Levomepromazine 6mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levomepromazine maleate

Available from:

Special Order

ATC code:

N05AA02

INN (International Name):

Levomepromazine maleate

Dosage:

6mg

Pharmaceutical form:

Oral tablet

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Levomepromazine Maleate
6mg Tablets
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
•
K
eep 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 Levomepromazine Maleate Tablets are
and what they are used for
2.
What you need to know before you take
Levomepromazine Maleate Tablets
3.
How to take Levomepromazine Maleate
Tablets
4.
Possible side effects
5.
How to store Levomepromazine Maleate
Tablets
6.
Contents of the pack and other information
1.
What Levomepromazine Maleate Tablets
are and what they are used for
Levomepromazine is a phenothiazine used in
palliative care and indicated for second or third
line-treatment of adults with refractory nausea
unassociated with chemotherapy, where other
agents have failed to give adequate control
(CCC System - B62.1 Nausea Care).
2.
What you need to know before you take
Levomepromazine Maleate Tablets
Do not take Levomepromazine Maleate
Tablets:
•
if you are allergic to levomepromazine
maleate or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions:
Talk to your doctor or pharmacist before taking
Levomepromazine Maleate Tablets if you:
•
have liver problems
•
are elderly, frail or have heart disease as you
may feel faint or light-headed when you take
the tablets (if you have a large initial dose,
you will have to stay in bed)
•
suffer from slow or irregular heartbeats/
palpitations (Torsades de Pointes), or have a
family history of heart problems
•
or someone else in your family have a history
of blood clots, as

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Levomepromazine Maleate 6mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 6mg levomepromazine maleate.
_Excipient with known effect: _
Each tablet contains 85.74 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
White to off white round shaped tablet with break line on one side and
'L4' debossing
on another side.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levomepromazine is a phenothiazine used in palliative care and
indicated for
second or third line-treatment of adults with refractory nausea
unassociated
with chemotherapy, where other agents have failed to give adequate
control
(CCC System - B62.1 Nausea Care).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Nausea in palliative care.
Patients will require daily physician review.
TREATMENT
DURATION
DOSAGE
Initial (3 days)
Treatment is with 3-6mg once at night
4 to 5 days
Dose may be up-titrated to a maximum of 12 mg per day
in divided doses of 6 mg over days 4-5
6 to 14 days
From day 6 the dose may then be switched to 12 mg once
daily at night, or when steady state is achieved. Treatment
may be extended to a maximum of 2 weeks, as needed
_Paediatric population_
No data is available. Levomepromazine tablets should not be used in
children aged
under 18 years.
Method of administration
For oral use only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Levomepromazine tablets is contraindicated in children aged under 18
years.
Safety in pregnancy has not been established.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The drug should be avoided, or used with caution, in patients with
liver dysfunction
or cardiac disease.
The hypotensive effects of levomepromazine should be taken into
account when it is
administered to patients with cardiac disease and the elderly or
debilitated.