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Patient Information Leaflet
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
KEEP THIS LEAFLET IN A SAFE PLACE, YOU MAY WANT TO READ IT AGAIN.
IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR DOCTOR OR PHARMACIST.
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 PHARMACIST.
1. WHAT CODEINE PHOSPHATE INJECTION 60MG IN 1ML 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 Phosphate Injection 60mg in 1ml is a solution for injection for intramuscular use and is used for the relief of mild to
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 such as paracetamol or ibuprofen alone.
2. BEFORE USING CODEINE PHOSPHATE INJECTION 60MG IN 1ML
Please tell your doctor if you are taking any other medication.
Codeine Phosphate Injection 60mg in 1ml should NOT BE USED:
• if you are allergic to Codeine Phosphate or any other strong painkilling drugs
• in children who are under 12 years of age
• if you have liver disease
• if you have diverticulitis or acute colitis
• after bowel surgery
• 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
Codeine Phosphate Injection 60mg in 1ml should be used with caution in patients who:
• are very elderly
• have had a head injury
• have hypovolaemia (decreased amount of blood in the body)
• have a history of respiratory depression (breathlessness/shallow breathing)
• 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.
Check with your doctor if you are concerned about any of the above.
Taking other medicines:
This medicine may not be suitable for you to take; please tell your doctor if you:
• are taking medicines that induce liver enzymes such as nefopam, carbamazepine, rifampicin, quinidine or secobarbital
• are taking central nervous system depressants such as sedatives or alcohol
Check with your doctor if you are concerned about any of the above.
Children and adolescents
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.
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
Pregnancy and breast-feeding
Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.
Driving or using machines
Codeine Phosphate may cause drowsiness, therefore you should not operate machinery.
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 medicial or dental problem and
You have taken it according to the instruction given by the prescriber or in the information provided with the
It was not affecting your ability to drive safety
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
3. HOW TO USE CODEINE PHOSPHATE INJECTION 60MG IN 1ML
The doctor will decide what dose of Codeine Phosphate Injection you should take. Check the label carefully. If you are not
sure, ask your doctor, nurse or pharmacist.
Codeine Phosphate Injection 60mg in 1ml is a solution for intramuscular injection only. Adults, elderly and debilitated
patients can take 30-60mg every 4 hours. Children aged 12 years or above should take 500 micrograms/kg to 1mg/kg every
6 hours, as needed. Do not take more than 240mg in 24 hours. Codeine Phosphate should not be taken by children below
the age of 12 years, due to the risk of severe breathing problems.
Alcohol should be avoided whilst taking codeine.
If a dose of Codeine Phosphate is not given at the correct time - the dose should be given as soon as it is remembered. The
next dose should be given at the usual time.
If more Codeine Phosphate is given than should be - tell the doctor as soon as possible. If you are a medical practitioner
administering this medicine please refer to the Summary of Product Characteristics.
4. POSSIBLE SIDE EFFECTS OF CODEINE PHOSPHATE INJECTION 60MG IN 1ML
As with all medicines, there may be some side effects with Codeine Phosphate Injection although not everybody gets them.
The most common side effects are:• respiratory depression (slow or shallow breathing)
• nausea or vomiting
• tachycardia (fast heartbeat)
• muscle rigidity
• inability to concentrate
• feeling confused
• decreased potency
• hypothermia (low body temperature)
• postural hypotension (giddiness or feeling faint on standing up)
• spasm of the tubes of the kidney, bladder and gallbladder
• rash due to an allergic reaction in the skin
• oedema (fluid retention in the body), causing swelling to occur in the affected area
Tell your doctor, nurse or pharmacist, immediately, if you think you have any of these or other problems with Codeine
Long term treatment with Codeine:
Further side effects can occur during long-term treatment with Codeine. These side-effects include:
• inflammation of the pancreas
• imagining things, mood changes
• difficulty with passing water
• decreased libido
• dry mouth
• pinpoint pupils
• disruption of the menstrual cycle
• sweating or facial flushing
• reduced blood pressure
• abdominal pain
• slowed heart rate
• loss of appetite/loss in body weight
• spasm of the airways
• muscle contractions
• increased sensitivity to pain (hyperalgesia)
Repeated use of Codeine Phosphate can cause a tolerance to the drug and morphine type dependence and you may experience
withdrawal symptoms. If you are concerned that you are becoming dependent on this medicine, speak to your doctor.
5. HOW TO STORE CODEINE PHOSPHATE INJECTION 60MG IN 1ML
The product has an expiry date stated on the ampoule and carton. Before use the doctor or nurse will check the product has
not passed this date and that the injection does not show any sign of deterioration.
Do not use Codeine Phosphate Injection 60mg in 1ml if:
• Visible particles are present
• The solution is darker than pale straw
After the expiry date any unused product should be returned to a pharmacy.
Keep the container in the original outer carton and do not store above 25ºC.
Store this medicine in a safe place, where children cannot see or reach it.
6. FURTHER INFORMATION
Codeine Phosphate Injection 60mg in 1ml is presented in 1ml ampoules for single dose use only. It also contains the inactive
ingredient: Water for Injections.
The manufacturer and marketing authorisation holder is:
South Devon Healthcare NHS Foundation Trust, Torbay PMU,
Long Road, Paignton, Devon, TQ4 7TW
Revision date: 01/2014
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.