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DIAZEPAM RECTUBES 5MG RECTAL SOLUTION

Active substance(s): DIAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Diazepam RecTubes® 2.5mg Rectal Solution
Diazepam RecTubes® 5mg Rectal Solution
Diazepam RecTubes® 10mg Rectal Solution
(referred to as Diazepam RecTubes® in this leaflet)
Read all of this leaflet carefully before you start to
take this medicine.
- Keep this leaflet. You may need to read it again
while administering the treatment.
- If you have any further questions, please 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 get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Diazepam RecTubes® are and what they are
used for
2. Before using Diazepam RecTubes®
3. How to use Diazepam RecTubes®
4. Possible side effects
5. How to store Diazepam RecTubes®
6. Further information
1. What Diazepam RecTubes® are and what they are
used for
The name of your medicine is Diazepam RecTubes®.
The active ingredient is diazepam. 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.
Diazepam RecTubes® are used in adults and children
above one year:
• to treat severe anxiety or agitation
• to treat epileptic and feverish convulsions (fits)
• to relieve muscle spasm
• before minor surgical or dental procedures
• in circumstances where a rapid effect is required
and where injection may be impracticable or
undesirable.
2. Before using Diazepam RecTubes®
You should not be given Diazepam RecTubes® if
you:
• are allergic (hypersensitive) to diazepam or any of
the other ingredients in Diazepam RecTubes® (see
section 6, Further information)
• suffer from sleep apnoea (stopping breathing during
sleep)
• suffer from severe breathing difficulties
• have severe liver problems
• suffer from any fears (phobias) or obsessions
• suffer from depression, with or without anxiety
• are suffering and being treated for any long
standing mental illness
• have experienced recent loss or bereavement.

• medicines used to treat stomach ulcers (e.g.
cimetidine, omeprazole)
• medicines used to treat epilepsy (e.g. phenytoin,
carbamazepine).
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant
or breast-feeding unless your doctor specifically
recommends you to.
If you are using this medicine and planning to get
pregnant or think you are pregnant speak to your
doctor immediately.
Driving and using machinery
Diazepam RecTubes® may affect your muscles or
make you feel sleepy or forgetful (especially if you
don’t have enough sleep). If you are affected in this
way, do not drive or use any tools or machinery.
Important information regarding some of the
ingredients in Diazepam RecTubes®
Diazepam RecTubes® contains Benzoic acid and
sodium benzoate which may cause mild irritation to
the skin, eyes and mucous membrane.
The propylene glycol may cause skin irritation.
Diazepam RecTubes® contains alcohol and diazepam,
so you should not drink alcohol as sedation may be
enhanced.
3. How to use Diazepam RecTubes®
This medicine is for rectal use only.
The tubes are for single use only.
Always use Diazepam RecTubes® as your doctor has
told you. Your doctor will decide the right dose for you
according to your weight, age and state of health. The
dose will be on the pharmacist’s label.
This medicine is not to be used in children under
one year old.
Children above 1 year old:
the usual dose is 0.5mg/kg.
Adults:
• the usual dose is 0.5mg/kg body weight
• 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 period during which the dose will be
reduced gradually.
Step by step instruction on how to administer the
Diazepam RecTubes®:
1. If possible, turn adults to lie on their side, or front
for a child.
2. Tear open the foil pack
3. Remove the tube cap

