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DIAZEPAM 2MG/5ML SUGAR FREE ORAL SOLUTION

Active substance(s): DIAZEPAM

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A mnesia is more likely to occur when taking
high doses of diazepam.
• D ependence – when taking this medicine
there is a risk of dependence, which increases
2. What you need to know before you take
with the dose and duration of treatment and
Read all of this leaflet carefully before
Diazepam oral solution
also in patients with a history of alcoholism
you start taking this medicine because it
Do not take Diazepam oral solution if you
and drug abuse. Therefore, you should take
contains important information for you.
• are allergic to diazepam, benzodiazepine
Diazepam oral solution for as short period of
• Keep this leaflet. You may need to read it
medicines,
or
to
any
of
the
other
ingredients
of
time as possible.
again.
this medicine (listed in section 6)
• T olerance – if after a few weeks you notice
• If you have any further questions, ask your
• have a phobia or other mental illness or are
that the oral solution is not working as well as
doctor or pharmacist.
hyperactive
it did when first starting treatment, you should
• This medicine has been prescribed for you. Do

b

reathing
problems,
which
may
be
severe,
go and see your doctor.
not pass it on to others. It may harm them,
including slow and/or shallow breathing
•W
 ithdrawal – treatment should be gradually
even if their signs of illness are the same
• have myasthenia gravis (a condition which
withdrawn. Withdrawal symptoms occur with
as yours.
causes muscles to weaken and tire easily)
Diazepam oral solution even when normal
• If you get any side effects, talk to your doctor
doses are given for short periods of time. See
or pharmacist. This includes any possible side • suffer from sleep apnoea (a sleep disorder
where you have abnormal pauses in breathing
Section 3, ‘If you stop taking Diazepam’.
effects not listed in this leaflet. See section 4.
during sleep)
• The full name of this medicine is Diazepam
Children
and adolescents
2mg/5ml Oral Solution Sugar Free but within • have severe liver disorders
Use in children below 6 months is not
• have porphyria (an inherited condition
this leaflet it will be referred to as Diazepam
recommended.
Paradoxical side effects are more
causing skin blisters, abdominal pain and brain
Oral Solution.
likely to occur in children (see section 4).
or nervous system disorders)
What is in this leaflet
• planning a pregnancy or are pregnant (see Other medicines and Diazepam oral
1. What Diazepam oral solution is and
below ‘Pregnancy and breast-feeding’).
solution
what it is used for
• untreated depression (with or without
Do not take diazepam oral solution and tell
2. What you need to know before you take
anxiety)
your doctor or pharmacist if you are taking:
Diazepam oral solution
• amrenavir, atazanavir, ritonavir,
3. How to take Diazepam oral solution
Warnings and precautions
delavirdine, efavirenz, indinavir,
4. Possible side effects
Talk to your doctor or pharmacist before
nelfinavir, saquinavir or zidovudine
5. How to store Diazepam oral solution
taking Diazepam oral solution if you have
(antivirals). These can cause diazepam to be
6. Contents of the pack and other
• a history of alcoholism or drug abuse.
removed from the body more slowly than
information
• problems with your heart and lungs or have
usual and therefore increase the risk of side
kidney or liver disease
1. What Diazepam oral solution is and
effects, such as making you feel sleepy for
• someone close to you that has recently died
what it is used for
longer or cause difficulty breathing.

a

re
elderly
Diazepam
oral
solution
can
cause
Diazepam belongs to a group of medicines
confusion and have effects on muscles causing • sodium oxybate (for narcolepsy). Enhanced
called benzodiazepines. Diazepam helps in
effect of sodium oxybate when taken with
falls and injuries.
the treatment of anxiety, muscle spasms and
Diazepam.
• have breathing problems
convulsions (fits). It is used to treat:
• have suicidal thoughts
Tell your doctor or pharmacist if you are
In adults
• have epilepsy or a history of seizures
taking, have recently taken or might take any
• short term relief (14 days) of severe anxiety
• l ow blood levels of a protein called albumin other medicines, including medicines obtained
and may occur alone or with insomnia (trouble • a personality disorder
without a prescription. Especially:
sleeping) or mental health problems
• a poor blood supply to the brain
• a ntidepressants (e.g. fluvoxamine,
• cerebral palsy
(arteriosclerosis)
fluoxetine)
• muscle spasm caused by tetanus (when taken • s moke
• a ntipsychotics such as clozapine (to treat
with other medicines)
mental problems)
Other considerations
• epilepsy (when taken with other medicines)
• a ntihistamines (to treat allergies)

M

ental
side
effects

contact
your
doctor
if
• patients with the symptoms of alcohol
• g eneral anaesthetics
you experience side effects such as agitation,
withdrawal
• s edatives (used to give calming effects)
hyperactivity, restlessness, aggressiveness,
• helping to relax nervous dental patients.
• h ypnotics (to help you sleep)
nightmares or hallucinations. These side
• e rythromycin (an antibiotic)
In children
effects are more likely to occur in children or
•m
 uscle relaxants (e.g. suxamethonium,
• tension and irritability caused by cerebral
the elderly.
tubocurarin)
spasticity
• A mnesia (total or partial memory loss) – you

s
 ome strong pain killers such as morphine
• helping to relax and cause sleepiness before
could experience amnesia when taking this
(opioids) may give you a heightened sense of
an operation.
medicine.

