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NITRAZEPAM MIXTURE 2.5MG/5ML ORAL SUSPENSION BP

Active substance(s): NITRAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nitrazepam Mixture 2.5 mg/5 ml Oral
Suspension BP
Nitrazepam

Read all of this leaflet carefully before you start taking this medicine.
- 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. 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 become serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
What is in this leaflet:
1. What Nitrazepam Mixture Oral Suspension is and what it is used for
2. What you need to know before you take Nitrazepam Mixture Oral Suspension
3. How to take Nitrazepam Mixture Oral Suspension
4. Possible side effects
5. How to store Nitrazepam Mixture Oral Suspension
6. Contents of the pack and other information

1. What Nitrazepam Mixture Oral Suspension is and what it is
used for
Nitrazepam Mixture Oral Suspension contains the benzodiazepine nitrazepam.
Benzodiazepines are a group of medicines known as sedatives, which have a calming effect and reduce
anxiety and tension.
Nitrazepam Mixture Oral Suspension is for the short term treatment of insomnia (difficulty sleeping) in
patients where sleepiness during the day is acceptable. It should only be used by people who find it so
difficult to sleep that their daily lives are affected or they are distressed.
This medicine should be used for as short a time as possible and should not be used for more than four
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 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.

2. What you need to know before you take Nitrazepam
Mixture Oral Suspension
Do not take Nitrazepam Mixture Oral Suspension if:
• You are allergic (hypersensitive) to nitrazepam or any other benzodiazepines, e.g. temazepam, or any of
the other ingredients of Nitrazepam Mixture Oral Suspension.
• You have sleep apnoea syndrome (a sleep disorder characterized by pauses in breathing or instances of
shallow or infrequent breathing during sleep).
• Your doctor has told you that you have myasthenia gravis (a disease causing severe muscle weakness).
• You have chronic psychosis (long-standing mental illness with symptoms such as hearing, seeing or sensing
things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn).
• You have acute porphyria (an inherited condition causing skin blisters, abdominal pain and brain or
nervous system disorder).
• You have severe problems with your breathing.
• You have severe liver problems.
Talk to your doctor or pharmacist before taking Nitrazepam Mixture Oral Suspension if:
• You have a long term lung or liver disease.
• You suffer from depression or worry caused by depression.
• You are suffering from a mental illness.
• You notice that this medicine is not working as well as it did when first starting treatment
• You are not able to have 7 or 8 hours of unbroken sleep. If you are woken from sleep within this time
you may suffer from a loss of memory for a short while.
• You experience changes in behaviour such as aggression, confusion, restlessness, agitation, irritability,
rages, delusion (a fixed irrational idea not shared by others), nightmares, hallucinations, psychoses (severe
mental condition in which the person loses contact with reality and is unable to think and judge clearly) or
inappropriate behaviour. If these behavioural changes occur your doctor may want you to stop taking this
medicine.
Make sure your doctor knows if you have or have had a drug or alcohol problem as you are more likely to
become dependent on Nitrazepam Mixture Oral Suspension.
Other medicines and Nitrazepam Mixture Oral Suspension
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Examples of medicines that can affect Nitrazepam Mixture Oral Suspension are:
• Some medicines used for mental illness such as anxiety or depression.
• Other sleeping tablets.
• Some strong painkillers, such as codeine may give you a heightened sense of well being when taken with
nitrazepam. This can increase your desire to continue taking these medicines (dependency) or can make
you very sleepy.
• Anaesthetics, used to put you to sleep during an operation.
• Antihistamines, used for hayfever and other allergies which cause drowsiness.
• Medicines used for epilepsy such as phenytoin, carbamazepine or phenobarbital.
• Rifampicin, an antibiotic (commonly used in the treatment of tuberculosis as this can cause nitrazepam to
be removed from the body more quickly than usual).
• Cimetidine, used to treat stomach ulcers, (as this can cause nitrazepam to be removed more slowly than
usual from the body).
• Probenecid, used to treat gout (painful inflammation of the joints).
• Levodopa (to treat Parkinson’s disease) as nitrazepam may cause levodopa to not work as well as it
should.
Taking Nitrazepam Mixture Oral Suspension with food and drink
Do not drink alcohol when taking Nitrazepam Mixture Oral Suspension as it may make you excessively
sleepy.
Pregnancy and breast-feeding
Do not take Nitrazepam Mixture Oral Suspension 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
Do not drive or use machinery when taking Nitrazepam Mixture Oral Suspension because the effect of your
insomnia plus possible sedative effects of Nitrazepam Mixture Oral Suspension the next day may make you
unsafe.
This 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:
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o The medicine has been prescibed to treat a medical or dental problem and
o You have taken it according to the instructions given by the presciber 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 whilst taking this
medicine.
Important information about some of the ingredients of Nitrazepam Mixture Oral Suspension
Nitrazepam Mixture Oral Suspension contains 2 g of sucrose (sugar) in every teaspoon. If you have been
told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
product.

