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DIAZEPAM RECTUBES 20MG
Active substance(s): DIAZEPAM
DIAZEPAM RECTAL SOLUTION
PATIENT INFORMATION LEAFLET
INFORMATION FOR PATIENTS
If you are the patient, parent or carer, please read this leaflet carefully before you have to use this medicine.
It gives a brief outline of the more important things you should know. If you want to know more about this
medicine, or you are not sure about anything, ask your doctor or pharmacist.
THE NAME OF YOUR MEDICINE IS DIAZEPAM RECTUBES®
The active ingredient in Diazepam RecTubes® is diazepam. The tubes are available in four strengths:
2.5mg, 5mg, 10mg and 20mg. Other ingredients include: benzoic acid, benzyl alcohol, sodium benzoate,
ethanol, propylene glycol and purified water.
The presentation consists of a white polythene rectal tube in alufoil wrap in a printed outer carton of 2 or 5
Diazepam belongs to a group of medicines known as benzodiazepines, which are used as sedatives and
anticonvulsants (to control fits), or to relax tense muscles.
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
HOW DOES YOUR MEDICINE WORK?
Diazepam belongs to a group of medicines known as benzodiazepines, which are used as sedatives and
anticonvulsants (to control fits), or to relax muscles.
WHAT IS DIAZEPAM FOR?
Diazepam can be used for severe anxiety or agitation, for the control of epileptic or feverish convulsions
(fits), for sedation before minor surgical or dental procedures and to relieve muscle spasm. Diazepam
RecTubes® are for use in adults and children over the age of one year.
BEFORE ADMINISTERING THE MEDICINE
Diazepam should not be given to you if:
you are pregnant or breast feeding (unless your doctor decides it is essential). Tell your doctor
straight away if you think you may be pregnant or intend to start a pregnancy.
you are allergic to diazepam, or any other benzodiazepines or any of the ingredients. Check by
reading the list of ingredients above.
you are suffering from phobias (fears) or obsessions
you are suffering from depression, with or without anxiety, or other long-standing mental illness,
for which you are not being treated.
you are suffering from severe breathing difficulties
you have experienced recent loss or bereavement
you have serious liver problems
you suffer from sleep apnoea syndrome (stopping breathing during sleep)
Diazepam should not be given to patients who are in a coma, or used to treat anxiety in children without
careful prior assessment.
ADVICE WHEN DIAZEPAM RECTUBES® ARE ADMINISTERED
Special care will be necessary if you
are elderly or run down
have kidney or liver problems, myasthenia gravis (very weak muscles), difficulty with
breathing, poor blood supply to the brain or any brain damage, or porphyria (a rare blood
have a personality disorder, suicidal tendencies, are prone to aggressive outbursts or selfharm
have had problems with addiction to drugs or alcohol or if you currently smoke or drink
If you are using Diazepam RecTubes® on a daily basis, early checks should be made to ensure that the
dose is not too high.
If you are supposed to control the amount of sodium in your diet you should be aware that this
medicine contains sodium and that the amount of sodium in each dose is 0.42mmol for RecTubes
2.5mg, 0.85mmol for RecTubes 5mg and 10mg and 1.7mmol for RecTubes 20mg.
Your memory may be affected a few hours after inserting Diazepam RecTubes®, so ideally you need
to be able to have a period of 7-8 hours uninterrupted sleep after use of this medicine.
If given continuously for too long, there is a risk of becoming dependent on diazepam or having problems
with withdrawal symptoms when you stop. The dose should be reduced gradually to reduce the risk of
withdrawal symptoms, or “rebound symptoms” whereby the problem for which you were being given
Smoking can affect how diazepam works.
Taking another medicine whilst you are taking Diazepam RecTubes® can affect how it or the other
medicine works. Make sure that your doctor knows what other medicines you are taking. This includes
medicines you may have bought yourself.
Examples of medicines that can affect Diazepam RecTubes® are:
• Drugs used for mental illness (e.g. zotepine and clozapine), anxiety (other benzodiazepines) or
depression (e.g. fluvoxamine)
• Some painkillers, such as codeine.
• Sleeping tablets.
• Erythromycin, used to treat infections.
• Baclofen and tizanidine, used to relax the muscles.
• Drugs used for epilepsy such as phenytoin, carbamazepine and sodium valproate.
• Isoniazid and rifampicin, used in the treatment of tuberculosis
• Ritonavir and amprenavir, used to treat virus infections.
• Disulfiram, a drug used for alcohol dependence.
• Cimetidine or omeprazole, drugs used to treat stomach ulcers.
• Oral contraceptives.
• Levodopa, a drug used in the treatment of Parkinson’s disease.
• Theophylline, a drug used for asthma and bronchitis.
• Some antihistamines (used for hayfever and other allergic conditions)
• Lofexidine, used to treat heroin withdrawal
• Nabilone, used to treat vomiting due to cancer therapy
• Antihypertensives, used to lower blood pressure, such as moxonidine and doxazosin
• Digoxin, used in heart failure
This product contains more than 10% alcohol as well as diazepam so sedation may be enhanced. You
should not drink alcohol while using Diazepam RecTubes®. Diazepam also affects concentration and
muscle function, so you should not drive or operate machinery while you are being treated with Diazepam
If you have any doubts about whether you should use these rectal tubes then discuss things more fully with
your doctor BEFORE using them.
