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Active substance(s): CODEINE PHOSPHATE

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Codeine Phosphate 15mg, 30mg and 60mg tablets
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.

What Codeine Phosphate tablets are and what they are used for
Before you take
How to take
Possible side effects
How to store
Further information


What Codeine Phosphate tablets are and what they are 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 tablets are used for the relief of:
 mild to moderate pain.
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.
 symptoms of a dry cough or diarrhoea.


Before you take

Do not take Codeine Phosphate tablets:

if you are allergic (hypersensitive) to codeine or other opioids, or any of the ingredients in the
tablet (see section 6)
if you have difficulty breathing, or other chronic lung disease
if you have suffered head injury or raised pressure in the skull (may cause painful eyes, changes
in vision or headache behind the eyes)
if you are having an asthma attack
if you have liver failure
if you are at risk of blocked intestines
if you suffer with alcoholism
if you are under 12 years old
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

Check with your doctor or pharmacist before taking Codeine Phosphate tablets if you

liver or kidney problems
diseased adrenal glands (Addison’s disease) or high blood pressure caused by a tumour near a
kidney (phaeochromocytoma)
inflammatory bowel disease including severe bloody diarrhoea (pseudomembranous colitis)
gall bladder disease or gall stones
recently had surgery on your gastro-intestinal tract or urinary system
an enlarged prostate gland and have difficulty urinating and are male

are elderly or frail
suffer with asthma or breathing problems
an underactive thyroid gland
muscle weakness (myasthenia gravis)
low blood pressure or are in shock
suffered from alcoholism, drug abuse or dependence or mental illness.

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces
the effects of codeine and relieves pain and symptoms of cough. 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 or relieve their cough.
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.

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 these children.Adolescents older than 12 years of age:
Codeine is not recommended in adolescents with compromised respiratory function for the
treatment of cough

Other important warnings:

do not take for longer than directed by your prescriber
taking codeine regularly for a long time can lead to addiction, which might cause you to feel
restless and irritable when you stop the tablets
taking a painkiller for headaches too often or for too long can make them worse.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. Especially:
 medicines to treat depression such as monoamine oxidase inhibitors (MAOIs eg moclobemide,
linezolid, selegiline. Avoid Codeine Phosphate tablets for 2 weeks after stopping the MAOI) or
tricyclics (eg amitriptyline)
 ciprofloxacin (antibacterial medicine)
 metoclopramide or domperidone (to prevent sickness)
 mexiletine or quinidine (to treat irregular heartbeats)
 loperamide or kaolin (to treat diarrhoea)
 cimetidine (to treat stomach ulcers)
 medicines used to treat high blood pressure
 antiviral medicines such as ritonavir
 medicines to treat allergies (antihistamines) that can cause drowsiness
 atropine (anticholinergic medicines)
 medicines which affect the nervous system such as chlorpromazine, diazepam, temazepam
 anaesthetics
 opioid antagonists (buprenorphine, naltrexone, naloxone)

Driving and using machines
Codeine Phosphate tablets may make you feel drowsy, confused or dizzy, cause fits, blurred or double
vision or to see things that are not there. Make sure you are not affected before you drive or operate
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 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

Pregnancy and breast-feeding
Do not take Codeine Phosphate tablets during pregnancy unless advised by your doctor. Regular use
during pregnancy may cause withdrawal symptoms in the newborn.
Do not take codeine while you are breastfeeding. Codeine and morphine pass into breast milk. Usually
it is safe to take codeine phosphate while breast feeding as the level 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 taking 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.

Sugar intolerance
If you have been told you have an intolerance to some sugars, contact your doctor before taking this
medicine, as it contains a type of sugar called lactose.


How to take

Always take Codeine Phosphate tablets exactly as your doctor has told you. If you are not sure, check
with your doctor or pharmacist.
Do not drink alcohol whilst taking Codeine Phosphate tablets. Swallow the tablets with water.
Codeine Phosphate tablets are normally used only for short-term relief of symptoms, take this medicine
for as long as your doctor tells you to, it may be dangerous to stop without their advice.
 Adults:
For pain relief – 30 - 60mg every four hours up to a maximum of 240mg a day.
For diarrhoea – 15 - 60mg three to four times a day.
For cough – 15 - 30mg three to four times a day.
 Children aged 12 years or above:
 For pain relief - 30 - 60mg every 6 hours, as needed. Do not take more than 240mg in 24 hours.
This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days,
talk to your doctor for advice.
 Children under 12 years: codeine phosphate should not be taken by children below the age of 12
years, due to the risk of severe breathing problems.Elderly with liver or kidney damage: your
doctor may give you a smaller dose. If you are elderly, it is particularly important to take this
medicine exactly as directed by the doctor.

If you take more than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have
swallowed any contact your nearest hospital casualty department or tell your doctor immediately.
Symptoms of an overdose include feeling or being sick, drowsiness, tiredness, low blood pressure,
pinpoint pupils, slow breathing rate, fast heart rate.

If you forget to take the tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as
you remember it and then take the next dose at the right time.

If you stop taking the tablets
If you stop taking the tablets you may develop the following withdrawal symptoms:
tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood
pressure, restlessness, irritability, anxiety, depression, anorexia, diarrhoea, excessive tears, runny nose,

sneezing, yawning, hair standing on ends, widening of the pupil, weakness, fever, muscle cramps,


Possible side effects

Like all medicines, Codeine Phosphate tablets can cause side effects, although not everybody gets
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
 Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or
flushed face
 Gastrointestinal system - constipation, feeling or being sick, dry mouth, abdominal pain (may be
caused by spasm of the bile ducts)
 Heart - slow or fast heart rate, palpitations, low blood pressure, low blood pressure on standing
 Urinary system - pain and difficulty in passing urine and a less frequent need to do so
 Nervous system - drowsiness, malaise, tiredness, dizziness, ‘spinning’ sensation, fits, increased
pressure in the skull (painful eyes, changes in vision or headache behind the eyes), headache,
tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor,
sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being
sick if the medicine is stopped too quickly)
 Psychiatric effects – mood changes, depression, hallucinations (seeing or hearing things that are
not real), restlessness, excitation, nightmares, confusion
 Eyes - blurred or double vision, extremely small pupils
 Others - muscle stiffness, decrease in sex drive, difficulty breathing, low body temperature.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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:
By reporting side effects you can help provide more information on the safety of this medicine.


How to store

Keep out of the reach and sight of children.
Store below 25°C in a dry place, protected from light
Do not use Codeine Phosphate tablets after the expiry date stated on the label/carton/bottle. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.


Further information

What Codeine Phosphate tablets contain

 The active substance (the ingredient that makes the tablets work) is codeine phosphate. Each tablet
contains either 15mg, 30mg or 60mg of the active ingredient.
 The other ingredients are lactose, magnesium stearate, pregelatinised maize starch, maize starch,
stearic acid.

What Codeine Phosphate tablets look like and contents of the pack
Codeine Phosphate are white, circular, biconvex uncoated tablets.
Pack sizes are 28.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in July 2015

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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.