Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Nitrazepam 2.5 mg/5 ml Oral Solution (referred to as Nitrazepam Oral Solution throughout this leaflet) belongs to a group of medicines known as benzodiazepines, which are tranquillisers (medicines that have a calming effect). Nitrazepam Oral Solution shortens the time taken to fall asleep and lengthens the duration of sleep.
Nitrazepam Oral Solution is used for the short-term treatment of sleeplessness (also known as insomnia) when it is severe.
Nitrazepam Oral Solution helps you to sleep but does not cure the underlying cause of your insomnia, which you should discuss with your doctor.
This medicine has been prescribed to you and should not be given to anyone else.
Benzodiazepines can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
Do not take Nitrazepam Oral Solution if you: • are allergic (hypersensitive) to nitrazepam or any of the other ingredients of this medicine (listed in section 6).
• are allergic (hypersensitive) to any medicine known as a benzodiazepine (e.g. flurazepam, diazepam, chlordiazepoxide or temazepam).
• suffer from lung disease.
• suffer from difficulty breathing while awake or asleep.
• suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily).
• are suffering from a psychiatric illness or a personality disorder (severe mental problems).
• have a severe liver condition.
Warnings and precautions Nitrazepam Oral Solution is not for use in anyone under 18 years of age.
Take special care with Nitrazepam Oral Solution
Talk to your doctor or pharmacist before taking Nitrazepam Oral Solution if you:
• have a long-term lung, liver or kidney disease.
• suffer from depression or have recently suffered the death of a close friend or relative.
• are suffering or have suffered from a mental illness.
• are pregnant or breast-feeding.
• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake. You must not drink alcohol or use drugs while taking Nitrazepam Oral Solution.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of Nitrazepam Oral Solution to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.
Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine.
Withdrawal symptoms can include:
• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking this medicine suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
Because Nitrazepam Oral Solution relaxes the muscles, elderly patients should take extra care when they get up at night as there is a risk of falls and consequently of injuries including hip fractures.
Other medicines and Nitrazepam Oral Solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved. In particular, tell your doctor if you are taking any of the following medicines:
• Antidepressants, barbiturates, antipsychotics, hypnotics, anxiolytics, tranquillisers or sleeping tablets, or other such medicines that act on the brain and nerves.
• Medicines used to relieve pain or anaesthetics.
• Antihistamines (used for treating allergies) that cause drowsiness (e.g. chlorphenamine).
• Medicines for treating epilepsy (e.g. phenytoin and phenobarbital).
• Medicines that affect the liver (e.g. the antibiotic rifampicin, Cimetidine, omeprazole; medicines used to treat stomach problems, disulfiram and St John’s wort).
• Sodium oxybate used in patients with narcolepsy.
• Theophylline or aminophylline; medicines to make breathing easier.
Concomitant use of Nitrazepam Oral Solution and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening.
Because of this, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor does prescribe Nitrazepam Oral Solution together with opioids the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all opioid medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Nitrazepam Oral Solution with alcohol Do not drink alcohol for as long as you are taking Nitrazepam Oral Solution. Alcohol will increase the effects of this medicine and this can be dangerous.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will then decide whether you should take this medicine.
Tell your doctor before taking Nitrazepam Oral Solution if you are breast-feeding. Avoid taking this medicine if you are breast-feeding as nitrazepam passes into breast milk.
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 and breathing and feeding difficulties. Also, your unborn baby may be at risk of developing dependency to this medicine and after birth may be at some risk of developing withdrawal symptoms.
Driving and using machines Nitrazepam Oral Solution may cause side effects such as reduced alertness, confusion, tiredness, dizziness, poor muscle co-ordination and double vision. This may affect your ability to drive and operate machinery. Do not drive or operate machinery if you experience any of these side effects.
Nitrazepam Oral Solution can affect your ability to drive. Do not drive while taking this medicine until you know how it affects you.
It may be an offence to drive if your ability to drive safely is affected.
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 medicine.
Always take Nitrazepam Oral Solution exactly as your doctor has told you. Do not change the prescribed dose yourself. You should check with your doctor or pharmacist if you are not sure how to take this medicine.
Your doctor will find the lowest dose to control your symptoms.
The dose that your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and bodyweight.
If you think that the effect of your medicine is too weak or too strong, talk to your doctor.
