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DIAZEPAM ACTAVIS 5MG/ML EMULSION FOR INJECTION

Active substance(s): DIAZEPAM / DIAZEPAM / 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 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
• 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 breastfeeding).

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 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

Children

Diazemuls should not be given to children
under 6 months old.

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.
• 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.’

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

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

Continued top of next column

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Diazemuls Diazepam 5mg/ml Emulsion for Intravenous Injection PIL - UK
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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.
• I t 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 sideeffects, 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)

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 April 2017

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 breathing

Continued top of next column

Accord Healthcare Ltd, North Harrow, HA1 4HF, UK
BBBA0678

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

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0678

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
20.04.17
25.04.17
S.Anson

Date sent:
20.04.17
Date received: 25.04.17

Dimensions:
148 x 420
Min Body Text Size: 8pts
Supplier:
BBraun

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
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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