Active substance: CODEINE PHOSPHATE

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4. Possible side effects

Package leaflet: information for the user

Codeine Phosphate BP 60mg Injection
Codeine Phosphate


Read all of this leaflet carefully before you are given this
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
• 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. 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
Codeine Phosphate belongs to a group of medicines with pain
relieving properties known as alkaloids. This medicine is used
for the relief of mild to moderate pain.

2. Before you are given Codeine Phosphate
You should not be given Codeine Phosphate Injection if
• are allergic (hypersensitive) to Codeine Phosphate or to any
of the other ingredients listed in section 6 of this leaflet
• are currently having an asthma attack or you are suffering
from shallow breathing or other breathing difficulties
• suffer from alcoholism
• have bowel problems
• are suffering from severe headaches or have suffered a head
• have a tumour of adrenal glands known as
• are taking or have recently taken any drugs used to treat
depression known as Monoamine Oxidase Inhibitors
• are suffering from a problem that could cause paralysis of
the small intestine (paralytic ileus)
Take special care with Codeine Phosphate Injection
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
• 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
Special care will be taken when giving this medicine to
children under 1 year of age.
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 Injection must not be used with drugs
used to treat severe depression, such as phenelzine or
moclobemide, or if you are within 2 weeks of discontinuing
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 heart beat (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.
• 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
• 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.
Usually it is safe to use Codeine Phosphate Injection while
breast feeding as the levels of the active ingredients of this
medicine in breast milk are too low to cause your baby any
problems. However, some women who are at increased risk of
developing side effects at any dose may have higher levels in
their breast milk. If any of the following side effects develop in
you or your baby stop using this medicine and seek immediate
medical advice; feeling sick, vomiting, constipation, decreased
or lack of appetite, feeling tired or sleeping for longer than
normal, and shallow or slow breathing.
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.
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.

3. How Codeine Phosphate Injection will be
Your doctor will give you Codeine Phosphate Injection into a
muscle (intramuscularly).
Adults (including the elderly and ill)
The usual dose is 30-60mg every four hours up to a maximum
of 240mg per day.
Up to 1 month of age:
0.5-1mg per kilogram of

bodyweight every 4 to 6 hours.
1 month to 12 years of age: 0.5-1mg per kilogram of

bodyweight every 4 to 6 hours up

to a maximum of 240mg per day.
12 to 18 years of age:
30-60mg every four hours up to a

maximum of 240mg per day.
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.

Like all medicines, Codeine Phosphate Injection can cause side
effects, although not everybody gets them.
Repeated use of codeine can result in tolerance and
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.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or nurse.

5. How to store Codeine Phosphate Injection
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 injections.
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
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals
Bampton Road, Romford, RM3 3UG, United Kingdom
Product licence number: PL 01883/6128
Codeine Phosphate BP 60mg Injection
Leaflet revised: August 2012

Continued overleaf


100mm Measurement Verification Bar

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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.