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DIAMORPHINE HYDROCHLORIDE 100MG FOR INJECTION

Active substance: DIAMORPHINE HYDROCHLORIDE

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TEVA UK Ref:

86572-W LEA DIAMORPHINE A-S INJ 5x1 VIAL TUK
Version:

3

19 May 2015

PAGE 1: FRONT FACE

DIAMORPHINE HYDROCHLORIDE
5 mg, 10 mg, 30 mg, 100 mg or
500 mg FOR INJECTION
PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or nurse.
• If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.

• suffer from any abnormal curvature of the
spine
• depression of the nervous system.
Taking other medicines
DO NOT receive Diamorphine if you:
• are taking, or have taken in the last 14 days
any MAOI (monoamine oxidase inhibitor) e.g.
phenelzine, isocarboxazid, tranylcypromine.

1

WHAT DIAMORPHINE IS AND WHAT
IT IS USED FOR

Diamorphine is a narcotic analgesic.
Diamorphine is used to treat severe pain
associated with:
• terminal illness
• heart attack
• fluid on the lungs.

2

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.

BEFORE YOU RECEIVE
DIAMORPHINE

Pharma Code 36

However, you would not be committing an
offence if:
• The medicine has been prescribed to treat a
DO NOT receive Diamorphine if you:
medical or dental problem and
• are allergic (hypersensitive) to diamorphine
hydrochloride or any of the other ingredients • You have taken it according to the
instructions given by the prescriber or in the
of this medicine
information provided with the medicine and
• suffer from any breathing problems
• It was not affecting your ability to drive safely.
• suffer from biliary colic (stomach pain
usually caused by gallstones)
Talk to your doctor or pharmacist if you are not
• have phaeochromocytoma (a rare tumour of sure whether it is safe for you to drive while
the adrenal gland)
taking this medicine.
• are taking, or have taken in the last 14 days
any MAOI (monoamine oxidase inhibitor)
3 HOW TO RECEIVE DIAMORPHINE
medicines used to treat depression.
Take special care with Diamorphine
Talk to your doctor or nurse before you start to
receive this medicine if you:
• are elderly or frail
• have recently suffered a head injury or have
high pressure in your head
• have, or are being treated for problems with
your blood pressure
• have any kidney, liver or bowel problems
• have severe diarrhoea
• have ever been an alcoholic or a drug addict,
or are undergoing abrupt withdrawal from
alcohol
• have prostate problems and/or an urethral
stricture – both may make passing water
difficult and/or painful and can increase the
frequency of urinating
• suffer from any mental health problems
• suffer from an underactive thyroid or adrenal
gland

REG0047999

Driving and using machines
• Diamorphine may impair your alertness. DO
NOT drive or operate machinery if you are
affected.

Version 2.3

Diamorphine will be administered by a doctor
or nurse. Diamorphine can be given by
intramuscular (into the muscle), intravenous
(into a vein) or subcutaneous (under the skin)
injection. The usual dose is:
• Adults
Terminal illness:
5 mg to 10 mg every four hours to start with
although higher doses may be given. Your
doctor will adjust your dose as required.
Heart attack:
5 mg to start with, given by slow injection into
a vein, followed by 2.5 mg to 5 mg as required.
Fluid on the lungs:
2.5 mg to 5 mg given by slow injection into a
vein.
• Elderly
A starting dose lower than the normal adult
dose should be used.

Approved

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Pharma Code 36

Talk to your doctor if you are taking any of the
following:
• any other sedatives
• atropine or synthetic anticholinergics e.g.
mebeverine, or any medicines for
Parkinson’s disease or for incontinence of
urine.
Please tell your doctor or nurse if you are
IN THIS LEAFLET:
taking or have recently taken any other
1. What Diamorphine is and what it is used for
medicines, including medicines obtained
2. Before you receive Diamorphine
without a prescription.
3. How to receive Diamorphine
4. Possible side effects
Pregnancy and breast-feeding
5. How to store Diamorphine
• Ask your doctor or nurse for advice before
6. Further information
receiving this medicine.

