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DIAZEPAM INJECTION BP

Active substance(s): DIAZEPAM

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Package leaflet: Information for the patient

hameln

Diazepam Injection BP
diazepam

Important information about your medicine
Your doctor, nurse or dentist will give you the injection.
► If this injection causes you any problems talk to your doctor, nurse or pharmacist
► Please tell your doctor, nurse or dentist, if you have any other medical conditions or have an allergy
to any of the ingredients of this medicine
► Please tell your doctor, nurse or dentist, if you are taking any other medicines


Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
• If you get any side effects, talk to your doctor 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 BP is and what it is used for
2. What you need to know before you use Diazepam Injection BP
3. How to use Diazepam Injection BP
4. Possible side effects
5. How to store Diazepam Injection BP
6. Contents of the pack and other information

1. What Diazepam Injection BP is and
what it is used for
Diazepam belongs to a group of medicines called
benzodiazepines. It can cause you to fall asleep
and it can also have a calming effect.
Diazepam can be given by injection into a vein
(intravenously), by a drip (infusion) or injection
into a muscle (intramuscular). This medicine is
used in adults and children for sedation during
investigations and treatment.
It is also used as a premedication to calm
patients before treatment and to sedate
patients in intensive care units.
Diazepam is used as an anti-convulsant to treat
epileptic seizures and to control muscle spasms
as in tetanus. It is also used in the management
of alcohol withdrawal syndromes.

2. What you need to know before you use
Diazepam Injection BP
Do NOT use Diazepam Injection BP:
• if you are sensitive or allergic to diazepam, the
group of medicines known as benzodiazepines
or any of the other ingredients (listed in section
6) in this injection.
• if you have a phobia (a fear of a particular
object
or
situation),
obsessions,
a
personality disorder or other mental illness.
• if you have difficulty in breathing, are short
of breath or have weakness of your chest
muscles that help you breath (including a
condition called Myasthenia Gravis).
• if you have “Sleep Apnoea Syndrome” - a
condition where your breathing stops for short
spells when you are asleep.
• if you have Porphyria - a disorder of the blood.
• if you have a liver condition.
• if you are planning a pregnancy or are pregnant
(see Pregnancy and breast-feeding below).

Warnings and precautions
Talk to your doctor, pharmacist or nurse
before using Diazepam Injection BP:
• if you suffer from depression (with or without
anxiety).
• if you are over 60 years of age.
• if you have a kidney, liver, heart or lung
condition.
• if you have breathing problems.
• if you have epilepsy or a history of seizures.
• if you have a history of alcohol or drug abuse
or dependence.
• if someone close to you has recently died.
• if you have suicidal thoughts.
• if you have had changes in your brain,
particularly arteriosclerosis (a narrowing of the
blood vessels).
When given intravenously, Diazepam Injection BP
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 medicines and Diazepam Injection
BP:
Tell your doctor or pharmacist if you are using
or have recently used or might use any other
medicines, including medicines obtained without
a prescription.
Amnesia – you could experience amnesia
when taking this medicine. Amnesia is more
likely to occur when taking high doses of
medicines, including medicines obtained without
a prescription, especially:
• antidepressants (e.g. fluvoxamine, fluoxetine).
• antipsychotics such as clozapine (to treat
mental problems).
• antihistamines (for the treatment of allergies).
• general anaesthetics.
• sedatives
(used
to
give
calming
effects).
• erythromycin (an antibiotic).
• muscle relaxants (e.g. suxamethonium,
tubocurarine).
• 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
medications (dependency) or can make you
very sleepy.
• barbiturates such as phenobarbital (used 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.
• antacids (to reduce stomach acid) may slow
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.
• 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.
• 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.
• amprenavir, 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.
• valproic acid (used to treat epilepsy and mental
disorders) as it can slow down the removal of
diazepam from the body and increase its effect.
• 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).

Diazepam with drink and alcohol:
Do not drink alcohol if you are being given
Diazepam Injection BP. Alcohol may increase the
sedative effects of Diazepam Injection BP 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 Diazepam Injection BP 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 Diazepam Injection BP
if you are pregnant, planning to become pregnant
or are breast feeding.
If your doctor decides you should be given this
medicine during late pregnancy, labour or
caesarean section, your baby might have an
irregular heart beat, a low body temperature,
floppiness and 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
breast feeding.

Driving and using machines:
This medicine may make you sleepy, forgetful
or affect your concentration and coordination.
This may affect your performance at skilled tasks,
e.g. driving or operating machinery. Your doctor
should advise you when you can start these
again.
You should always be accompanied home by a
responsible adult after your treatment.
Details regarding a new driving offence
concerning driving after drugs have been taken in
the UK may be found here:
https://www.gov.uk/drug-driving-law
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.

3. How to use Diazepam Injection BP
Your doctor, nurse or dentist will give you the
injection.
Your doctor, nurse or dentist will decide the
correct dosage for you and how and when the
injection will be given.

If you use more Diazepam Injection BP
than you should

Since the injection will be given to you by a
doctor, nurse or dentist, it is unlikely that you will
be given too much. If you think you have been
given too much you must tell the person giving
you the injection.

4. Possible side effects
Like all medicines, Diazepam Injection BP 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
• Respiratory depression (very slow and/or
shallow breathing)

5. How to store Diazepam Injection BP
Keep this medicine out of the sight and reach of
children.
Your injection will be stored at less than 25°C and
protected from light.
Do not use this medicine after the expiry date
which is stated on the label/ carton after “EXP:”
The expiry date refers to the last day of that
month.

6. Contents of the pack and other
information
What Diazepam Injection BP contains:
The active substance is diazepam. In Diazepam
Injection BP each 1 ml of solution contains 5 mg
of diazepam.
The other ingredients are ethanol, propylene
glycol, sodium hydroxide and water for injections.
This medicinal product contains 0.04 mg sodium
per ml. This should be taken into consideration
for patients on a controlled sodium diet.

What Diazepam Injection BP looks like
and contents of the pack:
Diazepam Injection BP is a clear, colourless,
sterile solution contained in clear glass ampoules.
The injection is available in packs of 10 ampoules
containing 2 ml of solution.
The marketing authorisation number of this
medicine is: PL 01502/0025.

Marketing Authorisation Holder:
hameln pharmaceuticals ltd
Gloucester
United Kingdom

Rare: affects 1 to 10 users in 10,000
• Respiratory arrest (cessation of breathing)
• Unconsciousness
• Jaundice (yellowing of your skin or the white of
your eyes)

Manufacturer:

Very rare: affects less than 1 user in 10,000
• 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

hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic

Other side effects:
Very common: affects more than 1 user in 10
• Drowsiness
Common: affects 1 to 10 users in 100
• Fatigue
• Withdrawal symptoms (for possible symptoms
please see ‘Long term treatment’, below.
• Confusion
• Loss of coordination of muscle movements
(ataxia) and other movement disorders, tremor
Uncommon: affects 1 to 10 users in 1,000
• 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: affects 1 to 10 users in 10,000
• 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
• 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)
Very rare: affects less than 1 user in 10,000
• Low levels of white blood cells (leukopenia)
• 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)
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.

hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany

For
any
information
about
this
medicine, please contact the Marketing
Authorisation Holder.
This leaflet was last revised in November 2015
43741/48/15

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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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