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DIAZEPAM ACTAVIS 5MG/ML EMULSION FOR INJECTION

Active substance(s): DIAZEPAM

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Diazemuls® Emulsion for intravenous injection
5mg/ml (diazepam)
Read all of this leaflet carefully before you
start taking this medicine.
• 
Keep this leaflet. You may need to read it
again.
•  you have any further questions, ask your
If
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.
•  any of the side effects gets serious, or
If
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1 
What Diazemuls is and what it is
used for
2 
Before you use
3 
How to use
4 
Possible side effects
5 
How to store
6 
Further information
1 
What Diazemuls is and what it is
used for

Diazemuls contains diazepam which belongs to
a group of medicines called benzodiazepines.
Diazemuls is used to treat a number of
conditions, including:
• 
severe anxiety (which is an emotional state
where you may sweat, tremble, feel anxious
and have a fast heart beat ) or agitation
• 
muscle spasm due to tetanus or poisoning
• epilepsy
• 
patients with the symptoms of alcohol
withdrawal
• 
helping relax patients before minor operations
or procedures
•  a premedication before a general
as
anaesthetic.

2 
Before you are given Diazemuls

You should not be given Diazemuls if you:
• are allergic (hypersensitive) to diazepam or
to other benzodiazepine medicines or to any
of the other ingredients in the injection (see
section 6). This includes eggs or soya beans
as egg phospholipid and soya bean oil are
included in the injection
• have a phobia (a fear of a particular object or
situation), obsessions or other mental illness
• have acute respiratory depression (slow and/
or shallow breathing)
• suffer from depression (with or without
anxiety) or hyperactivity
• 
have a condition called myasthenia gravis
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, nurse or pharmacist
before being given Diazemuls if you
• suffer from depression (with or without
anxiety)
• 
have problems with your liver, kidney or
lungs
• have someone close to you has recently died
• have a personality disorder
• moke
s
• are elderly. Diazemuls can cause confusion
and have effects on muscles causing falls and
injuires.
• have breathing problems
• have suicidal thoughts
• have epilepsy or a history of seizures

Other considerations

•  ental side effects – contact your doctor if
M
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.
•  mnesia – you could experience amnesia
A
when taking this medicine. Amnesia is more
likely to occur when taking high doses of
diazepam.
•  ependence - when taking this medicine
D
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 tablets for a short a period of time as
possible.
• olerance – if after a few weeks you notice that
T
the tablets are not working as well as they did
when first starting treatment, you should speak
to your doctor.
•  ithdrawal – treatment should be gradually
W
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 tablets.’

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, fluoxetine)
a
• 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). Taking
d
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 esomeprazole
c
(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) as
R
this can cause diazepam to be removed from
the body more quickly than usual. The effect of
diazepam can be weakened.
• mrenavir, atazanavir, ritonavir, delavirdine,
a
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.
•  ral contraceptives, as they can slow down
o
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), as
c
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.
• 
levodopa (used to treat Parkinson’s disease).
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.
• 
lofexidine (to help relieve symptoms when
you stop taking opioids)
•  abilone (to treat nausea and vomiting)
n
• lpha blockers or moxonidine (to lower high
a
blood pressure)

Being given Diazemuls with food and
drink

Do not drink alcohol if you are being given
Diazemuls. Alcohol may increase the sedative
effects of Diazemuls 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 Diazemuls and you should
speak to your doctor, nurse or pharmacist.
Drinks containing caffeine may reduce the
effects of diazepam.

Pregnancy and breast-feeding

You should not be given Diazemuls if you are
pregnant, planning to become pregnant or are
breast feeding. If you are given Diazemuls late
in your pregnancy or during labour your baby
might have a low body temperature, floppiness,
Continued over page

Continued top of next column
AAAH0521

Diazepam (Diazemuls) Emulsion for Injection 5mg/ml PIL - UK

colours/plates:
1. Black

item no: AAAH0521

dimensions: 148 x 420

print proof no: 3

pharmacode:

origination date: 23.07.14

min pt size: 7pt

3.
4.
5.
6.

originated by: DR
approved for print/date

2.

revision date: 12.08.14

Technical Approval

revised by: S.Anson

date sent: 23.07.14

supplier: BBraun, Germany

technically app. date: 24.07.14

Non Printing Colours
1.
2.
3.

and breathing difficulties. If used regularly
during late pregnancy, your baby may develop
withdrawal symptoms. Ask your doctor or
pharmacist for advice before using any medicine.

Driving and using machines

Diazemuls 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.
•  not drive while taking this medicine until
Do
you know how it affects you.
•  is an offence to drive if this medicine affects
It
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
-  was not affecting your ability to drive safely
It
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 Diazemuls
Diazemuls contains egg phospholipid and soya
bean oil. If you are allergic to eggs or soya beans
tell your doctor or nurse before being given this
medicine.

