*    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 side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Codeine Phosphate Solution for Injection is and what it is used for

2.    Before you are given Codeine Phosphate Solution for Injection

3.    How Codeine Phosphate Solution for Injection is used

4.    Possible Side Effects

5.    How to store Codeine Phosphate Solution for Injection

6.    Further Information

1. What Codeine Phosphate Solution for Injection is and what it is used for

This medicine 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.

This medicine is a solution for injection for intramuscular use and is used for the relief of mild to moderate pain.

This medicine 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 you are given Codeine Phosphate Solution for Injection

Please tell your doctor if you are taking any other medication.

This medicine 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

This medicine 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:

This medicine 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:

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

Pregnancy and breast-feeding

Do not take this medicine while you are breastfeeding. Codeine and morphine passes into breast milk.

Driving or using machines

This medicine 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:

o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instruction given by the prescriber or in the information provided with the medicine and o 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.

3. How Codeine Phosphate Solution for Injection is used

The doctor will decide what dose of this medicine you should be given. Check the label carefully.

If you are not sure, ask your doctor, nurse or pharmacist.

This medicine is a solution for intramuscular injection only. Adults, elderly and debilitated patients can be given 30 - 60mg every 4 hours. Children aged 12 years or above should be given 500 micrograms/kg to 1mg/kg every 6 hours, as needed. Do not give more than 240mg in 24 hours. This medicine should not be given to 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 this medicine 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 of this medicine 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.

Additional information for Healthcare Professionals (as stated on the Summary of Product Characteristics)

Therapeutic indications

Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).

Posology and method of administration

For intramuscular use only.

Adults, elderly and debilitated patients

Codeine should be used at the lowest effective dose for the shortest period of time. This dose may be taken up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose of codeine should not exceed 240mg.

Hepatic impairment

Codeine Phosphate Solution for Injection is contraindicated in patients with hepatic impairment.

4. Possible side effects of Codeine Phosphate Solution for Injection

As with all medicines, there may be some side effects with this medicine although not everybody gets them.

The most common side effects are:-

•    Respiratory depression (slow or shallow breathing)

•    Nausea or vomiting

•    Constipation

•    Tachycardia (fast heartbeat)

•    Drowsiness

•    Muscle rigidity

•    Inability to concentrate

•    Feeling confused

•    Itchiness

•    Decreased potency

•    Hypothermia (low body temperature)

•    Postural hypotension (giddiness or feeling faint on standing up)

•    Rashes

•    Spasm of the tubes of the kidney, bladder and gallbladder

•    Rash due to an allergic reaction in the skin

•    Vertigo

•    Dizziness

•    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.

Long term treatment with this medicine:

Further side effects can occur during long-term include:

•    Seizures

•    Inflammation of the pancreas

•    Difficulty with passing water

•    Dry mouth

•    Colic

•    Sweating or facial flushing

•    Headache

•    Slowed heart rate

•    Palpitations

•    Spasm of the airways

•    Hallucinations

Repeated use of this medicine 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.

Reporting of Side Effects

If you get any side effects, talk to your doctor, nurse or pharmacist. 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.

5. How to store Codeine Phosphate Solution for Injection

This medicine 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 medicine does not show any sign of deterioration. The expiry date refers to the last day of the month.

Only use this medicine if it is particle free and the solution is straw or lighter in colour.

After the expiry date any unused medicine should be returned to a pharmacy.

Keep the container in the original outer carton and store below 25°C.

Store this medicine in a safe place, where children cannot see or reach it.

6. Further information

What this medicine contains:

•    The active ingredient is Codeine Phosphate at a strength of 60mg in 1mL.

•    It also contains the inactive ingredient Water for Injections.

What this medicine looks like and contents of pack:

This medicine is a clear and straw coloured solution. This medicine comes in 1mL ampoules for single use only. This medicine is packed into cartons containing 10 ampoules.

Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust,

Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG

Sites of Manufacture

This leaflet was last revised in: 01/2016

PL 13079/0010

PIL/9/8

Renal impairment

The dosage for patients with renal impairment should be adjusted according to the table below.

Glomerular filtration rate (mL/minute)	Dose
20 - 50	Dose as for normal renal function
10 - 20	75% of normal dose
<10	50% of normal dose

Children aged 12 years to 18 years:

The recommended codeine dose for children 12 years and older should be 500 micrograms/kg to 1mg/kg every 6 hours when necessary up to a maximum dose of codeine of 240mg daily. The dose is based on the body weight (0.5 - 1mg/kg).

Children aged less than 12 years:

Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine.

Incompatibilities

Not applicable.