Your prescriber should have discussed with you how long the course of medicine will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Nitrazepam Oral Solution is not for use in children.
The usual starting dose is 5 mg (10 ml). However, if you are elderly or suffer from a lung, liver or kidney condition, or are generally unwell, your starting dose will not usually be more than 2.5 mg (5 ml).
Ensure you fill the measuring cup provided to the correct graduation line.
You may not need to take this medicine every night.
Take the medicine just before going to bed. Make sure that you can sleep without interruptions for 7 to 8 hours after taking Nitrazepam Oral Solution.
Treatment will not normally be continued for more than four weeks.
Nitrazepam Oral Solution may become less effective if you take it for more than four weeks. If you think that your medicine is no longer working or your insomnia does not improve, you should consult your doctor. Also, you may become dependent on Nitrazepam Oral Solution if you use it at high doses and for long periods. Therefore, this medicine is not suitable for long-term use and after a few weeks it is worth trying to get by without Nitrazepam Oral Solution. This will help to prevent you becoming used to Nitrazepam Oral Solution and reduce the risk of dependence.
Withdrawal symptoms may occur when you stop taking Nitrazepam Oral Solution (see section below “If you stop taking Nitrazepam Oral Solution”).
Do not stop taking Nitrazepam Oral Solution without speaking to your doctor.
If you take more Nitrazepam Oral Solution than you should If you take too much or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.
If you forget to take Nitrazepam Oral Solution Do not take a double dose to make up for a forgotten dose. Instead, you should simply continue with the next dose when it is due.
If you stop taking Nitrazepam Oral Solution Your doctor will advise you when to stop taking this medicine.
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Withdrawal symptoms such as:
• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your medicine suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
If you have taken benzodiazepines for a long time, the reduction in your dosage will be over a longer period of time than would normally be required when you stop taking this medicine. You may need additional help. Your doctor will be able to discuss this with you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Route and method of administration This medicinal product must be taken orally.
Use the measuring cup provided in the pack to deliver the required dose.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and/or seek urgent medical advice immediately if you notice the following.
• Serious allergic reactions which may include swelling of the face including throat and tongue, breathing difficulties/wheezing, feeling faint, weak and/or collapse.
• Allergic skin reaction including skin that is red or itchy, pale or red irregular raised patches with severe itching (hives), circular irregular red patches on the skin of the hands and arms (erythema multiforme) and severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome).
Changes in behaviour may occur rarely. If these behavioural symptoms occur, you must inform your doctor. He/she may want you to stop taking this medicine.
These changes may include aggression, excitement, confusion, restlessness, agitation, irritability, rages, hallucinations, nightmares and depression.
Common side effects (may affect up to 1 in 10 people):
• Drowsiness during the day
• A feeling of emptiness
• Reduced alertness
• Confusion
• Tiredness
• Headache
• Dizziness
• Muscle weakness
• Poor muscle co-ordination
• Double vision
• Depressed state
Rare side effects (may affect up to 1 in 1,000 people):
• Giddiness
• Reduced blood pressure
• Stomach upsets
• Skin rashes
• Changes in your vision other than double vision
• Changes in the level of sexual desire
• Inability to pass urine
• Spinning sensation
• Nausea
• Speech disorder
Frequency not known (frequency cannot be estimated from the available data):
• An abnormality of the blood (Blood disorder)
• Trouble falling and/or staying asleep, decline in mental abilities (memory and thinking skills), Dependence (at regular dose) – You may become dependent on Nitrazepam Oral Solution and find it difficult to stop taking it. If you stop taking this medicine suddenly, you may suffer from withdrawal reactions (see section 3 “If you stop taking Nitrazepam Oral Solution” for withdrawal symptoms)
• Unsteadiness, reduced muscle movement, tremor, memory loss, epileptic fits
• Breathing problems, increased bronchial secretions
• Yellowing of the eyes and skin (jaundice)
• Muscle cramps
• There is a risk of falls and consequently fractures in the elderly
• Irritability, rebound effect
• Dependence and addiction (see section “How do I know if I am tolerant or addicted?”).
Drug Withdrawal When you stop taking Nitrazepam Oral Solution, you may experience drug withdrawal symptoms, which include:
• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your medicine suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
How do I know if I am tolerant or addicted? If you notice any of the following signs whilst taking Nitrazepam Oral Solution, it could be a sign that you have become addicted.
