Nitrazepam Tablets 5mg
PATIENT INFORMATION LEAFLET
NITRAZEPAM Tablets5mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nitrazepam Tablets are and what they are used for
2. Before you take Nitrazepam Tablets
3. How to take Nitrazepam Tablets
4. Possible side effects
5. How to store Nitrazepam Tablets
6. Further information
1. What Nitrazepam Tablets are and what they are used for
Nitrazepam is a sedative and belongs to a group of drugs called benzodiazepines which work by having a calming effect.
This medicine is used for the short-term treatment of insomnia (difficulty sleeping) when it is severe, affecting your daily life or causing you extreme distress. Your doctor will work out the reason for your insomnia before prescribing this medicine.
This medicine should be used for as short a time as possible and should not be used for more than 4 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.
The risk of dependence (a need to keep taking the medicine) increases with dose and length of treatment period and is greater if you have ever had a history of alcohol or drug abuse, or in patients with personality disorders. Your doctor will monitor you whilst you are taking this medicine and will withdraw your treatment gradually.
2. Before you take Nitrazepam Tablets
Do not take these tablets if you:
* are allergic to nitrazepam, other benzodiazepines e.g. diazepam, or to any of the other ingredients in the tablets (see section 6)
■ have difficulty in breathing, any kind of lung disease e.g. asthma, or you suffer from sleep apnoea (sometimes stop breathing during sleep)
- suffer from phobias (fears), obsessions or have suffered a mental illness for a long time
* have severe liver disease
* suffer from myasthenia gravis (a condition characterised by muscle weakness)
* are pregnant, planning to become pregnant or you are breast feeding (see Pregnancy and breast feeding section below)
* are to use nitrazepam alone to treat depression or anxiety associated with depression.
Check with your doctor before taking these tablets if you:
* have glaucoma (increased pressure in the eye)
* have a history of alcohol or drug abuse
■ are elderly or have a personality disorder as you are more likely to experience side effects (see section 4 Possible side effects)
* have recently suffered from a bereavement as this medicine may prevent you from accepting the fact.
Taking other medicines:
Check with your doctor or pharmacist before taking these tablets if you are taking any other medicines, including any that you can buy without a prescription. This is particularly important if you are taking:
* other sedative/tranquilliser medicines for helping you to sleep, or medicines for treating depression, mental illness or anxiety
■ strong pain killers e.g. codeine
■ anaesthetics - before you have any surgical or dental operations tell your doctor or dentist you are taking nitrazepam
- are taking sodium oxybate used to treat narcolepsy (excessive sleepiness)
* anti-histamines (used to treat hay fever or other allergies) which cause drowsiness
* medicines used to treat epilepsy e.g. phenobarbital or phenytoin
* cisapride used to treat acid reflux (GORD)
* lofexidine used to relieve drug addiction withdrawal symptoms
- nabilone used to reduce nausea and vomiting caused by many anticancer medicines
* disulfiram used to treat alcoholism
■ baclofen or tizanidine used to treat muscle spasms caused by multiple sclerosis or spinal cord injury or disease
- medicines that affect liver enzymes e.g. cimetidine (used to treat stomach ulcers) and rifampicin (used to treat bacterial infections)
- any medicines used to treat high blood pressure, angina, irregular heart beat or to reduce fluid retention
■ levodopa used to treat Parkinson’s disease
■ medicines containing aluminium hydroxide used to treat acid indigestion.
Other special warnings:
If you are elderly you should take extra care if you get up during the night because Nitrazepam Tablets relax the muscles. This means there is a risk you may fall and consequently hip fractures may occur.
Alcohol:
Avoid drinking alcohol while taking this medicine as it will increase the effects of this medicine.
Pregnancy and breast feeding:
Do not take Nitrazepam Tablets if you are pregnant, might become pregnant or 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.
Driving and using machines:
The medicine can affect your ability to drive or operate machinery as it may make you sleepy or dizzy or may cause memory loss, lack of concentration, blurred vision and poor muscle function. If affected, do not drive or operate machinery, or take part in any activities that would put yourself or others at risk. If you do not get enough sleep at night the likelihood of reduced alertness may be increased.
Taking nitrazepam at the same time as some other medicines such as CNS depressants (sometimes referred to as tranquillisers and sedatives) may increase these effects.
