Nitrazepam 5mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
NITRAZEPAM 5 mg TABLETS
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Nitrazepam is for
2. Before you take Nitrazepam
3. How to take Nitrazepam
4. Possible side effects
5. How to store Nitrazepam
6. Further information
1. WHAT NITRAZEPAM IS FOR
Nitrazepam belongs to a group of medicines called benzodiazepines. It can be used to treat:
In adults:
• the short-term relief of insomnia (difficulty in sleeping) when it is severe, disabling or distressing
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.
2. 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
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.
Taking other medicines
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.
Taking Nitrazepam with food and drink
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 and breast-feeding
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.
Important information about some of the ingredients of Nitrazepam
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
Always take Nitrazepam tablets exactly as your doctor has told you. Take this medicine by mouth.
When taking Nitrazepam tablets try to make sure you sleep well for 7-8 hours per night.
Dosage
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 suddenly stop taking Nitrazepam
Nitrazepam should not be stopped suddenly; keep taking it until your doctor tells you how to reduce the dose slowly.
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
• afeeling 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.
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE NITRAZEPAM
Keep 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.
Medicines should not be disposed of 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. FURTHER INFORMATION
What Nitrazepam tablets contain
The active ingredient in Nitrazepam 5 mg tablets is nitrazepam.
The other ingredients are lactose, maize starch, pregelatinised starch, magnesium stearate and ethylcellulose.
What Nitrazepam tablets look 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.
This leaflet was last revised in 04/2016
GE0024/O/PIL/GE1