NITRAZEPAM 5MG TABLETS

Active substance: NITRAZEPAM

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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.
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 effect 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.
Storing your medicine
You must keep this medicine in a safe place where children cannot get it. Your medicine could harm them. Keep your
medicine in a dry place and store below 25ºC in a well-closed container. Keep the tablets in the container in which they
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 revised in March 2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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