Lexotan 3mg Tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

BROMAZEPAM

Commercializzato da:

Roche Products Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

Codice ATC:

N05BA08

INN (Nome Internazionale):

BROMAZEPAM 3 mg

Forma farmaceutica:

TABLET

Composizione:

BROMAZEPAM 3 mg

Tipo di ricetta:

POM

Area terapeutica:

PSYCHOLEPTICS

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2006-05-24

Foglio illustrativo

mt-pl-lexotan-clean-181204-tab
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEXOTAN 3 MG TABLETS
Bromazepam
PLEASE 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 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. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lexotan is and what it is used for
2.
What you need to know before you take Lexotan
3.
How to take Lexotan
4.
Possible side effects
5.
How to store Lexotan
6.
Contents of the pack and other information
1.
WHAT LEXOTAN IS AND WHAT IT IS USED FOR
Lexotan contains a medicine called bromazepam. This belongs to a group
of medicines called
‘benzodiazepines’.
Lexotan is used for severe anxiety (very strong fear or deep worry
that can affect feelings, mood, behaviour
and thinking patterns). Lexotan will be prescribed for as short a time
as possible. This will normally be up
to a maximum of 8 to 12 weeks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEXOTAN
DO NOT TAKE LEXOTAN IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO:

Bromazepam or any of the other ingredients of Lexotan (listed in
Section 6: Contents of the pack and
other information).

Other ‘benzodiazepine’ medicines. These include diazepam,
clonazepam, flurazepam and temazepam.
Do not take Lexotan if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before taking Lexotan.
DO NOT TAKE LEXOTAN IF:

You have severe breathing problems or lung disease.

You have severe liver problems.

You have a condition called ‘myasthenia gravis’ (where your
muscles become weak and get tired easily).

You have a condition called ‘sleep apnoea syndrome’

Scheda tecnica

1
mt-spc-lexotan-clean-181204-tab
MALTA
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lexotan 3 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg bromazepam.
Excipients: Also contains 94.4 mg lactose monohydrate.
Excipient(s) with known effect:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Lexotan 3 mg Tablets: _
Tablet
Pale red, slightly speckled, cylindrical, biplane tablets scored on
one side and marked
Roche 3 on reverse.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anxiety
Benzodiazepines are only indicated when the disorder is severe,
disabling or
subjecting the individual to extreme distress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Anxiety
Treatment should be as short as possible. The overall duration of
treatment
generally should not be more than 8 – 12 weeks, including a tapering
off
process.
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 patient should
be
2
mt-spc-lexotan-clean-181204-tab
reassessed regularly and the need for continued treatment should be
evaluated,
especially in case the patient is symptom free.
In certain cases, extension beyond the maximum treatment period may be
necessary; if so, it should not take place without re-evaluation of
the patient’s
status with special expertise.
Posology
_Adults _
The lowest dose which can control symptoms should be used.
The optimum dosage and frequency of administration of Lexotan should
be
based on the individual patient, the severity of symptoms and previous
psychotropic drug history.
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.
A reduction in dose for elderly patients is recommended. Treatment
should
always be