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DIAZEPAM INJECTION BP 10MG/2ML

Active substance(s): DIAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Diazepam Injection 10mg/2ml

Read all of this leaflet carefully before
these could lower your blood
you start taking this medicine
pressure too much
because it contains important
!
antacids (to reduce stomach acid)
information for you.
may slow down absorption of
!
Keep this leaflet. You may need to
diazepam in the body.
read it again.
!
If you have any further questions,
Taking these medicines with diazepam
ask your doctor or pharmacist or
could affect your mental status, make
nurse.
you very sleepy and suppress your
!
This medicine has been prescribed
breathing and blood pressure.
for you only. Do not pass it on to
!
disulfiram (to treat alcohol
others. It may harm them, even if
addiction). Taking this medicine with
their signs of illness are the same as
diazepam could make you very
yours.
sleepy and can cause diazepam to
!
If you get any side effects, talk to
be removed from the body more
your doctor, or pharmacist or nurse.
slowly than usual
This includes any possible side
!
medicines for epilepsy e.g.
effects not listed in this leaflet. See
phenobarbital, phenytoin and
section 4.
carbamazepine, sodium valproate,
(diazepam can affect the blood levels
What is in this leaflet:
of these medicines). Diazepam can
1. What Diazepam Injection
furthermore affect how phenytoin
10mg/2ml is and what it is used for
works
2. What you need to know before you
!
theophylline (to treat asthma and
are given Diazepam Injection
other breathing disorders), as it can
10mg/2ml
weaken the effect of diazepam
3. How to take Diazepam Injection
!
cimetidine, omeprazole or
10mg/2ml
esomeprazole (stomach acid
4. Possible side effects
reducing medicines), as these can
5. How to store Diazepam Injection
cause diazepam to be removed from
10mg/2ml
the body more slowly than usual
6. Contents of the pack and other
!
rifampicin, to treat infections (an
information
antibiotic) as this can cause
diazepam to be removed from the
1. WHAT DIAZEPAM INJECTION
body more quickly than usual. The
10MG/2ML IS AND WHAT IT IS
effect of diazepam can be weakened
USED FOR
!
amprenavir, atazanavir, ritonavir,
delavirdine, efavirenz, indinavir,
Diazepam Injection 10mg/2ml contains a
nelfinavir or saquinavir (antivirals),
medicine called diazepam. It belongs to
fluconazole, itraconazole,
a group of medicines called
ketoconazole or voriconazole (antibenzodiazipines.
fungal medicines) as these can
It is used:
cause diazepam to be removed from
in the short-term treatment of anxiety
!
the body more slowly than usual and
and agitation that is severe, disabling
therefore increase the risk of side
or associated with unacceptable
effects. As these can make you feel
distress
sleepy for longer or cause difficulty
for the control of muscle spasms
!
breathing
including tetanus
!
isoniazid (used to treat
for the treatment of convulsions with
!
tuberculosis), as it can cause
fever (e.g febrile conditions) and as a
diazepam to be removed from the
result of poisoning
body more slowly than usual
in the treatment of some forms of
!
!
oral contraceptives, as they can
epilepsy (e.g status epilepticus)
slow down the removal of diazepam
as premedication prior to and as
!
from the body and increase its effect.
sedative cover during surgery and
Breakthrough bleeding can occur
minor surgical procedures
when taking diazepam and oral
in the short term treatment of anxiety
!
contraceptives together, but the
and agitation due to alcohol
contraceptive protection is not
withdrawal (delirum tremens) that is
reduced
severe.
!
cisapride (used to treat stomach
problems), as it can cause diazepam
2. WHAT YOU NEED TO KNOW
to be removed from the body more
BEFORE YOU ARE GIVEN
slowly than usual
DIAZEPAM INJECTION 10MG/2ML
!
corticosteroids (medicines used to
treat inflammation in the body) as
You should not be given Diazepam
they can weaken the effect of
Injection 10mg/2ml if you:
diazepam
!
are allergic to diazepam, other
!
levodopa (used to treat Parkinson's
benzodiazepines or any of the other
disease). Diazepam can reduce the
ingredients in this medicine (listed in
effect of levodopa
section 6)
!
valproic acid (used to treat epilepsy
!
have a phobia (a fear of a particular
and mental disorders) as it can slow
object or situation), obsessions, a
down the removal of diazepam from
personality disorder or other mental
