Codeine Phosphate Tablets Bp 15mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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. 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.
In this leaflet:
1. What Codeine Phosphate Tablets are and what they are used for
2. 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. Further information
1. 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 painkillers such as paracetamol.
Codeine can be used in adults and 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 take Codeine Phosphate Tablets
Do not take these tablets if:
• you are allergic to codeine or any other opioid analgesic or to any of the other ingredients (See Section 6)
• you suffer from any kind of lung disease, have difficulty in breathing, or are having an asthma attack
• you suffer from diarrhoea due to pseudomembraneous colitis or poisoning
• you suffer from severe liver disease
• you are at risk from a blocked intestine
• you have a head injury or pressure on the brain
• you are addicted to alcohol
• you know that you metabolise very rapidly codeine into morphine
• you are breastfeeding
• do not use 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 tablets should not be given to anyone who is unconscious.
Check with your doctor before taking these tablets if:
• you have kidney or liver disease, or any bowel problems
• you have asthma or any lung problems
• you have low blood pressure, are in a state of shock, or feel weak and feeble
• you have an enlarged prostate (in men)
• you have difficulty passing urine
• you suffer with convulsions (fits)
• you have an underactive thyroid or adrenal glands
• you have a history of drug abuse or dependence taking this medicine.
Taking other medicines:
Check with your doctor or pharmacist before taking these tablets if you are taking any other medicines, including any that you can buy without a prescription. This is particularly important if you are taking:
• medicines to treat diarrhoea and peristalsis e.g. difenoxin, atropine, kaolin, pectin, belladonna alkaloids, opium preparations and loperamide
• medicines to treat high blood pressure e.g. guanethidine and diuretics (water tablets)
• medicines to treat stomach spasms or cramps e.g. metoclopramide, or domperidone to treat nausea and vomiting
• cimetidine to treat stomach ulcers
• medicines which are Central Nervous System (CNS) depressants (medicines which slow down the nervous system, possibly causing drowsiness) e.g. chlorpromazine, diazepam, temazepam
• moclobemide, tricyclic antidepressants (e.g. amitriptyline) or are taking, or have taken a monoamine oxidase inhibitor (e.g. phenelzine) in the last 2 weeks, all of which are used to treat depressive illness.
If you are going to have an anaesthetic make sure you tell the doctor or dentist you are taking codeine.
Other special 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.
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.
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.
Pregnancy and breastfeeding:
Consult your doctor if you are pregnant or think you may be pregnant. Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.
Driving and using machines:
The medicine can affect your ability to drive and operate machinery as it may make you sleepy or dizzy or may cause confusion, fits, eyesight problems or hallucinations (seeing or hearing things that are not real).
• 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 medicine.
Alcohol:
Avoid drinking alcohol while you are taking this medicine. Important information about an ingredient of Codeine Phosphate Tablets:
It contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Codeine Phosphate Tablets
The tablets should be swallowed with a drink of water.
The usual doses are given below but your doctor has decided the dose which is best for you. Always follow your doctor’s instructions. The pharmacist’s label will tell you how many tablets to take and how often to take them. If you are not sure about anything, ask your doctor or pharmacist.
Adults, the elderly and children over 12 years: Take 30-60mg every 6 hours, as needed. Do not take more than 240mg in 24 hours.
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.
For children under 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.
DO NOT EXCEED THE RECOMMENDED DOSE If you have taken too many tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
If you forget to take a dose:
Take your dose as soon as you remember and then your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSES.
If you stop taking the tablets:
If you wish to stop taking the tablets consult your doctor who will advise you how to reduce the dose slowly. If you stop taking the tablets suddenly you may experience withdrawal effects such as feeling restless or irritable. If you experience any of these effects or any other side effects (see section 4) whilst stopping taking the tablets, please speak to your doctor.
4. Possible side effects
Like all medicines, codeine phosphate can cause side effects, although not everybody gets them.
If you experience any of the following contact your doctor or go to a hospital immediately:
• allergic reaction such as hives, itching, skin rashes, swelling of the face, shortness of breath, difficulty in breathing
• convulsions
• slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite as these could be symptoms of high amounts of morphine.
