Lorazepam 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lorazepam

Available from:

Sigma Pharmaceuticals Plc

ATC code:

N05BA06

INN (International Name):

Lorazepam

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200

Patient Information leaflet

TEMESTA
® 1MG TABLETS/LORAZEPAM 1MG TABLETS
(lorazepam)
Your medicine is known by the above names, but will be referred to as
Lorazepam Tablets throughout this:
PATIENT INFORMATION LEAFLET
IN THIS LEAFLET:
1) What Lorazepam Tablets are and what they are used for
2) Before you take Lorazepam Tablets
3) How to take Lorazepam Tablets
4) Possible side-effects
5) How to store Lorazepam Tablets
6) Further information
1) WHAT LORAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Lorazepam Tablets. Lorazepam is a member
of a group of medicines called benzodiazepines. It can help to relieve
anxiety. Lorazepam is prescribed as short-term therapy for anxiety (2
-4
weeks), or sleeping difficulties due to anxiety. It may also be used
as a
sedative before surgery or operative dental treatment.
Lorazepam Tablets are not to be used for longer than 4 weeks, to treat
mild
or moderate anxiety in adults or for anxiety/insomnia in children.
2) BEFORE YOU TAKE LORAZEPAM TABLETS
DO NOT TAKE LORAZEPAM TABLETS:
•
if you have severe breathing or chest problems
•
if you are allergic to benzodiazepines or any of the other ingredients
in
Lorazepam Tablets (see list under ‘What Lorazepam Tablets
contain’)
•
if you have myasthenia gravis (very weak or tired muscles)
•
if you have serious liver problems
•
if you suffer from sleep apnoea (breathing problems when you are
asleep)
•
if you are breast-feeding, since the drug may pass into breast milk.
•
if you are planning a pregnancy or are pregnant.
If you have been only prescribed Lorazepam Tablets for anxiety and no
other
medications,
please
consult
with
your
doctor
whether
other
medications should also be prescribed.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Lorazepam Tablets:
•
if you abuse or have in the past abused drugs or alcohol
•
if you have a personality disorder. If so, you have a greater chance
of
becoming dependent on lorazepam
•
if you have any kidney or liver problems
•
if you are suffering from depression, since lo

Summary of Product characteristics

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