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CODEINE PHOSPHATE BP 60MG INJECTION

Active substance: CODEINE PHOSPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Codeine Phosphate BP 60mg Injection
Codeine Phosphate

D02796

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

In this leaflet:
1. What Codeine Phosphate Injection is and what it is used for
2. What you need to know before you are given Codeine
Phosphate Injection
3. How Codeine Phosphate Injection will be given
4. Possible side effects
5. How to store Codeine Phosphate Injection
6. Further information

1. What Codeine Phosphate Injection is and
what it is used for
This product contains codeine. Codeine belongs to a group of
medicines called opioid analgesics which act to relieve pain.
It can be used on its own or in combination with other pain
killers such as paracetamol.
Codeine can be used in children over 12 years of age for the
short-term relief of moderate pain that is not relieved by other
painkillers.

Codeine is transformed to morphine in the liver by an enzyme.
Morphine is the substance that produces pain relief. Some
people have a variation of this enzyme and this can affect
people in different ways. In some people, morphine is not
produced or produced in very small quantities, and it will not
provide enough pain relief. Other people are more likely to get
serious side effects because a very high amount of morphine
is produced. If you notice any of the following side effects, you
must stop taking this medicine and seek immediate medical
advice: slow or shallow breathing, confusion, sleepiness, small
pupils, feeling or being sick, constipation, lack of appetite.

Warnings and precautions
Tell your doctor if you:
• have low blood pressure
• have an under-active thyroid gland
• are unable to take deep breaths
• have an enlarged prostate gland and/or difficulty passing
urine
• have liver or kidney problems
• suffer from seizures (fits) e.g. epilepsy
• are pregnant or breastfeeding
• are elderly or ill
• are suffering from an irregular heartbeat
• suffer from a muscle disorder known as myasthenia gravis
• are suffering from severe stomach pains
• are suffering from gallstones

Reporting of side effects
If you get any side effects, talk to your doctor 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.

3. How Codeine Phosphate Injection will be
given

5. How to store Codeine Phosphate Injection

Your doctor will give you or your child Codeine Phosphate
Injection into a muscle (intramuscularly).
This medicine should not be used for more than 3 days. If the
pain does not improve after 3 days, talk to your doctor for
advice.

Children and adolescents
Do not give this medicine to children under 12 years of
age.

Adults (including the elderly and ill)
The usual dose is 60mg every 6 hours up to a maximum of
240mg per day.

Use in children and adolescents after surgery
Codeine should not be used for pain relief in children and
adolescents after removal of their tonsils or adenoids due to
Obstructive Sleep Apnoea Syndrome.

Children
Children aged 12 years and above should be given 30 to 60mg
every 6 hours, as needed. They should not be given more than
240mg in 24 hours.

Use in children with breathing problems
Codeine is not recommended in children with breathing
problems, since the symptoms of morphine toxicity may be
worse in these children.

Codeine Phosphate Injection should not be given to children
below the age of 12 years, due to the risk of severe breathing
problems.

Taking other medicines:
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.

Codeine Phosphate
2. What you need to know before you are given used to treat severe Injection must not be used with drugs
depression, such as phenelzine or
Codeine Phosphate Injection
moclobemide, or if you are within 2 weeks of discontinuing
You should not be given Codeine Phosphate Injection:
• if you are allergic (hypersensitive) to Codeine Phosphate
or to any of the other ingredients listed in section 6 of this
leaflet.
• if you are currently having an asthma attack or you are
suffering from shallow breathing or other breathing
difficulties.
• if you suffer from alcoholism.
• if you have bowel problems.
• if you are suffering from severe headaches or have suffered
a head injury.
• if you have a tumour of adrenal glands known as
phaeochromocytoma.
• if you are taking or have recently taken any drugs used to
treat depression known as Monoamine Oxidase Inhibitors
(MAOI’s).
• if you are suffering from a problem that could cause
paralysis of the small intestine (paralytic ileus).
• for pain relief in children and adolescents (0-18 years of age)
after removal of their tonsils or adenoids due to obstructive
sleep apnoea syndrome.
• if you know that you metabolise very rapidly codeine into
morphine.
• if you are breastfeeding.