Package leaflet: Information for the patient

Diazepam 2mg/5ml Oral Solution Sugar Free

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
• f luconazole, itraconazole, ketoconazole
or voriconazole (anti-fungal medicines).
These can cause diazepam to be removed from
the body more slowly than usual and therefore
increase the risk of side effects, such as making
you feel sleepy for longer or cause difficulty
breathing.
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.
•m
 edicines 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.
• t heophylline (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.
• c imetidine, omeprazole or esomeprazole
(stomach acid reducing medicines), as these
can cause diazepam to be removed from the
body more slowly than usual.
• r ifampicin, 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.
• i soniazid (used to treat tuberculosis), as it can
cause diazepam to be removed from the body
more slowly than usual.
• o ral 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.
• c isapride (used to treat stomach problems),
as it can cause diazepam to be removed from
the body more slowly than usual.

• c orticosteroids (medicines used to treat
inflammation in the body) as they can weaken
the effect of diazepam.
• l evodopa (used to treat Parkinson’s disease).
Diazepam can reduce the effect of levodopa.
• v alproic acid (used to treat epilepsy and
mental disorders) as it can slow down the
removal of diazepam from the body and
increase its effect.
• k etamine (an anaesthetic) as diazepam
increases the effect of ketamine.
• l ofexidine (to help relieve symptoms when
you stop taking opioids)
• n abilone (to treat nausea and vomiting)
• a lpha blockers or moxonidine (to lower
high blood pressure)
Diazepam oral solution with food, drink
and alcohol
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
Do not take Diazepam oral solution if you
are pregnant, planning to have a baby 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
this 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 section 4). 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.

Diazepam 2mg/5ml Oral Solution Sugar Free PIL - UK
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Item no:
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Revised By:

S.Anson
04.10.16
25/01/16
C.Grant

Dimensions:
210 x 148
Min Body Text Size: 7pts
Supplier:
Pinewood Labs

Colours

Non Printing Colours

1. Black

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2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
04.10.16 + 20/10/16 + 25/10/16
Date received: 28/10/16

6.

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• 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.

• Epilepsy as a premedication: 2mg-60mg per
day, in divided doses
• Epilepsy: 5mg-20mg daily
• Alcohol withdrawal symptoms: 5mg-20mg,
which may be repeated after 2 to 4 hours if
necessary
• Before dental treatment: 5mg the night before
treatment, 5mg on waking and 5mg two hours
before the appointment

(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.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

• D izziness
• H eadache
• S lurred speech
• S tomach and intestinal problems such as
nausea, vomiting, constipation, diarrhoea
• I ncreased salivation (particularly in children)
• A llergic skin reactions in the form of itching,
skin redness and swelling and skin rash.

Rare: may affect up to 1 in 1,000 people
•M
 ental 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.
Diazepam oral solution contains
Talk to your doctor.
Specific patient groups
sorbitol, Propylhydroxybenzoate (E216),
• D ecreased alertness
• E lderly or frail: you are likely to be more
Methylhydroxybenzoate (E218) and
• D epression
sensitive to the effects of Diazepam oral
glycerol
• E motional withdrawal
solution, especially sedation, drowsiness and
Diazepam oral solution contains 1.91g to 2.58g
• I nsomnia (problems sleeping)
confusion. Your doctor will give you much
of sorbitol per 5ml solution. This may have a
4. Possible Side Effects
• H eart problems such as slow heartbeat
lower doses, this should not be more than half Like all medicines, this medicine can cause side- (bradycardia), heart failure and cessation of
mild laxative effect. If you have been told that
the
adult
dose.
you have an intolerance to some sugars, contact
effects, although not everybody gets them.
heartbeat (cardiac arrest).
your doctor before taking this medicine. Calorific • B reathing difficulties: you may be given
• L ow blood pressure, fainting (syncope)
a lower dose.
Stop treatment and contact a doctor at
value 2.6 kcal/g sorbitol.
• I ncreased mucus in the lungs (particularly
once if you have:
Diazepam oral solution contains 2.500mg
in children)
If you take more Diazepam oral solution
• a llergic reaction e.g. itchy skin, rash, sudden • D ry mouth
of Propyl parahydroxybenzoate (E216)
than you should
wheezing,
swelling
of
the
face,
lips,
tongue
per 5ml solution and 5.000mg of Methyl
• I ncreased appetite
If you (or someone else) swallow a lot of
or throat, or body, rash, fainting or difficulty
parahydroxybenzoate (E218) per 5ml solution. Diazepam Oral Solution, or you think a child
• C hanges in certain liver enzymes as seen in
breathing or swallowing.
May cause allergic reactions (possibly delayed). may have swallowed any, contact your nearest
blood tests

