INFORMATION FOR CONSUMERS
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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.
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:
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.
Do not take NITRADOS if you have had an allergic reaction to:
Do not take NITRADOS if you have the following medical conditions:
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:
If you are not sure if you should be taking NITRADOS tablets, talk to your doctor.
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.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
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.
The usual dose is 5-10 mg before bedtime for sleep disturbances or 0.5 mg/kg body weight per day for chronic epilepsy.
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.
The usual dose is 2.5-5 mg before bedtime for sleep disturbance.
Swallow NITRADOS tablets whole with a glass of water. NITRADOS tablets may be taken with or without meals.
Sleep disturbances - take just before bedtime.
Epilepsy - take as directed by your doctor.
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.
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.
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.
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:
Tell your doctor immediately, or go to your nearest Accident and Emergency Centre, if you notice any of the following:
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.
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.
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.
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.
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.
Maize cornflour, Lactose and Magnesium stearate.
Douglas Pharmaceuticals Ltd
Central Park Drive, Lincoln
Auckland 1008
Date of preparation: 18th February 2004