Lorazepam Hualan 0.5 mg tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Verfügbar ab:

Hualan Pharmaceuticals Limited 16/17 College Green Dublin D02 V078 , Ireland

ATC-Code:

N05BA06

INN (Internationale Bezeichnung):

LORAZEPAM 0.5 mg

Darreichungsform:

TABLET

Zusammensetzung:

LORAZEPAM 0.5 mg

Verschreibungstyp:

POM

Therapiebereich:

PSYCHOLEPTICS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2023-11-09

Gebrauchsinformation

1
Lorazepam 0.25/0.5/1.0/2.5 milligram tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LORAZEPAM HUALAN 0.25 MG TABLETS
LORAZEPAM HUALAN 0.5 MG TABLETS
LORAZEPAM HUALAN 1 MG TABLETS
LORAZEPAM HUALAN 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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lorazepam Hualan is and what it is used for
2.
What you need to know before you take Lorazepam Hualan
3.
How to take Lorazepam Hualan
4.
Possible side effects
5.
How to store Lorazepam Hualan
6.
Contents of the pack and other information
1.
WHAT LORAZEPAM HUALAN IS AND WHAT IT IS USED FOR
Lorazepam Hualan is a sedative and anti-anxiety medicine
(tranquilizer) from the group of active
substances designated benzodiazepines.
Lorazepam Hualan is used for the short-term treatment of anxiety, or
sleeping difficulties due to
anxiety in adults.
It may also be used as a sedative before diagnostic procedures and
surgery in adults, adolescents
and children 6 years and above.
Lorazepam Hualan is not to be used to treat mild or moderate anxiety
in adults or for anxiety and
sleeping difficulties in children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORAZEPAM HUALAN
DO NOT TAKE LORAZEPAM HUALAN
- if you are allergic to lorazepam, other benzodiazepines, or any of
the other ingredients of this
medicine (listed in section 6).
- if you have serious liver problems (severe hepatic insufficiency)
- if you are pregnant (see section “Pregnancy and breast-feeding)
- if you have, or have ever had, an addiction to any medicines,
alcohol or drugs
-

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lorazepam Hualan 0.25 mg tablets
Lorazepam Hualan 0.5 mg tablets
Lorazepam Hualan 1 mg tablets
Lorazepam Hualan 2.5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.25 mg tablet contains 0.25 mg of lorazepam.
Each 0.5 mg tablet contains 0.5 mg of lorazepam
Each 1 mg tablet contains 1 mg of lorazepam
Each 2.5 mg tablet contains 2.5 mg of lorazepam
Excipient with known effect
Each 0.25 mg tablet contains 34.075 mg of lactose monohydrate.
Each 0.5 mg tablet contains 68.15 mg of lactose monohydrate.
Each 1 mg tablet contains 67.65 mg of lactose monohydrate.
Each 2.5 mg tablet contains 169.125 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Lorazepam Hualan 0.25 mg tablets:
White coloured, round, flat, bevelled edged, score line on one side
and plain on other side.
The score line is not intended for breaking the tablet. The tablet
size is 5.00 mm x 1.85 mm.
Lorazepam Hualan 0.5 mg tablets:
White coloured, round, flat, bevelled edged, letter ‘L’ embossed
on one side and plain on
other side. The tablet size is 6.00 mm x 2.60 mm.
Lorazepam Hualan 1 mg tablets:
White coloured, round, flat, bevelled edged, letter ‘M’ embossed
on one side and plain on
other side. The tablet size is 6.00 mm x 2.60 mm.
Lorazepam Hualan 2.5 mg tablets:
White coloured, round, flat, bevelled edged, score line on one side
and plain on other side.
The score line is not intended for breaking the tablet. The tablet
size is 8.50 mm x 3.60 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Symptomatic short-term treatment of anxiety and insomnia caused by
anxiety, where the
anxiety is severe, disabling or subjecting the individual to
unacceptable distress.
Adults, adolescents and children 6 years and above
Premedication before diagnostic procedures or before surgical
interventions.
Children and adolescents under 18 years of age should not be treated
with lorazepam except
after strict indication fo