1. Name Of The Medicinal Product
Codis 500
2. Qualitative And Quantitative Composition
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*Equivalent to 6.2mg codeine
3. Pharmaceutical Form
Dispersible tablet
4. Clinical Particulars
4.1 Therapeutic Indications
For the short term treatment of acute, moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone, such as headache, muscular aches, rheumatic pain, toothache, period pains or acute, moderate pain associated with migraine, neuralgia, sprains, strains, sciatica, lumbago, fibrositis, and joint swelling.
4.2 Posology And Method Of Administration
For oral administration, after dissolution in water.
Adults and children 16 years and over: One to two tablets or as directed, dissolved in water. The dose may be repeated after 4 hours: maximum eight tablets in 24 hours in divided doses.
Do not give to children aged under 16 years unless specifically indicated (e.g. Kawasaki's disease).
There is no indication that dosage needs to be modified for the elderly.
Not to be taken more frequently than every 4 hours.
Do not take for more than three days continuously without medical review.
4.3 Contraindications
Not to be given to patients with known allergy to aspirin, suffering from peptic ulceration or haemophilia.
4.4 Special Warnings And Precautions For Use
There is a possible association between aspirin and Reye's Syndrome when given to children. Reye's Syndrome is a very rarer disease which affects the brain and liver and can be fatal. For this reason aspirin should not be given to children aged under 16 years unless specifically indicated (e.g, for Kawasaki's disease). If you are receiving regular medical treatment, are asthmatic, allergic to aspirin or have or have had a stomach ulcer, seek your doctor's advice before taking this product.
The label will include:
Front of pack:
•Can cause addiction
•For three days use only
Back of pack:
•For the short term treatment of acute moderate pain when other painkillers have not worked. Do not take less than four hours after taking other painkillers
•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 labeling on packs intended for public sale will also include the statement “Do not give to children aged under 16 years unless on the advice of a doctor”.
The leaflet will include:
• Headlines section (to be prominently displayed at the start of the PIL)
• 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 2 : Before taking – Do not take
• 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
• Section 3: Dosage
• (In the dosage warning section): 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:
o You need to take the medicine for longer periods of time
o You need to take more than the recommended dose
o When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
May enhance the effects of anticoagulants and inhibit the effects of uricosurics.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
4.6 Pregnancy And Lactation
There is clinical and epidemiological evidence for the safety of aspirin in human pregnancy, but it may prolong labour and contribute to maternal and neonatal bleeding and is best avoided at term in the last trimester of pregnancy and during breastfeeding.
4.7 Effects On Ability To Drive And Use Machines
None known
4.8 Undesirable Effects
May precipitate bronchospasm and include attacks of asthma or hypersensitivity in susceptible subjects, and may include gastrointestinal hemorrhage, occasionally major.
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.
4.9 Overdose
Codeine
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotrophic drugs.
Symptoms
Central nervous system depression, including respiratory depression, may develop, but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible, but unlikely.
Management
This should include general symptomatic and supportive measures, including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within 1 hour of ingestion of more than 350mg or a child more than 5mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least 4 hours after ingestion, or 8 hours if a sustained release preparation has been taken.
Salicylates/Aspirin
Salicylate poisoning is usually associated with plasma concentrations>350mg/L (2.5mmol/L). Most adult deaths occur in patients whose concentrations exceed 700mg/b (5.1mmol/L). Single doses less than 100mg/kg are unlikely to cause serious poisoning.
Symptoms
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of 4 years. In children aged 4 years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopenia, increased INRIPTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.
Central nervous system features, including confusion, disorientation, coma and convulsions, are less common in adults than in children.
Management
Give activated charcoal if an adult presents within 1 hour of ingestion of more than 250mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone, and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous
8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations>700mg/b (5.1mmoIIL), or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Aspirin
Aspirin inhibits the cyclo-oxygenase enzyme involved in conversion of phospholipids to prostaglandins and its effect on the body are believed to result primarily from prevention of prostaglandin production. These effects include peripheral analgesia, fever reduction, reduction in inflammation and inhibition of platelet aggregation.
Codeine
Codeine is an opioid analgesic structurally related to morphine which acts upon the central nervous system and the bowel though specific binding sites. Its actions include analgesia, inhibition of the cough reflex and reduction in gastrointestinal motility.
5.2 Pharmacokinetic Properties
Aspirin
Aspirin is rapidly absorbed from the stomach and upper gastrointestinal tract with peak levels after around 20-30 minutes following dissolution. It is subject to first-pass metabolism with an overall bioavailability of around 70%. Metabolism is by conversion to salicylic acid and then further to other metabolites. These are excreted both free and conjugated mainly by the kidneys. The plasma half-life of aspirin is around 15-20 minutes and of salicylic acid is 2-3 hours.
Codeine
Codeine is well absorbed from the gastrointestinal tract with peak concentrations occurring after around 1 hour. Absorption is rapid and virtually complete with a bioavailability of around 60%. It is metabolised in the liver and excreted mainly in the urine as free and conjugated metabolites. The half-life of codeine in plasma is 2.5-4 hours.
5.3 Preclinical Safety Data
No preclinical findings of relevance to the prescriber have been reported.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Calcium carbonate
Maize starch
Citric acid
Talc
Sodium lauryl sulphate
Saccharin
6.2 Incompatibilities
None known
6.3 Shelf Life
Three years
6.4 Special Precautions For Storage
Store below 30°C in a dry place
6.5 Nature And Contents Of Container
Cardboard carton containing tablets in strips of 30 micron aluminium soft temper foil with the addition of a 12 micron polyester laminate on the unprinted side.
Pack sizes: 8, 12, 16, 24, 32 (Those packs in bold are currently marketed)
6.6 Special Precautions For Disposal And Other Handling
Tablets to be dissolved in water prior to administration
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
8. Marketing Authorisation Number(S)
PL 00063/0012
9. Date Of First Authorisation/Renewal Of The Authorisation
22/05/1995 / 16/09/2005
10. Date Of Revision Of The Text
22/12/2009
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