
Format: 200 x 420 mm – Laetus-Code: 1461 – Schrift: 9 p PROOF
PACKAGE LEAFLET: INFORMATION FOR THE USER
Diazepam 5 mg rectal solution
Diazepam 10 mg rectal solution
Diazepam
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 using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
What is in this leaflet
1. What Diazepam is and what it is used for
2. What you need to know before you use
Diazepam solution
3. How to use Diazepam solution
4. Possible side effects
5. How to store Diazepam solution
6. Contents of the pack and other 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. What you need to know before you use
Diazepam solution
Do not use Diazepam solution
• if you are allergic to diazepam or any of the
other ingredients of this medicine (listed in
section 6). An allergic reaction may include
rash, itching, difficulty of breathing or swelling
of the face, lips, throat or tongue.
• if you have myasthenia gravis (very weak
muscles).
• if you suffer from sleep apnoe (temporary
stopping of breathing during sleep).
• if you have a severe liver disorder.
• if you have a severe breathing disorder.
Diazepam should not be used for premature
babies.
Warnings and precautions
Talk to your doctor before using Diazepam solution
• if you have a kidney or liver disorder.
• if you have a breathing disorder.
• if you have a poor blood supply to the brain
or any brain damage.
• if you have a history of alcohol or drug
abuse.
• if you are suffering from mental illness
(such as depression, phobia or obsession).
Patients in shock may be treated with Diazepam
only if measures are concurrently undertaken to
correct the volume deficiency.
Diazepam solution should not be taken at the
same time as alcohol and/or medicines with a
depressant effect on the central nervous system.
If taken at the same time, the effect of Diazepam
can be enhanced and may lead to unconsciousness
and depression of the cardiovascular function
and/or breathing, requiring emergency treatment.
If you received Diazepam for e.g. minor surgical or
dental procedures, you should only go home
accompanied by someone else.
Development of tolerance
Following repeated use of Diazepam solution over
a few weeks, there may be a loss of effectiveness
(due to the development of tolerance to the
hypnotic effect of benzodiazepines).
Development of dependence
Diazepam solution is an addictive medicine
(primary dependence potential). Diazepam solution
may cause dependence, even at therapeutic
dosages. The risk of dependence increases with
dose and duration of treatment; it is also greater
in patients with a history of alcohol or drug abuse.
Therefore, you should use Diazepam solution for
as short period of time as possible.
Discontinuation of therapy/withdrawal symptoms
Once physical dependence has developed, abrupt
termination of treatment will be accompanied by
withdrawal symptoms. These may consist of
increased dreaming, sweating, trembling,
headaches, muscle pain, extreme anxiety, mood
swings, tension, restlessness, confusion and
irritability.
In severe cases, the following symptoms may
occur: impaired self-perception or perception of
one’s surroundings (derealization, deperso-
nalization), confusional state, hypersensitivity to
light, noise (hyperacusis) and physical contact,
numbness and tingling of the extremities,
hallucinations or epileptic seizures.
The symptoms that led to treatment with Diazepam
solution may recur in an enhanced form on
withdrawal of treatment. Since the risk of
withdrawal phenomena is greater after abrupt
discontinuation of treatment, it is recommended
that the dosage is decreased gradually.
Memory disorder
Diazepam may cause short-term memory loss
(anterograde amnesia) using therapeutic dosages.
For example, this means that you may no longer
be able to recall actions you carried out after using
Diazepam solution. The condition occurs often
several hours after administration of the medicinal
product. This risk increases with the dosage level
and can be reduced by a sufficiently long,
uninterrupted duration of sleep (7-8 hours).
Psychological and “paradoxical” reactions
Reverse effects such as restlessness, agitation,
irritability, aggressive behaviour, nightmares,
hallucinations, delusions, rages, inappropriate
behaviour and other behavioural disorders or
abnormal condition of the mind (psychosis), may
occur when using benzodiazepines, especially in
elderly patients or children (see section 4). In such
cases, treatment with Diazepam solution should
be discontinued.
Psychoses
Diazepam is not recommended for the primary
treatment of mental and psychiatric disorders
(psychotic illness).
Depression
Diazepam should not be used alone to treat
depression or states of anxiety that occur in
association with depression. In some circum-
stances, the clinical symptoms of depression may
be aggravated (risk of suicide).
