Nitrazepam Tablets B.P. 5 Mg
Package leaflet: Information for the user
SKH 1015
NITRAZEPAM TABLETS BP 5MG
Nitrazepam
Read all of this leaflet carefully before you
start taking this medicine because contains
important information for you.
• 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 only. Do not pass it on to others. It may harm them, even iftheirsigns of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, see section 4.
What is in this leaflet
1. What Nitrazepam Tablets are and what they are used for
2. What you need to know before you take Nitrazepam Tablets
3. Howto take Nitrazepam Tablets
4. Possible side effects
5. Howtostore Nitrazepam Tablets
6. Contents of the pack and other information
1. What Nitrazepam Tablets are and what they are used for
Nitrazepam belongs to a group of medicines known as benzodiazepines, which are tranquillisers (medicines that have a calming effect)
Nitrazepam Tablets are used:
• for the short term treatment of sleeplessness (also known as insomnia), when it is severe, disabling or distressing, and when sleepiness during the day is acceptable.
2. What you need to know before you take Nitrazepam Tablets
Do not take Nitrazepam Tablets if:
• you are allergic to Nitrazepam or to any other Benzodiazepine (e.g. flurazepam, diazepam, chlordiazepoxide or temazepam) or to other ingredients of this medicine (listed in Section 6)
• you have a phobia (you are really afraid of something or some situation)
• you have an obsession (you cannot stop thinking about or doing something for example, handwashing)
• you suffer from chronic psychosis (a personality disorder where you lose contact with reality).
• you suffer from neuromuscular disease such as myasthenia gravis (a form of muscle weakness)
• you suffer from loss of vision due to abnormally high pressure in the eye (closed angle glaucoma)
• you have difficulty breathing
• you have sleep apnoea (a condition where you temporarily stop breathing whilst asleep)
• you sufferfrom severe liver problems.
If you think any of these apply to you, do not take the tablets, talk to your doctor and follow the advice given.
Do not give this medicine to children
Warnings and precautions
Talk to your doctor or pharmacist before taking
Nitrazepam Tablets if:
• you have a long-term lung, liver, or kidney disease.
• Someone close to you has recently died
• you have a history of alcoholism ordrug abuse.
• you suffer from depression with or without anxiety
If you think any of these apply to you, talk to your doctor or pharmacist before taking this medicine.
To reduce the risk of memory amnesia (loss of memory), you need to have uninterrupted sleep for 7-8 hours when taking this medicine.
Because Nitrazepam Tablets relax the muscles, older 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.
Important information about your medicine
• Tolerance - if after a few weeks you notice that the tablets are not working as well as they did when first starting treatment, you should speak to your doctor.
• Dependence - when taking this medicine 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, or sufferfrom a personality disorder.
• Withdrawal - treatment should be gradually withdrawn. Withdrawal symptoms occur with Nitrazepam even when normal doses are given for short periods of time. See section 3” If you stop taking Nitrazepam Tablets”.
• Changes in behaviour may occur rarely. These changes may include aggression, excitement, confusion, restlessness, agitation, irritability, rages, delusion (a fixed, inational idea not shared by others), psychoses (severe menial condition in which the person loses contact with reality and is unable to think and judge dearly), inappropriate behaviour, hallucinations, nightmares and depression with suiddal tendencies.
If these behavioural symptoms occur, you must inform yourdoctor.
He/she may want you to stop taking this medicine.
These side effects are more likely to occur in children orthe older patients.
Other medicines and Nitrazepam Tablets
Tell yourdoctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 yourdoctor if you are taking any of the following medicines:
• medicines that act on the brain or nerves such as: antipsychotics (medicines for psychiatric conditions), tranquillisers (medicine used to produce calmness), hypnotics (to help you sleep), anxiolytics (medicines used to treat anxiety), anti-depressants, anaesthetics (drugs used to put you to sleep during an operation or surgery)
• cimetidine (stomach acid reducing medicine)
• disulfiram (used to treat alcoholism)
• isoniazid (used fortuberculosis treatment)
• contraceptives
• rifampicin (an antibiotic used for tuberculosis treatment)
• antihistamines (used for treating allergies) that cause drowsiness (e.g. chlorphenamine)
• some strong painkillers - may give you heightened sense of well-being when taken with nitrazepam which can increase your desire to continue taking these medicines (dependency)
• medicines used to treat epilepsy (e.g. hydrantoins or barbiturates)
Nitrazepam Tablets with food, drink and alcohol
DO NOT drink alcohol whilst taking Nitrazepam Tablets. Alcohol may increase the sedative effects ofNitrazepam.
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.
DO NOT take Nitrazepam Tablets if you are pregnant, might become pregnant, or are breastfeeding.
If your doctor has decided that you should receive this medicine during the last three months of pregnancy or during labour, your baby might have a low body temperature, floppiness, irregular heart rate and breathing and feeding difficulties. Giving this medicine during last three months of pregnancy can cause irregular heart beat in the unborn child. If this medicine is taken regularly in late pregnancy, your baby may develop dependency to this medicine and may be at some risk of developing withdrawal symptoms.
Driving and using machines
Nitrazepam Tablets may make you feel sleepy, forgetful, affect your concentration or coordination. It may also impair your alertness especially if you don't have 7-8 hours uninterrupted sleep.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• 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 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.