the body and increase its effect
illness
!
ketamine (an anaesthetic) as
!
have difficulty in breathing, are short
diazepam increases the effect of
of breath or have weakness of your
ketamine
chest muscles that help you breathe
!
lofexidine (to help relieve symptoms
(including a condition called
when you stop taking opioids)
Myasthenia Gravis)
!
nabilone (to treat nausea and
!
have 'sleep apnoea syndrome' a
vomiting)
condition where your breathing stops
!
alpha blockers or moxonidine (to
for short spells when you are asleep
lower high blood pressure).
!
have severe liver problems
!
have Porphyria, a disorder of the
Diazepam Injection 10mg/2ml with
blood
food, drink and alcohol
!
are planning a pregnancy or are
Do not drink alcohol if you are being
pregnant (see section pregnancy and
given Diazepam Injection 10mg/2ml.
breast-feeding).
Alcohol may increase the sedative
effects of Diazepam Injection 10mg/2ml
Warnings and precautions:
and make you very sleepy.
This medicine will be given under the
supervision of a doctor or nurse.
Grapefruit juice may increase the
amount of diazepam in your blood. If you
Talk to your doctor before you are given
are elderly, suffer from cirrhosis or any of
Diazepam Injection 10mg/2ml:
the conditions listed in section 2, this
!
if you suffer from depression (with or
could possibly increase the sedative
without anxiety)
effects of Diazepam Injection 10mg/2ml
!
if you are elderly
and you should speak to your doctor,
!
if you have a kidney, liver, heart or
pharmacist or nurse.
lung condition
!
if you have breathing problems
Drinks containing caffeine may reduce
!
if you have epilepsy or a history of
the effects of diazepam.
seizures
!
if you have a history of alcohol or
Pregnancy and breast-feeding:
drug abuse or dependence
Do not take this medicine if you are
!
if someone close to you has recently
pregnant, might become pregnant, or
died
are breast-feeding. If your doctor has
!
if you have suicidal thoughts
decided that you should receive this
!
if you have had changes in your
medicine during late pregnancy or during
brain, particularly arteriosclerosis (a
labour, your baby might have a low body
narrowing of the blood vessels).
temperature, floppiness, breathing and
feeding difficulties.
When given intravenously, Diazepam
Infants born to mothers who receive this
Injection 10mg/2ml can slow down your
medicine for a prolonged period during
breathing and heart rate. On rare
late pregnancy may develop
occasions this has caused breathing or
dependence and be at risk of
the heart to stop. To avoid this, doses
withdrawal symptoms after birth.
are given slowly and are as low as
Infants born to mothers who receive this
possible.
medicine during the first three months
of pregnancy may be at increased risk
Other medicines and Diazepam
of deformities being present at birth.
Injection 10mg/2ml
Please tell your doctor or nurse before
Tell your doctor or nurse if you are using
being given this injection if you are
or have recently used or might use any
breast-feeding - if possible this injection
other medicines, including medicines
should be avoided during breastobtained without a prescription.
feeding.
Amnesia - you could experience
amnesia when taking this medicine.
Driving and using machines:
Amnesia is more likely to occur when
Diazepam may cause drowsiness,
taking high doses of medicines,
blurring of vision, unsteadiness and loss
including medicines obtained without
of alertness, you should not drive or
a prescription, especially:
operate any machinery during treatment,
!
antidepressants (e.g. fluvoxamine,
particularly if you notice any of these
fluoxetine)
effects.
!
antipsychotics such as clozapine
(to treat mental problems)
Details regarding a new driving offence
!
antihistamines (for the treatment of
concerning driving after drugs have been
allergies)
taken in the UK may be found here:
!
general anaesthetics
https://www.gov.uk/drug-driving-law
!
sedatives (used to give calming
effects)
The medicine can affect your ability
!
erythromycin (an antibiotic)
to drive as it may make you sleepy or
!
muscle relaxants (e.g.
dizzy.
suxamethonium, tubocurarine)
!
Do not drive while taking this
!
some strong pain killers such as
medicine until you know how it
morphine (opioids) may give you a
affects you
heightened sense of well-being when
!
It is an offence to drive if this
taken with diazepam which can
medicine affects your ability to drive
