Nitrazepam 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nitrazepam

Available from:

Kent Pharma (UK) Ltd

ATC code:

N05CD02

INN (International Name):

Nitrazepam

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
REMNOS
NITRAZEPAM 5 MG TABLETS
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF
REMNOS.
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR
PHARMACIST FOR MORE INFORMATION.
_WHAT IS IN YOUR MEDICINE?_
The name of this medicine is REMNOS. Each tablet contains Nitrazepam
BP 5 mg together with the following ingredients:
lactose, maize starch, pregelatinised maize starch, ethylcellulose,
magnesium stearate.
Your tablets are round, white, flat tablets with bevelled edges and a
breakline. They are engraved REMNOS 5.
REMNOS is available in containers of 100 and 500 tablets.
The Product Licence holder of REMNOS is Chelonia Healthcare Limited,
Boumpoulinas 11, 3
rd
Floor, Nicosia, P.C. 1060,
Cyprus.
The manufacturer of REMNOS is DDSA Pharmaceuticals Ltd., Chatfield
Road, off York Road, London SW11 3SE.
_HOW DOES REMNOS WORK?_
REMNOS belongs to a group of medicines known as the benzodiazepine
hypnotics (medicines used in the treatment of
insomnia).
_WHY HAVE YOU BEEN PRESCRIBED REMNOS?_
Nitrazepam is used in the short term treatment of insomnia only when
it is severe, disabling or subjecting the patient to
extreme distress.
_BEFORE TAKING YOUR MEDICINE_
Before you start treatment with REMNOS study this section of the
leaflet carefully so you can be sure this medicine is
suitable for you.
Before taking these tablets, tell your doctor if you have ever had any
unusual or allergic reactions to Nitrazepam or other
medicines belonging to the same benzodiazepine group.
Also tell your doctor or pharmacist if you are allergic to any of the
other ingredients listed under “What is in your
medicine?” above, or any other substances such as food,
preservatives or dyes.
It is important to tell your doctor if you are pregnant or likely to
become pregnant.
Do not use Nitrazepam if you have suffered or suffer from:
•
a lung or other respiratory problem
•
a disorder known as ‘myasthenia gravi

Summary of Product characteristics

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