* Do not drive 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:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instruction 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 an ingredient of Nitrazepam Tablets:
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Nitrazepam Tablets
The tablets should be swallowed with a drink of water just before going to bed.
Your doctor will decide the dose that is best for you. You should not take Nitrazepam Tablets for longer than 4 weeks. The pharmacist’s label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.
This medicine can make you suffer memory loss several hours after taking it. Try to make sure you can have 7 to 8 hours of uninterrupted sleep each night whilst you are taking this medicine.
Adults: Take 1 tablet. In some cases your doctor may prescribe a dose of 2 tablets.
Elderly and debilitated (weak) patients and patients with liver, kidney or breathing problems: If you are elderly, weak, or suffer from a lung, kidney or liver condition, your dose will usually be not more than 2.5 mg (half a tablet).
Children: This medicine is not recommended for use in children.
If you have taken too many tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
If you forget to take a dose:
If you miss a dose of this medicine, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSE.
Tolerance:
After a few weeks of taking this medicine you may notice that it is not working as well as it did when you first started taking it. If this happens speak to your doctor.
Stopping Nitrazepam and withdrawal effects:
Insomnia may re-occur when you stop taking this medicine and is greater if you suddenly stop taking the tablets.
This medicine should not be stopped suddenly; keep taking it until your doctor tells you how to reduce the dose slowly. If you do stop taking the tablets suddenly you may experience the following withdrawal effects: headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability, sleep disturbance, diarrhoea and mood changes. In severe cases the following may occur: a feeling of unreality or of being separated from your body, numbness and tingling in the arms and legs, sensitivity to light, noise and physical contact, seeing or hearing things that are not real, epileptic fits. Withdrawal symptoms will be worse in patients who have a history of alcohol or drug addiction, but can occur in patients receiving normal doses for a short period of time.
4. Possible side effects
Like all medicines nitrazepam can cause side effects, although not everybody gets them.
Isolated cases of liver problems and blood disorders have been reported. If you develop jaundice (yellowing of the eyes and/or skin, dark urine, pale stools), or unexplained bruising or bleeding, repeated sore throats or other infections (particularly with mouth ulcers), paleness, tiredness and/or weakness, STOP TAKING the tablets and speak to your doctor IMMEDIATELY.
The elderly are more susceptible to side effects and may experience confusion.
Tell your doctor or pharmacist if you suffer from any of the side effects listed in the sections below.
The most common side effects include:
• drowsiness, light-headedness, reduced alertness, dizziness, tiredness, double vision
■ muscle weakness, unsteadiness, and poor muscle co-ordination.
These effects are usually dose related but may occur after a single dose and may last into the following day. They generally occur at the start of treatment and usually disappear with repeated use of your medicine.
Rare effects include:
* numbed emotions, reduced alertness, tiredness, headache, vertigo (feeling of dizziness or spinning)
* fits
■ blurred vision, eyesight problems
* low blood pressure (symptoms include light-headedness (particularly on standing up), fainting, tiredness)
* stomach upsets such as nausea, vomiting and diarrhoea
* skin rashes
* changes in sex drive
■ difficulty passing urine.
Other side effects include:
■ dependence on nitrazepam
■ confusion, feeling restless, agitated or irritable, aggressive outbursts, rages
* delusions, seeing or hearing things that are not real, inappropriate behaviour, nightmares
* tremor, difficulty speaking
* changes in saliva
* incontinence
■ depression and memory loss may occur with high doses. Pre-existing depression may be uncovered by taking nitrazepam. Anterograde amnesia (difficulty making new memories and remembering new information) may occur at normal doses with the risk increasing at high doses.
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nitrazepam Tablets
Keep this medicine in the pack provided and protect from heat, light and moisture.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN. Do not take the tablets if the expiry date on the pack has passed.
If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information Ingredients:
Each tablet contains 5 mg of nitrazepam as the active ingredient. The tablets also contain the following other ingredients: maize starch, lactose, pregelatinised starch, magnesium stearate and sodium starch glycolate.
What the medicine looks like:
Nitrazepam tablets are white, flat, scored tablets. The tablets are available in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90,100,112, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed.)
Who makes this medicine and holds the Product Licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.
Date leaflet revised: February 2014
If you would like this leaflet in a different format please contact the licence holder at the above address.