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DIHYDROCODEINE INJECTION BP 50MG/ML

Active substance(s): DIHYDROCODEINE TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dihydrocodeine Injection BP 50mg/ml
Dihydrocodeine Tartrate

D02814 00000

Read all of this leaflet carefully before you are
given Dihydrocodeine injection.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your
doctor or nurse
• If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or nurse.

In this leaflet:
1. What Dihydrocodeine Injection is and what it is used
for
2. Before Dihydrocodeine Injection is given
3. How Dihydrocodeine Injection is given
4. Possible side effects
5. Storing Dihydrocodeine Injection
6. Further information

1. What Dihydrocodeine Injection is and
what it is used for
Dihydrocodeine belongs to a group of medicines
known as analgesics which are used to relieve pain.
Dihydrocodeine is used for the relief of severe pain.

2. Before Dihydrocodeine Injection is
given
You should not be given Dihydrocodeine Injection
if you:
• are allergic (hypersensitive) to dihydrocodeine or any
of the other ingredients listed in section 6
• suffer from breathing difficulties, or you are having an
asthma attack
• have difficulty opening your bowel
• have a tumour of the adrenal gland known as
phaeochromocytoma
Dihydrocodeine Injection should not be given to
children under 4 years of age.
Take special care with Dihydrocodeine Injection.
Tell your doctor if you:
• suffer from asthma
• have an underactive thyroid gland
• suffer from low blood pressure
• suffer from seizures (fits) e.g. epilepsy
• have been diagnosed as suffering from an enlarged
prostate gland
• have any breathing or lung problems
• are suffering from severe headaches or have suffered
a head injury
• have liver or kidney problems
If any of the above applies to you or your child, please
consult your doctor.

Taking other medicines
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, including those
obtained without prescription
Medicines that may interact with Dihydrocodeine
Injection include:
• anxiolytics or hypnotics (these are medicines that
reduce anxiety or cause sleepiness) e.g. diazepam
and chlordiazepoxide.
• D
 ihydrocodeine injection should not be
administered to patients receiving severe depression
treatment known as Monoamine Oxidase Inhibitors
(MAOIs), such as phenelzine or moclobemide or
within two weeks of their withdrawal.
Taking Dihydrocodeine Injection with food and
drink:
You are advised not to drink alcohol while being
treated with Dihydrocodeine Injection.
Pregnancy and breast-feeding:
Dihydrocodeine injection should not be used if you
are pregnant or try to become pregnant unless it is
prescribed by your doctor.
Dihydrocodeine is likely to cross the placenta and
be present in breast milk and it may cause breathing
problems in new born babies.
Effects on the ability to drive and use machines:
Dihydrocodeine Injection may cause drowsiness. If you
are affected in this way, however slightly , you should not
drive or operate machinery.
This 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.
Important information about some of the
ingredients:
This medicine contains sodium metabisulfite which
may cause allergic (hypersensitive) type reactions in
some people and can lead to breathing difficulties or
collapse. People with a history of asthma or allergies are
most likely to experience these problems.

3. How Dihydrocodeine Injection is given

5. Storing Dihydrocodeine Injection

Your doctor or nurse will give you Dihydrocodeine
Injection either into a muscle or deep beneath the
surface of the skin.
Under some circumstances your doctor may prescribe a
dose higher than those stated here.
Adults
Up to 50mg.
Elderly or ill patients
It is recommended that a reduced dose be used.
Children (over 4 years)
0.5 - 1 mg per kg of body weight every 4 to 6 hours.
Children (under 4 years)
Not recommended.
If you are given too much Dihydrocodeine Injection
As this medicine will be given to you whilst you are in
hospital, it is unlikely that you will be given too little
or too much, however, tell your doctor or nurse if you
have any concerns.

Keep out of the reach and sight of children.
This product has an expiry date on the ampoule and
carton label. The expiry date refers to the last day of
that month. The doctor or nurse will check that the
product has not passed this date.
Store protected from light.

4. Possible side effects
Like all medicines, Dihydrocodeine Injection can cause side

effects, although not everybody gets them:
Repeated use of dihydrocodeine can result in
tolerance and addiction.
If you experience any of the following side effects
you should tell your doctor immediately. These are
symptoms of an allergic reaction.
• difficulty in breathing with or without swelling of the
face, lips, tongue and/or throat
• swelling of the face, lips tongue and/or throat, which
may cause difficulty in swallowing
• severe itching of the skin (with raised lumps).
Other possible side effects include:
• constipation
• nausea (feeling sick)
• vomiting (being sick)
• headaches
• dizziness or a feeling of spinning (vertigo)
• drowsiness
• difficulty breathing
• difficulty in passing urine
• feeling of anxiety, depression and/or restlessness
(dysphoria)
• dry mouth
• sweating
• pin-point pupils
• facial flushing
• feeling faint when getting up from a seated position
• hallucinations (seeing or hearing things that aren’t
real)
• feeling of being unwell
• mood changes
• itching or skin rashes
If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or nurse.

6. Further Information
What Dihydrocodeine Injection contains:
The active ingredient is Dihydrocodeine Tartrate 50mg
in 1ml.
The other ingredients are Sodium Metabisulphite,
Water for injections. Sodium Hydroxide and Tartaric
Acid may be added to adjust the pH.
What Dihydrocodeine Injection looks like and the
contents of the pack:
The injection is supplied in glass ampoules each
containing 1ml. The ampoules are supplied in packs of
5 or 10 ampoules.
Product Licence Holder and Manufacturer:
Martindale Pharmaceuticals Ltd
Bampton Road
Romford, Essex, RM3 8UG, UK
Product licence number: PL 00156/0091
Dihydrocodeine injection BP 50mg in 1ml
Leaflet last revised: July 2014

D0281400000

Headings 11 on 11pt
100mm Measurement Verification Bar

Body text 9 on 10pt

2814-C

DEVELOPMENT ARTWORK
Component Code: D02814
Paper size: 170 x 296mm
Version Control Date

By

Version A Created 26/03/14 AC
Version B

15/04/14 AC

Version C

17/07/14 HM

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Amherst House, 22 London Road
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e:alan@grand-fromage.co.uk
www.grand-fromage.co.uk

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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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