Nitrazepam 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nitrazepam

Available from:

Esteve Pharmaceuticals 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: 5039021003122

Patient Information leaflet

Nitrazepam, the active ingredient in these tablets, belongs to a group
of
medicines known as benzodiazepines which are tranquillisers (medicines
that are known to have a calming effect). Nitrazepam shortens the time
taken to fall asleep and lengthens the duration of sleep. This
medicine
should only be used in adults and the elderly for the short-term
treatment of
sleeplessness (also known as insomnia) when it is severe, causing
distress
and where daytime sleepiness is acceptable.
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 please 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.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NITRAZEPAM 5MG TABLETS
Nitrazepam Ph Eur
(referred to as Nitrazepam Tablets in the remainder of this leaflet)
1. WHAT NITRAZEPAM TABLETS ARE AND WHAT ARE THEY USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITRAZEPAM TABLETS
WHAT IS IN THIS LEAFLET
1.
What Nitrazepam Tablets are and what are they used for
2.
What you need to know before you take Nitrazepam Tablets
3.
How to take Nitrazepam Tablets
4.
Possible side effects
5.
How to store Nitrazepam Tablets
6.
Contents of the pack and other information
DO NOT TAKE NITRAZEPAM TABLETS AND TELL YOUR DOCTOR IF YOU:
Examples of medicines that can affect Nitrazepam Tablets are:
medicines that act on the brain or nerves such as antidepressants,
anaesthetics, other tranquilisers, sleeping pills and hypnotics
drugs used to relax muscles, such as baclofen or tizanidine
probenecid, used to treat gout
drugs used to treat high blood pressure, such as moxonidine or
medicines called alpha blockers
antihistamines (that make you feel sleepy)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nitrazepam 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg Nitrazepam Ph Eur.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablets
The score line is not intended for breaking the tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nitrazepam Tablets should be used for short term treatment of insomnia
only when it
is severe, disabling, or subjecting the individual to extreme
distress, where daytime
sedation is acceptable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be as short as possible and should be started with
the lowest
effective 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. Dosage should be adjusted on an
individual basis.
If possible, the treatment should be on an intermittent basis.
Long-term chronic use is
not recommended.
Adults: 5 mg before retiring. This dose may be increased, if
necessary, to 10
mg.
Children below the age of 12 years: Do not use.
Elderly and debilitated patients: 2.5 – 5 mg before retiring, doses
should not exceed
half those normally recommended for adults.
In patients with chronic pulmonary insufficiency, and in patients with
chronic renal or
hepatic disease, dosage may need to be reduced.
Further details are given in Section 4.4 Special warnings and
precautions for use,
Duration of treatment.
Method of administration: For oral administration.
4.3
CONTRAINDICATIONS
• Patients with known hypersensitivity to benzodiazepines or any of
the excipients
(see Section 6.1).
• Hypersensitivity reactions with benzodiazepines include rash,
angioedema and
hypertension been reported on rare occasions in susceptible patients.
• Acute pulmonary insufficiency, respiratory depression, as
ventilatory failure
may be exacerbated
• Acute Porphyria
• Myasthenia gravis, as the condition may be exacerbated
• Sl