TEVA UK Ref:

Version:

86572-W LEA DIAMORPHINE A-S INJ 5x1 VIAL TUK
3

19 May 2015

• Children
• decreased sexual desire or impotence
The starting dose will be given every four
(inability to get or maintain an erection)
hours and will depend on the child’s age, size, • itching
symptoms and previous pain-relief medication. • nettle rash/hives or other skin rashes.
Your doctor will adjust the dose as required.
Drug tolerance may occur as the body adapts
If you receive more Diamorphine than you
to the actions of the drug. Tolerance is the need
should
to take increasingly higher doses of the drug to
As a doctor or nurse will be giving you your
obtain the same physical or mental effect.
medicine, it is unlikely that you will receive an
incorrect dose. Tell your doctor or nurse if you Reporting of side effects
have any concerns about the amount of
If you get any side effects, talk to your doctor,
medicine that you receive.
pharmacist or nurse. This includes any possible
If you (or someone else) accidentally takes
side effects not listed in this leaflet. You can
Diamorphine injection, or if you think a child
also report side effects directly via the Yellow
has, contact your nearest hospital casualty
Card Scheme at:
department or your doctor immediately.
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
If you stop receiving Diamorphine
more information on the safety of this
Diamorphine should not be stopped being
medicine.
given suddenly. If it is you may suffer from
withdrawal symptoms e.g. sweating, shaking,
5 HOW TO STORE DIAMORPHINE
anxiety and nausea. If your doctor decides to
stop giving you Diamorphine they will reduce
Keep out of the reach and sight of children.
the dose gradually.
Store below 25°C. Keep the vials in the outer
If you have any further questions on the use of carton in order to protect from light.
Do not use Diamorphine after the expiry date
this product, ask your doctor or nurse.
that is stated on the outer packaging. The
POSSIBLE SIDE EFFECTS
expiry date refers to the last day of that month.
4
Return all unused medicines to your
Like all medicines, Diamorphine can cause side pharmacist for safe disposal.
effects, although not everybody gets them.

6

FURTHER INFORMATION

Tell your doctor or nurse immediately, if any of
What Diamorphine contains:
the following happen:
• The active ingredient is diamorphine
• difficulty breathing and swelling of the lips,
hydrochloride 5 mg, 10 mg, 30 mg, 100 mg
face and neck, rash, itching, shortness of
or 500 mg
breath, abnormal heart beat, low blood
• The other ingredient is water.
pressure (feeling dizzy or faint).

Pharma Code 36

The following are serious side effects of
Diamorphine therapy:
• poor circulation
• heart and breathing problems
• shock.
The most commonly reported side effects are:
• sleepiness
• feeling sick and being sick
• constipation
• sweating.
The following side effects have also been
reported:
• a fall in blood pressure on standing up which
causes dizziness, light-headedness or
fainting
• fainting
• dizziness
• palpitations
• fast heart rate
• confusion
• occasional hallucinations
• weakness
• an abnormal feeling of well-being
• anxiety, depression, restlessness
• difficulty sleeping
• loss of appetite
• alterations to taste
• dry mouth
• problems passing urine
• cramps

What Diamorphine looks like and contents of
the pack:
• Diamorphine comes as a white cake plug in
a clear glass vial. Each Diamorphine vial
contains 5 mg, 10 mg, 30 mg, 100 mg or
500 mg of diamorphine hydrochloride.
Colour of flip-off caps for each strength is as
follows: 5 mg: grey, 10 mg: green, 30 mg:
light blue, 100 mg: orange, and 500 mg: dark
blue.
• The product is available in pack sizes of 5,
10, 20, 50, or 100 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
The Marketing Authorisation holder and
company responsible for manufacture is TEVA
UK Limited, Eastbourne, BN22 9AG England.
Company responsible for manufacture:
Teva Pharmaceutical Works Private Limited
Company, H-2100 Gödöllo, Táncsics Mihaly.út
82. Hungary.
This leaflet was last revised: May 2015
PL 00289/0220-0223, 00289/0250

86572-W
3-29118060/C

REG0047999

Version 2.3

Approved

Page 2 of 3

Pharma Code 36

PAGE 2: REAR FACE

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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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