Also tell your doctor straight away if you notice any of the following effects:
• inflammation of the pancreas causing severe pain in the abdomen and back
• mental depression, hallucinations (seeing or hearing things that are not real), unusual excitement in children
• uncontrolled muscular movements, tremors
• muscle rigidity
• irregular heartbeat
• visual disturbance (e.g. blurred or double vision)
• difficulty or pain in urination.
Other side effects include:
• dry mouth, stomach pain, stomach cramps
• low blood pressure, feeling of dizziness or spinning, or feeling light headed or faint on standing up
• mood changes, feeling anxious, uneasy or very happy, restlessness
• dizziness, headache
• sweating, flushing
• slower or faster heartbeat or feeling your heart beat
• decrease in sex drive
• nightmares
• rarely, loss of hearing.
Development of tolerance, psychological and physical dependence may occur especially if large doses are taken. 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: 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 Tablets
Keep this medicine in the pack provided and protect from heat, light and moisture.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information
Ingredients:
Codeine Phosphate Tablets contain either 15mg, 30mg or 60mg of codeine phosphate as the active ingredient.
The other ingredients are: maize starch, lactose, sodium laurilsulfate (not in the 15mg tablets), talc and magnesium stearate.
What the medicine looks like:
Codeine Phosphate 15mg tablets are white, round, tablets engraved on one side with the company logo and A023 on the other. Codeine Phosphate 30mg tablets are white, round, tablets engraved on one side with the company logo and A024 on the other. Codeine Phosphate 60mg tablets are white, round, tablets engraved on one side with the company logo and A025 on the other. The medicine is available in pack sizes of 28, 30, 42, 50, 56, 84, 100, 112, 250, 500 and 1,000 tablets. (Not all pack sizes may be marketed).
Who makes this medicine and holds the product licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants,
RG253ED
Date leaflet prepared: February 2014 If you would like this leaflet in a different format please contact the licence holder at the above address.
PATIENT INFORMATION LEAFLET
CODEINE PHOSPHATE
Tablets I 5mg, 30mg and 60mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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. 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.
In this leaflet:
1. What Codeine Phosphate Tablets are and what they are used for
2. 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. Further information
1. 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 painkillers such as paracetamol.
Codeine can be used in adults and 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 take Codeine Phosphate Tablets
Do not take these tablets if:
• you are allergic to codeine or any other opioid analgesic or to any of the other ingredients (See Section 6)
• you suffer from any kind of lung disease, have difficulty in breathing, or are having an asthma attack
• you suffer from diarrhoea due to pseudomembraneous colitis or poisoning
• you suffer from severe liver disease
• you are at risk from a blocked intestine
• you have a head injury or pressure on the brain
• you are addicted to alcohol
• you know that you metabolise very rapidly codeine into morphine
• you are breastfeeding
• do not use 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 tablets should not be given to anyone who is unconscious.
Check with your doctor before taking these tablets if:
• you have kidney or liver disease, or any bowel problems
• you have asthma or any lung problems
• you have low blood pressure, are in a state of shock, or feel weak and feeble
• you have an enlarged prostate (in men)
• you have difficulty passing urine
• you suffer with convulsions (fits)
• you have an underactive thyroid or adrenal glands
• you have a history of drug abuse or dependence taking this medicine.
Taking other medicines:
Check with your doctor or pharmacist before taking these tablets if you are taking any other medicines, including any that you can buy without a prescription. This is particularly important if you are taking:
• medicines to treat diarrhoea and peristalsis e.g. difenoxin, atropine, kaolin, pectin, belladonna alkaloids, opium preparations and loperamide
• medicines to treat high blood pressure e.g. guanethidine and diuretics (water tablets)
• medicines to treat stomach spasms or cramps e.g. metoclopramide, or domperidone to treat nausea and vomiting
• cimetidine to treat stomach ulcers
• medicines which are Central Nervous System (CNS) depressants (medicines which slow down the nervous system, possibly causing drowsiness)
e.g. chlorpromazine, diazepam, temazepam
• moclobemide, tricyclic antidepressants (e.g. amitriptyline) or are taking, or have taken a monoamine oxidase inhibitor (e.g. phenelzine) in the last 2 weeks, all of which are used to treat depressive illness.
