Skip to Content

UK Edition. Click here for US version.

DIAZEPAM ORAL SOLUTION BP 2MG/5ML

Active substance(s): DIAZEPAM

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
• p roblems with your heart and lungs or have
What Diazepam oral solution is
1. 
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 oral solution can
called benzodiazepines. Diazepam helps in
cause 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
• low blood levels of a protein called albumin
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
• muscle spasm caused by tetanus (when taken (arteriosclerosis)
• depression (with or without anxiety)
with other medicines)
• epilepsy (when taken with other medicines) • smoke
• patients with the symptoms of alcohol
Other considerations
withdrawal
• Mental side effects – contact your doctor if
• 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
• Amnesia (total or partial memory loss) – you
an operation.
could experience amnesia when taking this
2. Before you take
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
• Dependence – when taking this medicine
• 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 oral solution for as short period of
time as possible.
• T olerance – if after a few weeks you notice
that the oral solution is not working as well
as it did when first starting treatment, you
should go and see your doctor.
•W
 ithdrawal – treatment should be
gradually withdrawn. Withdrawal symptoms
occur with Diazepam oral solution 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:
• a ntidepressants (e.g. fluvoxamine,
fluoxetine)
• a ntipsychotics such as clozapine (to treat
mental problems)
• a ntihistamines (to treat allergies)
• g eneral anaesthetics
• s edatives (used to give calming effects)
• h ypnotics (to help you sleep)
• e rythromycin (an antibiotic)
•m
 uscle relaxants (e.g. suxamethonium,
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.
• b arbiturates such as phenobarbital (to treat
epilepsy and mental disorders)
•m
 edicines to lower high blood pressure,
diuretics (water tablets), nitrates (for heart
conditions) as these could lower your blood
pressure too much.
• a ntacids (reduces stomach acid) may slow
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.
• d isulfiram (to treat alcohol addiction).
Taking this medicine with diazepam could
make you very sleepy and can cause diazepam
to be removed from the body more slowly
than usual.

• medicines for epilepsy e.g. phenobarbital,
phenytoin and carbamazepine, sodium
valproate, (diazepam can affect the blood
levels of these medicines). Diazepam can
furthermore affect how phenytoin works.
• theophylline (to treat asthma and other
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.
• cimetidine, omeprazole or esomeprazole
(stomach acid reducing medicines), as these
can cause diazepam to be removed from the
body more slowly than usual.
• rifampicin, to treat infections (an antibiotic)
as this can cause diazepam to be removed
from the body more quickly than usual. The
effect of diazepam can be weakened.
• amrenavir, atazanavir, ritonavir,
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.
• isoniazid (used to treat tuberculosis), as it
can cause diazepam to be removed from the
body more slowly than usual.
• oral contraceptives, as they can slow 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.
• cisapride (used to treat stomach problems),
as it can cause diazepam to be removed from
the body more slowly than usual.
• corticosteroids (medicines used to treat
inflammation in the body) as they can
weaken the effect of diazepam.
• levodopa (used to treat Parkinson’s disease).
Diazepam can reduce the effect of levodopa.
• valproic acid (used to treat epilepsy and
mental disorders) as it can slow down the
removal of diazepam from the body and
increase its effect.
• ketamine (an anaesthetic) as diazepam
increases the effect of ketamine.
• lofexidine (to help relieve symptoms when
you stop taking opioids)
• nabilone (to treat nausea and vomiting)

Diazepam 2mg 5ml Oral Solution PIL UK
item no:

AAAI7548

dimensions: 210 x 148

print proof no:

03

pharmacode:

origination date: 11.2.16
approved for print/date

min pt size:

• alpha blockers or moxonidine (to lower
high blood pressure)
• sodium oxybate, used to prevent episodes
of sudden onset of sleep (narcolepsy) with
muscle weakness. Enhanced effect of the
sodium oxybate when used in combination
with Diazepam.
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

colours/plates:
1. black
2.
3.
4.

7 pt

originated by:

db

revision date:

09-06-2016

Technical Approval

revised by:

NM

date sent:

supplier:

Pinewood

approved:

5.
6.

11.2.16

Non Printing Colours
1.
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

- 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
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.

