Patient leaflet - Nitrazepam 5 mg tablets
1. WHAT NITRAZEPAM IS AND WHAT IT IS USED FOR
This medicine has been prescribed for you for the short-term relief of insomnia (difficulty in sleeping) when it is severe, disabling or distressing.
It contains the Nitrazepam which belongs to a class of medicines called benzodiazepines.
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.
Nitrazepam may help you to sleep but it does not cure the underlying cause of your insomnia, which you should discuss with your doctor.
Nitrazepam should be used for as short a time as possible and should not be used for more than four weeks. If used for too long without a break, there is a risk of becoming dependent or of having problems when you stop taking it.
When taking Nitrazepam there is a risk of dependence (a need to keep taking the medicine). The risk increases with the dose and length of treatment period. The risk is greater if you have ever had a history of alcohol or drug abuse.
You must talk to a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITRAZEPAM
Do not take Nitrazepam and tell your doctor if you:
- are allergic to Nitrazepam, any of the other ingredients in the tablets (listed in section 6 of this leaflet) or to other benzodiazepines
- have severe liver, lung or breathing problems
- have muscle weakness sometimes causing difficulty breathing (myasthenia gravis)
- suffer from breathing problems whilst asleep (sleep apnoea)
- suffer from depression, mental health problems, irrational fears (phobias) or obsessions
Warnings and precautions
Talk to your prescriber before taking this medicine if you:
- 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.
- 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 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 your tablets 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.
Take special care with Nitrazepam
Tell your doctor before you take this medicine if you:
- have a history of alcohol or drug abuse
- suffer from a personality disorder
- have recently suffered a loss or bereavement
- are elderly or have problems with your liver, kidneys or lungs
- have weak or tired muscles
- suffer from an inherited iron disorder (porphyria)
Medicines such as Nitrazepam may lead to addiction. Any risk is more likely with high doses, prolonged treatment or if you have a history of alcohol or drug abuse or you suffer from a personality disorder.
Other medicines and Nitrazepam
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Nitrazepam tablets work:
- Medicines to treat depression such as Fluvoxamine or Mirtazapine
- Medicines to treat mental health problems such as Olanzapine or Prochlorperazine
- Medicines to calm you down or to help you sleep
- Sodium oxybate to reduce daytime sleepiness or sudden loss of muscle strength
- Disulfiram or Lofexidine for drug dependence
- Strong pain killers or general anaesthetics
- Probenecid to treat pain and swelling of the joints (gout)
- Nabilone to treat sickness caused by chemotherapy
- Medicines to treat epilepsy such as Phenytoin or barbiturates
- Levodopa to treat Parkinson's disease
- Medicines to treat high blood pressure or heart failure such as Moxonidone, Diazoxide, Hydralazine or Minoxidil
- Medicines to increase urine production such as Diuretics
- Muscle relaxants such as Baclofen or Tizanidine
- Isoniazid or Rifampicin to treat bacterial infections
- Ritonavir to treat viral infections
- Cimetidine to treat ulcers
- Antihistamines for allergies
- Theophylline for asthma
If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Nitrazepam.
Nitrazepam with food, drink and alcohol
Alcohol may increase the sedative effects of Nitrazepam and make you feel very sleepy.
Do not drink alcohol whilst taking Nitrazepam.
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including benzodiazepines.
Do not drink grapefruit juice whilst taking Nitrazepam.
Pregnancy, breast-feeding and fertility
Do not take Nitrazepam if you are pregnant, might become pregnant or are breast-feeding.
If you and your doctor decide that you should take this medicine towards the end of your pregnancy (or during labour) this may harm your baby. The baby may have a low temperature, be listless, have breathing problems or difficulty in feeding.
Also, if you take this medicine regularly during your pregnancy your baby may get withdrawal symptoms. Make sure you follow your doctor's advice.
Driving and using machines
Nitrazepam can affect your ability to drive and use machine as it may make you sleepy or dizzy. Do not drink alcohol, as it can make these effects worse.
Do not drive or operate machinery while taking this medicine until you know how it affects you.