ADMINISTERING THIS MEDICINE
These tubes are for rectal use only. The usual dose is 0.5mg/kg body weight but the dose will vary
according to the patient's weight, age and state of health. They should not be used for children under one
Your doctor will decide the dose, which is best for you. Your doctor's instructions must be followed
completely and any special instructions or warnings, which appear on the label which the pharmacist, has
put on the package. If you do not understand, or are in any doubt, ask your doctor or pharmacist.
If used continuously for too long, there is a risk of becoming dependent on diazepam or of having problems
when stopping it (withdrawal symptoms). If Diazepam RecTubes® are being prescribed for anxiety, your
doctor will normally recommend that you do not use them for more than 8-12 weeks, including a tapering off
period during which the dose will be reduced gradually.
When the medicine is withdrawn, especially if it is stopped suddenly, the following symptoms may occur: headache, muscle pain, extreme anxiety, tension, restlessness, depression, confusion and irritability.
Sometimes, anxiety symptoms return after the medicine is stopped, or you could have problems with mood
changes or difficulty sleeping.
If too much diazepam is accidentally inserted you should contact your doctor or nearest Casualty
AFTER ADMINISTERING THIS MEDICINE
Like many medicines diazepam RecTubes® may cause side effects in some patients, particularly when you
start using them. The side-effects that some other patients have had with diazepam are sedation,
drowsiness, headaches, muscle weakness, dizziness (with risk of falls in the elderly), unsteadiness,
confusion, slurred speech, trembling hands, numbed emotions, reduced alertness, tiredness, forgetfulness
and a hangover effect. Elderly or run down patients are more likely to have side effects and may need
Other effects which may occur rarely are dry mouth, stomach or bowel upsets, problems with your vision,
changes in the liver, jaundice (yellow skin), problems passing water, incontinence, low blood pressure, slow
pulse, changes in sexual desire, skin rashes and other allergic reactions (with swelling of the face and eyes
and difficulty breathing in severe cases), blood problems, chest pain and breathing problems. Diazepam
may uncover depression in susceptible individuals.
Rarely, instead of feeling sleepy, some patients, particularly if they are children or elderly, may become
irritable, aggressive, overexcited, “high”, uninhibited, overanxious or have difficulty sleeping. If this
happens, tell your doctor so that the medicine can be discontinued under his/her direction.
The benzoic acid in Rectubes may cause stinging.
If any of these side effects are troublesome or if you experience any side effects other than the ones
mentioned here, tell your doctor or pharmacist.
There may be a slight increase in abnormalities, particularly hare lip, in babies born to mothers given
benzodiazepines during the first three months of pregnancy. Babies exposed to benzodiazepines during
pregnancy may be slow developers. If a mother has received diazepam towards the end of pregnancy or
during labour, the baby may be affected, with feeling cold, floppiness, difficulty breathing and suckling, or
SAFE KEEPING FOR YOUR MEDICINE
Do not use the tubes if the expiry date on the tube has passed or if they show signs of deterioration. These
tubes should be kept at room temperature (but not above 25 C) in the package or container in which they
were given to you. Do not transfer them to another container.
KEEP THEM IN A SECURE PLACE OUT OF THE REACH AND SIGHT OF CHILDREN
REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their
symptoms are the same as yours. Unless your doctor tells you to, do not keep the tubes that you no longer
need. Give them back to the pharmacist.
DATE OF REVISION
INFORMATION FOR YOUR CARER
HOW TO ADMINISTER THE MEDICINE
COMMON QUESTIONS AND ANSWERS
How long does it take to work?
What if I give it and there's no change?
Under these circumstances it may be more difficult to administer Diazepam
RecTubes®. If you think this may be a problem we recommend you consult
Do I need to lubricate the tube?
Your doctor would have told you what to do in these circumstances. If you
are in doubt talk to your doctor.
What if I can't turn the patient on his/her side?
Usually it works within 10 minutes.
No, the plastic is very smooth and designed to be used without lubrication.
Can I give less than the whole tube to see what happens?
Why do I have to maintain pressure on the tube?
Emptying the tube is easiest when pointing downwards. It is possible to
empty it at other angles but this is usually more difficult.
Why do I have to keep the tube in the foil?
No, using Diazepam RecTubes® should not hurt the patient.
How important is it to point the tube downwards?
Perhaps you forgot to keep the tube compressed as you withdrew it. A small amount
of solution is intended to be left in the tube after the dose has been given. If you are
worried about how much you have been given, we recommend you consult the doctor.
Will I hurt the patient?
If you hold the patient's buttocks together for a few minutes keeping the
patient in the same position, this should not happen.
What if I find there is some solution left in the tube afterwards?
To avoid the solution being sucked back into the tube as it is being
What if the solution leaks out of the patient's bottom?
The whole dose should be given as prescribed.
Diazepam RecTubes® have a shelf life of 36 months in the foil bag. Once
the foil is opened, the shelf life is reduced to 6 months.
Do I need to keep Diazepam RecTubes® in the fridge?
No - they can be stored at room temperature (but not above 25 C).
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.