Lexotan 1.5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bromazepam

Available from:

Roche Products (Ireland) Ltd

ATC code:

N05BA; N05BA08

INN (International Name):

Bromazepam

Dosage:

1.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine derivatives; bromazepam

Authorization status:

Marketed

Authorization date:

1980-10-31

Patient Information leaflet

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’ (where your breathing
stops when you are asleep), so you may
be closely monitored.
Do not take Lexotan if a

Summary of Product characteristics

Health Products Regulatory Authority
04 December 2018
CRN008K1C
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lexotan 1.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.5 mg bromazepam.
Excipient(s) with known effect: Also contains 96.1mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Off white to slightly yellow, cylindrical, biplane tablets scored on
one side and
marked Roche 1.5 on the 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 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.
Health Products Regulatory Authority
04 December 2018
CRN008K1C
Page 2 of 13
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 patient