DIAZEPAM ORAL SOLUTION BP 2MG/5ML

Active substance: DIAZEPAM

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Diazepam oral solution 2mg/5ml
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 oral solution is and
what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

• have a phobia or other mental illness or
are hyperactive
• breathing problems, which may be severe,
including slow and/or shallow breathing
• have myasthenia gravis (a condition which
causes muscles to weaken and tire easily)
• suffer from sleep apnoea (a sleep disorder
where you have abnormal pauses in
breathing during sleep)
• have severe liver disorders
• have porphyria (an inherited condition
causing skin blisters, abdominal pain and
brain or nervous system disorders)
• planning a pregnancy or are pregnant (see
below ‘Pregnancy and breast-feeding’).
Check with your doctor or pharmacist
before taking Diazepam oral solution if you
have
• a history of alcoholism or drug abuse.
• problems with your heart and lungs or
1.  hat Diazepam oral solution is
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have kidney or liver disease
and what it is used for
• someone close to you that has recently died
Diazepam belongs to a group of medicines
• are elderly Diazepam tablets can cause
called benzodiazepines. Diazepam helps in
confusion and have effects on muscles
the treatment of anxiety, muscle spasms and
causing falls and injuries.
convulsions (fits). It is used to treat:
• have breathing problems
• have suicidal thoughts
In adults
• have epilepsy or a history of seizures
• short term relief (14 days) of severe anxiety
• ow blood levels of a protein called albumin
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and may occur alone or with insomnia
(trouble sleeping) or mental health problems • a personality disorder
• a poor blood supply to the brain
• cerebral palsy
(arteriosclerosis)
• muscle spasm caused by tetanus (when
•  epression (with or without anxiety)
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taken with other medicines)
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• epilepsy (when taken with other medicines) • moke
• patients with the symptoms of alcohol
Other considerations
withdrawal
•  ental side effects – contact your doctor if
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• helping to relax nervous dental patients.
you experience side effects such as agitation,
hyperactivity, restlessness, aggressiveness,
In children
nightmares or hallucinations. These side
• tension and irritability caused by cerebral
effects are more likely to occur in children or
spasticity
the elderly.
• helping to relax and cause sleepiness before
•  mnesia (total or partial memory loss) –
A
an operation.
you could experience amnesia when taking
2. Before you take
this medicine. Amnesia is more likely to occur
Do not take Diazepam oral solution and tell
when taking high doses of diazepam.
your doctor if you
•  ependence – when taking this medicine
D
• are allergic (hypersensitive) to diazepam,
there is a risk of dependence, which increases
benzodiazepine medicines, or to any of the
with the dose and duration of treatment and
other ingredients in Diazepam oral solution
also in patients with a history of alcoholism
(see section 6)

and drug abuse. Therefore, you should take
Diazepam tablets for as short period of time
as possible.
• olerance – if after a few weeks you notice
T
that the tablets are not working as well as
they did when first starting treatment, you
should go and see your doctor.
•  ithdrawal – treatment should be
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gradually withdrawn. Withdrawal symptoms
occur with Diazepam tablets even when
normal doses are given for short periods of
time. See Section 3, ‘If you stop taking
Diazepam’.
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. Especially:
•  ntidepressants (e.g. fluvoxamine,
a
fluoxetine)
•  ntipsychotics such as clozapine (to treat
a
mental problems)
•  ntihistamines (to treat allergies)
a
•  eneral anaesthetics
g
• edatives (used to give calming effects)
s
•  ypnotics (to help you sleep)
h
•  rythromycin (an antibiotic)
e
•  uscle relaxants (e.g. suxamethonium,
m
tubocurarin)
• some strong pain killers such as
morphine (opioids) may give you a
heightened sense of well being when taken
with diazepam, which can increase your
desire to continue taking these medicines
(dependency) or can make you very sleepy.
• barbiturates such as phenobarbital (to treat
epilepsy and mental disorders)
•  edicines to lower high blood pressure,
m
diuretics (water tablets), nitrates (for heart
conditions) as these could lower your blood
pressure too much.
•  ntacids (reduces stomach acid) may slow
a
down absorption of diazepam in the body.
Taking these medicines with diazepam could
affect your mental status, make you very
sleepy and suppress your breathing and blood
pressure.
•  isulfiram (to treat alcohol addiction).
d
Taking this medicine with diazepam
could make you very sleepy and can cause
diazepam to be removed from the body more
slowly than usual.

