CODIPAR 15MG/500MG CAPSULES
Active substance: PARACETAMOL
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Codipar 15mg/500mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Paracetamol 500mg, and Codeine Phosphate 15mg.
3
PHARMACEUTICAL FORM
Capsule red (cap) and white (body) coloured hard gelatine capsules (size 0) filled with a homogenous white powder
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the relief of moderate pain
4.2
Posology and method of administration Method of administration: Oral Adults: The usual dose is one or two capsules every four hours as required. The total daily dose should not exceed 4 g paracetamol (8 capsules in a day). Elderly: A reduced dosage may be necessary. Children: Not recommended in children below the age of 12 years. Dosage needs to be adjusted according to the severity of pain and the response of the patient. Tolerance to Codeine can develop with continued use. The incidence of unwanted effects is dose related. Doses of Codeine above 60 mg are associated with an increase in unwanted effects.
4.3
Contraindications Hypersensitivity to either paracetamol or codeine, or any of the excipients of Codipar capsules.
Children under 12 years of age. Codipar is contraindicated in patients with moderate to severe degrees of renal or hepatic impairment. It is contraindicated in patients for whom opiate medications should not be used, such as patients with acute asthma, obstructive airway disease, respiratory depression, acute alcoholism, head injuries, raised intracranial pressure, after biliary surgery, patients suffering from diarrhoea of any cause, and patients who have taken MAOIs within 14 days.
4.4
Special warnings and precautions for use The efficacy and safety of Codipar capsules in children below the age of 12 years has not been established, and use in such children is contraindicated. Codipar capsules must be used with caution in patients with increases intracranial pressure, acute abdominal conditions, the elderly, the debilitated, impaired hepatic or renal function, hypothyroidism, Addisons disease, prostatic hypertrophy, and urethral stricture. (See also Contraindications. Note particularly that Codipar is contraindicated in patients with severe renal or hepatic impairment.) 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 ultrarapid 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. Overdosage in patients with non-cirrhotic alcoholic liver disease can be hazardous. The hazard of paracetamol overdose is greater in those with alcoholic liver disease. Codeine at high doses has the same disadvantages as morphine, including respiratory depression. Drug dependence of the morphine type can be produced by the Codeine, and the potential for drug abuse with codeine must be considered. Codeine may impair mental or physical abilities required in the performance of potentially hazardous tasks. Patients must be advised not to exceed the recommended doses. Tolerance to Codeine can develop with continued use. The incidence of unwanted effects is dose related. The risk-benefit of continued use should be assessed regularly by the prescriber.
The leaflet will state in a prominent position in the before taking section 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 taking the capsules. Taking a painkiller for headaches too often or for too long can make them worse.
The label will state (To be displayed prominently on outer pack- not boxed): Do not take for longer than directed by you prescriber as taking codeine regularly for a long time can lead to addiction. Patients must be advised not to take other products containing paracetamol or opiate derivatives when taking Codipar, and to consult their doctor if symptoms persist. The cough suppressant effect of codeine may be undesirable in patients with some respiratory conditions. The leaflet will state in the Pregnancy and breast-feeding subsection of section 2 Before taking your medicine: Usually it is safe to take Codipar 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. 4.5 Interaction with other medicinal products and other forms of interaction 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 Codipar may be enhanced by coadministration with any other drug which has a CNS depressant effect (e.g. 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 Codipar 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-diarrhoeal agent increases the risk of severe constipation, and coadministartion with an antimuscarine drug may cause urinary retention. The absorption of paracetamol is speeded by metaclopramide or domperidone, and absorption is reduced by colestyramine. 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.
4.6
Pregnancy and lactation Codipar is not recommended during pregnancy At normal therapeutic doses codeine and its active metabolites 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 the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant. If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects. Use during pregnancy may lead to withdrawal syndromes in neonates, and use during labour may cause neonatal respiratory depression.
Paracetamol is excreted in breast milk but not in a clinically significant amount.
4.7
Effects on ability to drive and use machines Patients should be advised not to drive or operate machinery if Codipar causes dizziness or sedation. Codeine may cause visual disturbances.
4.8
Undesirable effects The commonest side effects of codeine are nausea, vomiting, light headedness, dizziness, sedation, shortness of breath and constipation. Some of these side effects appear more commonly in ambulatory rather than non-ambulatory patients. Lying down may alleviate these effects if they occur. In addition, miosis, visual disturbances, headache, bradycardia, respiratory depression, difficult micturition and urinary retention, and allergic reaction (including skin rash) can occur. Codeine can cause respiratory depression particularly in overdosage and in patients with compromised respiratory function. Euphoria, dysphoria, constipation, abdominal pain, and pruritus can occur as reactions to Codipar. 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 argranulocytosis, with the use of paracetamol- containing products, but the causal relationship has not been established. 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 pain killer for headaches can make them worse.