- It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
- Nitrazepam 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.
Nitrazepam contains
Nitrazepam 5 mg tablets contain lactose (a type of sugar). If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE NITRAZEPAM
Your prescriber should have discussed with you how long the course of tablets 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.
Always take Nitrazepam tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take this medicine by mouth.
When taking Nitrazepam tablets try to make sure you sleep well for 7-8 hours per night.
The recommended dose is:
You will be prescribed the lowest effective dose for the shortest time necessary to treat your symptoms. This will reduce the risk of addiction.
Typically, Nitrazepam will not be prescribed for more than 4 weeks.
Adults:
Typical starting dose is 5 mg at bedtime. This may be increased to 10 mg if necessary.
Elderly or debilitated (those that are weak or feeble):
Typically require half the adult dose, as you are more likely to be sensitive to the effects of Nitrazepam. Follow your doctor's advice.
If you have liver or kidney problems or breathing difficulties you may also require lower doses.
Children: Not recommended for children.
If you take more Nitrazepam than you should
Contact your doctor or go to a hospital immediately. Show them the package or container. Symptoms of an overdose may include drowsiness, confusion, tiredness, breathing problems, difficulty in controlling movements, low blood pressure or falling into a coma.
If you forget to take Nitrazepam
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you stop taking Nitrazepam
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 tablets 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 stop taking the tablets suddenly you may experience the following withdrawal effects:
- depression
- nervousness
- difficulty in sleeping
- irritability
- sweating
upset stomach/diarrhoea
or the symptoms you are being treated for can come back worse than before.
You may also experience mood changes, anxiety, restlessness and changes in sleep patterns. These effects may occur even after taking low doses for a short period of time.
If you stop taking these tablets suddenly after being treated with high doses of Nitrazepam, you may experience confusion, hallucinations, shaking, faster heartbeat or fits.
Withdrawal may also cause unusual behaviour including aggressive outbursts, excitement or depression with suicidal thoughts or actions.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nitrazepam can cause side effects, although not everybody gets them.
If you get any of the following side effects, STOP TAKING this medicine and tell your doctor at once:
- feeling excited, restless, agitated or irritated
- nightmares or hallucinations (hearing or seeing things that are not there)
- aggressive outbursts or rages
- depression
- unusual behaviour or false beliefs (delusions)
The most common side effects are:
- feeling sleepy, light-headed during the daytime
- muscle weakness
- unsteadiness
- clumsiness and loss of co-ordination
- confusion
- numbed emotions
- headache
- dizziness
- reduced alertness and tiredness
- double vision
You could notice the common side effects even after a single dose and they may continue for more than 24 hours. If you are elderly, you are more likely to suffer from side effects, especially confusion and loss of co-ordination.
Other side effects that occur less often are:
- loss of memory
- a feeling of spinning (vertigo)
- low blood pressure
- stomach upsets
- shaking (tremor)
- skin rashes
- problems with your vision other than double vision
- difficulty in speaking
- making more saliva than usual
- changes in your sex drive
- difficulty passing urine
- loss of control of your bladder or bowels (incontinence)
A few cases of unusual bleeding or bruising of the skin, feeling feverish or yellowing of the skin and whites of the eyes (jaundice) have been known to occur.
Unknown frequency: dependence and addiction (see section “How do I know if I am tolerant or addicted?”).
Drug Withdrawal
When you stop taking Nitrazepam, you may experience drug withdrawal symptoms, which include:
- Benzodiazepines: headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets 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, 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via 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.
5. HOW TO STORE NITRAZEPAM
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package to protect from light or store in the original container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nitrazepam tablets contains
The active substance is Nitrazepam 5 mg tablets is nitrazepam.
The other ingredients are lactose, maize starch, pregelatinised starch, magnesium stearate and ethylcellulose.
What Nitrazepam tablets looks like and contents of the pack
Nitrazepam 5 mg tablets are round white tablets with the marking MP37 on one side.
The tablets come in containers of 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets and in blister packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41-43 Klimentos, Klimentos Tower,
Nicosia 1061, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.