Lorazepam 1mg/ml oral solution sugar free

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Lorazepam

Disponible depuis:

Thame Laboratories Ltd

Code ATC:

N05BA06

DCI (Dénomination commune internationale):

Lorazepam

Dosage:

1mg/1ml

forme pharmaceutique:

Oral solution

Mode d'administration:

Oral

classe:

Schedule 4 (CD Benz)

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04010200; GTIN: 05055935100832

Notice patient

PIL/UK/MFG024/05/v8
TURN OVER
L
PACKAGE EAFLET: INFORMATION FOR THE USER
LORAZEPAM 1MG/ML ORAL SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
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. This includes any
possible side effects not listed in this
your leaflet. See section 4.
The name of your medicine is Lorazepam
1mg/ml Oral Solution but it will be
referred to as 'Lorazepam' throughout
this leaflet.
WHAT IS IN THIS LEAFLET
1.
WHAT LORAZEPAM IS AND WHAT IT IS
USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE LORAZEPAM
3.
HOW TO TAKE LORAZEPAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LORAZEPAM 1MG/ML
ORAL SOLUTION
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
Lorazepam is not to be used for longer
than 4 weeks or to treat mild or moderate
anxiety in adults.

if you have severe breathing or chest
problems

if you are allergic to benzodiazepines
or any of the other ingredients in
Lorazepam (see list under ‘What
Lorazepam contains’)

if you have myasthenia gravis (very
weak or tired muscles)

if you have serious liver problems



if you are planning a pregnancy or are
pregnant.
If you have been only prescribed
Lorazepam for anxiety and no other
medications, please consult with your
doctor whether other medications should
also be prescribed.
1.
WHAT LORAZEPAM IS AND WHAT
IT IS USED FOR
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE LORAZEPAM
You should avoid alcohol while you are
taking lorazepam, since this you very
drowsy and seriously affect your ability to
drive or use machines.
The medicine can affect your ability to
drive as it may make you feel sleepy or
dizzy.
DRIVING AND USING MACHINES
Lorazepam may make you feel dizzy,
sleepy or forgetful during the day, or may

Résumé des caractéristiques du produit

OBJECT 1
LORAZEPAM 1MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 06-Jun-2018 | Thame
Laboratories
1. Name of the medicinal product
Lorazepam 1mg/ml Oral Solution
2. Qualitative and quantitative composition
Each ml of oral solution contains 1mg lorazepam.
_Excipients with known effect: _
Each ml of oral solution contains 20.21mg ethanol (alcohol).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
A clear, colourless to pale yellow colour oral solution
4. Clinical particulars
4.1 Therapeutic indications
FOR SHORT TERM (2-4 weeks only) USE
• 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
• Before operative dentistry and general surgery
NOT FOR USE
• Long term (i.e. longer than 4 weeks)
• For mild/moderate anxiety
Lorazepam Oral Solution is not recommended for use in children.
4.2 Posology and method of administration
Route of administration: oral
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 - 4ml (1 - 4mg) daily in divided doses.
• Insomnia: 1 - 2ml (1 - 2mg) before retiring
• Premedication before operative dentistry or general surgery: 2 -
3ml (2 - 3mg) the night before operation
2 - 4ml (2 - 4mg) one to two hours before the procedure
_Elderly:_
The elderly may respond to lower doses (half normal adult