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Drug Details

Paracodol tablets

• Drug Class Description
  Codeine phosphate hemihydrate (antalgic opioid) / paracetamol (compound analgesics).
• Generic Name
  paracetamol, codeine phosphate hemihydrate
• Presentation
  Soluble Tablet
• Description
  Paracetamol DC : 520.0 mg (equivalent to paracetamol 500.0 mg) Codeine Phosphate Hemihydrate : 8.0 mg
• Indications
  For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. For the treatment of acute moderate pain, including muscular and rheumatic pains, headache, migraine, neuralgia, toothache, period pains, aches and pains.
• Adult Dosage
  

  1 - 2 tablets, which may be repeated every four to six hours with a maximum of 8 tablets in 24 hours.

• Child Dosage
  

  Children under 12 years: Not recommended.

  If symptoms persist for more than 3 days a doctor should be consulted.

  Do not take for more than 3 days continuously without medical review.

• Elderly Dosage
  

  No current evidence for the alteration of the adult dose except where there is impaired hepatic function when dosage reduction may be necessary.

• Contra Indications
  

  Preparations containing paracetamol should be given with care to patients with impaired liver function. Hypersensitivity to paracetamol and/or other constituents.

• Special Precautions
  

  Keep out of the reach of children.

  Warning: Do not exceed the stated dose.

  If symptoms persist, consult you doctor.

  An overdose of paracetamol can cause hepatic necrosis. Preparations containing paracetamol should be given with care to patients with impaired renal and liver function. The hazards of overdose are greater in those with alcoholic liver disease.

  Do not take with any other paracetamol - containing products. Immediate medical advice should be sought in the event of an overdose even if you feel well because of the risk of delayed, serious liver damage.

  Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the Caucasian population may be ultra-rapid metabolisers.

   

  The label will state:

  Front of Pack

  • Can cause addiction

  • For three days use only

  Back of Pack

  • This medicine can only be used for the short term treatment of acute moderate pain when other pain killers have not worked. If you have already taken another pain killer wait at least four hours before taking this medicine. For relief from muscular and rheumatic pains, headache, migraine, neuralgia, toothache, period pain, aches and pains.

  • If you need to take this medicine continuously for more than three days you should see your doctor or pharmacist

  • This medicine contains codeine which can cause addiction if you take it continuously for more than three days. If you take this medicine for headaches for more than three days it can make them worse

   

  The leaflet will state:

  Headlines section (to be prominently displayed)

  • This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

  • You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice

  • This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it

  • If you take this medicine for headaches for more than three days it can make them worse

  Section 1: What the medicine is for

  • This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This includes muscular and rheumatic pains, headache, migraine, neuralgia, toothache, period pain, aches and pains.

  Section 2: Before taking

  • This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it

  • If you take a painkiller for headaches for more than three days it can make them worse

  The leaflet will state in the 'Pregnancy and breast-feeding' subsection of section 2 'Before taking your medicine':

  Usually it is safe to take Paracodol Capsules while breast feeding as the levels 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.

  Section 3: Dosage

  • Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist

  • This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

  Section 4: Side effects

  • Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.

  How do I know if I am addicted?

  If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

  • You need to take the medicine for longer periods of time

  • You need to take more than the recommended dose

  • When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again

• Interactions
  

  Paracetamol should be given with care to patients taking other drugs which affect the liver.

  The speed of absorbtion of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

  The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding: Occasional doses have no significant effect.

• Adverse Drug Reactions
  

  Codeine may sometimes cause constipation.

  Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been some reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but there were not necessarily causally related to paracetamol.

  Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.

  Prolonged use of a painkiller for headaches can make them worse.