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NITRAZEPAM TABLETS B.P. 5MG.

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Patient Information Leaflet

NITRAZEPAM 5mg TABLETS
Read all of this leaflet carefully because it contains
important information for you.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or
advice.
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.
1. WHAT NITRAZEPAM IS AND WHAT IT IS USED FOR
Nitrazepam is a benzodiazepine tranquilliser. It is used for the
short-term treatment of insomnia when it is severe, disabling
or causing distress, and when daytime sedation is acceptable.
2. BEFORE YOU TAKE NITRAZEPAMTABLETS
Do NOT take this medicine if you:
• are allergic (hypersensitive) to nitrazepam, any other
similar benzodiazepine or any of the other ingredients of
this medicine (listed in section 6)
• suffer from any mental illness such as obsessions,
phobias or chronic psychosis
• suffer from depression or anxiety associated with
depression
• have a serious lung disease or difficulty breathing
• have a condition known as porphyria
• have myasthenia gravis (a condition which causes your
muscles to weaken and tire easily)
• have sleep apnoea (you stop breathing during sleep)
• have severe liver problems.
Tell your doctor before you start to take this medicine if
you:
• have serious liver or kidney problems
• have suffered a loss or bereavement (nitrazepam can
affect the way you react to this)
• have a personality disorder
• have a history of alcoholism or drug abuse
• are elderly, as there is an increased risk of falls and,
therefore, fractures
Taking other medicines
Tell your doctor if you are taking any other medicines,
including those obtained without a prescription. In particular
tell your doctor if you are taking:



other medicines that act on the brain such as
antidepressants, other tranquillisers or sleeping pills
• medicines used to relieve pain, or general anaesthetics
• antihistamines, used to treat allergies, that cause
drowsiness e.g. chlorphenamine
• medicines used to treat epilepsy e.g. phenytoin or
phenobarbital
• cimetidine, used to treat ulcers
• rifampicin, an antibiotic.
Pregnancy and breast feeding
Do not take this medicine if you are pregnant, planning to
become pregnant or are breast feeding. Infants born to
mothers who took benzodiazepine medicines late in
pregnancy, may develop withdrawal symptoms.
Driving and using machines
Nitrazepam may affect your reactions (such as drowsiness,
confusion or double vision), make sure you are not affected
before you drive a car or operate machinery.
Important information about some of the ingredients of
this medicine
This medicine contains lactose. If you have been told by
your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
3. HOW TO TAKE NITRAZEPAM TABLETS
Your doctor has carefully chosen the correct dose for you.
Always follow your doctor’s instructions and those on the
pharmacy label. You should check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed.
Adults: One 5mg tablet to be taken at bedtime. This may be
increased to 10mg if necessary.
Elderly or debilitated patients: Half the usual dose, i.e.
2.5mg, which may be increased to 5mg if necessary.
Nitrazepam should not be given to children.
Do not drink alcohol while taking the tablets.
Treatment should be intermittent if possible and the lowest
dose used to control symptoms.
Treatment should not exceed 4 weeks and should be
gradually withdrawn, as side effects have been observed on
abrupt withdrawal.
Continued overleaf

Excessive or prolonged use may result in some
psychological dependence.
There may be some loss of effect of this medicine after
repeated use for a few weeks. Tell your doctor or pharmacist
if the tablets do not seem to be working as well as they did.
If you take more than you should
If you (or someone else) accidentally take more than your
prescribed dose, contact your nearest hospital casualty
department, or tell your doctor immediately. Take this leaflet
and any remaining tablets and the container with you.
If you forget to take a tablet take one as soon as you
remember, unless it is nearly time to take the next dose. Do
not take a double dose to make up for a forgotten dose and
do not take more than the maximum dose per day.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nitrazepam Tablets can cause side
effects, although not everybody gets them. The elderly are
particularly sensitive to side effects of nitrazepam.
Tell your doctor immediately if you experience any of
the following:
• An allergic reaction such as skin rash, itching or difficulty
breathing.
• yellowing of the skin or eyes (jaundice)
• changes in behaviour such as excitement, aggression,
confusion, nightmares or hallucinations.
These are serious but rare side effects.
Tell your doctor or pharmacist if you have any of the
following:
Common side effects
• Drowsiness, dizziness, confusion, headache, double
vision, shaky movements
• Reduced alertness, numbed emotions, fagitue, muscle
weakness
• Amnesia (reduced recall of recent events).
Rare side effects
• vertigo, visual disturbances
• low blood pressure
• stomach upsets, skin rashes
• changes in libido, difficulty passing water
• changes in the number and type of blood cells ( you may
develop sore throats, infections, bruising or nose bleeds)
Other side effects
• pre-existing depression may become evident
• dependence on the medicine may develop.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE NITRAZEPAM TABLETS
Keep out of the reach and sight of children.
Store in a cool place and protect from light. Store in the
original packaging. Do not use after the expiry date shown on
the label.
6. FURTHER INFORMATION
What these tablets contain:
The active ingredient in each tablet is 5mg nitrazepam.
The other ingredients are lactose, maize starch, povidone and
magnesium stearate.
What these tablets look like and contents of the pack:
Nitrazepam Tablets are flat, round and white, with “MA” logo
above and “NIT 5” below a break line on one side and plain on
the reverse.
They are available in containers of 28, 30, 500 and 1250
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
M & A Pharmachem Ltd, Bolton
BL5 2AL, UK
Date of Approval: 01/2011

PP 0008

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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.

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