Skip to Content

DIAMORPHINE HYDROCHLORIDE BP 500 MG LYOPHILISATE FOR SOLUTION FOR INJECTION

Active substance(s): DIAMORPHINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT INFORMATION LEAFLET

Diamorphine Hydrochloride BP 100 mg and 500 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.
Driving and using machines
The injection may cause drowsiness and loss of
concentration so you should not operate a
machine or drive a vehicle.

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

AAAI7503

dimensions: 182 x 265

print proof no:

2

pharmacode:

origination date: 8.2.16
approved for print/date

min pt size:

colours/plates:
1. black
2.
3.
4.

9 pt

originated by:

db

revision date:

10.2.16

Technical Approval

revised by:

db

date sent:

supplier:

Baccinex

approved:

5.
6.

8.2.16

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.

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.

palpitations, mood changes, dry mouth, skin
rash, itching and headache.

Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.

By reporting side effects you can help provide more
information on the safety of 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,

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

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 5 ml ampoule contains either 100 mg or
500 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

AAAI7503

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

AAAI7503

dimensions: 182 x 265

print proof no:

2

pharmacode:

origination date: 8.2.16
approved for print/date

min pt size:

colours/plates:
1. black
2.
3.
4.

9 pt

originated by:

db

revision date:

10.2.16

Technical Approval

revised by:

db

date sent:

supplier:

Baccinex

approved:

5.
6.

8.2.16

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.

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