Nitrazepam Tablets Bp 5mg
KEEP ALL MEDICATION OUT OF THE REACH OF CHILDREN
NITRAZEPAM TABLETS BP 5mg
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY
This leaflet contains a summary of the information about your medicine, Nitrazepam Tablets BP 5mg.
YOUR MEDICINE
Your medicine is in the form of a tablet. Each tablet contains 5mg of the active ingredient Nitrazepam. Each tablet also contains lactose, maize starch, pregelatinised starch, magnesium stearate, talc and collodial anhydrous silica.
Nitrazepam Tablets are available in containers and blister packs of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250 and 500 tablets. Your pharmacist will dispense the number of tablets prescribed by your doctor.
(*Only marketed pack sizes will feature on the printed leaflet).
HOW DOES YOUR MEDICINE WORK?
Your tablet contains Nitrazepam, which belongs to a group of medicines called BENZODIAZEPINES that act as hypnotics or sleep inducers. This means that after you take Nitrazepam you should feel tired and fall asleep. The exact way in which your medicine acts is not known but it is believed that it increases the activity of a naturally occurring substance called GABA which acts as a messenger (neurotransmitter) in the brain.
Product Licence Holder Generics (UK) Limited, Station Close, Potters Bar, Herts And Manufacturer: EN6 1TL.
WHY DO YOU NEED TO TAKE YOUR MEDICINE?
Nitrazepam Tablets BP 5mg may be used to treat insomnia over a short period of time, from a few days to two weeks. Insomnia is a difficulty in falling asleep or sleeping properly, and your doctor will prescribe Nitrazepam Tablets BP 5mg if this disorder is having a severe, disabling or very distressing effect on you.
You must tell your doctor before taking your medicine if:
• you are pregnant (see below)
• you have taken Nitrazepam or a similar medicine before and suffered an unusual or allergic reaction to it
• you suffer from the condition which causes your muscles to weaken (Myasthenia Gravis)
• you are known to suffer from the condition of breathing irregularly whilst asleep called ‘sleep apnoea syndrome’
• you have a history of alcohol or drug abuse
• you suffer from chronic renal disease
• you have severe liver disease
• you suffer from severe breathing problems
• you are suffering from depression or being treated for a psychiatric illness
• you are already taking any of the following medicines:
• antidepressants
• strong painkillers
• medicine to treat epilepsy
• antihistamines which have a sedative effect, eg Chlorpheniramine or Clemastine, or any other medicines which cause sleepiness
• sedatives or other medicine used to treat anxiety Do not take these tablets if
• you think you are allergic to any of the ingredients especially lactose
• you are pregnant, might become pregnant, or are breast-feeding
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 difficulties. If this medicine is taken regularly in late pregnancy , your baby may develop withdrawal symptoms.
Nitrazepam Tablets BP 5mg may make you sleepy or affect your concentration. This may affect your performance at skilled tasks e.g. driving and operating machinery.
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:
o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o 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.
DO NOT drink alcohol whilst taking Nitrazepam Tablets BP 5mg.
Alcohol will increase the sedative effects of Nitrazepam Tablets BP 5mg and should therefore, be avoided.
If you need to have an operation when you will have a general anaesthetic, tell the doctor that you are taking Nitrazepam Tablets BP 5mg.
HOW SHOULD YOU TAKE YOUR TABLETS?
Your doctor will not usually prescribe Nitrazepam Tablets BP 5mg for longer than 4 weeks to treat insomnia. Do not take your tablets more often or for longer than your doctor advised, as too much Nitrazepam can become habit-forming. It is also advisable to make sure that having taken your Nitrazepam Tablets BP 5mg, you will be able to have an interrupted sleep of 7-8 hours as this will reduce the likelihood of side-effects such as memory loss.
The adult dose is usually one or two Nitrazepam Tablets BP 5mg on going to bed or up to half an hour before going to bed.
Elderly or frail patients and patients who suffer from blood vessel disease eg hardened arteries, usually require a smaller dose of no more than one Nitrazepam Tablet BP 5mg at night.
Patients who suffer from liver problems, are likely to be prescribed lower doses of Nitrazepam.
Nitrazepam should not be given to children.
Do not stop taking your medicine without telling your doctor, as he/she may wish to reduce your dose of Nitrazepam before stopping treatment completely. This reduces the likelihood of unpleasant side effects including restlessness, headache, difficulty sleeping, tension, sweating, numbness or tingling in the arms or legs, fits, unusual behaviour, ringing in the ears, feeling unusually sensitive to light, noise or physical contact, confusion, stomach cramps, muscle cramps and being sick, feeling anxious or mood changes.
If you forget to take your dose of Nitrazepam Tablets BP 5mg, take it as soon as you remember the same evening. Otherwise if you miss a dose, do not double the next dose, just take your normal dose the following night.
IF YOU TAKE TOO MUCH OF YOUR MEDICATION CONTACT YOUR DOCTOR IMMEDIATELY
CAN YOUR MEDICINE HAVE ANY SIDE EFFECTS?
The most common side effects are feeling drowsy during the day, reduced alertness, dizziness, numbed emotions, confusion, headaches, muscle weakness or lack of coordination, double vision. These side effects usually disappear on continuation of treatment.
Other side effects include
• memory loss
• feeling depressed
• restlessness, agitation, irritability, aggressiveness, loss of a sense of reality, rages, unusual or unexpected behaviour, nightmares or hallucinations (feeling, hearing or seeing things that are not there)
and less frequent side effects such as
• stomach pain or diarrhoea, lack or heightening of sexual desire or skin rashes.
Tell your doctor if you have recently suffered from loss or bereavement, as adjustment to this situation may be prolonged.
If you should suffer from any of these undesired effects or any other unwanted effect please tell your pharmacist or doctor. Your doctor may wish to reduce the dose of Nitrazepam Tablets BP 5mg that you are taking.
DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE SHOWN ON THE LABEL.
REMEMBER this medicine was prescribed by your doctor for you.
DO NOT give it to others. It may harm them.
Store in a dry place below 25°C. Protect from light.
Date of revision: July 2014