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The product codes for this leaflet are: PL 00142/6459R, PL 00142/6548R, PL 00142/6458R

 

Codeine Phosphate Tablets 15mg, 30mg, 60mg

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:medinfo@actavis.co.uk
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PATIENT INFORMATION LEAFLET

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.

Index

1 What Codeine Phosphate tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

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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 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.
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2 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.
  • 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 have:

  • 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
  • epilepsy
  • 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 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.

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 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:
    • 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.

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 passes 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.

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3 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.

Doses:

  • 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, dehydration.

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4 Possible side effects

Like all medicines, Codeine Phosphate tablets 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 - 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: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

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5 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.

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6 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
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This leaflet was last revised in May 2014

AAAG9079 50808876


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