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This is a text only leaflet, designed for the visually impaired. Please visit our electronic Medicines Compendium (eMC) website to view the original document which may contain images or tables.

To get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Information line on 0800 198 5000.

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

 

Codeine Phosphate Tablets 15mg, 30mg, 60mg (Actavis UK Ltd)

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
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The MHRA have issued updated advice on non-prescription medicines containing codeine or dihydrocodeine (DHC). This affects all OTC solid dose medicines containing codeine or DHC. The MHRA states that changes to the marketing authorisations need to take place by 31 December 2009, and that packs with the new information should be available within 3-6 months.

Further information can be found on the MHRA website.

 

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

Codeine Phosphate tablets belong to a group of medicines called analgesics and are used for the relief of:

  • mild to moderate pain.
  • symptoms of a dry cough or diarrhoea.
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2 Before you take

Do not take Codeine Phosphate tablets and tell your doctor if you:

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

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.

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.

Pregnancy and breast-feeding

Do not take Codeine Phosphate tablets during pregnancy or whilst breast-feeding, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn.

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 and children over 12 years:
    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 under 12 years: not recommended.
  • 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. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

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.

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

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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

This leaflet was last revised in July 2008

Actavis
Barnstaple
EX32 8NS
UK
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50136045


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