•  edicines for epilepsy e.g. phenobarbital,
m
phenytoin and carbamazepine, sodium
valproate, (diazepam can affect the blood
levels of these medicines). Diazepam can
furthermore affect how phenytoin works.
• heophylline (to treat asthma and other
t
breathing disorders), as it can weaken
the effect of diazepam. As this can cause
diazepam to be removed from the body more
quickly than usual.
• imetidine, omeprazole or
c
esomeprazole (stomach acid reducing
medicines), as these can cause diazepam to
be removed from the body more slowly than
usual.
• ifampicin, to treat infections (an antibiotic)
r
as this can cause diazepam to be removed
from the body more quickly than usual. The
effect of diazepam can be weakened.
•  mrenavir, atazanavir, ritonavir,
a
delavirdine, efavirenz, indinavir,
nelfinavir or saquinavir (antivirals),
fluconazole, itraconazole, ketoconazole
or voriconazole (anti-fungal medicines)
as these can cause diazepam to be removed
from the body more slowly than usual and
therefore increase the risk of side effects. As
these can make you feel sleepy for longer or
cause difficulty breathing.
• soniazid (used to treat tuberculosis), as it
i
can cause diazepam to be removed from the
body more slowly than usual.
•  ral contraceptives, as they can slow
o
down the removal of diazepam from the
body and increase its effect. Breakthrough
bleeding can occur when taking diazepam
and oral contraceptives together, but the
contraceptive protection is not reduced.
• isapride (used to treat stomach problems),
c
as it can cause diazepam to be removed from
the body more slowly than usual.
• orticosteroids (medicines used to treat
c
inflammation in the body) as they can
weaken the effect of diazepam.
• evodopa (used to treat Parkinson’s disease).
l
Diazepam can reduce the effect of levodopa.
• alproic acid (used to treat epilepsy and
v
mental disorders) as it can slow down the
removal of diazepam from the body and
increase its effect.
• etamine (an anaesthetic) as diazepam
k
increases the effect of ketamine.

• ofexidine (to help relieve symptoms when
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you stop taking opioids)
•  abilone (to treat nausea and vomiting)
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•  lpha blockers or moxonidine (to lower
a
high blood pressure)
Taking Diazepam oral solution with food
and drink
Do not drink alcohol while you are taking
Diazepam oral solution. Alcohol may increase
the sedative effects of Diazepam oral solution
and make you very sleepy.
Grapefruit juice may increase the amount of
diazepam in your blood. If you are elderly,
suffer from cirrhosis or any of the conditions
listed in section 2, this could possibly increase
the sedative effects of Diazepam oral solution
and you should speak to your doctor or
pharmacist.
Drinks containing caffeine may reduce the
effects of diazepam.
Pregnancy and breast-feeding
You should not take Diazepam oral solution
if you are pregnant, planning to become
pregnant or are breast feeding. If you take
Diazepam oral solution late in pregnancy or
during labour your baby might have a low
body temperature, floppiness, and breathing
difficulties. If taken regularly during late
pregnancy, your baby may develop withdrawal
symptoms. Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Diazepam oral solution can make you sleepy,
forgetful, have poor co-ordination along with
other side effects that can affect everyday
activities (see Possible side effects). You should
not drive, operate machinery or take part in
such activities where, if affected, you could put
yourself or others at risk.
The 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:
- 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

Specific patient groups
• lderly or frail: you are likely to be more
E
sensitive to the effects of Diazepam oral
solution, especially sedation, drowsiness and
confusion. Your doctor will give you much
lower doses, this should not be more than
half the adult dose.
•  reathing difficulties: you may be given a
B
lower dose.
If you take more Diazepam oral solution
than you should
If you (or someone else) swallow a lot of
Diazepam Oral Solution, or you think a child
may have swallowed any, contact your nearest
hospital casualty department or tell your
doctor immediately. Signs of an overdose
include clumsiness and loss of coordination,
feeling sleepy or deep sleep, speech problems,
irregular or slow heartbeat, uncontrolled eye
3. How to take
movement, muscle weakness or excitement.
Always take Diazepam oral solution exactly as An extreme overdose may lead to coma
your doctor has told you. You should not take (unrousable unconsciousness), reflex problems
Diazepam oral solution for longer than 4 and breathing difficulties.
weeks. You should check with your doctor or
If you forget to take Diazepam oral
pharmacist if you are not sure.
solution
You should make sure you are able to have 7-8 Do not take a double dose to make up for a
hours of uninterrupted sleep.
forgotten dose. If you forget to take a dose take
Doses
it as soon as you remember it and then take the
Adults
next dose at the right time.
• Anxiety or mental health problems: 2mgIf you stop taking Diazepam oral solution
30mg each day, in divided doses
• Do not stop taking your medicine without
• Insomnia: 5mg-30mg at bedtime
telling your doctor as he may gradually
• Cerebral palsy: 2mg-60mg each day, in
reduce your dose before stopping it
divided doses
completely. If stopped suddenly, you may
• Other spasticities: 5mg-60mg each day, in
have unpleasant side effects including
divided doses
headaches, muscle pain, extreme
• To control muscle spasm: 2mg-15mg each
anxiety, tension, restlessness, confusion
day, in divided doses
and irritability. In severe cases you may
• Epilepsy as a premedication: 2mg-60mg per
experience depersonalisation (feeling that
day, in divided doses
your mind is becoming separated from your
• Epilepsy: 5mg-20mg daily
body), derealisation (feeling that the world
• Alcohol withdrawal symptoms: 5mg-20mg,
around you is not real), abnormally acute
which may be repeated after 2 to 4 hours if
hearing or painful sensitivity to sound,
necessary
numbness and tingling in arms and legs,
• Before dental treatment: 5mg the night
over sensitivity to light, noise and physical
before treatment, 5mg on waking and 5mg
contact, seeing, hearing or feeling things that
two hours before the appointment
are not there (hallucinations) or fits.
Children
• Withdrawal symptoms include depression.
• Cerebral spasticity: 2mg-40mg each day, in
Withdrawal symptoms may occur between
divided doses
normal and high doses or if your doctor is
• For muscle spasm associated with tetanus,
switching you to another benzodiazepine.
the adult dose is usually given
• Epilepsy: 2mg-10mg daily
in the information provided with the
medicine and
- 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 while
taking this medicine.
Important information about some of the
ingredients of Diazepam oral solution
Diazepam oral solution contains 1.91g to
2.58g of sorbitol per 5ml solution. This may
have a mild laxative effect. If you have been
told that you have an intolerance to some
sugars, contact your doctor before taking
this medicine. This medicine also contains
propylene glycol which may cause alcohol-like
symptoms and glycerol, which may cause
headache, stomach upset and diarrhoea.

