Skip to Content

UK Edition. Click here for US version.

DIAZEPAM INJECTION BP 10MG/2ML

Active substance(s): DIAZEPAM

View full screen / Print PDF » Download PDF ⇩
Transcript
Artwork No.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

120215/3

Colours Used

Customer

Ennogen

Black

Description

Diazepam Leaflet

Keyline

Market

UK

Language

English

Size

130 x 480 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

2

Date

17-02-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diazepam Injection 10mg/2ml
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 or
nurse.
! 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 or nurse.
This includes any possible side
effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1. What Diazepam Injection
10mg/2ml is and what it is used for
2. What you need to know before you
are given Diazepam Injection
10mg/2ml
3. How to take Diazepam Injection
10mg/2ml
4. Possible side effects
5. How to store Diazepam Injection
10mg/2ml
6. Contents of the pack and other
information
1. WHAT DIAZEPAM INJECTION
10MG/2ML IS AND WHAT IT IS
USED FOR
Diazepam Injection 10mg/2ml contains a
medicine called diazepam. It belongs to
a group of medicines called
benzodiazipines.
It is used:
! in the short-term treatment of anxiety
and agitation that is severe disabling
or associated with unacceptable
distress
! for the control of muscle spasms
including tetanus
! for the treatment of convulsions with
fever (e.g febrile conditions) and as a
result of poisoning
! in the treatment of some forms of
epilepsy (e.g status epilepticus)
! as premedication prior to and as
sedative cover during surgery and
minor surgical procedures
! in the short term treatment of anxiety
and agitation due to alcohol
withdrawal (delirum tremens) that is
severe.
2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN
DIAZEPAM INJECTION 10MG/2ML
You should not be given Diazepam
Injection 10mg/2ml if you:
! are hypersensitive (allergic) to
diazepam, other benzodiazepines or
any of the other ingredients in this
medicine (listed in section 6)
! have breathing difficulties
! have 'sleep apnoea syndrome' a
condition where your breathing stops
for short spells when you are asleep
! have severe liver problems.
Use in neonates (new born babies)
should be avoided as the product
contains benzyl alcohol. See section:
Diazepam Injection 10mg/2ml
contains
Warnings and precautions:
This medicine will be given under the
supervision of a doctor or nurse.
Talk to your doctor before you are given
Diazepam Injection 10mg/2ml if you:
! have myasthenia gravis (a
condition which causes muscles to
weaken and tire easily)
! have porphyria (an inherited blood
disorder causing skin blisters,
abdominal pain and brain or nervous
system disorders)
! are planning a pregnancy or are
pregnant (see below Pregnancy and
breast-feeding).
! have problems with your liver,
kidney or lungs
! have a history of alcohol or drug
abuse
! have had changes in your brain,
particularly narrowing of the blood
vessels
! are elderly
! have a personality disorder.
When given intravenously, Diazepam
Injection 10mg/2ml can slow down your
breathing and heart rate. On rare
occasions this has caused breathing or
the heart to stop. To avoid this, doses
are given slowly and are as low as
possible.
Other warnings:
! Dependence
there is a risk of dependence, which
increases with the dose and duration
of treatment and if you have a history
of alcoholism and drug abuse.

!

!

Withdrawal
treatment should be gradually
withdrawn. Withdrawal symptoms
occur with this medicine even when
normal doses are given for short
periods of time. See Section 3,
'Stopping treatment with
Diazepam Injection 10mg/2ml'.
There is a risk of benzyl alcohol
poisoning with prolonged use of this
medicine.

If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking this
medicine.
Other medicines and Diazepam
Injection 10mg/2ml
Tell your doctor or nurse if you are using
or have recently used or might use any
other medicines, including medicines
obtained without a prescription. This is
especially important with the following
medicines as they may interact with
your Diazepam Injection 10mg/2ml.
! Tranquilisers or Sedatives
! Hypnotics (sleep inducing drugs)
! Antidepressants
! Narcotic analgesics (very strong
pain killers)
! Antiepileptics (for treating epilepsy)
! Anaesthetics
! Some antihistamines (for the
treatment of allergies)
! Levodopa - a medicine for
Parkinson's Disease
! Theophylline - a medicine to help
you breathe
! Sodium Oxybate - a medicine to
help you stay awake
! Antibiotics (erythromycin &
rifampicin)
The effects of diazepam may also be
increased by medicines such as:
! Antifungals (voriconazole,
fluconazole and itraconazole)
! Disulfiram - used to treat alcohol
dependency
! Drugs used to treat blood pressure
! Drugs used to treat digestive
problems
! Some drugs used to treat HIV and
AIDS
! Baclofen and tizanidine (used to
relax your muscles).
Diazepam Injection 10mg/2ml with
alcohol:
Alcohol may increase the sedative
effects of diazepam and should therefore
be avoided. Do not drink alcohol until
your doctor tells you it is all right to do
so.
Pregnancy and breast-feeding:
Do not take this medicine if you are
pregnant, might become pregnant, or
are breast-feeding. If your doctor has
decided that you should receive this
medicine during late pregnancy or during
labour, your baby might have a low body
temperature, floppiness, breathing and
feeding difficulties.
Infants born to mothers who receive this
medicine for a prolonged period during
late pregnancy may develop
dependence and be at risk of
withdrawal symptoms after birth.
Infants born to mothers who receive this
medicine during the first three months
of pregnancy may be at increased risk
of deformities being present at birth.
Please tell your doctor or nurse before
being given this injection if you are
breast-feeding - if possible this injection
should be avoided during breastfeeding.
Driving and using machines:
Diazepam may cause drowsiness,
blurring of vision, unsteadiness and loss
of alertness, you should not drive or
operate any machinery during treatment,
particularly if you notice any of these
effects.
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.
Taking with food and drink:
Do not drink alcohol as it may increase
the sedative effects of this medicine and
make you very sleepy.

