DIAZEPAM DESITIN 5MG RECTAL SOLUTION

Active substance: DIAZEPAM

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Format: 180 x 210 mm – Laetus-Code: 261 – Schrift: 7 p

UK/H/0126/01-02

Leaflet mock-up Diazepam rectal solution 5/10 mg 11/2012

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Diazepam 5mg / 10mg rectal solution
The name of your medicine is Diazepam rectal solution,
which will be referred to as ‘Diazepam’ or ‘Diazepam
solution’ throughout this leaflet.
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 gets 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 is and what it is used for
2. Before you use Diazepam
3. How you use Diazepam
4. Possible side effects
5. How to store Diazepam
6. Further information
1. WHAT DIAZEPAM IS AND WHAT IT IS USED FOR
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 is used:
to
•  control epileptic or febrile convulsions (fits)
for
•  sedation before minor surgical or dental
procedures
for
•  muscle spasms in tetanus
for
•  severe, disabling, or extremely distressing anxiety
or agitation
Diazepam solution may be used as above when an
injection is not practical or not wanted.
Diazepam solution may be useful for the immediate
treatment of convulsions in children.
2. BEFORE YOU USE DIAZEPAM
Do not use Diazepam solution if:
you
•  are allergic (hypersensitive) to diazepam or
any of the other ingredients of Diazepam solution (see
list of ingredients in Section 6). An allergic reaction
may include rash, itching, difficulty of breathing or
swelling of the face, lips, throat or tongue.
you
•  have myasthenia gravis (very weak muscles)
•  suffer from sleep apnoe (temporary stopping
you
of breathing during sleep)
you
•  have a severe liver disorder
you
•  have a severe breathing disorder
Diazepam should not used for premature babies
• 
Take special care with Diazepam solution
(and talk to your doctor) if you:
have a kidney or liver disorder
• 
have a breathing disorder
• 
• 
have glaucoma (high pressure in the eye)

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• 
have a poor blood supply to the brain or any
brain damage
have a history of alcohol or drug abuse
• 
are
•  suffering from mental illness
Diazepam should only be given to children if a doctor
thinks this is necessary and any treatment should be
kept to a minimum.
Withdrawal symptoms
The dependence potential of diazepam is low when
limited to short-term use. However, withdrawal symptoms
might be experienced including headaches, muscle pain,
extreme anxiety, tension, restlessness, confusion and
irritability. In severe cases, the following symptoms may
occur: derealization (the world feels unreal),
depersonalization (feeling detached from your body),
hyperacusis (sensitivity to sound), numbness and
tingling, sensitivity to light, voices or physical contact,
hallucinations, epileptic fits, mood changes, an­ iety or
x
sleep disturbances and restlessness.
Reducing the dose gradually can help prevent any
withdrawal effects. Diazepam solution may not be as
effective after repeated use for a few weeks.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or
have recently taken, any other medicines, including
m
­ edicines obtained without a prescription. This is
especially important of the following medicines as they
may interact with Diazepam solution:
antipsychotics (treatments for mental illness)
• 
anxiolytics (treatments for anxiety)
• 
sedatives or hypnotics (e.g. sleeping pills)
• 
antidepressants (treatments for depression)
• 
narcotic analgesics (strong painkillers)
• 
anaesthetics
• 
• 
antiepileptics (treatments for epilepsy, e.g. phenytoin)
sedative antihistamines (treatments for allergies that
• 
make you sleepy)
isoniazid (for tuberculosis – TB)
• 
disulfiram (for treatment of alcoholism)
• 
cimetidine, omeprazole (drugs for heartburn and ulcers)
• 
oral
•  contraceptives (e.g. ‘The Pill’)
muscle relaxants
• 
rifampicin (an antibiotic)
• 
theophylline (tablets for asthma)
• 
levodopa (for Parkinson’s disease)
• 
Nicotine (e.g. smoking) may reduce the efficacy
(effectiveness) of Diazepam solution

Driving and using machines
You should not drive or use machines until 24 hours after
the last dose. After 24 hours, if you still feel sleepy or find
it hard to concentrate, if you notice muscle weakness or
episodes of memory loss you should not drive or operate
machines and tell your doctor.
Important information about some of the
ingredients of Diazepam solution
Diazepam solution contains Benzoic acid (E210) and
sodium benzoate (E211). These may irritate the skin,
eyes, nose and throat and may also increase the risk of
jaundice (yellow skin) in newborn babies.
HOW YOU USE
3. 
DIAZEPAM RECTAL SOLUTION
Dosage
Always use Diazepam solution exactly as your doctor has
instructed you. You should check with your doctor or
pharmacist if you are unsure. The usual dose is 0.25 –
0.5mg/kg (body weight). The dose also depends on the
patient's age and health. Diazepam is for use in adults
and children (weighing more than 10kg).
The recommended dose would be normally:
for
•  children between 1 and 3 years (10 – 15kg):
one 5mg tube
for
•  children over 3 years (more than 15kg):
one 10mg tube
for
•  adults: two 10mg tubes
Diazepam solution is for use in emergency cases.
They are not intended for long-term use. If it becomes
necessary, the dose may be repeated every 12 hours. If
convulsions (fits) are still not controlled the doctor should
be contacted.
The tubes containing Diazepam solution are for
rectal (into the anus) and single use only. Treatment
should be as short as possible. The lowest dose that can
control the symptoms should be used. If used
continuously for too long, there is a risk of becoming
dependent on diazepam or of having problems when
stopping it.
If no effect is seen after 10 minutes, the dose can be
repeated in children or an additional 10mg tube given to
adults.
Elderly and debilitated patients or those with liver
or kidney dysfunction may need a reduced dose.

