Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cannabidiol; Dronabinol
GW Pharma Ltd
N02BG10
Cannabidiol; Dronabinol
2.5mg/1dose ; 2.7mg/1dose
Spray
Oromucosal
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 10020200; GTIN: 5010605400018
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 Read the complete document
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 Read the complete document