Nitredon Tablets 5mg

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

NITRAZEPAM

थमां उपलब्ध:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ए.टी.सी कोड:

N05CD02

INN (इंटरनेशनल नाम):

NITRAZEPAM 5 mg

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

NITRAZEPAM 5 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

PSYCHOLEPTICS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2007-04-05

सूचना पत्रक

page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NITREDON 5 MG TABLETS
Nitrazepam
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 Nitredon is and what it is used for
2.
What you need to know before you take Nitredon
3.
How to take Nitredon
4.
Possible side effects
5.
How to store Nitredon
6.
Contents of the pack and other information
1.
WHAT NITREDON IS AND WHAT IT IS USED FOR
Nitrazepam, the active substance of Nitredon belongs to the group of
medicines called
benzodiazepines, which are tranquillisers (medicines that have a
calming effect).
Nitredon shortens the time taken to fall asleep and lengthens the
duration of sleep.
Nitredon is used for the short-term treatment of sleeplessness (also
known as insomnia) when
it is severe. Nitredon helps you to sleep but do not cure the
underlying cause of your insomnia,
which you should discuss with your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITREDON
DO NOT TAKE NITREDON
•
if you are allergic to nitrazepam or any of the other ingredients of
this medicine (listed in
section 6).
•
if you are allergic (hypersensitive) to any medicine known as a
benzodiazepine (e.g.
flurazepam, diazepam, chlordiazepoxide or temazepam).
•
if you suffer from lung disease.
•
if you suffer from difficulty breathing while awake or asleep.
•
if you suffer from myasthenia gravis (a condition in which the muscles
become weak and
tire easily).
•
if you are suffering from a psychiatric illness or a personality
disorder (severe mental
problems).
•
if yo

उत्पाद विशेषताएं

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nitredon 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg nitrazepam.
Excipient(s) with known effect
This product contains 69 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round, flat scored tablets.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of insomnia when it is severe, disabling or
subjecting the
individual to unacceptable distress, where daytime sedation is
acceptable.
An underlying cause for insomnia should be sought before deciding upon
the use of
benzodiazepines for symptomatic relief.
Benzodiazepines are not recommended for the primary treatment of
psychotic illness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
5 mg before retiring. This dose may, if necessary, be increased to 10
mg.
_Elderly _
Elderly or debilitated patients: the elderly or patients with impaired
renal and/or hepatic
function will be particularly susceptible to the adverse effects of
Nitredon. Doses should
not exceed half those normally recommended.
Page 2 of 9
If organic brain changes are present, the dosage of Nitredon should
not exceed 5 mg in
these patients.
_Other populations _
In patients with chronic pulmonary insufficiency and in patients with
chronic renal or
hepatic disease, dosage may need to be reduced.
_Paediatric population_
Nitredon tablets are contra-indicated for use in children.
Dosage should be adjusted on an individual basis. Treatment should, if
possible, be on
an intermittent basis.
Treatment should be as short as possible and should be started with
the lowest
recommended dose. The maximum dose should not be exceeded. Generally
the duration
of treatment varies from a few days to two weeks with a maximum of
four weeks;
including the tapering off process. Patients who have taken
benzodiazepines for a
prolonged time may require a longer period during which doses are