Diazepam RecTubes® should not be given to patients
who are in a coma, or used to treat anxiety in children
without careful prior assessment.
If you are elderly or severely unwell speak to your
doctor first before using Diazepam RecTubes®.
Talk to your doctor or pharmacist before using
Diazepam RecTubes® if you:
• suffer from any kidney or liver disease
• suffer from severe muscle weakness (myasthenia
gravis)
• suffer from a rare blood disorder (porphyria)
• have difficulty with breathing
• suffer from poor blood supply to the brain or any
brain damage
• suffer from any kind of personality disorder
• have suicidal tendencies
• are prone to aggressive outbursts harming either
yourself or others
• have had problems with addiction to drugs or
alcohol
• currently smoke or drink alcohol.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
The following medicines can affect or can be affected
by Diazepam RecTubes®:
• medicines used to reduce pain (e.g. codeine)
• medicines used before surgery (anaesthetics)
• medicines used to treat depression (e.g.
fluvoxamine)
• medicines used to treat mental illness (e.g.
clozapine, zotepine)
• medicines used to treat bacterial infection (e.g.
erythromycin, isoniazid, rifampicin)
• medicines used to treat hayfever or other allergic
conditions
• medicines used to treat high blood pressure (e.g.
moxonidine)
• medicines used to treat viral infections (e.g.
amprenavir and ritonavir)
• medicines used to treat anxiety (e.g. other drugs of
benzodiazepine group)
• medicines used for asthma and bronchitis (e.g.
theophylline)
• oral contraceptives
• medicines used to treat heart failure (e.g. digoxin)
• medicines used to treat alcohol dependence (e.g.
disufiram)
• medicines used to treat heroin withdrawal (e.g.
lofexidine)
• medicines used to treat vomiting due to cancer
therapy (e.g. nabilone)
• medicines used to treat parkinsons disease (e.g.
levodopa)
• medicines used to relax the muscles (e.g. baclofen,
tinidazine)

4. Insert the nozzle completely into the rectum,
pointing it downwards
NOTE: In children under 15kgs (33 lbs) insert the
nozzle only half way

5. Empty the tube by pressing firmly between the
thumb and index finger

6. Keep the tube completely pressed together until
you have withdrawn it out of the rectum.
Note: A small amount of the solution is intended to be
left in the tube after the dose is given.
7. Maintain the patient’s position and hold the
buttocks together for a few minutes to prevent
seepage

If you accidentally insert too much of the
medicine
If you (or anybody else, including a child) has
accidentally had an overdose of this medicine, then
you should contact your nearest hospital casualty
department or your doctor immediately. Always take
the container and this leaflet with you.
The symptoms of mild overdose may include
confusion, loss of consciousness with a sleep-like
state, abnormally slow breathing, slurred speech,
difficulty in controlling movements, loss of muscle
co-ordination, difficulty in breathing, low blood
pressure and muscular weakness.
The symptoms of severe overdose include deep
coma and severe depression of breathing.
Stopping Diazepam Treatment
If Diazepam RecTubes® are given continuously for
too long, there is a risk of becoming dependent on
diazepam or developing withdrawal symptoms when
stopped or “rebound phenomenon” whereby the
problem for which you were being treated recurs.
You should not stop the treatment suddenly and
it is recommended that the dose is decreased
gradually.
4. Possible side effects
Like all medicines, Diazepam RecTubes® can cause
side effects in some patients, especially the elderly,
although not everybody gets them.
As can happen with any medicine, a few people may
develop an allergic reaction. If you experience any of
the following, tell your doctor immediately:
• Rash, itching, swelling of the face and eyes,
difficulty breathing.
• If you feel restless, have nightmares or notice
behavioural changes after applying Diazepam.
• Blood disorders (you may develop a sore throat,
nose bleeds or infections).
• Chest pain, slow pulse, slow heart rate, stopping
breathing during sleeping, yellow skin (jaundice).
Rarely instead of feeling sleepy, opposing effects may
be seen in some patients especially in children or
elderly which include aggressive behaviour, irritability,
over excitement, increased anxiety, feeling “high” and
difficulty sleeping.
Tell your doctor or pharmacist if you notice any of
the following side effects or notice any other effects
not listed:
• drowsiness
(feeling sleepy)
• dizziness
• muscle weakness
• slurred speech
• low blood pressure
• trembling hands
• problems with vision
• dry mouth
• changes in sexual
desire
• fatigue or tiredness
• enlargement of
breasts in males
• headache with
hangover effect

• forgetfulness
• difficulty in controlling
movements
• loss of coordination or
reduced alertness
• confusion
• increased liver enzymes
• loss of memory with
inappropriate behaviour
• stomach or bowel upset
• problems in passing urine
• inability to control flow of
urine (incontinence)
• difficulty in breathing
• skin rash or other
allergic symptoms.

