Lorazepam 2.5mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Lorazepam

제공처:

Viatris UK Healthcare Ltd

ATC 코드:

N05BA06

INN (국제 이름):

Lorazepam

복용량:

2.5mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

Schedule 4 (CD Benz)

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04010200; GTIN: 5016695000657

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
LORAZEPAM TABLETS 1MG AND 2.5 MG
LORAZEPAM
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 gets 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
Lorazepam Tablets contain lorazepam as the active ingredient. This
belongs to a group of medicines known as
benzodiazepines, which have sedative and muscle relaxing properties.
Lorazepam Tablets are used for the short term treatment of anxiety,
which may or may not be associated with
sleeping problems and is severe, disabling, or causing unacceptable
distress.
Lorazepam Tablets are also used as a sedative and pre-medication
before investigative or surgical procedures,
such as dental surgery.
2.
BEFORE YOU TAKE LORAZEPAM TABLETS
DO NOT TAKE LORAZEPAM TABLETS IF YOU HAVE:

an allergy (hypersensitivity) to lorazepam or any of the other
ingredients in the tablets (see
Section 6: Further information)

myasthenia gravis (extreme tiredness and weakness of selected muscles,
symptoms of which
may include drooping of the upper eyelid, double vision or speech
difficulties
)

difficulties in breathing

sleep apnoea syndrome (when you stop breathing while asleep)

severe liver damage.
TAKE SPECIAL CARE WITH LORAZEPAM TABLETS IF YOU:

are suffering with depression, or anxiety associated with depression,
and are not taking any
other medication

have an alcohol or drugs problem,

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lorazepam 2.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lorazepam 1 mg.
Excipients with known effect
Each tablet contains 60 mg of lactose as monohydrate. For the full
list of excipients,
see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Pink, biconvex, odourless capsule shaped tablets. Scored on one side
and
engraved MP61.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
Anxiety
Benzodiazepines are only indicated for the short term relief (2 – 4
weeks only)
of anxiety that is severe, disabling or subjecting the individual to
extreme
distress, occurring alone or in association with insomnia or
short-term
psychosomatic, organic or psychotic illness.
Insomnia
Benzodiazepines are only indicated when the insomnia is severe,
disabling or
subjecting the individual to extreme distress.
Premedication
Benzodiazepines may be given to sedate and relieve anxiety in
apprehensive
patients.
CHILDREN
Not recommended
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For all indications: treatment should be started with the lowest
recommended dose.
The maximum dose should not be exceeded. Treatment should be as short
as possible
(see section 4.4 Special warnings and precautions for use).
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.
ADULTS
Anxiety:
1-4 mg daily in divided doses. Start with a low dose and increase
gradually to achieve
symptom control.
The patient should be reassessed regularly and the need for continued
treatment
should be evaluated, especially in the case the patient is symptom
free. The overall
duration of treatment generally should not be more than 2 – 4 weeks,
including a
tapering off process.
Insomnia associated with anxiety:
1-2 mg at bedtime, for administration when required rather than
regular use.
Generally, the duration of treatment varies from a few days to two
weeks w