Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, E91 D768, Ireland
Adults: Moderate to severe pain.
Children 12‐18 years: Co‐Tipol is only suitable for use in children older than 12 years for treatment of acute moderate pain that cannot be relieved by other analgesics such as paracetamol and ibuprofen (alone).
| Age | Single dose | Maximum daily dose (24 hours) |
|---|---|---|
| Adults (18 years and over) | 1‐2 hard capsules (equivalent to 500‐1,000 mg of paracetamol and 30‐60 mg of codeine phosphate hemihydrate) | Up to 8 hard capsules (equivalent to up to 4,000 mg of paracetamol and up to 240 mg of codeine phosphate hemihydrate) |
The maximum daily dose must not be exceeded, and the interval between doses should be at least six hours (if any further capsules are needed).
This product should not be used with other paracetamol or codeine‐containing medicines.
Co‐Tipol should be used at the lowest effective dose for the shortest possible time. This dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose of codeine should not exceed 240mg.
The maximum daily dose of paracetamol should not exceed 60mg/kg/day (up to a maximum of 2g per day) in the following situations, unless directed by a physician:
The dose should be reduced or the interval between doses should be increased in the presence of impaired liver and/or kidney function and in subjects suffering from Gilbert’s syndrome (Meulengracht’s disease). Patients with severe renal impairment (creatinine clearance <10 ml/min) must not exceed a dose interval of at least 8 hours.
A reduced dose may be required (see section 4.4). Experience has indicated that normal adult dosage of paracetamol is usually appropriate. However in frail, immobile, elderly subjects or in elderly patients with renal or hepatic impairment, a reduction in the amount or frequency of dosing may be appropriate.
| Age | Single dose | Maximum daily dose (24 hours) |
|---|---|---|
| Adolescents over 15 years | 1‐2 hard capsules (equivalent to 500‐1,000 mg of paracetamol and 30‐60 mg of codeine phosphate hemihydrate) | Up to 8 hard capsules (equivalent to up to 4,000 mg of paracetamol and up to 240 mg of codeine phosphate hemihydrate) |
| Children aged 12 to 15 years | 1 hard capsule (equivalent to 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate) | Up to 4 hard capsules (equivalent to up to 2,000 mg of paracetamol and up to 120 mg of codeine phosphate hemihydrate) |
Children and adolescents with a low body weight.
The administration of Co‐Tipol 500 mg/30 mg is not recommended for children below 40 kg bodyweight as the dosage strength is not suitable for this patient group.
Co‐Tipol 500 mg/30 mg 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 (see sections 4.3 and 4.4).
The capsules should be swallowed whole with fluid. They should not be taken in a supine position.
Co-Tipol may have a delayed onset of action if the capsules are taken after meals.
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.
The symptoms of an overdose with Co‐Tipol correspond to the manifestations of poisoning with the single agents.
Paracetamol overdose can result in liver damage which may be fatal.
Symptoms generally appear within the first 24 hours and may comprise: nausea, vomiting, anorexia, pallor, and abdominal pain, or patients may be asymptomatic.
Overdose of paracetamol can cause liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.
Liver damage is likely in patients who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite become irreversibly bound to liver tissue.
Some patients may be at increased risk of liver damage from paracetamol toxicity:
Risk factors include;
Acute renal failure with acute tubular necrosis may also develop. Cardiac arrhythmias and pancreatitis have also been reported.
Immediate transfer to hospital.
Blood sampling to determine initial paracetamol plasma concentration. In the case of a single acute overdose, paracetamol plasma concentration should be measured 4 hours post ingestion. Administration of activated charcoal should be considered if the overdose of paracetamol has been ingested within the previous hour.
The antidote N‐acetylcysteine, should be administered as soon as possible in accordance with national treatment guidelines.
Symptomatic treatment should be implemented.
Respiratory depression is a characteristic symptom of codeine overdosage. Furthermore, somnolence including stupor and coma, as well as vomiting, headache, urinary and faecal retention and sometimes bradycardia and a fall in blood pressure may occur. Seizure disorders have been reported occasionally, especially in children.
These symptoms may be intensified by the simultaneous ingestion of alcohol or drugs producing a sedative effect on the CNS. The elderly, patients with liver or renal disease, patients with compromised respiratory function, children under 18 years and ultra‐rapid metaboilisers for CYP2D6 are at a higher risk of toxic symptoms.
Codeine may increase the smooth muscle tone, especially after the ingestion of single doses over 60 mg.
In the event that amounts exceeding 2 mg of codeine per kg bodyweight have been ingested and if the patient develops clinical symptoms, respiration should be monitored and resuscitation should be available until subsidence of symptoms. In the absence of clinical symptoms, these measures should be taken for a period of up to six hours.
The effect of codeine may be blocked in manifest respiratory depression by administration of opiate antagonists such as naloxone. The administration of naloxone is to be repeated because the period of action of codeine lasts longer than that of naloxone. If naloxone cannot be administered, symptomatic measures, in particular, putting the patient in recovery position, ventilation and shock treatment are recommended.
5 years.
Store in the original package to protect from light.
This medicinal product does not require any special temperature storage conditions.
White PVC/aluminium blisters strips containing 10 hard capsules.
Pack sizes: 10, 20, 100 and hospital pack sizes of 200 and 1,000.
Not all pack sizes may be marketed.
No special requirements.
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