It may still be all right for you to be given Diazepam and
your doctor will be able to decide what is suitable for you.
Using Diazepam solution with food and drink
Using alcohol may interact also with Diazepam solution
by increasing the sedative (calming) effects of diazepam.
Pregnancy and breast-feeding
You should not use Diazepam if you are pregnant, think
you may be pregnant or if you are breast-feeding an
infant unless your doctor tells you to. Ask your doctor or
pharmacist before taking any medicine.

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Format: 180 x 210 mm – Laetus-Code: 261 – Schrift: 7 p

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Leaflet mock-up Diazepam rectal solution 5/10 mg 11/2012

How to use Diazepam solution

If you take more Diazepam solution than you
should
If you have taken more Diazepam solution than you
should, talk to a doctor or pharmacist immediately.
Symptoms of overdose include drowsiness, mental
confusion and lethargy (a drowsy dullness).
In serious cases, symptoms include low blood pressure,
shallow breathing, co-ordination problems, floppiness,
coma (rare) and death (very rare).

I
1. f possible, turn patient on side, or front for a child.
T
2.  ear open the foil back.
R
3.  emove the tube cap.

If you stop taking Diazepam solution
Since the risk of withdrawal phenomena/rebound
phenomena is greater after abrupt discontinuation of
treatment, it is recommended that the dosage is
decreased gradually.

I
4. nsert the nozzle completely into the anus, pointing it
downwards.

Withdrawal symptoms include headaches, muscle pain,
extreme anxiety, tension, restlessness, confusion and
irritability. In severe cases, the following symptoms may
occur: derealization (the world feels unreal),
depersonalization (feeling detached from your body),
hyperacusis (sensitivity to sound), numbness and
tingling, sensitivity to light, voices or physical contact,
hallucinations, epileptic fits, mood changes, anxiety or
sleep disturbances and restlessness.

I
Note: n children under 15kg insert the nozzle only half
way.

If you have any further questions about the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Diazepam solution can cause side
effects, although not everybody gets them.

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

K
g
6.  eep the tube completely pressed to­ ether until
you have drawn it out of the rectum.
Note:  small amount of the solution is intended to be
A
left in the tube after the dose has been given.
K
7.  eep the patient’s position and hold the buttocks
together for a few minutes to prevent leakage.

All medicines can cause allergic reactions, although
serious allergic reactions are very rare. Tell your doctor
straight away if you get any sudden difficulty in
breathing, swelling of the eyelids, face or lips, rash
or itching (especially affecting your whole body).
The following side effects have been reported:
Common (between 1 and 10 patients out of 100):
Sedation, drowsiness, headaches, dizziness (with risk of
falls in the elderly), unsteadiness, slurred speech,
trembling hands, tiredness, hangover effect, seeing
double, muscle weakness, reduced alertness, numbed
emotions, confusion, and forgetfulness.
Also common are paradoxical reactions – instead of
feeling sleepy, some patients (particularly children or the
elderly) may feel agitated with a change in their
personality. Other symptoms are restlessness, changing
mood, rage, delusions (irrational ideas), nightmares or
hallucinations (sensing things that are not real).
Rare (between 1 and 10 patients out of 10000):
Low blood pressure, slow pulse, chest pain, blood cell
changes, eye changes, Dry mouth, Nausea (feeling sick),
vomiting (being sick), epigastric pain (heartburn/

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indigestion), obstipation (severe constipation), diarrhoea,
jaundice (yellow skin), problems in passing water,
changes in sexual desire, problems with periods, spasm
of the ­ irway, difficulty with breathing, apnoea (temporary
a
s
­ topping of breathing), increased appetite.
Very rare (less than 1 patient out of 10000):
Skin rashes.
Diazepam solution may cause dependence, even at
t
­herapeutic dosages. Stopping treatment may cause
withdrawal effects. In some patients, depression may
occur.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. 
HOW TO STORE
DIAZEPAM RECTAL SOLUTION
Diazepam solution should be kept out of the reach and
sight of children.
Store below 25°C. Do not use after the expiry date ­ tated
s
on the package.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicine no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Diazepam solution contains:
The active substance is diazepam. The other ingredients
are: benzyl alcohol, ethanol 96%, propylene glycol,
benzoic acid, sodium benzoate and purified water
What Diazepam solution looks like and contents
of the pack
Diazepam Rectal Solution is a clear, colourless or slightly
yellowish solution in a white polythene tube.
Pack of 5 rectal tubes. Each tube contains 2.5ml solution
of diazepam 5mg or 10mg.
Marketing Authorisation Holder and Manufacturer
Desitin Arzneimittel GmbH
Weg beim Jäger 214
D-22335 Hamburg
Germany
Fax: +49 4059101 433

This leaflet was last revised in
11/2012

11/12  10392711-GB

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Diazepam 10392711-GB

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S-00-0013

DDRT 5/10 mg
08.11.12 14:04

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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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