Sativex Oromucosal Spray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Delta-9-tetrahydrocannabinol botanical drug substance (thc bds); Cannabidiol botanical drug substance (cbd bds)

Available from:

Jazz Pharmaceuticals Ireland Limited

ATC code:

N02B; N02BG10

INN (International Name):

Delta-9-tetrahydrocannabinol botanical drug substance (thc bds); Cannabidiol botanical drug substance (cbd bds)

Pharmaceutical form:

Oromucosal spray, solution

Therapeutic area:

OTHER ANALGESICS AND ANTIPYRETICS; cannabinoids

Authorization status:

Marketed

Authorization date:

2014-07-18

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SATIVEX® OROMUCOSAL SPRAY
(delta-9-tetrahydrocannabinol and cannabidiol)
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 has been prescribed 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.
See section 4
WHAT IS IN THIS LEAFLET:
1.
What Sativex is and what it is used for
2.
What you need to know before you use 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 a mouth spray which contains cannabis extracts called
cannabinoids.
WHAT SATIVEX IS USED FOR
Sativex is used in multiple sclerosis (MS) to improve symptoms related
to muscle
stiffness. This is also called “spasticity”.
Spasticity means there is an increase in 'muscle tone' which makes the
muscles feel
more stiff or rigid. This means it is more difficult than normal to
move the muscle.
Sativex is used when other medicines have not helped your muscle
stiffness.
YOUR 4 WEEK TRIAL OF SATIVEX
Only a specialist doctor can start you on treatment with Sativex.
•
Before you start using Sativex your specialist doctor will do an
assessment.
This is to see how bad your muscle stiffness is. They will look at how
well
other treatments have worked.
•
You will then have a 4 week trial of Sativex. After this, your
specialist doctor
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.
2. 2.

Summary of Product characteristics

Health Products Regulatory Authority
21 April 2023
CRN00DGN4
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sativex Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
38-44 mg and 35-42 mg of two extracts (as soft extracts) from
_Cannabis sativa _L., folium cum flore (Cannabis leaf and flower)
corresponding to 27 mg delta-9-tetrahydrocannabinol and 25 mg
cannabidiol.
Extraction solvent: Liquid carbon dioxide
Each single 100 microlitre spray contains:
2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD)
(from _Cannabis sativa _L.)
Excipient(s) with known effect:
Each 100 microlitre spray contains up to 40 mg ethanol.
Each 100 microlitre spray contains 52 mg propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution.
A yellow/brown solution in a spray container.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sativex is indicated as treatment for symptom improvement in adult
patients with moderate to severe spasticity due to multiple
sclerosis (MS) who have not responded adequately to other
anti-spasticity medication and who demonstrate clinically
significant improvement in spasticity related symptoms during an
initial trial of therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Sativex is for oromucosal use only.
Sativex is intended to be used in addition to the patient's current
anti-spasticity medication.
Treatment must be initiated and supervised by a physician with
specialist expertise in treating this patient population.
ADULTS:
The spray container should be shaken before use and the spray should
be directed at different sites on the oromucosal surface
changing the application site each time the product is used.
Patients should be advised that it might take up to 2 weeks to find
the optimal dose and that undesirable effects can occur
during this time, most commonly dizziness. These undesirable effects
are usually mild and resolve in a few days. However,
physicians should co