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DIAZEMULS EMULSION FOR INJECTION

Active substance(s): DIAZEPAM

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Package leaflet: Information for the patient

Diazemuls® Emulsion for intravenous injection 5mg/ml
(diazepam)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

What is this leaflet:
1 What Diazemuls is and what it is used for
2 Before you are given Diazemuls
3 How to use Diazemuls
4 Possible side effects
5 How to store Diazemuls
6 Contents of the pack and other
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:
• s evere anxiety (which is an emotional state where
you may sweat, tremble, feel anxious and have a fast
heartbeat) 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
• as a premedication before a general anaesthetic.

2 Before you are given Diazemuls

Do not take Diazemuls
• if you are allergic to diazepam, to other
benzodiazepine medicines or any of the other
ingredients in this medicine (listed in section 6). This
includes eggs or soya beans as egg phospholipid and
soya bean oil are included in the injection
• if you have a phobia (a fear of a particular object or
situation), obsessions or other mental illness
• if you have acute respiratory depression (slow and/
or shallow breathing)
• a s the only treatment for depression (with or without
anxiety)
• if you suffer from hyperactivity
• if you have a condition called myasthenia gravis
which causes muscles to weaken and tire easily
• if you suffer from sleep apnoea (a sleep disorder
where you have abnormal pauses in breathing during
sleep)
• if you have severe liver disorders
• if you have porphyria (an inherited condition causing
skin blisters, abdominal pain and brain or nervous
system disorders)
• if you are planning a pregnancy or are pregnant (see
below Pregnancy and breast-feeding).

Warnings and precautions

Talk to 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 who has recently died
• have a personality disorder
• are elderly. Diazemuls 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.

Other medicines and Diazemuls

Tell your doctor or pharmacist if you are taking, have
recently taken or might take 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)
· sodium oxybate (to treat narcolepsy)
• 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
•b
 arbiturates 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.
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 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.
• zidovudine, 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.
• 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).
• alpha blockers or moxonidine (to lower high blood
pressure).

Diazemuls with food and drink

Children

Do not drink alcohol if you are being given Diazemuls.
Alcohol may increase the sedative effects of Diazemuls
and make you very sleepy.

Other considerations

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.

Diazemuls should not be given to children under 6
months old.
•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.
• Amnesia – 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 Diazemuls for a short a period of time as
possible.
• Tolerance – if after a few weeks you notice that the
medicine is not working as well as they did when first
starting treatment, you should speak to your doctor.
• Withdrawal – treatment should be gradually
withdrawn. Withdrawal symptoms occur with
Diazemuls even when normal doses are given for
short periods of time. See Section 3, ‘If you stop being
given Diazemuls.’

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, and breathing
difficulties. If used regularly during late pregnancy, your
baby may develop withdrawal symptoms.

Package leaflet: Information for the user

Diazemuls® Emulsion
for intravenous injection
5mg/ml
(diazepam)

Diazemuls® Emulsion
for intravenous injection
5mg/ml
(diazepam)

Continued over page

Package leaflet: Information for the user

Continued top of next column

Diazemuls Diazepam 5mg/ml Emulsion for Intravenous Injection PIL - UK
approved for print/date

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA1050

Originator:
C.Grant
Origination Date: 12/07/17
Revision Date:
22/08/17
Revised By:
C.Grant

Dimensions:
155x447
Min Body Text Size: 8pts
Supplier:
BBraun

Colours

Non Printing Colours

1. Black

1. Varnish/text free area

2.

2. Marked area

3.

3.

4.
5.

Technical
Approval

Date sent:
12/07/17
Date received: 10/08/17

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.

If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
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.
• 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.

Diazemuls contains egg phospholipid and
soya bean oil

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

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).
The recommended dose is:
•a
 nxiety, agitation, muscle spasm, symptoms of
alcohol withdrawal: 10mg repeated at intervals of 4
hours, as required
• tetanus: 0.1-0.3mg per kg of body weight by
intravenous injection repeated every 1-4 hours as
required, or a continuous infusion of 3-10mg per kg of
body weight every 24 hours
• epilepsy: initial dose of 0.15-0.25mg per kg of 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
•b
 efore a general anaesthetic: 0.1-0.2mg per kg
of body weight by intravenous injection, should be
adjusted to the patient’s response
• s edation before a minor operation or 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.
Diazemuls should be taken for a short a period of time
as possible. Your dose should be reduced gradually
near the end of treatment.
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, this medicine 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 (may affect up to 1 in 100 people)
• Respiratory depression (very slow and/or shallow
breathing)
• Allergic skin reactions in the form of itching, skin
redness and swelling and skin rash
Rare (may affect up to 1 in 1,000 people)
• Respiratory arrest (cessation of breathing)
• Unconsciousness
• Jaundice (yellowing of your skin or the white of your
eyes)
• Blood disorders (you may develop sore throats, nose
bleeds or infections)

Very rare (may affect up to 1 in 10,000 people)
• Anaphylaxis (severe allergic reaction) with symptoms
such as sudden wheezing, swelling of your lips,
tongue and throat or body, rash, fainting or difficulties
to swallow
• Low levels of white blood cells (leukopenia)
Not known (frequency cannot be estimated from
the available data)
• Temporary stopping of breathing
Other side effects:
Very common (may affect more than 1 in 10 people)
• Drowsiness
Common (may affect up to 1 in 10 people)
• Fatigue
• Withdrawal symptoms (for possible symptoms please
see ‘If you stop being given Diazemuls’ (in section 3))
• Confusion
• Loss of coordination of muscle movements (ataxia)
and other movement disorders, tremor
Uncommon (may affect up to 1 in 100 people)
• 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
Rare (may affect up to 1 in 1,000 people)
• 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
•D
 epression
• Emotional poverty
• 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
• 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)
• E nlargement of mammary glands in men
• Impotence, changes in sexual drive (libido)
Very rare (may affect up to 1 in 10,000 people)
• 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 dissappear after you
have stopped taking diazepam)

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 Diazemuls

Keep this medicine out of the sight and reach of
children.
Store below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on
the label/carton. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

6 Contents of the pack and other
Information

What Diazemuls contains:
• The active substance (the ingredient that makes the
medicine 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:
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom

Manufacturers:

Actavis Group PTC ehf, Reykjavíkurvegur 76-78, IS-220
Hafnarfjörður, Iceland
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised August 2017
Accord Healthcare Ltd, North Harrow, HA1 4HF, UK
BBBA1050

Continued top of next column

Druckfrei

Druckfrei

Druckfrei

Druckfrei

Diazemuls Diazepam 5mg/ml Emulsion for Intravenous Injection PIL - UK
approved for print/date

Proof Round

05

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA1050

Originator:
C.Grant
Origination Date: 12/07/17
Revision Date:
22/08/17
Revised By:
C.Grant

Dimensions:
155x447
Min Body Text Size: 8pts
Supplier:
BBraun

Colours

Non Printing Colours

1. Black

1. Varnish/text free area

2.

2. Marked area

3.

3.

4.
5.

Technical
Approval

Date sent:
12/07/17
Date received: 10/08/17

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.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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