Nitrazepam 5mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Nitrazepam

Доступна с:

A A H Pharmaceuticals Ltd

код АТС:

N05CD02

ИНН (Международная Имя):

Nitrazepam

дозировка:

5mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

Schedule 4 (CD Benz)

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 04010100; GTIN: 5012252103458

тонкая брошюра

MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
Item Code
Profile
Size
Min. Point Size
Market
Language
Proof By
Proof No.
Date
Artwork No.
Pharma
Code
Colours Used
Wockhardt UK Limited
Nitrazepam leaflet
105232/4
n-a
128 x 420mm
matt.pirie-scott
1
26/08/2015
591904
n-a
Process Black
Keylines (non-printing)
[e-mail]
CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS
WARNING! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.
UK
English
8pt (main body) / 8pt (variables)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TO TAKE THIS MEDICINE.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, please ask
your doctor or pharmacist.
- This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
- If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Nitrazepam Tablets are and what they
are used for
2. Before you take Nitrazepam Tablets
3. How to take Nitrazepam Tablets
4. Possible side effects
5. How to store Nitrazepam Tablets
6. Further information
1. What Nitrazepam Tablets are and what
they are used for
The name of your medicine is Nitrazepam
Tablets. The active ingredient in your medicine
is nitrazepam. Nitrazepam Tablets belong to
a group of medicines called benzodiazepines
which are used as sedatives.
Nitrazepam Tablets are used to treat severe
sleeplessness problems (insomnia) and the
worry such sleeping problems may cause.
2. Before you take Nitrazepam Tablets
DO NOT TAKE NITRAZEPAM TABLETS IF YOU
• are allergic (hypersensitive) to nitrazepam,
or other benzodiazepines, or to any of the
other ingredients in

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nitrazepam 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of Nitrazepam
Excipient with known effect: Each tablet contains 445 mg of Lactose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets.
Uncoated white flat bevel edged tablets with breakline on one face and
stamped “SPN5” on the other.
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: 5mg before retiring. This dose may, if necessary, be increased
to
10mg.
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 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 longer period
during which doses