Ativan 1 mg Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Lorazepam

Доступна с:

Pfizer Healthcare Ireland

код АТС:

N05BA; N05BA06

ИНН (Международная Имя):

Lorazepam

дозировка:

1 milligram(s)

Фармацевтическая форма:

Tablet

Тип рецепта:

Product subject to prescription which may not be renewed (A)

Терапевтические области:

Benzodiazepine derivatives; lorazepam

Статус Авторизация:

Marketed

Дата Авторизация:

1997-01-10

тонкая брошюра

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

Характеристики продукта

Health Products Regulatory Authority
20 March 2023
CRN00D4DN
Page 1 of 9
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. Ativanmay 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.
ADULTS:
Moderate and seve