• F or muscle spasm associated with tetanus, the
adult dose is usually given
• E pilepsy: 2mg-10mg daily
Specific patient groups
• E lderly or frail: you are likely to be more
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.
• B reathing difficulties: you may be given
a 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,
3. How to take
irregular or slow heartbeat, uncontrolled eye
Always take Diazepam oral solution exactly as movement, muscle weakness or excitement.
your doctor has told you. You should not take An extreme overdose may lead to coma
Diazepam oral solution for longer than 4 (unrousable unconsciousness), reflex problems
weeks. You should check with your doctor or
and breathing difficulties.
pharmacist if you are not sure.
If you forget to take Diazepam oral
You should make sure you are able to have 7-8 solution
hours of uninterrupted sleep.
Do not take a double dose to make up for a
Doses
forgotten dose. If you forget to take a dose take
Adults
it as soon as you remember it and then take the
• Anxiety or mental health problems: 2mgnext dose at the right time.
30mg each day, in divided doses
If you stop taking Diazepam oral solution
• Insomnia: 5mg-30mg at bedtime
• D o not stop taking your medicine without
• Cerebral palsy: 2mg-60mg each day, in
telling your doctor as he may gradually reduce
divided doses
your dose before stopping it completely. If
• Other spasticities: 5mg-60mg each day, in
stopped suddenly, you may have unpleasant
divided doses
side effects including headaches, muscle
• To control muscle spasm: 2mg-15mg each
pain, extreme anxiety, tension, restlessness,
day, in divided doses
confusion and irritability. In severe cases you
• Epilepsy as a premedication: 2mg-60mg per
may experience depersonalisation (feeling
day, in divided doses
that your mind is becoming separated from
• Epilepsy: 5mg-20mg daily
your body), derealisation (feeling that the
• Alcohol withdrawal symptoms: 5mg-20mg,
world around you is not real), abnormally
which may be repeated after 2 to 4 hours if
acute hearing or painful sensitivity to sound,
necessary
numbness and tingling in arms and legs, over
• Before dental treatment: 5mg the night
sensitivity to light, noise and physical contact,
before treatment, 5mg on waking and 5mg
seeing, hearing or feeling things that are not
two hours before the appointment
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
switching you to another benzodiazepine.

• 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 oral solution 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)
• Temporary pause in breathing
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

Diazepam 2mg 5ml Oral Solution PIL UK
item no:

AAAI7548

dimensions: 210 x 148

print proof no:

03

pharmacode:

origination date: 11.2.16
approved for print/date

min pt size:

By reporting side effects you can help provide
more information on the safety of this
medicine.

5. How to store

Keep out of the sight and reach 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,
aluminium magnesium silicate, propylene
glycol, raspberry flavour, saccharin sodium,
percol erythrosine (E127), sorbic acid (E200),
propyl parahydroxybenzoate (E216), methyl
parahydroxybenzoate (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: June 2016

Actavis, Barnstaple, EX32 8NS, UK
AAAI7548

colours/plates:
1. black
2.
3.
4.

7 pt

originated by:

db

revision date:

09-06-2016

Technical Approval

revised by:

NM

date sent:

supplier:

Pinewood

approved:

5.
6.

11.2.16

Non Printing Colours
1.
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

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
1. W
 hat Diazepam oral solution is and what it
is used for
Diazepam belongs to a group of medicines called
benzodiazepines. Diazepam helps in the treatment of
anxiety, muscle spasms and convulsions (fits). It is used to
treat:

In adults
• short term relief (14 days) of severe anxiety and may occur
alone or with insomnia (trouble sleeping) or mental health
problems
• cerebral palsy
• muscle spasm caused by tetanus (when taken with other
medicines)
• epilepsy (when taken with other medicines)
• patients with the symptoms of alcohol withdrawal
• helping to relax nervous dental patients.
In children
• tension and irritability caused by cerebral spasticity
• helping to relax and cause sleepiness before an operation.

2. Before you take

Do not take Diazepam oral solution and tell your doctor
if you
• are allergic (hypersensitive) to diazepam, benzodiazepine
medicines, or to any of the other ingredients in Diazepam
oral solution (see section 6)
• h ave a phobia or other mental illness or are
hyperactive
• b reathing 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’)..

