Nitrazepam 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nitrazepam

Available from:

Teva 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; GTIN: 5017007031895

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NITRAZEPAM 5 MG TABLETS
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 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 NITRAZEPAM IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITRAZEPAM
3.
HOW TO TAKE NITRAZEPAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NITRAZEPAM
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT NITRAZEPAM IS AND WHAT IT IS USED FOR
Nitrazepam is a sedative drug which is used in the short-term to help
people sleep. It belongs to a group of
drugs called benzodiazepines.
Nitrazepam is used for the short-term treatment of difficulty in
sleeping, which is severe, disabling or causing
extreme distress.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITRAZEPAM
DO NOT TAKE NITRAZEPAM IF YOU:
•
are allergic (hypersensitive) to nitrazepam, other benzodiazepines
(e.g. temazepam or diazepam) or any
of the other ingredients of this medicine (listed in section 6)
•
suffer from severe lung problems
•
suffer from problems such as phobias or obsessional behaviour
•
suffer from myasthenia gravis, a specific condition causing severe
muscle tiredness
•
suffer from sleep apnoea (difficulty breathing while asleep)
•
have severe liver disease
•
are under the age of 12 years
•
have acute porphyria
•
are pregnant, or planning a pregnancy, unless you have discussed this
with your doctor.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE IF YOU:
•
suffer from depression or depression with anxiety
•
have kidney or liver probl

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 5.0 mg of Nitrazepam Ph. Eur.
Excipient(s) with known effect
One Nitrazepam 5 mg Tablet contains 350 mg of lactose monohydrate Ph.
Eur.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
A white, flat, bevel edged tablets. Engraved, Berk 1N4 or 1N4 with a
breakline on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For short term (2-4 weeks only) use:
•
Insomnia – but only if severe, disabling or subjecting the
individual to
extreme distress
•
An underlying cause should always be sought (and addressed) before
deciding to use benzodiazepines for insomnia
Not for use:
•
Long term (i.e. longer than 4 weeks)
•
In children under the age of 12 years
•
If daytime sedation is not acceptable
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest effective dose should be used. Treatment should not be
continued
beyond 4 weeks including the tapering off process, and should, where
possible,
be intermittent. Long term chronic use is not recommended. Treatment
with
benzodiazepines should always be withdrawn gradually. Patients who
have been
receiving treatment for a long time may require longer periods during
which the
doses are reduced.
In certain cases extension beyond the maximum treatment period may be
necessary, but it should not take place without re-evaluation of the
situation.
In addition, for long-acting benzodiazepines, such as nitrazepam, the
patient
should be checked regularly at the start of treatment in order to
decrease if
necessary, the dosage or the frequency of administration to prevent
overdosage
due to accumulation.
When treatment is started the patient should be informed that:
•
Treatment will be of limited duration
•
The dosage will be progressively decreased
•
There is the possibility of rebound insomnia
_ Adults:_
Usually 5 mg before retiring. This may be increased to 10 mg when
necessary or
to