4.9
Overdose Paracetamol Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below). Risk Factors: If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St Johns Wort or other drugs that induce liver enzymes. Or b, Regularly consumes ethanol in excess of recommended amounts. Or c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. Symptoms Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Management Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable) but results should not delay initiation of treatment beyond 8 hours after ingestion, as the effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Codeine The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs. Symptoms Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been coingested, 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 one hour of ingestion of more than 350 mg or a child more than 5 mg/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 four hours after ingestion, or eight hours if a sustained release preparation has been taken.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Paracetamol (N02B E51) has analgesic and antipyretic actions. It is a weak inhibitor of prostaglandin biosynthesis. Single or repeated therapeutic doses of paracetamol do not affect the cardiovascular or respiratory systems. Gastric irritation, erosion, or bleeding is not produced by paracetamol. There is minimal effect on platelets, no effect on bleeding time or excretion of uric acid. Codeine (N02A A59) is an analgesic with similar uses to morphine, but only mild sedative effects. Codeine effects the CNS and the gut, including analgesia, drowsiness, mood changes, respiratory depression, reduced gastrointestinal motility, nausea or vomiting, changes in the endocrine and autonomic nervous system. Codeines effect on pain relief is selective, and it does not effect other sensations such as touch, vibration, vision, or hearing.
5.2
Pharmacokinetic properties Paracetamol is readily absorbed from the gastro-intestinal tract. It is metabolised in the liver and undergoes extensive biotransformation. The major metabolites are inactive phenolic sulphate and glucuronide conjugates. An adequate supply of SH groups can prevent hepatic toxicity. Paracetamol is excreted in the urine. The elimination half life varies from about 1 to 4 hours. Codeine is absorbed from the gastro-intestinal tract and peak plasma concentrations are produced in about 1hour. It is metabolised in the liver to morphine and norcodeines. Codeine and its metabolites are excreted almost entirely by the kidney. The plasma half line is between 3 and 4 hours.
5.3
Preclinical safety data There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Maize Starch Sodium Lauryl sulfate Cross carmellose sodium Purified Talc Magnesium Stearate Gelatin Titanium dioxide E171 Erythrosine E127 Red Iron Oxide E172
6.2
Incompatibilities None relevant
6.3
Shelf life 24 months
6.4
Special precautions for storage Do not store above 25C
6.5
Nature and contents of container Blister strips of PVDC coated PVC /Aluminium , 10 capsules per strip In pack size of 30, 32 or 100 capsules.
6.6
Special precautions for disposal None
7
MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK
8
MARKETING AUTHORISATION NUMBER(S)
PL 12762/0413
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/09/2010
10
DATE OF REVISION OF THE TEXT
03/09/2012
1
NAME OF THE MEDICINAL PRODUCT
Codipar 15mg/500mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Paracetamol 500mg, and Codeine Phosphate 15mg.
3
PHARMACEUTICAL FORM
Capsule red (cap) and white (body) coloured hard gelatine capsules (size 0) filled with a homogenous white powder
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the relief of moderate pain
4.2
Posology and method of administration Method of administration: Oral Adults: The usual dose is one or two capsules every four hours as required. The total daily dose should not exceed 4 g paracetamol (8 capsules in a day). Elderly: A reduced dosage may be necessary. Children: Not recommended in children below the age of 12 years. Dosage needs to be adjusted according to the severity of pain and the response of the patient. Tolerance to Codeine can develop with continued use. The incidence of unwanted effects is dose related. Doses of Codeine above 60 mg are associated with an increase in unwanted effects.
4.3
Contraindications Hypersensitivity to either paracetamol or codeine, or any of the excipients of Codipar capsules.
Children under 12 years of age. Codipar is contraindicated in patients with moderate to severe degrees of renal or hepatic impairment. It is contraindicated in patients for whom opiate medications should not be used, such as patients with acute asthma, obstructive airway disease, respiratory depression, acute alcoholism, head injuries, raised intracranial pressure, after biliary surgery, patients suffering from diarrhoea of any cause, and patients who have taken MAOIs within 14 days.
4.4
Special warnings and precautions for use The efficacy and safety of Codipar capsules in children below the age of 12 years has not been established, and use in such children is contraindicated. Codipar capsules must be used with caution in patients with increases intracranial pressure, acute abdominal conditions, the elderly, the debilitated, impaired hepatic or renal function, hypothyroidism, Addisons disease, prostatic hypertrophy, and urethral stricture. (See also Contraindications. Note particularly that Codipar is contraindicated in patients with severe renal or hepatic impairment.) 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 ultrarapid 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. Overdosage in patients with non-cirrhotic alcoholic liver disease can be hazardous. The hazard of paracetamol overdose is greater in those with alcoholic liver disease. Codeine at high doses has the same disadvantages as morphine, including respiratory depression. Drug dependence of the morphine type can be produced by the Codeine, and the potential for drug abuse with codeine must be considered. Codeine may impair mental or physical abilities required in the performance of potentially hazardous tasks. Patients must be advised not to exceed the recommended doses. Tolerance to Codeine can develop with continued use. The incidence of unwanted effects is dose related. The risk-benefit of continued use should be assessed regularly by the prescriber.