• Amnesia (total or partial memory loss) – you could
experience amnesia when taking this medicine. Amnesia is
more likely to occur when taking high doses of diazepam.
• Dependence – when taking this medicine there is a risk of
dependence, which increases with the dose and duration of
treatment and also in patients with a history of alcoholism
and drug abuse. Therefore, you should take Diazepam oral
solution for as short period of time as possible.
• Tolerance – if after a few weeks you notice that the oral
solution is not working as well as it did when first starting
treatment, you should go and see your doctor.
• Withdrawal – treatment should be gradually withdrawn.
Withdrawal symptoms occur with Diazepam oral solution
even when normal doses are given for short periods of time.
See Section 3, ‘If you stop taking Diazepam’.

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 have kidney or
liver disease
• someone close to you that has recently died
• are elderly Diazepam oral solution can cause confusion and
have effects on muscles causing falls and injuries.
• have breathing problems
• have suicidal thoughts
• have epilepsy or a history of seizures
• l ow blood levels of a protein called albumin
• a personality disorder
• a poor blood supply to the brain (arteriosclerosis)
• d epression (with or without anxiety)
• s moke

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:
• antidepressants (e.g. fluvoxamine, fluoxetine)
• antipsychotics such as clozapine (to treat mental
problems)
• antihistamines (to treat allergies)
• general anaesthetics
• sedatives (used to give calming effects)
• hypnotics (to help you sleep)
• erythromycin (an antibiotic)
• muscle relaxants (e.g. suxamethonium, 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)
• medicines to lower high blood pressure, diuretics
(water tablets), nitrates (for heart conditions) as these
could lower your blood pressure too much.
• antacids (reduces stomach acid) may slow down
absorption of diazepam in the body.

Other considerations
•M
 ental side effects – contact your doctor if you
experience side effects such as agitation, hyperactivity,
restlessness, aggressiveness, nightmares or hallucinations.
These side effects are more likely to occur in children or
the elderly.

Taking these medicines with diazepam could affect your
mental status, make you very sleepy and suppress your
breathing and blood pressure.
• disulfiram (to treat alcohol addiction). Taking this
medicine with diazepam could make you very sleepy and
can cause diazepam to be removed from the body more

colours/plates:

Diazepam Oral Solution 2mg/5ml PIL - UK

1. Black

item no: AAAI6743

dimensions: 296 x 170

print proof no: 05

pharmacode:

origination date: 19.01.16

min pt size: 8

2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

slowly than usual.
• medicines for epilepsy e.g. phenobarbital, phenytoin
and carbamazepine, sodium valproate, (diazepam can
affect the blood levels of these medicines). Diazepam can
furthermore affect how phenytoin works.
• theophylline (to treat asthma and other 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.
• cimetidine, omeprazole or esomeprazole (stomach
acid reducing medicines), as these can cause diazepam to
be removed from the body more slowly than usual.
• rifampicin, to treat infections (an antibiotic) as this can
cause diazepam to be removed from the body more quickly
than usual. The effect of diazepam can be weakened.
• amrenavir, atazanavir, ritonavir, 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.
• isoniazid (used to treat tuberculosis), as it can cause
diazepam to be removed from the body more slowly than
usual.
• oral contraceptives, as they can slow 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.
• cisapride (used to treat stomach problems), as it can cause
diazepam to be removed from the body more slowly than
usual.
• corticosteroids (medicines used to treat inflammation in
the body) as they can weaken the effect of diazepam.
• levodopa (used to treat Parkinson’s disease). Diazepam can
reduce the effect of levodopa.
• valproic acid (used to treat epilepsy and mental disorders)
as it can slow down the removal of diazepam from the body
and increase its effect.
• ketamine (an anaesthetic) as diazepam increases the
effect of ketamine.
• lofexidine (to help relieve symptoms when you stop
taking opioids)
• nabilone (to treat nausea and vomiting)

revision date: 09-06-2016

Technical Approval

revised by: NM

date sent: 19.01.16 + 11.02.16

supplier: Martindale Pharma

technically app. date: 12.02.16

Non Printing Colours
1.
2.
3.