increase your desire to continue
!
However, you would not be
taking these medications
committing an offence if:
(dependency) or can make you very
, The medicine has been
sleepy
prescribed to treat a medical or
!
barbiturates such as phenobarbital
dental problem and
(used to treat epilepsy and mental
, You have taken it according to
disorders)
the instructions given by the
!
medicines to lower high blood
prescriber or in the information
pressure, diuretics (water tablets),
provided with the medicine and
nitrates (for heart conditions) as
, 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.
Diazepam Injection 10mg/2ml
contains benzyl alcohol, benzoic acid,
sodium benzoate and dehydrated
alcohol
This medicine contains 15mg/ml of
benzyl alcohol. This medicine must not
be given to premature babies or
neonates. It may cause toxic reactions
and allergic reactions in infants and in
children up to 3 years old.
This medicine also contains 1mg/ml of
benzoic acid and 49mg/ml of sodium
benzoate. This may increase the risk of
jaundice in newborn babies.
This medicinal product contains less
than 1 mmol sodium (23 mg) per dose,
i.e. essentially 'sodium- free'.
This medicinal product contains 12.5 vol
% ethanol (alcohol) i.e. 100mg per ml,
equivalent to 10ml beer, 4ml wine per
dose. It is therefore harmful to those
suffering from alcoholism. This should
also be taken into account in pregnant or
breast-feeding women, children and high
risk groups such as patients with liver
disease or epilepsy.
3. HOW TO USE DIAZEPAM
INJECTION 10MG/2ML
This medicine will be given to you by a
doctor or nurse.
The dose of Diazepam Injection
10mg/2ml may vary according to the
condition being treated and the following
is a guide to the doses usually given:
Adults:
Severe acute anxiety or agitation:
10mg by intramuscular injection (i.m.) or
intravenous injection (i.v.) which may be
repeated after a minimum period of 4
hours.
Alcohol withdrawal symptoms
(delirum tremens): 10mg to 20mg by
i.v. or i.m. injection. If the symptoms are
very severe a higher dose may be given.
Acute muscle spasms: 10mg by i.m. or
i.v. injection which may be repeated after
a minimum period of 4 hours.
Tetanus: In this case the dose will
depend on body weight and is usually
based on 0.1-0.3mg/kg weight and the
dose is repeated at intervals of
1 to 4 hours. In very severe cases, your
doctor may decide a higher dose is
appropriate.
Epilepsy and for convulsions due to
poisoning: 10mg to 20mg by i.v. or i.m.
injection and repeated if necessary
30-60 minutes later.
As premedication: The dose will
depend on body weight and is based on
0.2mg/kg body weight. The usual adult
dose will be 10-20mg but higher doses
may sometimes be given.
Elderly or debilitated patients:
The dose is usually not more than half
that recommended for a healthy adult.
Children:
Epilepsy, convulsions due to
poisoning and feverish conditions:
0.2mg to 0.3mg/kg body weight by i.v. or
i.m. injection. Alternatively, the dose
may be based on 1mg per year of life.
Tetanus: The dose is the same as that
recommended for adults.
As premedication: The dose is based
on 0.2mg/kg body weight.
Your doctor may decide to change your
dose according to your condition. Ask
your doctor if you want more information.
In usual circumstances, your course of
treatment with diazepam should not be
longer than four weeks.
If you are given more Diazepam
Injection 10mg/2ml than you should:
Overdose by this medicine is unlikely
since treatment is carefully monitored.
Stopping treatment with Diazepam
Injection 10mg/2ml:
Treatment with this medicine will be
tapered off gradually. If you have been
treated with benzodiazepines for a long
time this tapering off may be for a long
period.
Sudden withdrawal of diazepam,
particularly if you have been given large
doses, may produce confusion, serious
mood or behavioural changes, tremors
or convulsions.
Patients on long-term treatment may
become dependent upon this medicine.
After long-term treatment the following
withdrawal symptoms may occur:
headache, muscle pain, anxiety,
restlessness, confusion, irritability,
inability to sleep, hallucinations (seeing
and hearing things that are not there)
and convulsions. Your doctor will advise
you on how to reduce your dose
gradually to avoid these effects
happening to you.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can
cause side effects, although not
everyone gets them.
Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:

treatment' below)
!
Confusion
!
Loss of coordination of muscle
movements (ataxia) and other
movement disorders, tremor.

Uncommon: may affect up to 1 to 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
!
Allergic skin reactions in the form of
itching, skin redness and swelling
and skin rash.

Rare: may affect up to 1 to 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
!
Decreased alertness
!
Depression
!
Numbing of your emotions
(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)
!
Enlargement of mammary glands in
men
!
Impotence, changes in sexual drive
(libido)
!
Blood disorders (you may develop
sore throats, nose bleeds or
infections)
!
Difficulty speaking.

Very rare: may affect up to 1 in 10,000
people
!
Low levels of white blood cells
(leukopenia)
!
Reduction in the number of certain
types of blood cells
(Thrombocytopenia)
!
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)
!
Sensation that you, or the
environment around you, is moving
or spinning (vertigo)
!
Breathing difficulties (apnoea)
!
Injection site pain or redness
!
Swelling and redness of veins
!
Blood clots
!
Worsening of lung disease
!
Metabolic disorders.
Long term treatment:
Patients who receive long term
treatment with diazepam may become
tolerant (their medicine becomes less
effective) or dependent upon their
medicine.
After treatment for a long time (such as
in an intensive care unit) the following
withdrawal symptoms may occur:
headaches, muscle pain, anxiety,
restlessness, confusion, irritability,
inability to sleep, hallucinations and
convulsions.
Your doctor will reduce your dose
gradually to avoid these effects
happening to you.
If you think this injection is causing you
any problems, or you are at all worried,
talk to your doctor, pharmacist or
nurse.
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
INJECTION 10MG/2ML
Keep this medicine out of the sight and
reach of children.
This medicine will be given by a doctor
or nurse.
Do not use this medicine after the expiry
date which is stated on the label and
carton. The expiry date refers to the last
day of that month. Store below 25°C and
protect from light.
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 Diazepam Injection 10mg/2ml
contains:
This medicine contains the active
substance diazepam.
Each ampoule contains 10mg of
diazepam in 2ml of solution.

Some side effects can be serious and
may require immediate medical
treatment
Uncommon: may affect up to 1 in 100
people
The other ingredients are: benzoic acid,
!
Respiratory depression (very slow
dehydrated alcohol, propylene glycol,
and/or shallow breathing).
sodium benzoate, benzyl alcohol and
water.
Rare: may affect up to 1 in 1,000 people
!
Respiratory arrest (cessation of
What Diazepam Injection 10mg/2ml
breathing)
looks like and contents of the pack:
!
Unconsciousness
Diazepam Injection 10mg/2ml is a
!
Jaundice (yellowing of your skin or
colourless to light yellow solution for
the white of your eyes).
injection.
Diazepam Injection 10mg/2ml are
Very rare: may affect up to 1 in 10,000
packed into boxes of 10 ampoules.
people
!
Anaphylaxis (severe allergic
Marketing Authorisation Holder:
reaction) with symptoms such as
Ennogen Pharma Limited
sudden wheezing, swelling of your
Unit G4, Riverside Industrial Estate,
lips, tongue and throat or body, rash,
Riverside Way, Dartford, DA1 5BS, UK.
fainting or difficulties to swallow.
Manufacturer:
Other side effects
Human Serum Production & Medicine
Very common: may affect more than 1 in
Manufacturing Co Limited
10 people
H-2100 Godollo, Tancsics Milhaly UT 82
!
Drowsiness.
Budapest, Hungary
Common: may affect up to 1 in 10
This leaflet was last revised in July
people
2017.
!
Fatigue
!
Withdrawal symptoms (for possible
symptoms please see 'Long term

+ 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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