If you are going to have an anaesthetic make sure you tell the doctor or dentist you are taking codeine.
Other special 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. 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.
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.
Pregnancy and breastfeeding:
Consult your doctor if you are pregnant or think you may be pregnant. Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.
Driving and using machines:
The medicine can affect your ability to drive and operate machinery as it may make you sleepy or dizzy or may cause confusion, fits, eyesight problems or hallucinations (seeing or hearing things that are not real).
^ • 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, o
a.
■ 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 medicine.
Alcohol:
Avoid drinking alcohol while you are taking this medicine.
Important information about an ingredient of Codeine Phosphate Tablets:
It contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Codeine Phosphate Tablets
The tablets should be swallowed with a drink of water.
The usual doses are given below but your doctor has decided the dose which is best for you. Always follow your doctor’s instructions. The pharmacist’s label will tell you how many tablets to take and how often to take them. If you are not sure about anything, ask your doctor or pharmacist.
Adults, the elderly and children over 12 years: Take 30-60mg every 6 hours, as needed. Do not take more than 240mg in 24 hours.
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.
For children under 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.
DO NOT EXCEED THE RECOMMENDED DOSE If you have taken too many tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified. If you forget to take a dose:
Take your dose as soon as you remember and then your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSES.
If you stop taking the tablets:
If you wish to stop taking the tablets consult your doctor who will advise you how to reduce the dose slowly. If you stop taking the tablets suddenly you may experience withdrawal effects such as feeling restless or irritable. If you experience any of these effects or any other side effects (see section 4) whilst stopping taking the tablets, please speak to your doctor.
4. Possible side effects
Like all medicines, codeine phosphate can cause side effects, although not everybody gets them.
If you experience any of the following contact your doctor or go to a hospital immediately:
• allergic reaction such as hives, itching, skin rashes, swelling of the face, shortness of breath, difficulty in breathing
• convulsions
• slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite as these could be symptoms of high amounts of morphine.
Also tell your doctor straight away if you notice any of the following effects:
• inflammation of the pancreas causing severe pain in the abdomen and back
• mental depression, hallucinations (seeing or hearing things that are not real), unusual excitement in children
• uncontrolled muscular movements, tremors
• muscle rigidity
• irregular heartbeat
• visual disturbance (e.g. blurred or double vision)
• difficulty or pain in urination.
Other side effects include:
• dry mouth, stomach pain, stomach cramps
• low blood pressure, feeling of dizziness or spinning, or feeling light headed or faint on standing up
■ mood changes, feeling anxious, uneasy or very happy, restlessness
• dizziness, headache
■ sweating, flushing
• slower or faster heartbeat or feeling your heart beat
• decrease in sex drive
• nightmares
• rarely, loss of hearing.
Development of tolerance, psychological and physical dependence may occur especially if large doses are taken.
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: 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 Tablets
Keep this medicine in the pack provided and protect from heat, light and moisture.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information
Ingredients:
Codeine Phosphate Tablets contain either 15mg, 30mg or 60mg of codeine phosphate as the active ingredient. The other ingredients are: maize starch, lactose, sodium laurilsulfate (not in the 15mg tablets), talc and magnesium stearate.
What the medicine looks like:
Codeine Phosphate 15mg tablets are white, round, tablets engraved on one side with the company logo and A023 on the other. Codeine Phosphate 30mg tablets are white, round, tablets engraved on one side with the company logo and A024 on the other. Codeine Phosphate 60mg tablets are white, round, tablets engraved on one side with the company logo and A025 on the other. The medicine is available in pack sizes of 28, 30, 42, 50, 56, 84, 100, 112, 250, 500 and 1,000 tablets. (Not all pack sizes may be marketed).
Who makes this medicine and holds the product licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Date leaflet prepared: February 2014
^ If you would like this leaflet in a different format please contact the lo licence holder at the above address.
o
o.