Nitrazepam 5mg Tablets
PATIENT INFORMATION LEAFLET
REMNOS
NITRAZEPAM 5 mg TABLETS
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF REMNOS.
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION.
What is in your medicine?
The name of this medicine is REMNOS. Each tablet contains Nitrazepam BP 5 mg together with the following ingredients: lactose, maize starch, pregelatinised maize starch, ethylcellulose, magnesium stearate.
Your tablets are round, white, flat tablets with bevelled edges and a breakline. They are engraved REMNOS 5.
REMNOS is available in containers of 100 and 500 tablets.
The Product Licence holder of REMNOS is Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, Cyprus.
The manufacturer of REMNOS is DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE.
How does REMNOS work?
REMNOS belongs to a group of medicines known as the benzodiazepine hypnotics (medicines used in the treatment of insomnia).
Why have you been prescribed REMNOS?
Nitrazepam is used in the short term treatment of insomnia only when it is severe, disabling or subjecting the patient to extreme distress.
Before taking your medicine
Before you start treatment with REMNOS study this section of the leaflet carefully so you can be sure this medicine is suitable for you.
Before taking these tablets, tell your doctor if you have ever had any unusual or allergic reactions to Nitrazepam or other medicines belonging to the same benzodiazepine group.
Also tell your doctor or pharmacist if you are allergic to any of the other ingredients listed under “What is in your medicine?” above, or any other substances such as food, preservatives or dyes.
It is important to tell your doctor if you are pregnant or likely to become pregnant.
Do not use Nitrazepam if you have suffered or suffer from:
• a lung or other respiratory problem
• a disorder known as ‘myasthenia gravis’ characterised by muscle weakness sometimes leading to difficulty breathing
• a heart problem
• kidney disease
• liver disease
• blood condition known as porphyria
• personality disorders
• a condition known as ‘sleep apnoea’ where you recurrently stop breathing in your sleep
This medicine should not be used by people suffering from phobias (irrational fears) or obsessions.
Nitrazepam should not be used alone to treat depression or anxiety associated with depression.
If you suffer from any of the above conditions, or if you are pregnant do not take this medicine, speak to your doctor first.
Use in pregnancy and whilst breast-feeding
Remnos should not be used if you are pregnant, planning a pregnancy, or breast-feeding.
If used when pregnant there is a risk of the baby becoming dependent on the drug and experiencing withdrawal symptoms. Since Nitrazepam is present in breast milk you should not take this medicine if you are breast-feeding.
Effects of Nitrazepam on the ability to drive and use machines
You should not drive or operate machinery if you are using REMNOS.
This medicine can cause drowsiness and will affect concentration. These effects will be intensified by the use of alcohol. The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive or use machines 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.
Can you take REMNOS with other medicines?
There are some medicines that can interfere with Nitrazepam. It is very important to tell your doctor or pharmacist about all the medicines that you are taking, whether or not any medicines were prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere. Your doctor will be able to identify medicines you should not take with Nitrazepam.
Your doctor should be told if you are taking the following medicines:
• Cimetidine
• Omeprazole
• Isoniazid
• Rifampicin
• Zidovudine
• Anti-epileptic drugs
• Barbiturates
• Medicines Known as Hydantoins
These medicines can affect the way Nitrazepam works and could have side effects when taken together with REMNOS.
Tell your doctor whether you are taking alcohol or medicines that act on the Central Nervous System such as tranquilisers, hypnotics, anti-depressants, analgesics, anaesthetics. All of these substances will enhance the sedative effects of Nitrazepam and will depress the Central Nervous System.
How and when to take REMNOS tablets?
Take this medicine by mouth and only in the doses prescribed by your doctor. Do not take more of it and do not take it more often or for longer time than your doctor ordered.
If you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not double the dose.
Usual dosages stated below:
This medicine is to be taken by mouth.
Adults: the recommended dosage 5 mg (one tablet) before going to bed. This, however, may be increased to 10mg. The lowest dose which can control symptoms will be prescribed by your doctor.
The dosage may vary according to your response and the severity of your insomnia.
The medicine should not be continued beyond four weeks and treatment should always be tapered off gradually.
If you have taken other benzodiazepine medicines for a long time, then a longer period will be necessary during which the doses are reduced.
Elderly: half the normal adult dose may be sufficient for use in the elderly.
Children: these tablets should not be administered to children below twelve years of age.
What if too many tablets are taken at the same time?
If you think you may have taken too many of your tablets, either call your doctor straightaway or go to the nearest hospital casualty department. Always keep any remaining tablets in the container in which they were given to you, and also keep the label so that the doctor or pharmacist in the hospital can identify the medicine. Tell them whether you have taken any other medicines.
The symptoms of overdose include drowsiness, unsteady walking, altered speech and this may progress to loss of consciousness (coma) in severe cases.
What if you miss a dose?
If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not double the dose.
If you feel this medicine is not working as well after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check with your doctor.
What side effects can REMNOS cause?
The use of medicines like REMNOS, which belong to the benzodiazepine group, can lead to physical and mental addiction. This more likely to be the case with patients who have a history of drug dependence or alcoholism or when the medicine is given in high doses over a prolonged period of time.
Associated with abrupt withdrawal usually after dependence are the symptoms of depression, nervousness, irritability, inability to sleep, sweating, diarrhoea, and rarely convulsions, confusion and psychoses. Withdrawal symptoms may even occur following when normal doses are taken for short periods of time.
The elderly are particularly liable to experience symptoms of impaired alertness together with confusion, particularly if the symptoms of brain damage are present.
Abnormal psychological reactions to Nitrazepam have been reported. These include excitement, confusion, and unpredictable aggressive outbursts. They are more likely to occur in children.
Loss of memory and inappropriate behaviour may occur after taking this medicine, and in cases of loss or bereavement, psychological adjustment may be difficult.
In patients who are depressed and subject to aggressive behaviour towards themselves and others, there is a threat of suicide.
If you experience any changes in mood or behaviour after taking REMNOS stop taking the medicine and see your doctor.
Side effects related to how much Nitrazepam is taken include sedation, drowsiness, unsteadiness and difficulty walking.
Less common side effects are: headache, dizziness, low blood pressure, disturbances of the stomach and bowels, skin rashes, loss of sexual appetite, and difficulty passing urine. Rare cases of blood disease and jaundice (yellowing of the skin and eyeballs) have been reported.
If you experience any of the above or any other unusual effects, please contact your doctor.
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.
Storing your medicine
. Your medicine could harm them. Keep your Keep the tablets in the container in which they
You must keep this medicine in a safe place where children cannot get it medicine in a dry place and store below 25°C in a well-closed container. were given to you.
If your doctor tells you to stop the treatment, return any remaining tablets to the doctor or pharmacist. On the label you will find the words “expiry date” followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.
A reminder
Remember, this medicine is for you. Never give it to someone else even if their condition is the same as yours. This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
This leaflet was last revised in December 2014.