NITRADOS™

nitrazepam 5 mg tablets

What is in this leaflet

This leaflet answers some common questions about NITRADOS tablets.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What NITRADOS is used for

NITRADOS contains the active ingredient nitrazepam. NITRADOS belongs to a
group of medicines called benzodiazepines. It is recommended that treatment with
benzodiazapines should be short term in order to prevent dependency on this
medicine.

Nitrazepam acts on overactive nerves by means of chemical interactions. The
result is inhibition of signals in certain parts of your brain, which may be
responsible for your emotions or movement.

It is used to treat:

• nervous sleep disturbances due to irritability, overwork, conflicts,
  travelling, anxiety, worry, tension, and stress
• organic sleep disturbances - unknown origin and cause
• epilepsy (fits or convulsions)

Your doctor, however, may have prescribed NITRADOS tablets for another
purpose.

Ask your doctor if you have any questions why NITRADOS tablets have been
prescribed for you.

This medicine is a controlled drug (Class C) and can only be got on
prescription from your doctor.

Before you take NITRADOS

When you must not take it

Do not take NITRADOS if you have had an allergic reaction to:

• nitrazepam
• other benzodiazapines
• any ingredients listed at the end of this leaflet

Do not take NITRADOS if you have the following medical conditions:

• head injury, acute nerve damage, depression or coma
• myasthenia gravis - a syndrome characterised by fatigue, tired muscles and
  progressive paralysis
• acute pulmonary insufficiency - reduced blood flow to the lungs
• sleep apnoea - where breathing stops during sleep
• severe chronic obstructive airway with hypercapnia (excess carbon dioxide
  in the blood) and the beginnings of respiratory failure. This is a disease
  characterised by limited airflow.
• depression with or without anxiety unless NITRADOS is used in conjunction
  with another treatment since NITRADOS may induce suicide or aggressive
  behaviour.
• chronic psychotic, phobic or obsessive behaviour

Do not use NITRADOS at high altitude. NITRADOS may delay the body's automatic
response to low levels of oxygen and make worse a condition called sleep
hypoxaemia (lack of oxygen bound to haemoglobin)

Do not take NITRADOS if:

• the package is torn or shows signs of tampering
• the expiry date printed on the pack has passed
  
  If you take this medicine after the expiry date has passed, it may not work as
  well.
  
  If the pharmacist has repacked the medicine for you, there may not be an
  expiry date on the pack.

If you are not sure if you should be taking NITRADOS tablets, talk to your
doctor.

Before you start to take it

• Tell your doctor or pharmacist if you are allergic to any other
  medicines, foods, dyes or preservatives.
  
  
  
  
• NITRADOS may cause temporary amnesia or impaired memory.
  
  
  

• Tell your doctor if you are or intend to become pregnant.
  
  First trimester: There is limited knowledge as to the effects of
  nitrazepam on the foetus.
  
  Third trimester: High or prolonged doses of benzodiazepines may cause
  foetal heart irregularities, drowsiness in the new born, breathing problems
  and floppy infant syndrome characterised by hypotonia (lack of muscle
  resistance), hypothermia (low body temperature) and poor sucking.
  
  The infant may also experience withdrawal symptoms.
  

  Nitrazepam enters breast milk. Nursing mothers should avoid taking NITRADOS if
  they are breastfeeding or use an infant formula.
  
  Your doctor will discuss the risks and benefits of taking this medicine
  during pregnancy.
  
  
  
  

• Avoid drinking alcohol.
  
  Alcohol will make worse the effects of alcohol and the individual response
  cannot be predicted.
  
  
  

• Do not operate machinery of any sort or drive a vehicle while taking
  NITRADOSE. It may cause blurred vision, dizziness and impair concentration.
  
  
  
  
• Tell your doctor if you have chronic pulmonary insufficiency (reduced
  bloodflow to the lungs), liver or kidney disease.
  
  Regular monitoring and dose reduction may be necessary particularly in elderly
  patients.
  
  
  

• Tell your doctor if you have had a heart attack recently.
  
  You may stop breathing in your sleep if you use NITRADOS over a long period of
  time.
  
  
  
• Tell your doctor if you suffer from gout (pain in the joints, usually
  the toes).
  
  NITRADOS may cause a gout attack.
  

  
  

• Tell your doctor if you have epilepsy.
  
  
  
  
• Tell your doctor if you have glaucoma (high pressure in the eye).
  
  
  
  
• Caution is advised in the elderly.
  
  The elderly are more likely to experience side effects especially if combined
  with other centrally-acting medicines. Some side effects such as drowsiness,
  unsteadiness and lack of muscle co-ordination increases the risk of falling or
  dropping hot objects.
  
  Tell your doctor if you have cerebral arteriosclerosis (blocked blood flow in
  the brain) or heart failure.
  
  
  
• NITRADOS may result in psychological and physical dependence even with
  short term use. Withdrawal symptoms and rebound effects may occur on
  abrupt discontinuation of NITRADOS especially with short-term use. This is
  common in patients having personality disorders, alcoholism and drug abuse.

Taking other medicines

Tell your doctor if you are taking any other medicines including any
that you have bought from a pharmacy, supermarket or healthfood shop.

NITRADOS may enhance the action of central-acting medicines such as:
alcohol, antidepressants, neuroleptics, tranquillizers, sedatives, hypnotics,
opioid pain killers, antihistamines and general anaesthetics and hence doses of
any such combination should be reduced especially in elderly patients.