• You may feel the need to keep taking the medication for longer than your doctor recommended
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again
If you notice any of these signs, it is important you talk to your prescriber.
If you are woken up soon after taking the medicine your memory may be temporarily affected.
If you are an elderly patient, you may be more susceptible to side effects. If this happens, tell your doctor and he/she may decide to change your dose.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and bottle label after “EXP”. The expiry date refers to the last day of that month.
• After first opening use within one month.
• This medicine does not require any special storage conditions.
• Do not use your medicine if you notice that the container is damaged.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Nitrazepam Oral Solution contains • The active substance is nitrazepam. Each 5 ml of solution contains 2.5 mg of nitrazepam.
• The other ingredients are medium-chain triglycerides and mint oil, partly dementholised.
What Nitrazepam Oral Solution looks like and contents of the pack Nitrazepam Oral solution is a clear, colourless to yellowish oily solution, with mint odour.
Nitrazepam Oral solution is packed in a 100 ml amber glass bottle with child resistant screw cap and comes with a 20 ml measuring cup with marked volume graduations at 2.5 ml, 5 ml, 10 ml, 15 ml and 20 ml.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Roma Pharmaceuticals Ltd
Gibraltar House
Centrum 100
Burton upon Trent
DE14 2WE
UK
Email: [email protected] Manufacturer
LABOMED PHARMACEUTICAL COMPANY S.A.
84 Ioannou Metaxa str.
19441, Koropi
Athens
Greece
This leaflet was last revised in April 2026
For information in other formats contact [email protected]
Roma Pharmaceuticals Limited
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Nitrazepam 2.5 mg/5 ml Oral Solution comes as solution containing 2.5 mg/5. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Nitrazepam 2.5 mg/5 ml Oral Solution is nitrazepam.
Medicines with the same active substance include: Mogadon 5 mg Tablets, Nitrazepam Mixture 2.5mg/5ml Oral Suspension BP. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Nitrazepam 2.5 mg/5 ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Short-term treatment of insomnia when it is severe, disabling or subjecting the individual to unacceptable distress, where daytime sedation is acceptable.
Posology:
Adults
5 mg (10 ml) before retiring. This dose may, if necessary, be increased to 10 mg (20 ml).
Elderly
Elderly or debilitated patients: the elderly or patients with impaired renal and/or hepatic function will be particularly susceptible to the adverse effects of nitrazepam.
Doses should not exceed half those normally recommended.
If organic brain changes are present, the dosage of Nitrazepam 2.5mg/5ml Oral Solution should not exceed 5 mg (10 ml) in these patients.
Other populations
In patients with chronic pulmonary insufficiency and in patients with chronic renal or hepatic disease, the dosage may need to be reduced.
Paediatric population
Nitrazepam 2.5mg/5ml Oral Solution is contraindicated for use in children.
Dosage should be adjusted on an individual basis. Treatment should, if possible, be on an intermittent basis.
Prior to starting treatment with nitrazepam, a discussion should be held with patients to put in place a strategy for ending treatment with nitrazepam in order to minimise the risk of dependence, addiction and drug withdrawal syndrome (see section 4.4).
Treatment should be given for the shortest possible duration and should be started with the lowest recommended dose. The maximum dose should not be exceeded. Generally, the duration of treatment varies from a few days to two weeks with a maximum of four weeks; including the tapering off process. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced.
Specialist help may be appropriate. Little is known regarding the efficacy or safety of benzodiazepines in long-term use.
In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be decreased. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena (see Undesirable Effects) thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. Nitrazepam therapy should not be stopped abruptly, but the dose tapered off.
The product should be taken just before going to bed.
In addition, for long-acting benzodiazepines, it must be stated that the patient should be checked regularly at the start of treatment in order to decrease, if necessary, the dose or frequency of administration to prevent overdose due to accumulation.
Method of administration
For oral administration.
Patients with hypersensitivity to benzodiazepines, nitrazepam or to any of the excipients listed in section 6.1
Hypersensitivity reactions with the benzodiazepines including rash, angioedema and hypotension or hypertension have been reported on rare occasions in susceptible patients.
Use of this drug is also contraindicated in patients with severe respiratory insufficiency, short-term treatment of insomnia in children and juveniles, phobic or obsessional states, chronic psychosis, myasthenia gravis; sleep apnoea syndrome; severe hepatic insufficiency; use in children.
