Lorazepam 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lorazepam

Available from:

DE Pharmaceuticals

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

MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
28's
92793361808
420 x 120mm
2
29.08.2018
Lorazepam 1mg and 2.5mg Tablets
Yes
B
EBR
976859
14902
Safety update- addition of
concomitant use of benzodiaze-
pines/opioids wording
Helvetica Neue
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8pt
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*Trademark
_Please read the back of this leaflet._
PACKAGE LEAFLET: INFORMATION FOR THE USER
LORAZEPAM 1MG AND 2.5MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side-effects get serious, or if you notice any
side-effects not listed in
this leaflet, please tell your doctor or pharmacist.
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 benzodi

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