Using NITRADOS at the same time as anti-epileptics such as hydantoin or
barbiturates may increase side effects and toxicity.

Cimetidine, a medicine commonly used to treat stomach ulcers, may enhance the
effects of NITRADOS.

These medicines may be affected by NITRADOS, or may affect how well it works.
Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful
with or avoid while taking NITRADOS.

Ask your doctor or pharmacist if you are not sure you are taking any of these
medicines.

How NITRADOS tablets are taken

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

How much to take

Take NITRADOS tablets exactly as your doctor has prescribed.

Your doctor will tell you how many NITRADOS tablets you or your child should
take each day.

Adults

The usual dose is 5-10 mg before bedtime for sleep disturbances or 0.5 mg/kg
body weight per day for chronic epilepsy.

Children

The usual dose is 3.0 mg/kg body weight per day for spasms with
hypsarrhythmia (spasm and quivering spells) and 1.0 mg/kg body weight per day
for chronic epilepsy.

Elderly

The usual dose is 2.5-5 mg before bedtime for sleep disturbance.

How to take it

Swallow NITRADOS tablets whole with a glass of water. NITRADOS tablets may be
taken with or without meals.

When to take it

Sleep disturbances - take just before bedtime.

Epilepsy - take as directed by your doctor.

How long to take it

Take it for as long as your doctor has prescribed. However, courses should be
as brief as possible, up to one week for sleep disturbances or three weeks for
anxiety. Intermittent use may be acceptable.

If you forget to take it

If you forget to take this medicine and you wake up before you intended to,
do not take your missed dose as you may have trouble waking in the morning.

Onset of sleep usually takes about 30-60 minutes and lasts 6-8 hours.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering your dose, ask your pharmacist for some
hints.

While you are taking NITRADOS

Things you must do

Tell all doctors, dentists and pharmacists who are treating you, that you are
taking NITRADOS tablets.

Tell your doctor if you become pregnant while taking NITRADOS tablets.

If you are going to have surgery, tell your doctor you are taking NITRADOS
tablets.

Tell your doctor if you feel the tablets are not helping your condition.

After long term use, tolerance will occur.

Be sure to keep all your appointments with your doctor so that your progress
can be checked.

Things you must not do

Do not stop taking NITRADOS tablets or change the dose without first
checking with your doctor.

Abrupt discontinuation of NITRADOS may result in the following side effects:
depression, nervousness, rebound insomnia, irritability, perspiration and
diarrhoea. Rarely, confusion and convulsions may develop following withdrawal of
excessive doses in patients having personality disorders, alcoholism and drug
abuse.

Do not drive or operate machinery until you know how NITRADOS affects you.
Even though you may take NITRADOS before bedtime, the effects may still be felt
the following morning.

Do not let yourself run out of medicine over the weekend or on holidays.

Do not give NITRADOS tablets to anyone else even if they have the same
condition as you.

Do not use NITRADOS tablets to treat other complaints unless your doctor says
to.

Do not take any other medicines whether they require a prescription or not
without first telling your doctor or consulting a pharmacist.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking NITRADOS tablets.

All medicines can have side effects. Sometimes they are serious. You may need
medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

NITRADOS is usually well tolerated, however, tell your doctor if you
notice any of the following and they worry you:

• dose-related drowsiness
• unsteadiness
• ataxia (lack of muscle co-ordination)
• headache
• confusion
• vertigo
• dizziness
• muscular weakness
• changed libido
• loss of bladder control
• visual disturbances
• stomach upset
• tiredness
• secretion of excess saliva and mucus

Tell your doctor immediately, or go to your nearest Accident and Emergency
Centre, if you notice any of the following:

• signs of blood abnormalities such as ulcers in the mouth
• jaundice - yellowing of the skin
• allergic reaction - symptoms may include: rash, fainting, breathing
  difficulties
• mood changes such as aggression, excitement, restlessness, confusion and
  depression with suicidal tendencies
• difficulty swallowing
• increased dreaming

This is not a complete list of all possible side effects.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

Overdose

Immediately telephone your doctor or National Poisons Information Centre
(telephone 0800 POISON or 0800 764 766) for advice, or go to your nearest
Accident and Emergency Centre if you think that you or anyone else may have
taken too many NITRADOS tablets. Do this even if there are no signs of
discomfort or poisoning.

Common features of overdose include: drowsiness, confusion, lack of muscle
co-ordination, slurred speech and reduced reflexes and coma (severe cases).

If combined with other centrally acting drugs or alcohol, the effects of
NITRADOS will be intensified and may result in death if not treated.

Storage

Keep your tablets in the original container and protect from light until
it is time to take them.

If you take the medicine out of its container, it may not keep well.

Keep NITRADOS tablets in a cool dry place where the temperature stays
below 30°C.

Do not store it, or any other medicine, in a bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep NITRADOS tablets where children cannot reach them.

A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.

Disposal

If your doctor tells you to stop taking NITRADOS tablets, or the medicine has
passed its expiry date, ask your pharmacist what to do with any remaining
tablets.

Product description

What it looks like

NITRADOS 5 mg tablets: Circular, white, biconvex tablet with a diameter of
8.00 mm, scored on one side and the company logo on the other.

Available in packs of 100's in HDPE bottles.

Other ingredients

Maize cornflour, Lactose and Magnesium stearate.