Codipar Tablets

• The usual dose is one or two tablets every four hours as required. The total daily dose should not exceed 4g paracetamol (8 tablets in a day).
• Codeine should be used at the lowest effective dose for the shortest period of time. This dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose should not exceed 240 mg.
• The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.

Elderly:

• A reduced dosage may be necessary.

Paediatric population:

Children aged 12 years to 18 years:

• “The recommended codeine dose for children 12 years and older should be 30 to 60 mg every 4-6 hours when necessary up to a maximum dose of 240 mg daily. The dose is based on the body weight (0.5-1mg/kg).”

Children aged less than 12 years:

• “Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine.
• Dosage needs to be adjusted according to the severity of pain and the response of the patient.

Method of administration: Oral.

Contraindications

• Hypersensitivity to either Paracetamol or codeine, or any of the excipients of Copaz tablets.
• Children under 12 years of age.
• Patients who have taken MAOIs within 14 days.
• Severe renal or hepatic impairment.
• Copaz is contraindicated in patients for whom opiate medications are contraindicated.
• This will include some patients with acute asthma, obstructive airway disease, respiratory depression, acute alcoholism, head injuries, raised intracranial pressure and following biliary surgery.
• In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life threatening adverse reactions 
• In women during breastfeeding 
• In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers

Interactions

• The hypotensive effects of antihypertensive agents, including diuretics, may be potentiated by codeine.
• Quinine or quinidine may inhibit the analgesic actions of codeine.
• The CNS depressant action of Zapaain may be enhanced by coadministration with any other drug which has a CNS depressant effect (eg. anxiolytics, hypnotics, antidepressants, antipsychotics and alcohol). Concomitant use of any drug with a CNS depressant action should be avoided. If combined therapy is necessary, the dose of one or both agents should be reduced.
• Concomitant administration of Copaz and MAOIs or tricyclic antidepressants may increase the effect of either the antidepressant or codeine.
• Concomitant administration of codeine and anticholinergics may cause paralytic ileus. Concomitant administration of codeine with an anti-diarrhoel agent increases the risk of severe constipation, and coadministration with an antimuscarine drug may cause urinary retention.
• The absorption of paracetamol is speeded by metaclopramide or domperidone, and absorption is reduced by cholestyramine.
• Codeine may delay the absorption of mexilitine, and cimetidine may inhibit codeine metabolism.
• Opioids may interfere with the results of plasma amylase, lipase, bilirubin, ALP, LDH, AST, and ALT tests
• The effects of codeine on the gut may interfere with diagnostic tests of gastrointestinal functions.
• The anticoagulant effect of warfarin and other coumarins may be increased by long term regular daily use of paracetamol, with increased risk of bleeding.
• Occasional doses of paracetamol do not have a significant effect on these anticoagulants.

Side effects

• The commonest side effects of codeine are nausea, vomiting, light headaches, dizziness, sedation, shortness of breath and constipation. Some of these side effects appear more common in ambulatory: rather than non-ambulatory patients. Lying down may alleviate these effects they occur. In addition, miosis, visual disturbances, headache, bradycardia, respiratory depression, difficult micturition and urinary retention, and allergic reactions (including skin rash) can occur.
• Codeine can cause respiratory depression particularly in overdosage and in patients with compromised respiratory function.
• Euphoria, dysphoria, abdominal pain, and pruritus can occur as reactions to Copaz.
• Liver damage in association with therapeutic use of paracetamol has been documented; most cases have occurred in conjunction with chronic alcohol abuse.
• There have been some reports of blood dyscrasias – thrombocytopenia and agranulocytosis, with the use of paracetamol-containing products, but the causal relationship has not been established.
• Regular prolonged use of codeine/DHC is known to lead to addiction and symptoms of restlessness andirritability may result when treatment is then stopped.
• Prolonged use of a pain killer for headaches can make them worse.

Fertility, pregnancy and lactation

• Copipar is not recommended during pregnancy.
• Use during pregnancy may lead to withdrawal syndromes in neonates, and use during labour may cause neonatal respiratory depression.
• Codeine crosses the placenta and is found in breast milk.
• The use of codeine is contraindicated during breastfeeding.
• At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breast-fed infant. However, if the patient is an ultra rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children
Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

https://www.medicines.org.uk/emc/medicine/22901

https://www.hpra.ie/img/uploaded/swedocuments/2139406.PA0899_033_002.74a2e515-5d4c-465b-a06f-637dadc624e1.000001Product%20Leaflet%20Approved.141031.pdf

http://www.netdoctor.co.uk/medicines/aches-and-pains/a26365/co-codamol-uses-and-action/

http://www.drugs.com/uk/codipar-15mg-500mg-tablets-leaflet.html

http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con094130.pdf