• alpha blockers or moxonidine (to lower high blood
pressure)
• sodium oxybate, used to prevent episodes of sudden
onset of sleep (narcolepsy) with muscle weakness.
Enhanced effect of the sodium oxybate when used in
combination with Diazepam.
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 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.

3. How to take

Always take Diazepam oral solution exactly as your doctor
has told you. You should not take Diazepam oral
solution for longer than 4 weeks. You should check with
your doctor or pharmacist if you are not sure.
You should make sure you are able to have 7-8 hours of
uninterrupted sleep.
Doses
Adults
• A nxiety or mental health problems: 2mg-30mg each day,
in divided doses
• I nsomnia: 5mg-30mg at bedtime
• C erebral palsy: 2mg-60mg each day, in divided doses
• O ther spasticities: 5mg-60mg each day, in divided doses
• To control muscle spasm: 2mg-15mg each day, in divided
doses
• E pilepsy as a premedication: 2mg-60mg per day, in divided
doses
• E pilepsy: 5mg-20mg daily
• A lcohol withdrawal symptoms: 5mg-20mg, which may be
repeated after 2 to 4 hours if necessary
• B efore dental treatment: 5mg the night before
treatment, 5mg on waking and 5mg two hours before the
appointment
Children
• C erebral spasticity: 2mg-40mg each day, in divided doses
• F or muscle spasm associated with tetanus, the adult dose
is usually given
• E pilepsy: 2mg-10mg daily

Specific patient groups
• Elderly or frail: you are likely to be more 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.
• Breathing difficulties: you may be given a 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 movement, muscle weakness
or excitement. An extreme overdose may lead to coma
(unrousable unconsciousness), reflex problems and
breathing difficulties.
If you forget to take Diazepam oral solution
Do not take a double dose to make up for a forgotten dose. If
you forget to take a dose take it as soon as you remember it
and then take the next dose at the right time.
If you stop taking Diazepam oral solution
• Do not stop taking your medicine without telling your
doctor as he may gradually reduce your dose before
stopping it completely. If stopped suddenly, you may
have unpleasant side effects including headaches, muscle
pain, extreme anxiety, tension, restlessness, confusion
and irritability. In severe cases you may experience
depersonalisation (feeling that your mind is becoming
separated from your body), derealisation (feeling that the
world around you is not real), abnormally acute hearing
or painful sensitivity to sound, numbness and tingling in
arms and legs, over sensitivity to light, noise and physical
contact, seeing, hearing or feeling things that are not there
(hallucinations) or fits.
• Withdrawal symptoms include depression. Withdrawal
symptoms may occur between normal and high doses or if
your doctor is switching you to another benzodiazepine.
• 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 sideeffects, 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 oral solution 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.

dimensions: 296 x 170

print proof no: 05

pharmacode:

origination date: 19.01.16

min pt size: 8

revision date: 09-06-2016

Technical Approval

revised by: NM

date sent: 19.01.16 + 11.02.16

supplier: Martindale Pharma

technically app. date: 12.02.16

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, aluminium
magnesium silicate, propylene glycol, raspberry flavour,
saccharin sodium, percol erythrosine (E127), sorbic acid
(E200), propyl parahydroxybenzoate (E216), methyl
parahydroxybenzoate (E218), sorbitol (E420), glycerol
(E422).

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)
• Temporary pause in breathing

Pack sizes are 100ml.
Marketing Authorisation Holder and manufacturer:
Actavis, Barnstaple, EX32 8NS, UK
Date of Revision: June 2016

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.
Actavis, Barnstaple, EX32 8NS, UK
AAAI6743

2.
3.
4.
5.
6.

originated by: S.Anson

Keep out of the sight and reach 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.

What Diazepam oral solution looks like and contents
of the pack
Diazepam oral solution is a pink syrup with an odour of
raspberries.

1. Black

item no: AAAI6743

5. How to store

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)

colours/plates:

Diazepam Oral Solution 2mg/5ml PIL - UK

approved for print/date

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)

Non Printing Colours
1.
2.
3.

Expand view ⇕

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.

Hide