R

espiratory
depression
(very
slow
and/or
Diazepam oral solution contains 0.63g of
• L ack of ability to urinate, loss of bladder
hospital casualty department or tell your
shallow
breathing)
(Uncommon)
glycerol per 5ml solution. May cause headache, doctor immediately. Signs of an overdose
control (leakage of urine)
• R espiratory arrest (cessation of breathing)
stomach upset and diarrhoea in doses higher
• B reast enlargement in men
include clumsiness and loss of coordination,
(Rare)
than 31mg.
• I mpotence, changes in sexual drive (libido)
feeling sleepy or deep sleep, speech problems,
• B lood disorders (you may develop sore throats,
irregular or slow heartbeat, uncontrolled eye
Tell your doctor if you notice any of the
3. How to take Diazepam oral solution
nose bleeds or infections)
Always take this medicine exactly as your doctor movement, muscle weakness or excitement. An following side effects or notice any other effects • U nconsciousness
has told you. You should not take Diazepam extreme overdose may lead to coma (unrousable not listed:
• J aundice (yellowing of your skin or the white
unconsciousness),
reflex
problems
and
oral solution for longer than 4 weeks.
Very common: may affect more than 1 in 10
of your eyes)
breathing difficulties.
Check with your doctor or pharmacist if you
people
are not sure.
Very rare: may affect up to 1 in 10,000 people
If you forget to take Diazepam oral
• D rowsiness
You should make sure you are able to have 7-8
• L ow levels of white blood cells (leukopenia)
solution
Common: may affect up to 1 in 10 people
hours of uninterrupted sleep.
• H igher level of a certain enzyme in the blood
Do not take a double dose to make up for a

F

atigue
(transaminase)
forgotten dose. If you forget to take a dose take
The recommended dose is:


W
ithdrawal
symptoms
(for
possible
symptoms
it as soon as you remember it and then take the
Adults
Not known: frequency cannot be estimated from
please
see
‘If
you
stop
taking
Diazepam
oral
next dose at the right time.
• Anxiety or mental health problems: 2mgthe available data
solution’ in Section 3)
30mg each day, in divided doses
• B lurred vision, double vision and involuntary
If you stop taking Diazepam oral solution • C onfusion
• Insomnia: 5mg-30mg at bedtime
eye movements (these side effects disappear
• Do not stop taking your medicine without
• L oss of coordination of muscle movements
• Cerebral palsy: 2mg-60mg each day, in
telling your doctor as he may gradually reduce
(ataxia) and other movement disorders, tremor after you have stopped taking diazepam)
divided doses


T
emporary pause in breathing
your dose before stopping it completely. If
Uncommon: may affect up to 1 in 100 people
• Other spasticities: 5mg-60mg each day, in
stopped suddenly, you may have unpleasant

M

uscle
weakness
divided doses
side effects including headaches, muscle
•M
 emory loss
• To control muscle spasm: 2mg-15mg each day, pain, extreme anxiety, tension, restlessness,
in divided doses
confusion and irritability. In severe cases you • D ifficulty in concentrating
• B alance disorders
may experience depersonalisation
Children and adolescents
• Cerebral spasticity: 2mg-40mg each day, in
divided doses
• For muscle spasm associated with tetanus, the
adult dose is usually given
• Epilepsy: 2mg-10mg daily

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 Diazepam oral solution
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. C ontents of the pack and other
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
This leaflet was last revised in January 2017

Actavis, Barnstaple, EX32 8NS, UK
BBBA0067

Diazepam 2mg/5ml Oral Solution Sugar Free PIL - UK
approved for print/date

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

BBBA0067

Item no:
Originator:
Origination Date:
Revision Date:
Revised By:

S.Anson
04.10.16
25/01/16
C.Grant

Dimensions:
210 x 148
Min Body Text Size: 7pts
Supplier:
Pinewood Labs

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
04.10.16 + 20/10/16 + 25/10/16
Date received: 28/10/16

6.

* Please note that only Artwork Studio is 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.

+ Expand Transcript

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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