Important information about some of the ingredients:
This medicine contains sodium metabisulphite 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.

them. These drugs are known as Monoamine Oxidase
Inhibitors (MAOI’s).
Other medicines that may interact with Codeine Phosphate
Injection include:
• medicines used to relieve pain (opioid analgesics)
• medicines used to treat an irregular heartbeat (e.g.
mexiletine, quinidine)
• tricyclic antidepressants (used to treat depression) such as
amitriptyline and imipramine
• medicines used to treat serious mental problems
(antipsychotics) such as chlorpromazine and haloperidol
• antiviral medicines (used to treat HIV e.g. ritonavir)
• medicines used to treat bacterial infections (e.g.
ciprofloxacin)
• medicines used to reduce anxiety (anxiolytics) such as
diazepam and buspirone
• medicines used to help you to sleep (hypnotics) such as
temazepam and zopiclone
• CNS depressants (drugs that act on the brain and make
you feel drowsy or faint). These include sleeping pills,
antihistamines (medicines used to treat allergies) that
make you drowsy, medicines used to treat certain mental
disorders, other pain killers or a general anaesthetic.
• medicines used to treat vomiting (e.g. metoclopramide or
domperidone)
• medicines used to treat stomach ulcers (e.g. cimetidine)
If you are in any doubt please tell your doctor of any
medication you are taking.
Pregnancy and breast-feeding
You should not be given Codeine Phosphate Injection if you
are pregnant, or trying to become pregnant.
Do not use codeine while you are breast-feeding. Codeine and
morphine passes into breast milk.
Effects on the ability to drive and use machinery:
Codeine Phosphate Injection may cause drowsiness, dizziness
or confusion. If you are affected in this way, however slightly,
you should not drive or operate machinery.
Having Codeine Phosphate Injection with food and drink:
You are advised not to drink alcohol during your treatment
with this medicine. This may cause breathing difficulties or low
blood pressure.
Continued overleaf

If you are given too much Codeine Phosphate 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 if you have any concerns.

Keep out of the reach and sight of children.
You should not be given Codeine Phosphate Injection after
the 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.
Do not store above 25°C. Keep in outer carton.

6. Further Information
What Codeine Phosphate Injection contains:
• The active substance is Codeine Phosphate BP 60mg in 1ml.
• The other ingredients are sodium metabisulphite and water
for injection.
What Codeine Phosphate Injection looks like and contents
of the pack:
Codeine Phosphate Injection is a clear, colourless solution
supplied in 1ml clear glass ampoules. Each pack contains 10
ampoules.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals
Bampton Road, Romford,
RM3 8UG, United Kingdom

4. Possible side effects

Product licence number: PL 01883/6128R
Like all medicines, Codeine Phosphate Injection can cause side
effects, although not everybody gets them.
Codeine Phosphate BP 60mg Injection
Repeated use of codeine can result in tolerance and
addiction.

Leaflet revised: February 2014

If any of the following symptoms occur contact your doctor or
nearest accident and emergency department immediately.
These are symptoms of a serious allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse
Other possible side effects include:
• hallucinations
• mood changes
• restlessness
• headache
• dizziness
• drowsiness
• a feeling of spinning (vertigo)
• pinpoint pupils
• an irregular heartbeat
• feeling your heart beat (palpitations)
• feeling or being sick
• constipation
• a dry mouth
• rashes and itching
• facial flushing
• sweating
• difficulty passing urine
• reduction in body temperature
• feeling faint when getting up from a seated position
• reduced sex drive
• difficulty achieving or maintaining an erection
• spasms in the lower abdomen
• stomach pains
• loss of appetite
• seizures (fits)
• a feeling of being unwell
• muscle twitching
• worsening of a condition that affects the pancreas known as
pancreatitis. The symptoms of this include stomach pain and
feeling or being sick.

D02796

100mm Measurement Verification Bar

2796-A

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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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