Nitrazepam

Overview

Nitrazepam (Nite-raz-ep-am) is a medicine which is used in sleeping problems.

The information in this Medicine Guide for nitrazepam varies according to the condition being treated and the particular preparation used.

Your medicine

Nitrazepam should only be used at the lowest possible dose and for a maximum of up to four weeks. This will reduce the chance of tolerance, dependence and withdrawal symptoms.

Some people, in the course of taking Nitrazepam for a sleeping problem, may find that an undiagnosed psychiatric condition, such as depression, becomes apparent. People who have a psychiatric condition and who are taking Nitrazepam may experience some changes in behaviour.

It is essential to get at least seven or eight hours continuous and uninterrupted sleep after taking Nitrazepam. If you are woken before this time has passed, Nitrazepam may cause you to have some memory problems. You may have no memory of what happened from the time you were woken until the time when the effects of this medicine have worn off.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Whether this medicine is suitable for you

Nitrazepam is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

·         are allergic or sensitive to or have had a bad reaction to benzodiazepines in the past

·         are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine

·         are debilitated

·         are elderly

·         have a personality disorder

·         have a phobic or obsessional disorder

·         have abused alcohol in the past

·         have anxiety with depression

·         have been treated with Nitrazepam over a long period of time

·         have breathing problems

·         have depression

·         have had a recent loss or bereavement

·         have kidney problems

·         have liver problems

·         have lung problems

·         have misused drugs in the past

·         have myasthenia gravis

·         have organic brain syndrome

·         have psychosis

·         have sleep apnoea syndrome

Nitrazepam is not used in children.

Over time it is possible that Nitrazepam can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Nitrazepam has become unsuitable, it is important that the prescriber is contacted immediately.

Alcohol

Alcohol can interact with certain medicines.

In the case of Nitrazepam:

·         alcohol may increase the sedative effects of Nitrazepam

You must not drink any alcohol if you are taking this medicine.

Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Nitrazepam:

·         there are no specific foods that you must exclude from your diet when taking Nitrazepam

Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Nitrazepam:

·         this medicine could affect your ability to drive or operate machinery

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Nitrazepam:

·         you should only take this medicine during pregnancy if your doctor thinks that you need it

·         if you become pregnant, or think you have become pregnant while taking Nitrazepam, you must contact your prescriber

·         if you take this medicine during your pregnancy, your baby may have some problems after birth. Also, if you repeatedly take this medicine during the late stages of pregnancy, your baby may come to be physically dependent on Nitrazepam. This may lead to your baby having withdrawal symptoms from Nitrazepam after birth

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Nitrazepam, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Nitrazepam:

·         women who are breast-feeding must not take this medicine

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Nitrazepam:

·         rifampicin

The following types of medicine may interact with Nitrazepam:

·         anaesthetics

·         analgesics

·         antidepressants

·         antiepileptics

·         antipsychotics

·         barbiturates

·         hydantoins

·         hypnotics

·         liver enzyme inducers

·         liver enzyme inhibitors

·         medicines that act on the central nervous system

·         sedative antihistamines

·         tranquillisers

Nitrazepam is not used in children.

Over time it is possible that Nitrazepam can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Nitrazepam has become unsuitable, it is important that the prescriber is contacted immediately.

Alcohol

Alcohol can interact with certain medicines.

In the case of Nitrazepam:

·         alcohol may increase the sedative effects of Nitrazepam

You must not drink any alcohol if you are taking this medicine.

Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Nitrazepam:

·         there are no specific foods that you must exclude from your diet when taking Nitrazepam

Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Nitrazepam:

·         this medicine could affect your ability to drive or operate machinery

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Nitrazepam:

·         you should only take this medicine during pregnancy if your doctor thinks that you need it

·         if you become pregnant, or think you have become pregnant while taking Nitrazepam, you must contact your prescriber

·         if you take this medicine during your pregnancy, your baby may have some problems after birth. Also, if you repeatedly take this medicine during the late stages of pregnancy, your baby may come to be physically dependent on Nitrazepam. This may lead to your baby having withdrawal symptoms from Nitrazepam after birth

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Nitrazepam, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Nitrazepam:

·         women who are breast-feeding must not take this medicine

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Nitrazepam:

·         rifampicin

The following types of medicine may interact with Nitrazepam:

·         anaesthetics

·         analgesics

·         antidepressants

·         antiepileptics

·         antipsychotics

·         barbiturates

·         hydantoins

·         hypnotics

·         liver enzyme inducers

·         liver enzyme inhibitors

·         medicines that act on the central nervous system

·         sedative antihistamines

·         tranquillisers

If you are taking Nitrazepam and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Nitrazepam.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell you’re prescriber.

Side-effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

The frequency of these side-effects is unknown

• balance or coordination problems
• behavioural problems seek medical advice if you develop symptoms of depression including suicidal tendencies, paradoxical aggressive outbursts, rages, inappropriate behaviour, excitement, confusion, restlessness, agitation, irritability, delusions, nightmares, hallucinations, psychoses or other behavioural problems
• blood and bone marrow problems
• changes in libido
• confusion
• daytime sedation
• dose tolerance
• double vision
• eye or eyesight problems
• failure of Nitrazepam to achieve the intended medical effect - if Nitrazepam is repeatedly used for a few weeks
• feeling dizzy
• feeling emotionally numb
• gastrointestinal problems
• headaches
• hypersensitivity reactions including rash, angioedema and high blood pressure
• jaundice
• lowered blood pressure
• memory problems - these may lead to behavioural changes
• muscle weakness
• precipitation of suicide in people with depression
• psychological problems
• reduced alertness
• relaxed muscles - this may lead to an increased risk of falling or hip fractures. You should be careful when moving around after you have taken Nitrazepam
• side effects that may occur if Nitrazepam is taken at a high dose for long period of time. These may include physical and physiological dependence which may lead to drug abuse
• skin rash or rashes
• tiredness
• uncovering depression
• urinary retention
• vertigo
• withdrawal symptoms or rebound phenomena can occur when this medicine is stopped. These include depression, headaches, muscle weakness, nervousness, anxiety, tension, restlessness, confusion, convulsion, mood changes, rebound insomnia, psychotic-like behaviour, irritability, sweating and diarrhoea. If withdrawal is severe the following may occur: derealisation, depersonalisation, numbness, over-sensitive hearing and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or seizures

Source: http://www.nhs.uk