Ativan 1mg Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

LORAZEPAM

Disponible depuis:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

Code ATC:

N05BA06

DCI (Dénomination commune internationale):

LORAZEPAM 1 mg

forme pharmaceutique:

TABLET

Composition:

LORAZEPAM 1 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

PSYCHOLEPTICS

Statut de autorisation:

Authorised

Date de l'autorisation:

2006-11-29

Notice patient

Page 1 of 8 2022-0075703
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATIVAN
®
1MG 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 Ativan Tablets are and what they are used for
2.
What you need to know before you take Ativan Tablets
3.
How to take Ativan Tablets
4.
Possible side effects
5.
How to store Ativan Tablets
6.
Contents of the pack and other information
1. WHAT ATIVAN TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Ativan Tablets. Ativan Tablets contain
the active substance lorazepam.
Ativan Tablets are a member of a group of medicines called
benzodiazepines. It can help to relieve
anxiety.
Ativan Tablets 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 ATIVAN TABLETS
DO NOT TAKE ATIVAN TABLETS

If you are allergic to lorazepam, other benzodiazepines 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)
If any of the above apply to you, do not take Ativan Tablets.
WARNINGS AND PRECAUTIONS
Talk to your docto

Résumé des caractéristiques du produit

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2022-0075703
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ativan 1 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lorazepam 1 mg.
Excipient with known effect
This medicine contains 67.65 mg lactose monohydrate in each 1 mg
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Round, flat, white, bevelled-edged tablets impressed with “1.0” on
one side, and a breakbar on the other.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ativan 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. Ativan may also be used
as premedication before
operative dentistry and general surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and duration of therapy has to be individualised depending on
symptoms and underlying
condition. The risk of dependence may increase with dose and duration
of treatment; therefore, the
lowest effective dose should be prescribed for the shortest duration
and the need for continued treatment
reassessed frequently (see section 4.4).
Abrupt discontinuation or rapid dosage reduction of lorazepam after
continued use may precipitate
withdrawal reactions which can be life-threatening, and/or rebound
phenomena; therefore, the drug
should be discontinued gradually or reduce the dosage (see section
4.4).
Duration of Treatment
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.
Posology
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.
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2022-0075703
ADULTS:
Moderate and severe anxiety:
1-4 m