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PARACETAMOL & CODEINE CAPSULES
Active substance(s): CODEINE PHOSPHATE FINE CRYSTALS / PARACETAMOL
NAME OF THE MEDICINAL PRODUCT
Paracetamol & Codeine Capsules or Pain Relief Plus Capsules 2. Qualitative and Quantitative Composition Active ingredient Paracetamol Cryst EP Paracetamol DC EP Codeine Phosphate Fine Cryst EP mg/tablet 300.0 200.0 8.0
Pharmaceutical form Capsule
For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone such as: headache, migraine, period pain, dental pain, neuralgia, rheumatic and muscular pain and backache.
Posology and method of administration For oral administration Adults and children over 12 years One to two capsules, if necessary, three or four times daily at intervals of not less than four hours, up to maximum of eight capsules in 24 hours.
Children under 12 years Do not give to children under 12 years without consulting your doctor.
Elderly There is no need for dosage reduction in the elderly. Do not take for more than 3 days continuously without medical review.
Contra-Indications Hypersensitivity to any of the ingredients. Severe liver disease.
Special warnings and precautions for use Should be taken with caution by patients with impaired kidney or liver function. 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. Do not exceed the stated dose. If symptoms persist, consult your doctor. Do not give to children under 12 years without medical advice. Contains paracetamol. Do not take with any other paracetamol-containing products. Keep all medicines out of the reach of children. The label will state: Immediate medical advice should be sought in the event of an overdose even if you feel well. Front of pack Can cause addiction For three days use only Back of pack List of indications as agreed in 4.1 of the SPC If you need to take this medicine continuously for more than 3 days you should see your doctor or pharmacist This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. If you take this medicine for headaches for more than 3 days it can make them worse
The leaflet (or combined label/leaflet) will state: 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.
Headlines section (to be prominently displayed) This medicine can only be used for.....(indications) You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 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 3 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 3 days it can make them worse What this medicine is for section Succinct description of the indications from 4.1 of the SPC
Before you take this medicine section This medicine contains codeine which can cause addiction if you take it continuously for more than 3 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 3 days it can make them worse
Usually it is safe to take this medicine while breastfeeding 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. How to take this medicine section Do not take for more than 3 days. If you need to use this medicine for more than 3 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 3 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
Possible side effects section 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? section 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 you doctor: You need to take the medicine for longer periods of time You need to take more than the recommended amount When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
Interaction with other Medicinal Products and other Forms of Interaction Codeine may delay the absorption of mexiletine and thus reduce the antiarrhythmic effect of the latter. The depressant effects of codeine are enhanced by depressants of the central nervous system such as hypnotics, sedatives, tricyclic antidepressants and phenothiazines. Codeine may antagonise the gastrointestinal effects of metoclopramide and domperidone. The speed of absorption 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.
Pregnancy and lactation The safety of Pain Relief Plus Capsules during pregnancy has not been established and in view of the possible association of codeine with respiratory depression and heart malformations, use during this period should be avoided. Epidemiological studies in human pregnancy have shown no effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. 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 of 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. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding. 4.7 Effects on Ability to Drive and to Use Machines No adverse effects known. 4.8 Undesirable effects The most common side effects are nausea, vomiting, constipation, dry mouth, sweating, skin rashes and other allergic reactions. Very rarely there have been reports of blood dyscrasias including thrombocytopaenia and agranulocytosis, but these 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. 4.9 Overdose 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 and any patient who had ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous Nacetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia, abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion as liver function tests become abnormal. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe cases, liver failure may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop with or without severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
The hazards of overdose are greater in those with alcoholic liver disease. The effects of codeine in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs. Symptoms of overdosage include central nervous system depression, including respiratory depression, 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 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 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.
Pharmacological Properties 5.1 Pharmacodynamic Properties
Paracetamol is an analgesic with antipyretic activity. Codeine phosphate is an opioid analgesic which acts via the central nervous system.
Pharmacokinetic Properties Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucoronide and sulphate conjugates with about 10% as glutathione conjugates. Less than 5 % is excreted as unchanged paracetamol. The elimination half life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose dependent. Codeine phosphate is absorbed from the gastrointestinal tract and peak plasma concentrations occur after about one hour. Codeine is metabolised by 0- and N-demethylation in the liver to morphine and norcodeine. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. The plasma half life has been reported to be between 3 and 4 hours.
Preclinical Safety Data Not applicable.
List of excipients Sodium metabisulphite Magnesium stearate Sodium starch glycolate Sodium lauryl sulphate Erythrosine (El27) Indigo carmine (E132) Gelatine Water
Incompatibilities None Known
Shelf life 18 Months
Special precautions for storage None
Nature and contents of container A child resistant push through pack of opaque 250 micron PVC/40gsm PVdC blisters heat sealed to 35gsm Glassine paper/9micron soft temper aluminium foil. Pack sizes: 8/12/16/24/32.
Instructions for use and handling Not applicable.
MARKETING AUTHORISATION HOLDER The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
MARKETING AUTHORISATION NUMBER PL 00014/0325
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATE OF REVISION OF THE TEXT
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