NITRAZEPAM 5 MG TABLETS
Active substance(s): NITRAZEPAM / NITRAZEPAM / NITRAZEPAM
231-30-83918-Y LEA NITRAZEPAM 5MG TAB TUK
19 October 2016
NITRAZEPAM 5 mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms 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.
• anti-epileptic drugs e.g. hydantoins such as
• cimetidine (used to treat stomach ulcers)
• oestrogen containing contraceptives
• disulfiram (used to treat alcohol addiction)
• ritonavir (an antiviral)
• isoniazid (used to treat tuberculosis)
• rifampicin (an antibiotic, used to treat
• levodopa (used to treat Parkinson’s Disease).
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Important information about some of the
ingredients of Nitrazepam
• Patients who are intolerant to lactose should
IN THIS LEAFLET:
note that Nitrazepam tablets contain a small
amount of lactose. If your doctor has told you
1. What Nitrazepam is and what it is used for
that you have an intolerance to some sugars,
2. Before you take Nitrazepam
contact your doctor before taking this medicinal
3. How to take Nitrazepam
4. Possible side effects
Important safety messages about Nitrazepam:
5. How to store Nitrazepam
• When taking this medicine there is a risk of
6. Further information
dependence (a need to keep taking the
WHAT NITRAZEPAM IS AND WHAT IT IS
medicine). The risk increases with the dose and
length of treatment period. The risk is greater if
you have ever had a history of alcohol or drug
Nitrazepam is a sedative drug which is used in the
abuse, or suffer from a personality disorder.
short-term to help people sleep. It belongs to a group • When stopping this medicine you may
of drugs called benzodiazepines.
experience withdrawal effects (see section 3, If
Nitrazepam is used for the short-term treatment of
you stop taking Nitrazepam)
difficulty in sleeping, which is severe, disabling or
• Behavioural effects may occur while taking
causing extreme distress.
Nitrazepam (see section 4, Possible Side
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
• suffer from severe lung problems
• suffer from problems such as phobias or
• suffer from myasthenia gravis, a specific
condition causing severe muscle tiredness
• suffer from sleep apnoea (difficulty breathing
• 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.
Take special care with Nitrazepam
Talk to your doctor before you start to take this
medicine if you:
• suffer from depression or depression with
• have kidney or liver problems
• have a history of drug dependence or
• have been recently bereaved (if nitrazepam is
taken to help sleep during periods of
bereavement it may stop you coming to terms
with your loss)
• suffer from hypoalbuminaemia (a condition
where you have abnormally low levels of the
protein albumin in your blood).
Taking other medicines
Talk to your doctor if you are taking any of the
• anti-depressants (used to treat depression)
• monoamine oxidase inhibitors (MAOIs) e.g.,
tranylcypromine, phenelzine and isocarboxazid
• anti-histamines (used to treat allergies)
• anti-psychotics (used to treat mental problems)
• lofexidine (used to help relieve symptoms
when you stop taking opioids)
• nabilone (used to treat nausea and vomiting)
• hypnotics (used to help you sleep)
• alpha blockers or moxonidine (used to treat
high blood pressure)
• muscle relaxants, e.g. baclofen, tizanidine
• probenecid (used to treat gout)
• neuroleptics (e.g. chlorpromazine)
• pain killers
Elderly patients should be cautious whilst taking
Nitrazepam, as there is a risk that they may fall whilst
taking Nitrazepam, especially when they get up at
Taking Nitrazepam with food and drink
DO NOT drink alcohol whilst taking these tablets,
as it may increase the sedative effect of the drug.
Caffeine may reduce the effectiveness of these
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or
breast-feeding, you should not take Nitrazepam,
unless you have discussed this with your doctor.
If your doctor has decided that you should receive
this medicine during late pregnancy or during labour,
your baby might have a low body temperature,
floppiness, heart problems and breathing and
feeding difficulties. If this medicine is taken regularly
in late pregnancy, your baby may develop
Driving and using machines
Nitrazepam may cause drowsiness, forgetfulness,
dizziness, blurred vision, reduced concentration
or co-ordination. These effects may be increased if
you have not had enough sleep, or if you have
taken other medicines or drunk alcohol whilst
taking Nitrazepam (see section Taking other
If affected, do NOT drive or operate machinery.
The medicine can affect your ability to drive as it may
make you sleepy or dizzy.
• Do not drive while taking this medicine until
you know how it affects you
• It is an offence to drive if this medicine affects
your ability to drive.
However, you would not be committing an offence if:
• The medicine has been prescribed to treat a
medical or dental problem and
• You have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and
• It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
HOW TO TAKE NITRAZEPAM
Always take Nitrazepam exactly as your doctor has
told you. Your doctor has decided the dose which is
suited to you. Always follow your doctor's
instructions and those that are on the pharmacy
label. If you do not understand these instructions, or
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TEVA UK Ref:
231-30-83918-Y LEA NITRAZEPAM 5MG TAB TUK
you are in any doubt, ask your doctor or pharmacist.