Artwork No.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

120215/3

Colours Used

Customer

Ennogen

Black

Description

Diazepam Leaflet

Keyline

Market

UK

Language

English

Size

130 x 480 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

2

Date

17-02-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Diazepam Injection 10mg/2ml
contains benzyl alcohol, benzoic acid
and sodium benzoate
This medicine contains 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.

Quality Control (QC)

!

This medicine also contains benzoic acid
and sodium benzoate. This may
increase the risk of jaundice in newborn
babies.
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.
!

!
!

!

Immune system disorders:
hypersensitivity reactions including
anaphylaxis (a severe and rapid
allergic reaction) where you may
experience low blood pressure,
breathing difficulties, feeling sick,
itchiness, swelling of the lips, face,
neck and throat.
If you have any of these symptoms,
or you are at all worried, tell your
doctor, nurse or pharmacist
immediately.
Skin disorders: rash, itchiness,
allergic reaction
Nervous system disorders:
drowsiness and prolonged sedation,
reduced alertness, confusion,
euphoria (an excessive feeling of
wellbeing), hallucinations, tiredness,
headache, dizziness and difficulty
coordinating muscles
Temporary memory loss has been
reported. How long this lasts will
depend on how much diazepam you
were given and you may experience
this after your treatment. In isolated
cases this has been prolonged.

!
!

!
!
!

!
!

Production

Reactions such as agitation, muscle
spasms and muscle tremors,
restlessness, hostility, rages and
aggression, have been reported.
Other reactions include depression,
numbing of your emotions, changes
in your appetite and libido and ideas
of suicide.
Paradoxical (not typical or expected)
reactions include difficulty in
sleeping, nightmares, sexual arousal
and inappropriate behaviour.
Children and the elderly are more
susceptible to these reactions.
Dependence on Diazepam after
prolonged intravenous use. It is
important that you are withdrawn
from your medicine gradually to
avoid withdrawal symptoms,
including withdrawal convulsions
Gastrointestinal disorders: feeling
sick, dry mouth
Heart and breathing disorders:
Events include low blood pressure,
breathing complications, shortness of
breath, blockage of airway.
The elderly may be more
susceptible to the adverse effects of
Diazepam.
Blood disorders: You may have
reduced numbers of, and changes to,
certain types of your blood cells.
Liver disorders: changes in the
chemicals in your blood made by
the liver and jaundice (your skin and
the whites of your eyes may develop
a yellow tinge).
Injection site disorders: redness
and pain, swelling and redness of
veins, blood clots.
Other disorders: including visual
disturbances, weakness in your
muscles, difficulty to hold or pass
urine.

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, nurse 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 DIAZEPAM
INJECTION 10MG/2ML
This medicine will be given by a doctor
or nurse.
Check the expiry date printed on the
label or side of the box. Do not use after
the expiry date (last day of the month)
stated on the label.
Store below 25°C and protect from light.
In case of any visible signs of
deterioration, you should discard the
package.
Medicines should not be disposed of via
waste water or household waste. Ask
your pharmacist how to dispose of
medicines no longer required. These
measures help to protect the
environment.
Keep out of the sight and reach of
children
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.
The other ingredients are: benzoic acid,
dehydrated alcohol, propylene glycol,
sodium benzoate, benzyl alcohol and
water.
What Diazepam Injection 10mg/2ml
looks like and contents of the pack:
Diazepam Injection 10mg/2ml is a
colourless to light yellow solution for
injection.
Diazepam Injection 10mg/2ml are
packed into boxes of 10 ampoules.
Marketing Authorisation Holder:
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer:
Human Serum Production & Medicine
Manufacturing Co Limited
H-2100 Godollo, Tancsics Milhaly UT 82
Budapest, Hungary
This leaflet was last revised in
February 2015.

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.

Hide