Lorivan 2 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LORAZEPAM

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

N05BA06

INN (International Name):

LORAZEPAM 2 mg

Pharmaceutical form:

TABLET

Composition:

LORAZEPAM 2 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2007-02-28

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LORIVAN 2 MG TABLETS
lorazepam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lorivan is and what it is used for
2.
What you need to know before you take Lorivan
3.
How to take Lorivan
4.
Possible side effects
5.
How to store Lorivan
6.
Contents of the pack and other information
1. WHAT LORIVAN IS AND WHAT IT IS USED FOR
Lorivan contains the active substance lorazepam.
Lorivan is a member of a group of medicines called benzodiazepines. It
can help to relieve
anxiety.
Lorivan may be prescribed as short-term therapy for anxiety or
sleeping difficulties due to
anxiety which is significantly affecting normal daily life.
It may also be used as a sedative before surgery or operative dental
treatment.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORIVAN
DO NOT TAKE LORIVAN
•
if you are allergic to lorazepam or any of the other ingredients of
this medicine (listed in
section 6).
•
if you have severe breathing or chest problems.
•
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).
mt-pl-lorivan-2mg-tabs-a3
2
If any of the above apply to you, do not take Lorivan.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lorivan.
•
if you are pregnant or trying to become pregnant.
•
if you abuse or have

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICAL PRODUCT
Lorivan
2 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lorazepam 2 mg.
Excipient(s) with known effect
This product contains 60.1 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Yellow, flat, scored tablets.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lorivan is indicated for the short-term treatment of unacceptable
disabling or distressful
anxiety states including anxiety associated with psychosomatic,
organic and psychotic
illness and the short-term treatment of insomnia associated with
anxiety. Lorivan is also
used as premedication before operative dentistry and general surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage and duration of therapy should be individualised. The lowest
effective dose
should be prescribed for the shortest time possible. The risk of
withdrawal and rebound
phenomena is greater after abrupt discontinuation; therefore, the drug
should be
discontinued gradually for all patients (see section 4.4). Generally,
the duration of
treatment
varies
from
a
few
days
to
4
weeks
including
the
tapering
off
process. Extension of the treatment period should not take place
without re-evaluation
of the need for continued therapy.
Increases in the dosage of lorazepam should be made gradually to help
avoid adverse
effects. The evening dose should be increased before the daytime
doses.
mt-spc-lorivan-2mg-tabs-v04-r00-a2 Page 2 of 12
_Adults _
Moderate and severe 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
operation
_Elderly and debilitated patients _
_ _
For elderly and debilitated patients reduce the initial dose by
approximately 50% and
adjust the dosage as needed and tolerated (see section 4.4 Special
warni