The leaflet will state in a prominent position in the before taking section 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 taking the capsules. Taking a painkiller for headaches too often or for too long can make them worse.
The label will state (To be displayed prominently on outer pack- not boxed): Do not take for longer than directed by you prescriber as taking codeine regularly for a long time can lead to addiction. Patients must be advised not to take other products containing paracetamol or opiate derivatives when taking Codipar, and to consult their doctor if symptoms persist. The cough suppressant effect of codeine may be undesirable in patients with some respiratory conditions. The leaflet will state in the Pregnancy and breast-feeding subsection of section 2 Before taking your medicine: Usually it is safe to take Codipar 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. 4.5 Interaction with other medicinal products and other forms of interaction 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 Codipar may be enhanced by coadministration with any other drug which has a CNS depressant effect (e.g. 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 Codipar 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-diarrhoeal agent increases the risk of severe constipation, and coadministartion with an antimuscarine drug may cause urinary retention. The absorption of paracetamol is speeded by metaclopramide or domperidone, and absorption is reduced by colestyramine. 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.
4.6
Pregnancy and lactation Codipar is not recommended during pregnancy At normal therapeutic doses codeine and its active metabolites 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 the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant. If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects. Use during pregnancy may lead to withdrawal syndromes in neonates, and use during labour may cause neonatal respiratory depression.
Paracetamol is excreted in breast milk but not in a clinically significant amount.
4.7
Effects on ability to drive and use machines Patients should be advised not to drive or operate machinery if Codipar causes dizziness or sedation. Codeine may cause visual disturbances.
4.8
Undesirable effects The commonest side effects of codeine are nausea, vomiting, light headedness, dizziness, sedation, shortness of breath and constipation. Some of these side effects appear more commonly in ambulatory rather than non-ambulatory patients. Lying down may alleviate these effects if they occur. In addition, miosis, visual disturbances, headache, bradycardia, respiratory depression, difficult micturition and urinary retention, and allergic reaction (including skin rash) can occur. Codeine can cause respiratory depression particularly in overdosage and in patients with compromised respiratory function. Euphoria, dysphoria, constipation, abdominal pain, and pruritus can occur as reactions to Codipar. 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 argranulocytosis, with the use of paracetamol- containing products, but the causal relationship has not been established. 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 pain killer for headaches can make them worse.
4.9
Overdose Paracetamol Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below). Risk Factors: If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St Johns Wort or other drugs that induce liver enzymes. Or b, Regularly consumes ethanol in excess of recommended amounts. Or c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. Symptoms Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Management Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable) but results should not delay initiation of treatment beyond 8 hours after ingestion, as the effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Codeine The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs. Symptoms Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been coingested, 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 one hour of ingestion of more than 350 mg or a child more than 5 mg/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 four hours after ingestion, or eight hours if a sustained release preparation has been taken.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Paracetamol (N02B E51) has analgesic and antipyretic actions. It is a weak inhibitor of prostaglandin biosynthesis. Single or repeated therapeutic doses of paracetamol do not affect the cardiovascular or respiratory systems. Gastric irritation, erosion, or bleeding is not produced by paracetamol. There is minimal effect on platelets, no effect on bleeding time or excretion of uric acid. Codeine (N02A A59) is an analgesic with similar uses to morphine, but only mild sedative effects. Codeine effects the CNS and the gut, including analgesia, drowsiness, mood changes, respiratory depression, reduced gastrointestinal motility, nausea or vomiting, changes in the endocrine and autonomic nervous system. Codeines effect on pain relief is selective, and it does not effect other sensations such as touch, vibration, vision, or hearing.
5.2
Pharmacokinetic properties Paracetamol is readily absorbed from the gastro-intestinal tract. It is metabolised in the liver and undergoes extensive biotransformation. The major metabolites are inactive phenolic sulphate and glucuronide conjugates. An adequate supply of SH groups can prevent hepatic toxicity. Paracetamol is excreted in the urine. The elimination half life varies from about 1 to 4 hours. Codeine is absorbed from the gastro-intestinal tract and peak plasma concentrations are produced in about 1hour. It is metabolised in the liver to morphine and norcodeines. Codeine and its metabolites are excreted almost entirely by the kidney. The plasma half line is between 3 and 4 hours.
5.3
Preclinical safety data There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Maize Starch Sodium Lauryl sulfate Cross carmellose sodium Purified Talc Magnesium Stearate Gelatin Titanium dioxide E171 Erythrosine E127 Red Iron Oxide E172
6.2
Incompatibilities None relevant
6.3
Shelf life 24 months
6.4
Special precautions for storage Do not store above 25C
6.5
Nature and contents of container Blister strips of PVDC coated PVC /Aluminium , 10 capsules per strip In pack size of 30, 32 or 100 capsules.
6.6
Special precautions for disposal None
7
MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK
8
MARKETING AUTHORISATION NUMBER(S)
PL 12762/0413
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/09/2010
10
DATE OF REVISION OF THE TEXT
03/09/2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
