Nitrazepam 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nitrazepam

Available from:

Accord-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: 5012617009609

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

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 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
for a prolonged time may requi