Alcohol may increase the sedative effect of Nitrazepam tablets. This may affect your ability to drive or use machines.
Nitrazepam Tablets contains lactose
Therefore, if you have been told by your doctor that you have an intolerance to some sugars, contact yourdoctor before taking this medicinal product.
3. Howtotake Nitrazepam Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. You should check with yourdoctor orpharmacist if you are not sure.
The usual dose is:
5mg (1 tablet). If necessary, this may be increased to 10mg (2 tablets).
If you are an older patient or suffer from a lung, liver, or kidney condition, or are generally unwell, your starting dose will usually not be more than 2.5 mg (half a tablet).
If necessary, this may be increased to 5mg (1 tablet).
The tablet should be taken by mouth before going to bed. Your doctor will prescribe you the lowest dose possible to control yoursymptoms.
You may not need to take this medicine every night. Treatment will be as short as possible to improve your symptoms and will not normally be continued for more than 4 weeks.
Use in children:
Not for use in children.
Always follow your doctor or pharmacist's advice on how to take your medicine; it may be different to the above.
If you take more Nitrazepam Tablets than you should
If you take more Nitrazepam Tablets than you
should contact your doctor or go to the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so that your doctor will know what you have taken.
Signs of an overdose include slowing down of the nervous system ranging from tiredness to coma such as confusion, drowsiness, lack of coordination, reduced muscle tension, low blood pressure, breathing difficulties, in rare cases overdose may lead to coma (unrousable unconsciousness) and in very rare cases may lead to death.
If you forget to take Nitrazepam Tablets
If you forget to take a dose, you should never make up for the missing dose by doubling the dose next time. Instead you should simply continue with the next dose when itisdue.
Ifyou stop taking Nitrazepam Tablets
Keep taking these tablets for as long as your doctor or pharmacist advises. If your doctor decides to discontinue treatment, it should be gradually withdrawn. Stopping the treatment suddenly could in some cases lead to depression, nervousness, mood changes, sweating, diarrhoea, headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases, patients may also experience lack of awareness of their surroundings, changes in behaviour or way they feel, numbness and tingling of the fingers and toes, extreme sensitivity to light, noise and physical contact, hallucinations or seizures (fits).
Treatment should be gradually withdrawn otherwise the symptoms you are being treated for may return more intense than before (rebound insomnia and anxiety). The risk of this happening is greater when you stop taking Nitrazepam suddenly. You may also experience mood changes, anxiety, restlessness or changes in sleep patterns.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or local hospital for emergency help immediately if you notice any of the following:
• Allergic reaction - swelling of the face, lips, tongue or throat or difficulty breathing or swallowing
• yellowing of eyes and skin (jaundice)
If you experience any of these side effects, see your doctor at once. He/she may want you to stop taking this medicine:
• recurrence of previously controlled depression and suicidal thoughts
• aggressive outbursts, excitement, restlessness, agitation, irritability, delusion (a fixed irrational idea not shared by others), rages
• nightmares, hallucinations
• psychoses (severe mental condition in which the person loses contact with reality and is unable to think and judge clearly)
• inappropriate behaviour
Other side effects that may occur:
Common side effects include:
• drowsiness (during the day)
• numbed emotions, confusion, tiredness, reduced alertness
• headache, dizziness
• muscle weakness, ataxia (difficulty in controlling movements)
• double vision, unsteadiness and amnesia (loss of memory) may occur especially at high doses.
These effects usually occur at the start of treatment and disappear after repeat dosage. Performance at skilled tests and alertness may be impaired. The older people are particularly liable to experience these symptoms together with confusion.
Rare: side effects include:
• spinning sensation
• hypotension (low blood pressure)
• stomach upset
• changes in yourvision otherthan double vision
• skin rashes
■ changes in libido (interest in sex)
• inability to pass urine
• blood dyscrasias (an abnormality of the blood)
People may become dependent on Nitrazepam Tablets. Discontinuation of treatment in these patients may result in them experiencing withdrawal or a syndrome where the symptoms that resulted in the patients being prescribed Nitrazepam come back in a more severe form. These patients may also experience mood changes, nervousness and restlessness. Patients may also experience psychiatric dependence. Abuse of benzodiazepines has been reported.
If you have any of these symptoms or any other problems and you think these tablets may be causing them, talk to your doctor or pharmacist.
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 out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. These tablets should be stored below 25°C. Keep them in the pack they came in - do not transfer them to another container. Keep the container tightly closed.
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.
6. Contents of the pack and other information
What Nitrazepam Tablets contains:
• The active substance is 5 mg of nitrazepam.
• The other ingredients are lactose, maize starch, povidone, magnesium stearate E572, sodium starch glycollate and colloidal anhydrous silica.
What Nitrazepam Tablets looks like and contents of the pack:
Nitrazepam Tablets are white, circular tablets, breakline on one side, RN5 on the other.
The tablets are available in a 5mg strength and in packs of 5000,1000, 500,100, 84,70, 56, 50, 42,
28.25.21.15.14.7 tablets and in blister packs of
84.70.56.42.28.21.15.14.7 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Ranbaxy Ireland Ltd.
Spafield, Cashel Co. Tipperary Republic of Ireland
This leaflet was last revised: March 2015 PL 6809/0042
LNUK01/05/C