3 
How to use

Diazemuls will be given by a doctor or a nurse as
a slow intravenous injection (into a vein), or as a
continuous infusion (into a vein).
Doses:
• nxiety, agitation, muscle spasm, symptoms
a
of alcohol withdrawal: 10mg repeated at
intervals of 4 hours, as required
• etanus: 0.1-0.3mg per kg of body weight by
t
intravenous injection repeated every 1-4 hours
as required, or a continuous infusion of 3-10mg
per kg of body weight every 24 hours
• pilepsy: initial dose of 0.15-0.25mg per kg of
e
body weight by intravenous injection repeated
in 30 to 60 minutes if required, and followed if
needed by infusion up to 3mg per kg of body
weight over 24 hours.
•  efore a general anaesthetic: 0.1-0.2mg per
b
kg of body weight by intravenous injection,
should be adjusted to the patient’s response.
• edation before a minor operation or
s
procedure: 0.1-0.2mg per kg of body weight
by intravenous injection. The normal adult
dose is 10-20mg, but should be adjusted to the
patient’s response.
If you are elderly or debilitated you are likely to
be more sensitive to diazepam. Therefore, your
dose may be reduced to one half the normal
dose at the start of treatment.

If you are given more Diazemuls than
you should

If you think you have had too much Diazemuls,
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 miss a dose of Diazemuls

If you think you have missed a dose, let your
nurse or doctor know.

If you stop being given Diazemuls

Do not decide to stop your medicine, as your
doctor may wish to gradually reduce the number
of injections you have before stopping them
completely.
If you have any further questions on the use
of this medicine, ask your doctor, nurse or
pharmacist.

4 
Possible Side Effects

Like all medicines, Diazepam tablets can cause
side-effects, although not everybody gets them.
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
•  espiratory depression (very slow and/or
R
shallow breathing)
Rare: affects 1 to 10 users in 10,000
•  espiratory arrest (cessation of breathing)
R
•  nconsciousness
U
• aundice (yellowing of your skin or the white of
J
your eyes)
Very rare: affects less than 1 user in 10,000
•  naphylaxis (severe allergic reaction) with
A
symptoms such as sudden wheezing, swelling
of your lips, tongue and throat or body, rash,
fainting or difficulties to swallow

Other side effects:

Very common: affects more than 1 user in 10
•  rowsiness
D
Common: affects 1 to 10 users in 100
• atigue
F
•  ithdrawal symptoms (for possible symptoms
W
please see ‘If you stop being given Diazemuls’
(in Section 3)
•  onfusion
C
• oss of coordination of muscle movements
L
(ataxia) and other movement disorders, tremor
Uncommon: affects 1 to 10 users in 1,000
•  uscle weakness
M
•  emory loss
M
•  ifficulty in concentrating
D
•  alance disorders
B
•  izziness
D
•  eadache
H
• lurred speech
S
• tomach and intestinal problems such as
S
nausea, vomiting, constipation, diarrhoea
• 
Increased salivation
•  llergic skin reactions in the form of itching,
A
skin redness and swelling and skin rash.
Rare: affects 1 to 10 users in 10,000
•  ental side effects such as excitation, agitation,
M
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.
•  ecreased alertness
D
•  epression
D
• motional poverty
E
• 
Insomnia (problems sleeping)
•  eart problems such as slow heartbeat
H
(bradycardia), heart failure and cessation of
heartbeat (cardiac arrest).
• ow blood pressure, fainting (syncope)
L
• 
Increased mucus in the lungs
•  ry mouth
D
• 
Increased appetite
•  hanges in certain liver enzymes as seen in
C
blood tests
• ack of ability to urinate, loss of bladder control
L
(leakage of urine)
• nlargement of mammary glands in men
E
• 
Impotence, changes in sexual drive (libido)
•  lood disorders (you may develop sore throats,
B
nose bleeds or infections)
Very rare: affects less than 1 user in 10,000
• ow levels of white blood cells (leukopenia)
L
•  igher level of a certain enzyme in the blood
H
(transaminase)
Not known: frequency cannot be estimated from
the available data
•  lurred vision, double vision and involuntary
B
eye movements (these side effects dissappear
after you have stopped taking diazepam)
Withdrawal symptoms: see Section 3, ‘If you
stop being given Diazemuls’
.
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.
Store below 25°C. Do not freeze.
Do not use Diazemuls 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 Diazemuls contains:

• 
The active substance (the ingredient that
makes the tablet work) is diazepam.
• 
The other ingredients are soya bean oil,
monoglycerides, egg phospholipids, glycerol,
sodium hydroxide, and water for injections.

What Diazemuls looks like and contents
of the pack
Diazemuls is a white, milky fluid.
Pack sizes are in boxes of 10x2ml ampoules.

Marketing Authorisation Holder:
Actavis Group PTC ehf. Reykjavikurvegi 76-78,
220 Hafnarfjordur, Iceland
Manufacturers:
Actavis Nordic A/S, 2820 Gentofte, Denmark
Actavis Group PTC ehf, Reykjavíkurvegur 76-78,
IS-220 Hafnarfjörður, Iceland
Actavis, Barnstaple, EX32 8NS, UK
Date of Revision: July 2014

Continued top of next column
AAAH0521

Actavis, Barnstaple, EX32 8NS, UK

Diazepam (Diazemuls) Emulsion for Injection 5mg/ml PIL - UK

colours/plates:
1. Black

item no: AAAH0521

dimensions: 148 x 420

print proof no: 3

pharmacode:

origination date: 23.07.14

min pt size: 7pt

3.
4.
5.
6.

originated by: DR
approved for print/date

2.

revision date: 12.08.14

Technical Approval

revised by: S.Anson

date sent: 23.07.14

supplier: BBraun, Germany

technically app. date: 24.07.14

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.

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