Nabilone 1mg capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Nabilone

Commercializzato da:

Meda Pharmaceuticals Ltd

Codice ATC:

A04AD11

INN (Nome Internazionale):

Nabilone

Dosaggio:

1mg

Forma farmaceutica:

Oral capsule

Via di somministrazione:

Oral

Classe:

Schedule 2 (CD)

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04060000; GTIN: 5060035241019

Foglio illustrativo

J3640
F1020
1
Nabilone 1mg Capsule PIL F1020
400 x 148mm
as shown
n/a
Dales Pharma Limited
19.11.13
1
21.11.13
2
10.05.14
3
20.05.14
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tick box
initial
BLACK
PANTONE CG10
PROFILE
PANTONE 152
PANTONE 3125
PANTONE 3995
100mm Measurement Verification Bar
PATIENT INFORMATION LEAFLET
NABILONE 1 MG CAPSULES
(nabilone)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
•
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.
Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
•
If you experience any side effect and this becomes
serious, tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Nabilone is and what it is used for
2.
Before you take Nabilone Capsules
3.
How to take Nabilone Capsules
4.
Possible side effects
5.
How to store Nabilone Capsules
6.
Further information
1. WHAT NABILONE IS AND WHAT IT IS
USED FOR
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. BEFORE YOU TAKE NABILONE
CAPSULES
DO NOT TAKE NABILONE
•
If you are allergic (hypersensitive) to any of the
other ingredients of Nabilone Capsules (these are
listed in section 6, “Further Information”).
•
If your nausea / vomiting is not due to anticancer
treatment.
•
If you are under 18 years. Nabilone is not meant
for children.
TAKE SPECIAL CARE WITH NABILONE
It is best if you take Nabilone Capsules in hospital, as
you may experience side effects.
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 problem.
•
Any

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nabilone 1mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1 mg of Nabilone.
For excipients see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard.
Opaque blue, size 2 hard gelatin capsule cap imprinted with “NAB
1” and opaque
white body imprinted with “NAB 1”
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nabilone is indicated for the control of nausea and vomiting, caused
by
chemotherapeutic agents used in the treatment of cancer, in patients
who have failed
to respond adequately to conventional antiemetic treatments.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nabilone is for administration to adults only. It is not recommended
for use in
children younger than 18 years of age as safety and efficacy have not
been
established.
The usual adult dosage is 1 mg or 2 mg twice a day. To minimise
side-effects, it is
recommended that the lower starting dose is used and that the dose is
increased as
necessary. The first dose should be administered the night before
initiation of
chemotherapy, and the second dose should be given one to three hours
before the first
dose of the oncolytic agent is administered.
The maximum daily dose should not exceed 6 mg, given in three divided
doses.
Nabilone may be administered throughout each cycle of chemotherapy
and, if
necessary, for 48 hours after the last dose of each cycle. Data on the
chronic use of
nabilone are not available.
_The elderly _as for adults (see ‘precautions’).
4.3
CONTRAINDICATIONS
Nabilone is contra-indicated in patients with a known allergy to
cannabinoid agents
and when the nausea and vomiting arises from any cause other than
cancer
chemotherapy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As nabilone is excreted primarily by the biliary route, the drug is
not recommended
for use in patients with severe liver dysfunction.
Patients receiving nabilone should be closely observed, if possible,
within an
inpatient setting. This is especially important during th