Lorazepam 1mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Lorazepam

Disponibil de la:

A A H Pharmaceuticals Ltd

Codul ATC:

N05BA06

INN (nume internaţional):

Lorazepam

Dozare:

1mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

Schedule 4 (CD Benz)

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04010200; GTIN: 5025903001188

Prospect

PATIENT INFORMATION LEAFLET
LORAZEPAM 1MG & 2.5MG TABLETS
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 or pharmacist or
nurse.
This includes any possible side effects not listed in this leaflet.
•
This medicine should be used for as short a time as possible and
should
not be used for more than four weeks. If used for too long without a
break, there is a risk of becoming dependent or of having problems
when
you stop taking it.
IN THIS LEAFLET:
1. What Lorazepam is and what is it used for?
2. What you need to know before you take Lorazepam
3. How to take Lorazepam Tablets
4. Possible side effects
5. How to store Lorazepam Tablets
6. Contents of the pack and other information
1. WHAT LORAZEPAM IS AND WHAT IS IT USED FOR
•
Lorazepam belongs to a group of medicines called benzodiazepines.
•
Lorazepam tablets are used as a short-term therapy for severe anxiety
or
sleeping difficulties due to anxiety.
•
It may also be used as a sedative before general surgery or
pre-operative
dental treatment.
•
When taking this medicine there is a risk of dependence (a need to
keep
taking the medicine) the risk increases with the dose and length of
treatment period. The risk is greater if you have ever had a history
of
alcohol or drug abuse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORAZEPAM
DO NOT TAKE LORAZEPAM IF YOU:
•
are ALLERGIC to benzodiazepines or any of the other ingredients of
this
medicine (listed in section 6)
•
have severe BREATHING OR CHEST PROBLEMS
•
have ‘MYASTHENIA GRAVIS’ (very weak or tired muscles)
•
have serious LIVER PROBLEMS
•
suffer from ‘SLEEP APNOEA’ (breathing problems when you

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lorazepam 1mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Lorazepam 1mg tablets _
Each tablet contains 1mg lorazepam.
Excipient with known effect:
_Lorazepam 1mg tablets _
Each tablet contains 68.82mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
_Lorazepam 1mg tablets _
white, round, flat, bevelled, scored tablets, with “1.0”
inscription, diameter between
6.3 mm – 6.5 mm, thickness between 2.4 mm – 2.6 mm, theoretical
weight 106.5 mg.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FOR SHORT TERM (2-4 weeks only) USE (adults only)
•
Symptomatic relief of anxiety that is severe, disabling or subjecting
the individual
to unacceptable distress occurring alone or in association with
insomnia or short-
term psychometric, organic or psychotic illness.
AS PREMEDICATION (adults and children 6 years and above)
Before operative dentistry and general surgery
NOT FOR USE
•
Long term (i.e. longer than 4 weeks)
•
For mild/moderate anxiety
•
For insomnia or anxiety in children
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment to be given:
•
Under close medical supervision
•
At the lowest effective dose
•
For the shortest possible duration (not exceeding 4 weeks)
Doses should be individualised
Extension of use should not take place without further clinical
evaluation
Chronic use not recommended (little is known of the long term safety
and efficacy;
potential for dependence–see section 4.4).
When treatment is started the patient should be informed that
•
treatment will be of limited duration
•
the dosage will be progressively decreased
•
there is a possibility of rebound phenomena
Dosage:
_ _
_Adults: _
Anxiety: 1-4mg daily in divided doses.
Insomnia: 1-2mg before retiring
Premedication before operative dentistry or general surgery:
2-3mg the night before operation 2-4mg one to two hours before the
procedure
_Elderly: _
The