You should continue to take these tablets for as long
as your doctor tells you to.
The tablets should be swallowed preferably with a
glass of water just before going to bed.To reduce the
risk of loss of memory (amnesia), you should make
sure that you are able to have an uninterrupted sleep
of at least 7 hours after taking this medicine.
These effects are often mild and usually wear off
after a few days treatment.
If they are severe or last for more than a few days, tell
The following have also been commonly reported:
• numbed emotion
• reduced alertness
• difficulty in controlling movements
The usual dose is:
• muscle weakness
Usually one 5 mg tablet before going to bed.
If necessary your doctor may increase the dosage. • confusion
• memory loss
• Children under 12 years of age
Nitrazepam should not be used in children under
• double vision
12 years of age.
• Elderly or debilitated patients (including those • slurred speech.
with lung problems, kidney, or liver problems) The following have been rarely reported:
The dose should not exceed half of the
recommended adult dose.
You should not take these tablets for any longer than • stomach upset
• low blood pressure
recommended by your doctor, as dependence may
• cramps and muscle spasms
occur. It is generally recommended that nitrazepam
• visual disturbances
should not be taken for longer than 4 weeks,
• allergic reactions, e.g. skin rashes or itching
including any tapering off period where the dose is
• difficulties in passing urine
If you see another doctor or go into hospital, let them • changes in sex drive
• yellowing of the skin or the whites of the eyes
or the staff know what medicines you are taking.
If you take more Nitrazepam than you should
• blood disorders.
If you (or someone else) swallow a lot of the tablets
all together, or if you think a child has swallowed any
of the tablets, contact your nearest hospital casualty
department or your doctor immediately. An overdose
is likely to cause drowsiness, confusion, breathing
difficulties, low blood pressure, difficulty in
controlling movements and slurred speech. In
children behavioural changes are likely to occur.
Please take this leaflet, any remaining tablets and the
container with you to the hospital or doctor so that
they know which tablets were consumed.
If you forget to take Nitrazepam
If you fall asleep without having taken a dose and
wake up some hours later, do not take the missed
dose. If necessary, return to your normal dose
schedule the following night. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Nitrazepam
After you have taken these tablets for the
recommended time, your doctor may decide to stop
your tablets as dependence may occur.
Do not stop taking your tablets suddenly, or
without your doctor telling you, as you may suffer
from withdrawal effects. If your doctor decides to
stop your tablets, they will reduce the dose
gradually to minimise any withdrawal effects.
• These effects may include depression,
nervousness, irritability, diarrhoea, sweating,
headaches, muscle weakness, muscle pain,
confusion, extreme anxiety, tension,
restlessness, mood changes and have difficulty
If you experience any of these effects when you stop
taking Nitrazepam, and you are concerned about
them, ask your doctor for advice.
Loss of memory (amnesia) may occur, particularly if
you are woken soon after taking the medicine.
Elderly patients, and those with kidney and liver
damage are more likely to suffer the side effects
During treatment with Nitrazepam, pre-existing
depression may be unmasked (you may begin to
suffer symptoms of depression which were
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.
HOW TO STORE NITRAZEPAM
Keep out of the reach and sight of children.
These tablets should be stored in a cool place,
protected from light in the package or container
supplied. Do not transfer them to another
Do not use Nitrazepam after the expiry date that is
stated on the outer packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
What Nitrazepam Tablets contain:
• The active ingredient is nitrazepam 5 mg
Like all medicines, Nitrazepam can cause side effects, • The other ingredients are maize starch, lactose
monohydrate, pregelatinised maize starch,
although not everybody gets them.
microcrystalline cellulose, magnesium stearate,
If the following happens, stop taking the tablets
and sodium starch glycolate.
and tell your doctor immediately or go to the
What Nitrazepam Tablets look like and contents
casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or of the pack:
• Nitrazepam Tablets 5 mg are white, flat, bevel
neck leading to severe difficulty in breathing;
edged tablets. They are engraved “1N4” with a
skin rash or hives).
breakline on reverse
This is a very serious but rare side effect. You may
• The product is available in pack sizes of 7, 10,
need urgent medical attention or hospitalisation.
14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 110, 112,
Tell your doctor immediately if you suffer from:
120, 150, 160, 168, 500, 12000 or 10 x 50 tablets.
• behavioural changes such as restlessness,
Not all pack sizes may be marketed.
agitation, irritability, sweating, aggressiveness,
Marketing Authorisation Holder
delusions, excitement, rages, nightmares,
hallucinations, confusion, psychiatric disorders TEVA UK Limited, Eastbourne, BN22 9AG.
and inappropriate behaviour, as your treatment Manufacturer
TEVA Pharmaceutical Works Private Limited
may be stopped.
The most common side effects are:
H-4042 Debrecen, Pallagi út 13., Hungary
This leaflet was last revised: October 2016
• daytime drowsiness
POSSIBLE SIDE EFFECTS
TEVA UK Limited
Page 2 of 3
19 October 2016
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.