Zileze 7.5 mg Film-Coated Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Zopiclone

Доступна з:

Chiesi Limited

Код атс:

N05CF; N05CF01

ІПН (Міжнародна Ім'я):

Zopiclone

Дозування:

7.5 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

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

Терапевтична области:

Benzodiazepine related drugs; zopiclone

Статус Авторизація:

Not marketed

Дата Авторизація:

1999-06-25

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZILEZE
®
3.75 MG & 7.5 MG FILM-COATED TABLETS
ZOPICLONE
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 ZILEZE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZILEZE
3.
HOW TO TAKE ZILEZE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ZILEZE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ZILEZE IS AND WHAT IT IS USED FOR
Zileze Film-Coated Tablets contain zopiclone which belongs to a group
of medicines called
hypnotics that act on your brain. Zileze has been prescribed by your
doctor to help you
sleep. Your doctor will only prescribe these tablets if he/she
considers your sleep problem to
be severe, disabling or distressful. Sleeping problems do not usually
last for a long time and
therefore most people only need a short course of treatment. The
length of time for which
your doctor will prescribe you to take Zileze will vary from a few
days to three weeks, with a
maximum of four weeks. You should contact your doctor again if you
still have problems
sleeping after you have finished your course of tablets.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZILEZE
DO NOT TAKE ZILEZE:
• if you are under the age of 18. The safety and efficacy of Zileze
in children and
adolescents aged less than 18 years have not been established
• if you are allergic to zopiclone or any of the other ingredients
in Zileze, listed in Section 6 (Signs
of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips,
face, throat

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zileze 7.5 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Zopiclone 7.5 mg.
Excipients: Each tablet contains 30.8mg of lactose monhydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White, round, biconvex, film-coated tablets embossed with “zoc
7.5” on one side and a scoring on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zopiclone is indicated for the short-term treatment of insomnia in
adults.
Benzodiazepines and benzodiazepine-like agents are only indicated when
the disorder is severe, disabling or subjecting
the individual to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION_
_ORAL_
Treatment should be as short as possible. The duration of treatment,
including a tapering off period, should not exceed
4 weeks. In certain cases extension beyond the maximum treatment
period may be necessary; if so, it should not take
place without re-evaluation of the patient’s status. Long-term
continuous use is not recommended.
Treatment should be started with the lowest recommended dose. The
maximum dose should not be exceeded.
_POSOLOGY_
ADULTS:
The usual dose of zopiclone in healthy adults is 7.5 mg, taken orally
30 to 60 minutes before retiring.
THE ELDERLY:
An initial dose of 3.75 mg is recommended. This can be increased, if
necessary, to 7.5 mg per day.
USE IN PATIENTS WITH RENAL & HEPATIC IMPAIRMENT:
In general, in patients who have a decrease in renal and/or hepatic
function, the dose should be kept to a minimum. In
patients with mild hepatic and mild to moderate renal insufficiency a
daily dose of 3.75 mg should be used with
caution. In patients with severe hepatic and renal insufficiency a
daily dose of 3.75 mg should not be exceeded.
CHRONIC RESPIRATORY INSUFFICIENCY:
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