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DIAMORPHINE HYDROCHLORIDE BP 30MG LYOPHILISATE FOR SOLUTION FOR INJECTION

Active substance(s): DIAMORPHINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Pregnancy and childbirth

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. BEFORE 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

• If you are given diamorphine
during pregnancy, there is a risk
that your baby might become
dependant on it and suffer from
withdrawal symptoms after birth.

• you have severe problems with
breathing or suffer from bronchitis
or asthma

• 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.

• you have raised pressure in your
brain

• you have recently been treated for
depression with drugs called
mono amine oxidase inhibitors
(MAOIs)

Driving and using machines

• you are pregnant or
breast-feeding.

Before having the injection make
sure your doctor is aware if:

The injection may cause drowsiness
and loss of concentration so you
should not operate a machine or
drive a vehicle.

• you are ill or elderly

3. HOW THE INJECTION IS GIVEN

• you have problems with your liver
or kidneys

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).

• you have a head injury

• you are an alcoholic or have a
history of drug abuse

• you have a mental illness

• you have problems with your
thyroid, adrenal glands, prostate,
bladder or bowel

The usual doses for adults are:

• you have diarrhoea

To relieve pain 5 – 10 mg every 4
hours injected under the skin or into a
muscle.

• you have a severely deformed
spine.

If the drug is given directly into a
vein, you will be given one quarter or
one half of this dose.

Are you taking other medicines?

The dose may be increased if
necessary.

Before the doctor gives you the
injection tell him/her if you are
taking any of the following
medicines:

Following a heart attack 5 mg
directly into a vein, followed, if
needed, by a further 2.5 – 5 mg.

• Drugs to treat depression or mental
illness including phenothiazines or
tricyclic antidepressants as well as
monoamine oxidase inhibitors

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.

• Tranquillisers or sleeping tablets
• Antimuscarinic drugs such as
atropine

4. POSSIBLE SIDE EFFECTS

• Drugs to prevent vomiting such as
metoclopramide or domperidone

Like all medicines, Diamorphine
Hydrochloride BP Injection may
cause side effects in a few people.

• Cisapride which is used to
stimulate the gut

• Selegiline, a drug used in
Parkinson’s disease

The most serious side effect is that
your breathing or circulation may
become depressed. Your breathing
may become shallow or you may
collapse.

• An antibiotic called a 4-quinolone

• Cimetidine, used to treat stomach
ulcers and indigestion, or if
• You have been drinking alcohol.

The most common side effects are
drowsiness, feeling or being sick,
constipation and sweating.

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.

Other side-effects, which may
occur, include dizziness, constricted
pupils (eye), confusion, difficulty in

Diamorphine HCl 5mg, 10mg & 30mg Solution PIL - UK
item no: AAAH9677

dimensions: 129 x 296

print proof no: 3

pharmacode:

origination date: 22.05.15

min pt size: 8.46

originated by: S.Anson

colours/plates
1. black
2.
3.
4.
5.
6.

revision date: 12.06.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Biologika GmbH

technically app. date:

Non Printing Colours
1. Profile
2.

3.

* Please 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.

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 suddently stopped.
If you experience any other
side-effects or feel that the medicine
is affecting you badly, tell your doctor
or nurse immediately.
5. STORING THE INJECTION

• Do not store above 25 °C. 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:
ViroPharma SPRL,
rue Montoyer 47,
Brussels 1000, Belgium
This leaflet was prepared in
May 2015.

AAAH9677

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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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