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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31750/0110 .
Codeine Phosphate Tablets BP 15 mg and 30 mg
Codeine Phosphate Tablets BP 15 mg
Codeine Phosphate Tablets BP 30 mg
Codeine phosphate
1. What Codeine Phosphate Tablets are and what they are used for
2. What you need to know before you take Codeine Phosphate Tablets
3. How to take Codeine Phosphate Tablets
4. Possible side effects
5. How to store Codeine Phosphate Tablets
6. Contents of the pack and other information
This medicine contains codeine phosphate which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
This medicine has been prescribed for adults for relief of pain, relief of coughing and symptomatic relief of prolonged loose stools (diarrhoea) and for 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.
It contains codeine phosphate which belongs to a class of medicines called opioids, which are ‘pain relievers’.
This medicine has been prescribed to you and should not be given to anyone else.
Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
It can be used on its own or in combination with other painkillers such as paracetamol.
Do not use Codeine Phosphate Tablets 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.
Codeine is not recommended in adolescents with compromised respiratory function for the treatment of cough and/or cold.
Talk to your doctor or pharmacist before taking this medicine if you:
Other important warnings:
Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
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.
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Codeine is known to interfere with some medicines. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:
Concomitant use of Codeine Phosphate Tablets and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Codeine Phosphate Tablets together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Do not drink alcohol whilst taking Codeine Phosphate Tablets. Alcohol may increase the sedative effects of Codeine Phosphate Tablets and make you very sleepy.
You can take the tablets regardless of food intake.
Do not take Codeine Phosphate Tablets if you are pregnant or think you might be pregnant, unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.
If you use Codeine Phosphate Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Codeine Phosphate Tablets while you are breastfeeding as codeine phosphate passes into breast milk and will affect your baby. Some women who are at increased risk of developing side effects at any dose may have higher levels of codeine 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, being sick, constipation, poor appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.
Do not drive or operate machinery because you may suffer from confusion, drowsiness, hallucinations (seeing, feeling or hearing things that are not there), blurred or double vision, fits or dizziness. This can affect driving or the operation of machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
This medicine contains lactose monohydrate which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Codeine Phosphate Tablets contain less than 1 mmol sodium (23 mg) per maximum daily dose, that is to say essentially ‘sodium- free’.
Your prescriber should have discussed with you, how long the course of tablets will last.
They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
For the relief of pain
Adults and children over 12 years: 30-60 mg every four hours, when necessary to a maximum of 240 mg daily.
For the relief of coughing
Adults: 15-30 mg three or four times daily.
For the treatment of prolonged diarrhoea
Adults: 15-60 mg every four to six hours. Do not take more than 240 mg in 24 hours.
A lower dosage may be needed if you are an older person who may have liver or kidney problems.
The 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 below the age of 12 years
Codeine Phosphate Tablets should not be taken by children below the age of 12 years due to the risk of severe breathing problems.
Children aged 12 years to 18 years
In children and adolescents between 12 years and 18 years who have problems with their breathing, codeine is not recommended as this population may be more susceptible to breathing problems due to codeine.
Swallow these tablets with water.
If you take too many tablets, you may have symptoms such as feeling or being sick, depression, low blood pressure, pinpoint pupils, slow breathing rate, fast heart rate. Contact your doctor or pharmacist at once for advice.
If you forget to take a dose take it as soon as you remember and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.
Prolonged use can lead to tolerance and dependence on the medicine. Taking codeine regularly for a long time can be habit forming, which might cause you to feel restless and irritable when you stop the tablets. Your doctor will stop your tablets gradually to avoid you having withdrawal symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If the following happens, stop taking Codeine Phosphate Tablets and tell your doctor immediately or contact the casualty department at your nearest hospital
Other side effects
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)
Unknown frequency: dependence and addiction (see section “How do I know if I am addicted?”).
Drug Withdrawal
When you stop taking Codeine Phosphate Tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.
If you notice any of the following signs whilst taking Codeine Phosphate Tablets, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your prescriber
If you get any side effects, talk to your doctor 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton and blister after “EXP”. The expiry date refers to the last day of that month.
Store below 25°C. Store the tablets in the original packaging. Do not put them in another container. For container packaging replace the cap securely after use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Codeine Phosphate 15 mg tablets are white to off white, circular normal biconvex tablets embossed with R114.
Codeine Phosphate 30 mg tablets are white to off white, circular normal biconvex tablets embossed with R115.
The tablets are available in 15 mg and 30 mg strengths and in containers of 1000, 500, 100, 90, 80, 70, 60, 50, 40, 30, 20 and 10 tablets and in blister strips of 100, 90, 80, 70, 60, 50, 40, 30, 28, 20 and 10 tablets.
Not all packs may be marketed.
This leaflet was last revised in June 2021