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NABILONE 1MG CAPSULES

Active substance(s): NABILONE / NABILONE

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3. HOW TO TAKE NABILONE

PACKAGE LEAFLET: INFORMATION FOR THE USER

Always take Nabilone exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure how to take it. Your
doctor will usually start you on the lowest possible
dose. It is best if you take Nabilone in hospital,
especially the first time that you take Nabilone.
This is because you may experience side effects.

NABILONE 0.25 MG
& 1 MG CAPSULES
Read all of this leaflet carefully before you
start taking 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, pharmacist or nurse.
• 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
What is in this leaflet
1. What Nabilone is and what it is used for
2. What you need to know before you take
Nabilone
3. How to take Nabilone
4. Possible side effects
5. How to store Nabilone
6. Contents of the pack and other information
1. WHAT NABILONE IS AND WHAT IT IS
USED FOR
The name of your medicine is Nabilone 0.25mg
or 1mg Capsules (called Nabilone throughout
this leaflet). Nabilone is a medicine that helps to
reduce nausea and vomiting caused by many
anticancer medicines. Nabilone is often used when
other medicines have not helped your nausea or
vomiting.
Nabilone is a man-made chemical known as a
cannabinoid. It is not made from the Cannabis plant
but it is similar to some marijuana extracts and can
cause similar effects.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE NABILONE
Do not take Nabilone
• If you are allergic (hypersensitive) to any of the
other ingredients of Nabilone (listed in section
6).
• If your nausea/vomiting is not due to anticancer
treatment.
• If you are under 18 years. Nabilone is not meant
for children.
Warnings and precautions
It is best if you take Nabilone in hospital, as you may
experience side effects (see section 3).

The hospital doctor or nurse may give you your
first dose the night before you start chemotherapy
and the second dose one to three hours before it
begins. Swallow the capsules with water.

Tell your doctor before you start treatment if
you have any of the following problems or if you
develop any of these during treatment:
• any liver problems
• high blood pressure or any other heart problems
• any mental illness, for example depression or
schizophrenia.

Dose
• The usual dose is 1mg or 2mg twice a day.
• You should never take more than 2mg three
times a day. You can take Nabilone while
you are having chemotherapy treatment
and for up to 2 days after your last dose of
chemotherapy.

Other medicines and Nabilone
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.

The dosing recommendations for elderly patients
are the same as for other adults.

In particular, tell your doctor if you are taking any
sleeping pills, painkillers or tranquillisers.

If you take more Nabilone than you should
If you ever take too many capsules, tell your doctor
or get someone to take you to the nearest hospital
casualty department immediately together with
your medicine to show to the doctor.

Nabilone with alcohol
Do not drink alcohol while you are taking Nabilone.
Pregnancy and breast-feeding
Tell your doctor before you start treatment:
• if you are pregnant, if you think that you are
pregnant, or if you intend to become pregnant
• if you are breast-feeding or planning to breastfeed.

If you forget to take Nabilone
If you miss a dose, wait until it is time for the next
dose, and then continue as before.
Do not take a double dose to make up for a
forgotten dose.

Your doctor will decide if you can take this medicine.
4. POSSIBLE SIDE EFFECTS

Driving and using machines
Nabilone may cause side effects such as sleepiness,
confusion, hallucinations, a feeling of dizziness or
spinning, poor muscle co-ordination, problems
with your sight and problems with concentration.
These side effects may occur up to 3 days after
taking Nabilone. This may affect your ability to
operate machinery. Do not operate machinery if
you experience any of these side effects.
The medicine can affect your ability to drive as it
may make you sleepy or dizzy. Do not drive while
taking this medicine until you know how it affects
you.
It is an offence to drive if this medicine affects your
ability to drive.

Like all medicines, Nabilone can cause side effects,
although not everybody gets them. Side effects
that you may experience are:
• feeling sleepy, relaxed, or “high”. A few
patients have had hallucinations, felt confused,
depressed, anxious or had other changes in
their mood or mental state.
• a feeling of dizziness or spinning, especially
when you stand up
• poor muscle co-ordination
• dry mouth, problems with your sight or
concentration, difficulty sleeping, or headaches
• shaking, a faster heart beat than normal,
low blood pressure, losing your appetite and
stomach pains.
Any changes in your mood, such as feeling
depressed, relaxed or “high”, may last for 2 or 3
days after you stop taking Nabilone. You may find
that you get used to these feelings.

However, you would not be committing an offence
if the medicine has been prescribed to treat a
medical or dental problem and if:
• you have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and,
• it was not affecting your ability to drive safely.

reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE NABILONE






Keep this medicine out of the sight and reach
of children.
Do not use Nabilone after the expiry date
which is stated on the bottle or blister and
carton after “EXP”. The expiry date refers to
the last day of that month.
If your doctor tells you to stop taking the
capsules, please take them back to the
pharmacist.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Nabilone contains
• The active substance is nabilone.
Each 0.25mg capsule contains 0.25mg of
nabilone.
Each 1 mg capsule contains 1 mg of nabilone.


The other ingredients are:
povidone, pregelatinised-starch, isoproyl
alcohol, gelatin, water, indigo carmine (E132),
quinoline yellow (E104), titanium dioxide
(E171), shellac, propylene gycol, black iron
oxide (E172), potassium hydroxide. The 0.25mg
capsules also contain quinoline yellow (E104)
and the 1 mg capsules also contain iron oxide
red (E172).

What Nabilone looks like and contents of the
pack
Nabilone 0.25 mg capsules: Opaque green, size 2
hard gelatin capsule cap imprinted with “NAB 0.25”
and opaque white body imprinted with “NAB 0.25”.
Nabilone 1 mg capsules: Opaque blue, size 2 hard
gelatin capsule cap imprinted with “NAB 1” and
opaque white body imprinted with “NAB 1”.
They are supplied in bottles or blisters of 20
capsules.
Marketing Authorisation Holder and
Manufacturer
Kinedexe UK Limited, Unit 15 Moorcroft, Harlington
Road, Uxbridge, UB8 3HD, United Kingdom.
This leaflet was last revised in 03/2017

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By

Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.

Client: Kinedexe UK Ltd

PL Number: 44710/0022

Product: Nabilone Capsules PIL

Date: 08.03.17

Colours: n Black

Strength: 0.25mg / 1mg

Version: 2

Fonts: Vectora Light & Vectora Black

Arta Creative Solutions Ltd
Suite 1, Interlinks House
81c Church Road
London NW4 4DP

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020 8203 5976
020 8203 2357
info@artacreative.co.uk
www.artacreative.co.uk

44710/0023

Size: 160mm x 270mm

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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