Sativex oromucosal spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cannabidiol; Dronabinol

Available from:

GW Pharma Ltd

ATC code:

N02BG10

INN (International Name):

Cannabidiol; Dronabinol

Dosage:

2.5mg/1dose ; 2.7mg/1dose

Pharmaceutical form:

Spray

Administration route:

Oromucosal

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10020200; GTIN: 5010605400018

Patient Information leaflet

SATIVEX
®
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OROMUCOSAL SPRAY
A sticker has been provided for each spray container.
Write the date that you open your spray on one of the
stickers provided.
Stick the sticker on the spray so that you can check the date.
For each spray container:
Do not use the spray after it has been open for more than
6 weeks (42 days) and do not store above 25°C.
Once opened, use
within 42 days
Opening Date:
DD
MM
/
PEXXXX
Once opened, use
within 42 days
Opening Date:
DD
MM
/
Once opened, use
within 42 days
Opening Date:
DD
MM
/
Production Site
CCL Ashford
ITEM CODE
PROOF NO
MOCK-UP
1
Description
Sativex® Patient Leaflet
Market
UK
Language
English
Component
Booklet
No. of Colours
1
Profile
As Supplied
Dimensions
93 x 85 mm
Point of Sale Code
N/A
Data Matrix Code PEXXXX
Black
Artwork Originated on
12/10/2022
Keyline
(does not print)
Artwork Originated by
R Hibbitt
Artwork Originated at
Jazz Pharma
TEXT SIZES
Main Body Text 8.5pt
Line Spacing 10.2pt
PAGE 1 OF 25
Oromucosal Spray
(delta-9-tetrahydrocannabinol and cannabidiol)
SATIVEX
®
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Oromucosal Spray
(delta-9-tetrahydrocannabinol and cannabidiol)
Sativex
®
is a registered trade mark of GW Pharma Ltd.
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 Sat

Summary of Product characteristics

Page 1 of 15
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 single100 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:
Page 2 of 15
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 consider
maintaining the current dose, reducing the dose or interrupting, at
least