Lexilium 3 Tablets

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

BROMAZEPAM

Dostępny od:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

Kod ATC:

N05BA08

INN (International Nazwa):

BROMAZEPAM 3 mg

Forma farmaceutyczna:

TABLET

Skład:

BROMAZEPAM 3 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

PSYCHOLEPTICS

Status autoryzacji:

Authorised

Data autoryzacji:

2007-01-12

Ulotka dla pacjenta

mt-pl-lexillium-3mg-tabs-a0
Page 1 of 4
_ _
PATIENT INFORMATION LEAFLET
LEXILIUM BROMAZEPAM
LEXILIUM 1,5 Tablets 1,5 mg
LEXILIUM 3 Tablets 3 mg
LEXILIUM 6 Tablets 6 mg_ _
PLEASE
READ
CAREFULLY
THIS
LEAFLET
BEFORE
YOU
START
TAKING
THE
MEDICINE.
- Keep this leaflet in a safe place. You may need to read it again.
-
If you have any questions ask your doctor or your pharmacist.
-
This medicine was prescribed for you personally and you should
not pass it on to others. It can be harmful, even when their
symptoms are the same as yours.
COMPOSITION:
_Active substance_: Bromazepam
_Excipients_: Lactose, Maize Starch, Povidone, Microcrystalline
Cellulose,
Sodium
Starch
Glycollate,
Colloidal
Silicon
Dioxide,
Magnesium
Stearate, Talc.
_Additional Excipients for Lexilium 3_ : Ponceau 4R Lake E124.
_Additional Excipients for Lexilium 6 :_ Green Lake F1313.
MARKETING LICENCE HOLDER & MANUFACTURER: _ _
Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU.
MARKETING LICENCE NUMBER:
Lexilium 1,5 : 9935
Lexilium 3 : 9936
Lexilium 6 : 19953
1.
WHAT IS LEXILIUM AND WHAT ARE ITS USE
Bromazepam, the active substance of Lexilium, belongs to the group of
medicines called benzodiazepines. These have a depressive effect on
the Central Nervous System (CNS).
Benzodiazepines
have
anxiolytic,
hypnotic,
muscle
relaxing
and
anticonvulsant
qualities.
They
are
used
mainly
to
relieve
intense
pathological anxiety and hypertension. Benzodiazepines must not be
administered in cases of anxiety and tension associated with problems
of
everyday life.
INDICATIONS:
Lexilium is indicated for the short-term treatment (2-4 weeks) in the
symptomatic therapy of pathological anxiety and in anxiety disorders.
It is not indicated for anxiety associated with everyday life
problems.
2.
WHAT YOU SHOULD KNOW BEFORE YOU TAKE LEXILIUM
BE PARTICULARLY CAREFUL WITH LEXILIUM:
Inform your doctor:

if
you
are
allergic
to
bromazepam
or
to
any
other
benzodiazepine.

if you consume excessive quantities of alcohol.

if you are a drug abuser or if you are depende

Charakterystyka produktu

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADENAME OF THE MEDICAL PRODUCT
Lexilium 3 Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bromazepam 3mg
For excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL INFORMATION
4.1
THERAPEUTIC INDICATIONS
Lexilium is indicated for the short-term (2-4 weeks) symptomatic
treatment of anxiety
that is severe, disabling or subjecting the individual to unacceptable
distress, occurring
alone
or
in
association
with
insomnia
or
short-term
psychosomatic,
organic
or
psychotic illness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The optimum dosage and frequency of administration of Lexilium should
be based on
the individual patient, the severity of symptoms and previous
psychotropic drug
history.
Adults: The usual dosage in general practice is from 3 mg to 18 mg
daily in divided
doses.
In exceptional circumstances, in hospitalised patients, up to the
maximum daily
dosage of 60 mg in divided doses, may be given.
Elderly and/or debilitated patients: Elderly patients and those with
impaired hepatic
and/or renal function are more sensitive to the actions of Lexilium;
doses should not
exceed half those normally recommended.
Children: Lexilium is not for paediatric use.
The patient should be checked regularly at the start of treatment in
order to minimise
the
dosage
and/or
the
frequency
of
administration
to
prevent
overdose
due
to
accumulation.
These amounts are general recommendations, and dosage should be
individually
determined.
Treatment
of
outpatients
should
begin
with
low
doses,
gradually
increasing to the optimum level. The duration of treatment should be
as short as
possible. The patient should be reassessed regularly and the need for
continued
treatment should be evaluated, especially in case the patient is
symptom free. The
overall treatment generally should not be more than 8-12 weeks,
including a tapering
off process. In certain cases extension beyond the maximum treatment
period may be
necessary, if so, it should not take place without re-evaluation