Nitrazepam 5mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Nitrazepam

Saadav alates:

Ennogen Pharma Ltd

ATC kood:

N05CD02

INN (Rahvusvaheline Nimetus):

Nitrazepam

Annus:

5mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

Schedule 4 (CD Benz)

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04010100; GTIN: 05060313371216

Infovoldik

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
0906819/1
Ennogen
Nitrazepam 5mg Leaflet
UK
English
160 x 340 mm
9 pt
1 of 1
4
07-08-20
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
NITRAZEPAM 5MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
WHAT IS IN THIS LEAFLET
!
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 have any further questions, ask your doctor,
pharmacist or nurse.
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.
!
Suffer from myasthenia gravis (a condition in which the
muscles become weak and tire easily
!
TOLERANCE – if after a few weeks you notice that the
tablets are not working as well as they did when first
starting treatment, you should speak to your doctor
1.
WHAT NITRAZEPAM TABLETS ARE AND WHAT
THEY ARE USED FOR
6.
Contents of the pack and other information
1.
What Nitrazepam Tablets are and what they are used for
Nitrazepam Tablets are used for the short term treatment of
sleeplessness (also known as insomnia) when it is severe,
disabling or subjecting the individual to extreme stress.
Nitrazepam Tablets help you to sleep but do not cure the
underlying cause of your insomnia, which you should discuss
with your doctor.
3.
How to take Nitrazepam Tablets
4.
Possible side effects
Nitrazepam belongs to a group of medicines known as
benzodiazepines, which are tranquillisers (medicines that
have a calming effect). Nitrazepam shortens the time taken to
fall asleep and lengthens the duration of sleep.
!
Are suffering from a psychiatric illness or personality
disorder (severe mental problems)
!
Suffer from difficulty breathing while awake or asleep
DO NOT TAKE NITRAZEPAM TABLETS IF YOU

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nitrazepam 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of Nitrazepam.
Excipient with known effect
Lactose monohydrate 380mg per tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White, flat bevelled edged tablets, with a breakline.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nitrazepam Tablets are indicated for the short-term treatment of
insomnia when it is
severe, disabling or subjecting the individual to extreme 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_
5mg before retiring. This dose may, if necessary, be increased to
10mg.
_ _
_Elderly and debilitated patients _
The elderly or patients with impaired renal and/or hepatic function
will be particularly
susceptible to the adverse effects of Nitrazepam. Doses should not
exceed half those
normally recommended.
If organic brain changes are present, the dosage of Nitrazepam should
not exceed 5mg
in these patients.
_Other populations _
In patients with chronic pulmonary insufficiency, and in patients with
chronic renal or
hepatic disease, the dosage may need to be reduced.
_Paediatric population _
Nitrazepam Tablets are contraindicated 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 long