3. How to take Nitrazepam Mixture Oral Suspension
Always take Nitrazepam MIxture Oral Suspension exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
• Before you take Nitrazepam Mixture Oral Suspension make sure you have enough time for 7-8 hours
sleep.
• The usual dose for adults is 10 ml (2 teaspoonfuls) just before bedtime. Sometimes, if this dose doesn’t
work, the doctor may increase it to 20 ml (4 teaspoonfuls).
• Older people and patients with liver, kidney or breathing problems should take half the adult dose- 5 ml
(1 teaspoonful). Sometimes, if this dose doesn’t work, the doctor may increase it to 10 ml
(2 teaspoonfuls).
• The doctor may tell you not to take the medicine every night.
• If you forget to take Nitrazepam Mixture Oral Suspension and remember too late for 7 to 8 hours sleep,
do not take any Nitrazepam Mixture Oral Suspension until the next night.
Nitrazepam Mixture Oral Suspension is not recommended for children.
Duration of treatment: Normally treatment lasts from a few days to two weeks with a maximum of 4
weeks. To stop treatment, the doctor will probably advise you how to reduce your dose slowly until you
stop.
If you take more Nitrazepam Mixture Oral Suspension than you should, contact a doctor immediately.
Stopping Nitrazepam Mixture Oral Suspension and Withdrawal Effects:
This medicine should not be stopped suddenly; keep taking it until your doctor tells you how to reduce
the dose slowly. If you stop taking this medicine suddenly you may experience the following withdrawal
effects:
• depression,
• nervousness,
• difficulty in sleeping,
• irritability,
• sweating,
• upset stomach/diarrhoea,
• or the symptoms you are being treated for can come back worse than before.
You may also experience mood changes, anxiety, restlessness and changes in sleep patterns. These effects
may occur even after taking low doses for a short period of time. If you stop taking this medicine
suddenly after being treated with high doses of Nitrazepam MIxture Oral Suspension, you may experience
confusion, hallucinations, shaking, faster heartbeat or fits.
Withdrawal may also cause unusual behaviour including aggresive outbursts, excitement or depression
with suicidal thoughts or actions.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Nitrazepam Mixture Oral Suspension can cause side effects, although not everybody
gets them.
Tell your doctor immediately and stop taking NItrazepam MIxture Oral Suspension if you get a serious
allergic reaction which causes difficulty in breathing, or swelling of the face, lips, tongue or throat.
• Sometimes people feel sleepy, unemotional, less alert, confused, tired, dizzy, and weak or are unsteady
when they walk. They may get a headache or double vision. These effects happen more often at the
start of treatment then usually wear off.
• People can become addicted to Nitrazepam Mixture Oral Suspension.
• There may be changes in mood and patients become restless, agitated, irritable, very angry or aggresive
and any pre-existing depression may be revealed.
• Patients may get nightmares, delusions or hallucinations, become forgetful or show unusual behaviour.
All these are more likely in the elderly.
• Other side effects include stomach upsets, low blood pressure, yellowing of the skin or whites of the
eyes (jaundice), changes in sex drive or skin reactions, which happen occasionally.
• Blood disorders and difficulty passing water happens rarely.
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 Mixture Oral Suspension
Keep all medicines out of the sight and reach of children.
Do not store above 25°C and protect from light. Do not freeze it.
Do not use Nitrazepam Mixture Oral Suspension after the expiry date which is printed or embossed on the
carton and bottle label as month/year. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Nitrazepam Mixture Oral Suspension contains
The active substance of Nitrazepam Mixture Oral Suspension is nitrazepam. There are 2.5 mg of
nitrazepam in each 5 ml.
The other ingredients are sucrose, microcrystalline cellulose, carboxymethyl cellulose sodium, a
preservative (mixed esters of p-hydroxybenzoic acid), cherry flavour and water.
What Nitrazepam Mixture Oral Suspension looks like and contents of the pack
Each pack consists of a carton with an amber glass bottle of Nitrazepam Mixture Oral Suspension
containing 70 ml suspension.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Essential Pharma Ltd, 7 Egham Business Village, Crabtree Road,
Egham, Surrey, TW20 8RB, UK.
It is made by Famar Nederland B.V., Industrieweg 1, 5531 AD Bladel, The Netherlands.
UK Marketing Authorisation Number: PL 41871/0004
The leaflet was last revised in December 2015.

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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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