Withdrawal symptoms often include anxiety,
depression, loss of concentration, sleeplessness,
headache, dizziness, ringing noise in the ears, loss
of appetite, trembling hands, perspiration, irritability,
nausea, vomiting, abdominal cramps, abnormal heart
rate.

Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road
North, Wrexham LL13 9UF, UK.
Other formats: To listen to or request a copy of this
leaflet in Braille, large print or audio please call, free
of charge:
0800 198 5000 (UK Only). Please be ready to give
the following information:
Product name

Reference number

Diazepam RecTubes
2.5mg in 1.25ml Rectal
Solution

29831/0067

Diazepam RecTubes
5mg in 2.5ml Rectal
Solution

29831/0068

Diazepam RecTubes
10mg in 2.5ml Rectal
Solution

29831/0066

This is a service provided by the Royal National
Institute of Blind People.
Leaflet Prepared: October 2011
Common questions and answers
1. How long does it take to work?
Usually it works within 10 minutes.
2. What if I give it and there’s no change?
Your doctor would have told you what to do in
these circumstances. If you are in doubt talk to
your doctor.
3. What if I can’t turn the patient on his/her side?
Under these circumstances it may be more difficult
to administer Diazepam RecTubes®. If you think
this may be a problem we recommend that you
consult the doctor.
4. Do I need to lubricate the tube?
No, the plastic is very smooth and designed to be
used without lubrication.
5. Can I give less than the whole tube to see what
happens?
The whole dose should be given as prescribed.
6. Why do I have to maintain pressure on the
tube?
To avoid the solution being sucked back into the
tube as it is being withdrawn.
7. What if the solution leaks out of the patient’s
bottom?
If you hold the patient’s buttocks together for a few
minutes keeping the patient in the same position,
this should not happen.
8. What if I find there is some solution left in the
tube afterwards?
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 that you
consult the doctor.
9. Will I hurt the patient?
No, using Diazepam RecTubes® should not hurt
the patient.

As can happen with any medicine, a few people may
develop an allergic reaction. A severe form of allergic
reaction (anaphylactic shock) is extremely rare but
should be treated immediately.

10. How important is it to point the tube
downwards?
Emptying the tube is easiest when pointing
downwards. It is possible to empty it at other
angles but this is usually more difficult.

If you experience any side effects not mentioned here
or feel that the medicine is affecting you badly tell
your doctor or pharmacist immediately.

11. Why do I have to keep the tube in the foil?
Diazepam RecTubes® have a shelf life of 36
months in the foil bag.

5. How to store Diazepam RecTubes®
Keep out of the reach and sight of children.
Diazepam RecTubes® should be stored at room
temperature (below 25°C). Store in the original
container to protect from light; do not transfer
to another container. Once foil is opened use
immediately.
Do not use Diazepam RecTubes® after the expiry
date which is stated on the tube and the carton.
The expiry date refers to the last day of that 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 protect the environment.
6. Further information
What Diazepam RecTubes® contains:
The active ingredient is: diazepam
The other ingredients are: benzoic acid (E210), benzyl
alcohol, sodium benzoate (E211), ethanol, propylene
glycol and purified water.
What Diazepam RecTubes® look like and the
contents of the pack
The pack consists of 2 or 5 white polythene rectal
tubes wrapped individually in alufoil packs and
placed in an outer carton. The tubes have a nozzle
attached for application. The rectal solution is a clear,
colourless or almost yellow solution.
Diazepam RecTubes® are available in the following
strengths:
Diazepam RecTubes 2.5mg in 1.25ml (2mg/ml)
Diazepam RecTubes 5mg in 2.5ml (2mg/ml)
Diazepam RecTubes 10mg in 2.5ml (4mg/ml)

12. Do I need to keep Diazepam RecTubes® in the
fridge?
No, they can be stored at room temperature (but
not above 25ºC).

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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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