The package insert of the medicine Sativex

the package insert of the medicine Sativex . Therapeutic class of Anxiolytics, Hypnotics and muscle Relaxants. Active principles Cannabidiol and Delta-9-tetrahydrocannabinol.

what For?

Sativex is a solution for spraying mouth, indicated to improve symptoms of muscle stiffness or muscle tone in patients with multiple sclerosis.

Oral Use – Adult Use


How to use?

Sativex should only be used in the mouth or on the inside of the cheek or under the tongue, always in accordance with the indications of your doctor. The recommended dose of Sativex, the number of sprays per day, varies from patient to patient and should be administered in the fewest number of sprays that provide the best improvement of the symptoms of muscle rigidity, always with a range minimum of 15 minutes between sprays, and never exceeding the 12 sprays per day. However, when taking Sativex for the first time, you should do it according to the indications of the days and the number of sprays in the following table:

















Number of Sprays
Day Sprays in the morning

(since that wakes up in the middle of the day)

Sprays afternoon/night

(between 16.00 hours and the lie)

total Number of sprays per day
1 0 1 1
2 0 1 1
3 0 2 2
4 0 2 2
5 1 2 3
6 1 3 4
7 1 4 5
8 2 4 6
9 2 5 7
10 3 5 8
11 3 6 9
12 4 6 10
13 4 7 11
14 5 7 12

The patient should stop increasing the number of sprays so that you can know the best number of sprays for you. In the event of forgetting a dose, this should be taken as soon as possible or when the patient feels the need, never taking a double dose to compensate the missed dose.

The application of Sativex should be made by following the following instructions for use:

– The nebulizer should be stored in the fridge and on first use you must write on the package the date of opening, using the sticker provided, and shall not use the nebulizer if they have been more than 4 or 6 weeks;
– Shake the bottle before use and remove the capsule of locking protection;
– Before you can use directly in the mouth, hold the nebulizer between your thumb and middle finger and holding it in the vertical practice 2 or 3 sprays on a tissue paper, so as to prepare the pump for use;
– To use the nebulizer must secure it between the thumb and middle finger and place the index finger on the nozzle and holding it in the vertical pointing to the mouth;
– To make the spray, press the nozzle firmly, never applying more than one spray at a time.

Sativex can be found in the packaging 1, 2, 3, 4, 5, 6, 10 or 12 bottles of nebulizers that can be a 5.5 ml or 10 ml. .

Side Effects

What are the evils that can cause me?

Like all medicines, Sativex can cause side effects, although these do not manifest in all people and usually disappear in a few days. The most common side-effects of Sativex are: feeling of dizziness and drowsiness, feeling of depression or confusion, hyper-arousal, or feeling disconnected from reality, memory problems or difficulties in concentration, dizziness, blurred vision, difficulty speaking, changes in appetite, change in sense of taste or dry mouth, constipation or diarrhea, nausea or vomiting, problems in the mouth, including burning, pain, or ulcers in the mouth, lack of energy or a feeling of weakness or general malaise, abnormal sensation or drunkenness, loss of balance.

in addition To this symptoms, such as Sativex is applied in the mouth, this can also cause burning, pain, or ulcers in the mouth, change in color of the mouth or teeth, mouth red and swollen and alteration in taste.


When should I not use?

Sativex should not be used in case of allergy to the extracts of cannabis or any other component of the formula, in women who are breastfeeding and in patients who have schizophrenia, psychosis or other psychiatric illness, or have close family members with these problems.


How it works?

Sativex acts in the central nervous system by binding to receptors in the brain, responsible for regulating the movements of co-ordination, learning ability, memory and response to stress.

Warnings and Precautions

what should I know before using?

Sativex can only be prescribed by a doctor or specialist but must be tested rigoro of the severity of the symptoms of the patient.

Before you use Sativex should consult your doctor or pharmacist if you: are pregnant or planning to become pregnant, you are less than 18 years old, have epilepsy or seizures, have liver problems or kidney, has a serious problem of the heart such as angina pectoris, history of heart attack, high blood pressure, problem with the heart rate or beating of the heart, is a person who is elderly, suffers from problems of alcoholism or abuse of drugs or other substances.

If you are taking other medicines, such as drugs that reduce anxiety, to relax muscles, or to sleep, or if you drink alcoholic beverages regularly, you must tell your doctor before you start taking Sativex. If you are at the beginning of the treatment with Sativex the driving and use of machinery and vehicles should be avoided, since this medicine may cause drowsiness and dizziness. If you will be traveling abroad, check to see if Sativex is legal in the countries of destination, since it is a controlled substance.

Sativex in Pregnancy and Contraception:

The administration of Sativex is not recommended for pregnant women, who are planning to become pregnant or are breastfeeding without first consulting your doctor. During treatment with Sativex women and men must use for at least three months a contraceptive method that is reliable.


what to do if someone use a larger amount than is recommended?

If you accidentally take an excessive dose of Sativex may have hallucinations, feeling dizzy, drowsy, confused, or detect a change in the frequency of the beats of the heart.


GW Pharma

GW Pharma Limited – Salisbury Wiltshire SP4 0JQ – United Kingdom – Tel: +44 (0) 1980 557000 – [email protected]

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