limited
5th Floor Rear, Connaught House
1 Burlington Road
Dublin 4, Dublin
Ireland

Manufacturer

Jazz Pharmaceuticals Netherlands B.V.
Stationsplein 13A, 3818 LE, Amersfoort
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Almirall, S.A.
General Mitre, 151
08022 Barcelona, Spain
Telephone: 932913000
Email: [email protected]

Date of the most recent review of this leaflet: 12/2025

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)