Lorazepam 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lorazepam

Available from:

Arrow Generics Ltd

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

Product:
MA Holder:
GENETHICS EUROPE
PL No.:
42976/0034 & 0035
Pack Size:
ALL PACK
Livery:
GENETHICS EUROPE
Manufacturer:
-
Market:
UK
Component:
LEAFLET
Dimensions:
148 X 297 MM
Created By:
DTAWDE
Artwork Code:
GE0034-0035/O/PIL1/GE2
Bar Code:
-
Font Type:
ARIAL NARROW
Font Size:
8.2 PT
Printing Colours:
Non-Printing Colours:
Final Preparation Date For Submission:
01/08/2018
Packing Site Technical Approval:
00/00/0000
Authority Approval Date:
00/00/0000
Latest Implementation Deadline:
00/00/0000
Print Proof Approval:
00/00/0000
LORAZEPAM
1 & 2.5 MG TABLETS
Black
Profile
OTHER SIDE EFFECTS
VERY COMMON (may affect more than 1 in 10 people):

Daytime drowsiness.
COMMON (may affect around 1 in 100 people):

Dizziness, poor muscle control, muscle weakness,
fatigue.
RARE (may affect around 1 in 1,000 people):

Depression, numbed emotions, difficulty controlling urges
and impulses to speak, act or show emotions, a feeling of
well-being for no reason, appetite changes, sleep
problems, changes in sex drive, decreased orgasm,
headache, slurred speech, memory loss or forgetfulness,
problems with vision including double vision or blurred
vision, worsening of sleep apnoea (e.g. loud snoring,
restlessness and choking/gasping during the night),
breathing difficulties, stomach upsets, nausea,
constipation, changes in the amount of saliva in the
mouth, skin problems such as rashes and inflammation,
erectile dysfunction, blood or liver function changes, low
blood pressure or low body temperature.
VERY RARE (may affect around 1 in 10,000 people):

Trembling or shaking.
NOT
KNOWN
(frequency
cannot
be
estimated
from
the
available data:

Increased risk of falling.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist.
This
includes
any
possible
side
effects
not
listed
in
this leaflet. You can also report side effects directly via the
Yellow
Card
Scheme
at
www.mhra.gov.uk/yellowcard
or
search
for
‘MHRA
Yellow
Card’
in
the
Google
Play or Apple App Store. By reporting side effects yo

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