Codeine Phosphate Tablets Bp 15mg
24 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER_
CODEINE PHOSPHATE TABLETS BP 15MG CODEINE PHOSPHATE TABLETS BP 30MG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Codeine Phosphate is and what it is used for
2. What you need to know before you take Codeine Phosphate
3. How to take Codeine Phosphate
4. Possible side effects
5. How to store codeine Phosphate
6. Contents of the pack and other information
1. What Codeine Phosphate is and what it is used for
Codeine Phosphate 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. Codeine phosphate is used for symptomatic relief of dry cough and diarrhoea.
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.
| 2. What you need to know before you take Codeine Phosphate | Do not take codeine phosphate:
• 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 breast feeding
• For longer periods 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 regularly for headaches too often or for too long can make them worse.
• If you have ever been told you are allergic to codeine phosphate, other similar
(opioid) pain killers and/or any of the ingredients in the tablet (see Section 6)
• If you have breathing problems, or other chronic lung disease
• If you suffer with alcoholism or liver failure
• 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 are at a risk of blocked intestines
• If you are under 12 years old
• If you are unconscious
• If you have severe stomach cramps caused by a condition known as biliary colic
• If you are suffering from severe diarrhoea Warnings and Precautions
Check with your doctor or pharmacist before taking this medicine if you:
• have kidney or liver problems
• are older or frail
• have suffered from alcoholism, drug abuse or dependence or mental illness
• have low blood pressure or an under-active thyroid gland or are in shock
• have diseased adrenal glands (Addison's disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma)
• have an enlarged prostate gland and have difficulty in passing urine
• have inflammatory bowel disease including severe bloody diarrhoea (pseudomembranous colitis)
• have gall bladder disease or gall stones
• recently had surgery on your gastro-intestinal tract or urinary system
• suffer from muscle weakness (myasthenia gravis) or asthma or breathing problems
• have a history of seizures or fits (epilepsy)
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 Phosphate 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 Phosphate 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 Phosphate is not recommended in adolescents with compromised respiratory function for the treatment of cough.
Other medicines and Codeine Phosphate
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 e.g. moclobemide, linezolid, selegiline. Avoid Codeine Phosphate tablets for 2 weeks after stopping the MAOI) or trycydics (e.g. 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 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 (hypnotics, sedatives, antipsychotics)
• anaesthetics
• opioid antagonists (buprenorphine, naltrexone, naloxone)
• sodium oxybate (used to treat narcolepsy)
Codeine Phosphate with food, drink and alcohol
• DO NOT drink alcohol whilst taking Codeine Phosphate tablets.
Pregnancy, breast-feeding and fertility
• Do not take Codeine Phosphate tablets during pregnancy or while you are breastfeeding. Codeine and morphine passes into breast milk.
• Regular use during pregnancy may cause withdrawal symptoms in the new born.
• Always ask your doctor or pharmacist for advice before taking any other medicine. Driving and using machines
These tablets may make you feel confused, cause fits, blurred vision or double vision or to see things that are not there.
Codeine Phosphate 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 ifthis medicine affects your ability to drive. |
• However, you would not be committing an offence if: 1
- 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.
If you feel that your reactions are affected, do not operate machinery.
Codeine Phosphate tablets contain Lactose
If you have been told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.
| 3. How to take Codeine Phosphate |
• Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Swallow the tablets with water.
• 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.
The usual dose is as follows:
ADULTS AND CHILDREN OVER 12 YEARS:
• For the relief of mild to moderate pain: Children aged 12 years and above should take 30-60mg every 6 hours, as needed. Do not take more than 240mg in 24 hours.
• For the relief of diarrhoea: 15 - 60mg three to four times daily up to a maximum of 240mg daily.
• For cough: 15-30mg three to four times a day. Codeine phosphate is not recommended in adolescents over 12 years with compromised respiratory function for the treatment of cough.
• Elderly with liver or kidney damage: If you are elderly and have liver or kidney damage your doctor may give you a smaller dose. It is particularly important to take this medicine exactly as directed by the doctor.
Do not exceed the stated dose.
Codeine Phosphate should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.
If you take more Codeine Phosphate tablets 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 a dose of Codeine Phosphate tablets
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.
DO NOT TAKE ADOUBLE DOSE TO MAKE UP FORAFORGOTTEN DOSE.
If you stop taking these tablets
Do not stop taking these tablets without talking to your doctor. Treatment should continue for as long as your doctor feels it is needed.
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, dehydration.
| 4. Possible side effects |
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• Allergic reactions - Oedema, skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face,fluid retention (e.g. swollen ankles and feet)
• Gastrointestinal system - constipation, feeling or being sick, dry mouth, abdominal pain (including pain caused by inflammation of the pancreas (pancreatitis)), anorexia,loss of appetite
• Liver-bile duct problems - biliary spasm
• Heart - slow or fast heart rate, palpitations, low blood pressure, low blood pressure on standing
• Urinary system - pain and difficulty in passing urine and less frequent need to do so
• Nervous system - drowsiness, malaise, tiredness, dizziness, fits, increased pressure in the skull (painful eyes, change in vision or headache behind the eye), 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 effect - 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: www.mhra.gov.uk/yellowcarrt. By reporting side effects you can help provide more information on the safety of this medicine.
| 5. How to store Codeine Phosphate |
• Keep this medicine out of the sight and reach of children.
• Containers: Do not store above 250C. Store in the original container and keep the container tightly closed.
• Blister packs: Do not store above 25°C. Store in the original package.
• Do not use these tablets after the expiry date which is stated on the carton or label. The expiry date refers to the last day of that month.
• 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.
| 6. Contents of the pack and other information |
What Codeine Phosphate tablets contain
• The active substance is codeine phosphate.
• The other ingredients are: lactose and stearic acid.
• Codeine Phosphate tablets come in two strengths. Each tablet contains either 15mg or 30mg of the active ingredient codeine phosphate.
What Codeine Phosphate tablets look like and contents of the pack
• The tablets are smooth, round, flat faced, bevelled edge plain white to off white
• They are available in packs of 14, 25, 28, 30, 50, 56, 60, 84, 100, 250, 500 or 1000.
• Not all packsizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
E-mail:
Codeine Phosphate Tablets BP 15mg; PL 17907/0168 Codeine Phosphate Tablets BP 30mg ; PL 17907/0169 This leaflet was last revised in March 2016
To request a copy of this leaflet in Braille, large print or audio format then please contact x the licence holder at the address (or telephone, fax, email) above.
V26 17-03-16 D0 S