• Treatment should be gradually withdrawn
otherwise the symptoms being treated may
return more intense than before (rebound
insomnia and anxiety). Mood changes,
anxiety, restlessness or changes in sleep
patterns may also occur.

4. Possible Side Effects

Like all medicines, Diazepam oral solution can
cause side-effects, although not everybody
gets them.
Stop treatment and contact a doctor at
once if you have the following symptoms
of an allergic reaction e.g. itchy skin, rash,
sudden wheezing, swelling of the face, lips,
tongue or throat, or body, rash, fainting or
difficulty breathing or swallowing.
Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:
Some side effects can be serious and may
require immediate medical treatment:
Uncommon: affects 1 to 10 users in 1,000
• Respiratory depression (very slow and/or
shallow breathing)
Rare: affects 1 to 10 users in 10,000
• Respiratory arrest (cessation of breathing)
• Unconsciousness
• Jaundice (yellowing of your skin or the white
of your eyes)
Other side effects:
Very common: affects more than 1 user in 10
• Drowsiness
Common: affects 1 to 10 users in 100
• Fatigue
• Withdrawal symptoms (for possible
symptoms please see ‘If you stop taking
Diazepam tablets’ in Section 3)
• Confusion
• Loss of coordination of muscle movements
(ataxia) and other movement disorders,
tremor
Uncommon: affects 1 to 10 users in 1,000
• Muscle weakness
• Memory loss
• Difficulty in concentrating
• Balance disorders
• Dizziness
• Headache
• Slurred speech

• Stomach and intestinal problems such as
nausea, vomiting, constipation, diarrhoea
• Increased salivation (particularly in children)
• Allergic skin reactions in the form of itching,
skin redness and swelling and skin rash.
Rare: affects 1 to 10 users in 10,000
• Mental side effects such as excitation,
agitation, restlessness, irritability,
aggressiveness, memory loss, delusion, rages,
psychoses, nightmares or hallucinations. May
be or become serious. These side effects are
more likely to occur in children or the elderly.
Talk to your doctor.
• Decreased alertness
• Depression
• Emotional withdrawal
• Insomnia (problems sleeping)
• Heart problems such as slow heartbeat
(bradycardia), heart failure and cessation of
heartbeat (cardiac arrest).
• Low blood pressure, fainting (syncope)
• Increased mucus in the lungs (particularly in
children)
• Dry mouth
• Increased appetite
• Changes in certain liver enzymes as seen in
blood tests
• Lack of ability to urinate, loss of bladder
control (leakage of urine)
• Breast enlargement in men
• Impotence, changes in sexual drive (libido)
• Blood disorders (you may develop sore
throats, nose bleeds or infections)
Very rare: affects less than 1 user in 10,000
• Low levels of white blood cells (leukopenia)
• Higher level of a certain enzyme in the blood
(transaminase)
Not known: frequency cannot be estimated
from the available data
• Blurred vision, double vision and involuntary
eye movements (these side effects disappear
after you have stopped taking diazepam)
• emporary pause in breathing
T
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.
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

Keep out of the reach and sight of children.
Do not store above 25°C. Keep container
in the outer carton and keep the container
tightly closed.
Do not use Diazepam oral solution after the
expiry date stated on the label/carton/bottle.
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 to
protect the environment.

6. Further Information

What Diazepam oral solution contains
• The active substance (the ingredient that
makes the oral solution work) is diazepam.
Each 5ml spoonful contains 2mg of the active
ingredient.
• The other ingredients are docusate sodium,
magnesium aluminium silicate, propylene
glycol, raspberry flavour, saccharin sodium,
percol erythrosine (E127), sorbic acid (E200),
propyl hydroxybenzoate (E216), methyl
hydroxybenzoate (E218), sorbitol (E420),
glycerol (E422).
What Diazepam oral solution looks like
and contents of the pack
Diazepam oral solution is a pink syrup with an
odour of raspberries.
Pack sizes are 100ml.
Marketing Authorisation Holder and
Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK
Date of Revision: November 2014

Actavis, Barnstaple, EX32 8NS, UK
AAAG6980

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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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