Nitrazepam 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NITRAZEPAM

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

N05CD02

INN (International Name):

NITRAZEPAM 5 mg

Pharmaceutical form:

TABLET

Composition:

NITRAZEPAM 5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2016-05-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
NITRAZEPAM 5MG
TABLETS
Nitrazepam
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, 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 Tablet is and what it is 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
1.
WHAT NITRAZEPAM TABLET IS AND WHAT IT IS USED
FOR
Nitrazepam Tablets belongs to a group of medicines known as
benzodiazepines, which are tranquillisers
(medicines that have a calming effect).
Nitrazepam Tablets shortens the time taken to fall asleep and
lengthens the duration of sleep.
Nitrazepam Tablets are used for the short term treatment of
sleeplessness (also known as insomnia) when it
is severe.
Nitrazepam Tablets help you to sleep but do not cure the underlying
cause of your insomnia, which you
should discuss with your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITRAZEPAM TABLETS
DO NOT TAKE NITRAZEPAM TABLETS IF YOU:
• are allergic (hypersensitive) to nitrazepam or any of the other
ingredients of Nitrazepam Tablets (these
are listed in section 6, “Contents of the pack and other
information”).
• are allergic (hypersensitive) to any medicine known as a
benzodiazepine (e.g. flurazepam, diazepam,
chlordiazepoxide or temazepam).
• suffer from lung disease.
• suffer from difficulty breathing while awake or asleep.
• suffer from myasthenia gravis (a condition in which the muscles
become weak and tire easily)

Summary of Product characteristics

Page 1 of 10
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 nitrazepam 5 mg tablet contains 95 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White to off white round, flat, bevel edged tablets, debossed with
‘DM’ on one side and plain on
other side.
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
5 mg before retiring. This dose may, if necessary, be increased to 10
mg.
ELDERLY
_Elderly or debilitated patients_
: the elderly or patients with impaired renal and/or hepatic function
Page 2 of 10
will be particularly susceptible to the adverse effects of Nitrazepam
tablets. Doses should not
exceed half those normally recommended.
If organic brain changes are present, the dosage of Nitrazepam tablets
should not exceed 5 mg 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