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs such as barbiturates, antipsychotics, tranquillisers, antidepressants, hypnotics, anxiolytics, analgesics and anaesthetics, anticonvulsants and sedative antihistamines, antihypertensives and beta-blockers.
The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Nitrazepam 2.5mg/5ml Oral Solution with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited (see section 4.4).
In the case of narcotic analgesics, enhancement of the euphoria may also occur, leading to an increase in psychological dependence. The elderly require special supervision.
When Nitrazepam 2.5mg/5ml Oral Solution is used in conjunction with anticonvulsant drugs, side-effects and toxicity may be more evident, particularly with hydantoins or barbiturates or combinations including them. This requires extra care in adjusting dosage in the initial stages of treatment.
Known inhibitors of hepatic enzymes, particularly cytochrome P450 have been shown to reduce the clearance of benzodiazepines e.g. cimetidine, some azole antifungal agents, omeprazole, anti-retroviral protease inhibitors, macrolide antibiotics, calcium channel blockers, selective serotonin reuptake inhibitors (SSRIs), and disulfiram and may potentiate their action and known inducers of hepatic enzymes, e.g. rifampicin or St. John's wort, may increase the clearance of benzodiazepines.
Concomitant intake with alcohol should be avoided. The sedative effect may be enhanced when the product is used in combination with alcohol. This adversely affects the ability to drive or use machines.
Concomitant administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines.
Concomitant intake of benzodiazepines with sodium oxybate may increase the effect of sodium oxybate.
Concomitant intake of valerian may increase or decrease the effect of nitrazepam.
Fertility:
Human data are not available. In investigations with mice and rats, Nitrazepam showed an impairment of spermatogenesis in male animals.
Pregnancy:
Nitrazepam crosses the placental barrier. The feto-maternal ratio of plasma concentration in early pregnancy is about 0.6 and in late pregnancy about 0.9. There are limited data of the use of nitrazepam in pregnant women. There have been isolated reports of very large doses of nitrazepam causing congenital abnormalities in humans.
Studies in animals have shown reproductive toxicity (see section 5.3).
High doses of nitrazepam during early pregnancy resulted in malformations in rats but not in mice.
Do not use during pregnancy, especially during the first and last trimesters, unless there are compelling reasons.
If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant.
Administration of benzodiazepines in the last trimester of pregnancy or during labour has been reported to produce irregularities in the foetal heart rate, and hypotonia, poor sucking, hypothermia and moderate respiratory depression in the neonate.
Infants born to mothers who took benzodiazepines chronically in the latter stages of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.
Breast-feeding:
Since benzodiazepines are found in the breast milk, the use of Nitrazepam 2.5mg/5ml Oral Solution in mothers who are breast-feeding should be avoided.
Patients should be advised that, like all medicaments of this type, Nitrazepam 2.5mg/5ml Oral Solution may modify patients' performance at skilled tasks. Sedation, amnesia, impaired concentration and impaired muscle function may adversely affect the ability to drive or use machinery. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased. Patients should further be advised that alcohol may intensify any impairment, and should therefore be avoided during treatment.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive.
• Do not drive until you know how the medicine affects you.
• It is an offence to drive while under the influence of this medicine.
• However, you would not be committing an offence (called 'statutory defence') 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 and in the information provided with the medicine and
- It was not affecting your ability to drive safely.
Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.
When taken alone in overdosage nitrazepam presents few problems in management and should not present a threat to life unless combined with other CNS depressants (including alcohol).
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Symptoms:
Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, dysarthria and lethargy; in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
Management:
Following overdose with oral benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious, or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal to reduce absorption, can be given within 1 hour of ingesting a significant quantity, provided the patient is awake and the airway is protected.
Special attention should be paid to respiratory and cardiovascular functions in intensive care. The value of dialysis has not been determined. Flumazenil is a specific IV antidote for use in emergency situations. Patients requiring such intervention should be monitored closely in hospital (consult separate product information prior to use).
The benzodiazepine antagonist flumazenil is not indicated in patients with epilepsy who have been treated with benzodiazepines. Antagonism of the benzodiazepine effect in such patients may trigger seizures.
If excitation occurs, barbiturates should not be used.
Ask anything about Nitrazepam 2.5 mg/5 ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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