Lorans 0.5 mg tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

LORAZEPAM

Verfügbar ab:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC-Code:

N05BA06

INN (Internationale Bezeichnung):

LORAZEPAM 0.5 mg

Darreichungsform:

TABLET

Zusammensetzung:

LORAZEPAM 0.5 mg

Verschreibungstyp:

POM

Therapiebereich:

PSYCHOLEPTICS

Produktbesonderheiten:

Licence number in the source country: NOT APPLICAPABLE

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2022-02-03

Gebrauchsinformation

- 1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LORANS 0.5 MG TABLETS
LORANS 1 MG TABLETS
LORANS 2.5 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Lorans is and what it is used for
2.
What you need to know before you take Lorans
3.
How to take Lorans
4.
Possible side effects
5.
How to store Lorans
6.
Contents of the pack and other information
1.
WHAT LORANS IS AND WHAT IT IS USED FOR
The name of your medicine is Lorans, called lorazepam or lorazepam
tablets in the rest of the
leaflet. The tablets contain lorazepam.
The active ingredient is lorazepam, which is a type of medicine called
a benzodiazepine. It
relieves anxiety and it is used for short periods to relieve anxiety
that is severe, disabling, or
causing you extreme distress, and to treat difficulties sleeping that
are caused by anxiety. It may
also be used as a sedative shortly before a dental or surgical
operation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORANS
DO NOT TAKE LORANS
-
if you are allergic to lorazepam, or to any other benzodiazepine, or
any of the other
ingredients of this medicine (listed in section 6).
-
you have severe breathing or chest problems
-
you have very tired or very weak muscles, a condition called
myasthenia gravis
-
you have serious liver problems
-
you suffer from breathing problems when you are asleep, a condition
called sleep apnoea
-
you have a history of persistently abusing alcohol and / or drugs
- 2
-
you are breast feeding, as lorazepam may pass into breast milk (see
P

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lorans 0.5 mg tablets
Lorans 1 mg tablets
Lorans 2.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lorazepam 0.5 mg.
Each tablet contains lorazepam 1 mg.
Each tablet contains lorazepam 2.5 mg.
Excipient
with known effect: lactose monohydrate
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Lorans 0.5 mg: White, round with rounded edge tablets, diameter about
4.7 mm.
Lorans 1 mg: white, round, flat, bevelled, scored tablets, with
“1.0” inscription, diameter about
6.4 mm.
The tablet can be divided into equal doses.
Lorans 2.5 mg: white, round, flat, bevelled, scored, tablets, diameter
about 9.1 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lorans is indicated for:

Short-term symptomatic treatment of anxiety and insomnia caused by
anxiety, where
the anxiety is severe, disabling or subjecting the individual to
extreme distress.

Premedication
before
general
anaesthesia
or
before
minor
surgical
procedures,
investigations or operative dentistry.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
2
Posology
_General: _
The dosage and duration of therapy should be individualised. The
lowest effective dose should be
prescribed for the shortest time possible. Since the risk of
withdrawal and rebound phenomena is
greater after abrupt withdrawal, the drug should be discontinued
gradually for all patients (see
section 4.4). The maximum daily dose of 4mg should not be exceeded.
In general 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.
If the daily dose is taken as single dose in the evening it should not
be taken on a full stomach.
Due to a delayed onset of effect and depending on the length of the
sleeping period a hang-over
effect might be possible during the following day (see Sect