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DIAMORPHINE HYDROCHLORIDE BP 5MG LYOPHILISATE FOR SOLUTION FOR INJECTION

Active substance(s): DIAMORPHINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Diamorphine Hydrochloride BP for Injection 5 mg, 10 mg and 30 mg
Lyophilisate for Solution for Injection
Read all of this leaflet carefully,
before you are given this injection.
• Keep this leaflet. You may need to
read it again.
• If you have any other questions,
please ask your doctor.
• If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.

Before being used, the powder in the
ampoules will be mixed with a
liquid to make a solution which will
be given to you by injection. This is
called Diamorphine Hydrochloride
BP Injection in this leaflet.
1. What Diamorphine
Hydrochloride BP Injection is
and what it is used for
2. Before you are given the
injection
3. How the injection is given
4. Possible side effects
5. Storing the injection
6. Further information
1.WHAT DIAMORPHINE
HYDROCHLORIDE BP
INJECTION IS AND WHAT IT IS
USED FOR
Diamorphine hydrochloride belongs
to a class of medicines known as
opioid analgesics. They help to
relieve pain.
Diamorphine Hydrochloride BP
Injection can be used to
• relieve severe pain associated with
surgery, a heart attack or a
terminal illness, or
• relieve breathlessness caused by
fluid in the lungs.
2. B
 EFORE DIAMORPHINE
HYDROCHLORIDE BP
INJECTION IS GIVEN TO YOU
Diamorphine Hydrochloride BP
Injection is not suitable for
everyone. Tell the doctor or nurse
that you must not have the
injection if:
• you are aware that you are allergic
to diamorphine or any other opioid
analgesic such as codeine
• you have a tumour of the adrenal
gland near your kidney
• you have severe problems with
breathing or suffer from bronchitis
or asthma
• you have raised pressure in your
brain

• you have recently been treated for
depression with drugs called
monoamine oxidase inhibitors
(MAOIs)
• you are pregnant or
breast-feeding.
Before having the injection make
sure your doctor is aware if:
• you are ill or elderly
• you have problems with your liver
or kidneys
• you have a head injury
• you are an alcoholic or have a
history of drug abuse
• you have mental illness
• you have problems with your
thyroid, adrenal glands, prostate,
bladder or bowel
• you have diarrhoea
• you have a severely deformed
spine.
Are you taking other medicines?
Before the doctor gives you the
injection tell him/her if you are
taking any of the following
medicines:
• Drugs to treat depression or mental
illness including phenothiazines or
tricyclic antidepressants as well as
monoamine oxidase inhibitors
• Tranquillisers or sleeping tablets
• Antimusacarinic drugs such as
atropine
• Drugs to prevent vomiting such as
metoclopramide or domperidone
• Cisapride which is used to
stimulate the gut
• Selegiline, a drug used in
Parkinson’s disease
• An antibiotic called 4-quinolone
• Cimetidine, used to treat stomach
ulcers and indigestion, or if
• You have been drinking alcohol.
Make sure you tell your doctor
about any other medicines you
are taking or have taken recently,
including any bought from a
chemist or another shop.
Pregnancy and childbirth
• If you are given diamorphine during
pregnancy, there is a risk that your
baby might become dependent on it
and suffer from withdrawal symptoms
after birth.
• If you are given diamorphine during
labour there is a risk that you could
be sick and have breathing
difficulties, or the baby could have
difficulty starting to breathe.

Diamorphine HCI All Strengths Solution For Injection PIL UK
item no:

AAAI7502

dimensions: 129 x 296

print proof no:

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pharmacode:

origination date: 5.2.16
approved for print/date

originated by:

db

revision date:

10.2.16

Biologika

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Non Printing Colours
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 lease note that only Actavis Global Artwork Studios are 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.

Driving and using machines
The injection may cause drowsiness
and loss of concentration so you
should not operate a machine or drive
a vehicle.
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 THE INJECTION IS GIVEN
The doctor will prepare the injection
by mixing the powder with a liquid.
He/she will know how much to give
you. You can have the injection
either under the skin, or into a
muscle, or directly into a vein
(called intravenous infusion).
The usual doses for adults are:
To relieve pain 5 – 10 mg every 4
hours injected under the skin or into a
muscle.
If the drug is given directly into a vein,
you will be given one quarter or one
half of this dose.
The dose may be increased if
necessary.
Following a heart attack 5 mg
directly into a vein, followed, if needed,
by a further 2.5 – 5 mg.
For fluid in the lungs 2.5 – 5 mg
directly into a vein.
The elderly, children or people with
liver or kidney problems, may be
given a lower starting dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Diamorphine
Hydrochloride BP Injection may cause
side effects in a few people.
The most serious side effect is that
your breathing or circulation may
become depressed. Your breathing
may become shallow or you may
collapse.
The most common side effects are
drowsiness, feeling or being sick,
constipation and sweating.

Other side-effects, which may
occur, include dizziness, constricted
pupils (eye), confusion, difficulty in
passing water, spasm of the bile duct,
feeling faint on standing up, facial
flushing, palpitations, mood changes,
dry mouth, skin rash, itching and
headache.
If you have the injections for a long
time you might become dependent
on the drug and have withdrawal
symptoms if it is suddenly stopped.
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. STORING THE INJECTION
• Do not store above 25 oC. Keep the
injection in the outer carton to protect
it from light.
• This medicine should not be used
after the expiry date on the carton or
if the powder in the ampoule or the
solution are discoloured.
• Diamorphine Hydrochloride BP
Injection must be used immediately
after the solution has been prepared.
• Diamorphine Hydrochloride BP
Injection must be kept in a secure
place out of the reach and sight of
children.
• Diamorphine Hydrochloride BP is a
Controlled Drug and must be stored
and disposed of according to
regulations.
6. FURTHER INFORMATION
Each 2 ml ampoule contains either
5 mg, 10 mg or 30 mg of the active
ingredient, Diamorphine Hydrochloride
BP, which is a white or off-white
powder. The medicine is prepared
for use by dissolving the powder in a
liquid.
Each pack contains 5 glass ampoules.
Marketing Authorisation Holder:
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer:
Actavis Group PTC ehf
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
This leaflet was last revised in
February 2016.
AAAI7502

Diamorphine HCI All Strengths Solution For Injection PIL UK
item no:

AAAI7502

dimensions: 129 x 296

print proof no:

2

pharmacode:

origination date: 5.2.16
approved for print/date

originated by:

db

revision date:

10.2.16

Biologika

1. black
2.
3.
4.

8.5 pt

5.
6.

Technical Approval
date sent:

revised by:
supplier:

min pt size:

colours/plates:

approved:

5.2.16

Non Printing Colours
1.
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are 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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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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