The application without medical advice by a doctor
will reduce the opportunity that this medicine will
help you. At the latest after four weeks of use, your
doctor will decide whether your treatment should
be continued. Do not increase in any case your
prescribed dose, even if the effect ceases. The
aimed treatment is complicated by arbitrary
increase of dosage.
Do not use benzodiazepines because they help
others so good.
Children and adolescents
Diazepam should only be given to children and
adolescents if a doctor thinks this is necessary
and any treatment should be kept to a minimum.
Elderly patients
Elderly should be given a reduced dose (see
section 3). Caution is advised in elderly patients
due to the risk of falling and consequently
fractures, particularly when getting up at night
(see section 4). Falling may occur because of the
muscle relaxing effect of diazepam.
Specific patient groups
A lower dose is recommended for patients with
chronic respiratory insufficiency due to the risk of
respiratory depression. It is also recommended
that debilitated patients and those with hepatic
and renal impairment should receive a reduced
dose and special caution is advisable (see section
3). Benzodiazepines are not indicated to treat
patients with severely impaired liver function as
they may precipitate brain disorder
(encephalopathy).
High-risk patients
Benzodiazepines should be used with extreme
caution in patients with a history of alcohol or drug
abuse.
Other medicines and Diazepam solution
Tell your doctor or pharmacist if you are using,
have recently used, or might use any other
medicines. This is especially important for 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,
such as fluvoxamine, fluoxetine)
• narcotic analgesics (strong painkillers)
• anaesthetics
• antiepileptics (treatments for epilepsy, e.g.
phenytoin, phenobarbital)
• sedative antihistamines (treatments for allergies
that make you sleepy)
• pain killers, e.g. buprenorphine
• azole antimycotics, used to treat fungal
infections (itraconazole, ketoconazole,
fluconazole, voriconazole)
• HIV protease inhibitors which are used to treat
HIV infection
• 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)
• sodium oxybate (used to treat narcolepsy)
• St. John's wort (used to treat depression)
Concomitant use of Diazepam solution and opioids
(strong pain killers, medicines for substitution
therapy and some cough medicines) increases the
risk of drowsiness, difficulties in breathing
(respiratory depression), coma and may be life-
threatening. Because of this, concomitant use
should only be considered when other treatment
options are not possible.
However, if your doctor does prescribe Diazepam
solution together with opioids the dose and
duration of concomitant treatment should be
limited by your doctor.
Please tell your doctor about all opioid medicines
you are taking, and follow your doctor's dose
recommendation closely. It could be helpful to
inform friends or relatives to be aware of the signs
and symptoms stated above. Contact your doctor
when experiencing such symptoms.
Nicotine (e.g. smoking) may reduce the efficacy
(effectiveness) of Diazepam solution.
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.
Diazepam solution with alcohol
Do not drink alcohol while you are using Diazepam.
Alcohol may increase the sedative effects of
Diazepam and make you very sleepy.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
Pregnancy
You should not use this medicine if you are
pregnant unless your doctor tells you to use it. Tell
your doctor straight away if you think you may be
pregnant.
There may be a slight increase in abnormalities,
particularly hare lip, in babies born to mothers
given benzodiazepines during pregnancy. Babies
exposed to overdoses of benzodiazepines during
pregnancy may be slow developers, may have eye
movement disorders (nystagmus) or congenital
abnormalities. If you use Diazepam during
pregnancy over a longer period or in high doses,
your newborn may suffer from withdrawal
symptoms. If you have received Diazepam towards
the end of pregnancy or during labour, the baby
may be affected, with feeling cold, floppiness,
difficulty breathing and poor suckling (so-called
"floppy infant syndrome").
Breast-feeding
Do not use Diazepam during lactation because it
enters the breast milk. For this reason, if Diazepam
therapy is essential, breast-feeding should be
terminated in order to avoid side effects in the
breast-fed infant.
Driving and using machines
You must 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.
This medicine can affect your ability to drive as it
may make you sleepy or dizzy.
• Do not drive while using 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:
– the medicine has been prescribed to treat a
medical or dental problem and
– you have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and
– it was not affecting your ability to drive safely.
Diazepam 10392713-GB MASTER.indd 1 17.06.19 08:35