1. Name Of The Medicinal Product
Pain Relief Plus Capsules or Pharmacy Pain Relief for Migraine or Migraine Relief or Migraine Formula.
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Capsule
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of headache, migraine, period pain, dental pain, neuralgia, rheumatic and muscular pain and backache and symptoms of colds and 'flu'.
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4.2 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.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Severe liver disease.
4.4 Special Warnings And Precautions For Use
Should be taken with caution by patients with impaired kidney or liver function.
Do not take for more than three days without consulting your doctor.
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.
Label:
Immediate medical advice should be sought in the event of an overdose even if you feel well.
Leaflet or combined label/leaflet:
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.
4.5 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.
4.6 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. Codeine passes into breast milk in very small amounts which are probably insignificant and considered to be compatible with breastfeeding.
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.
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 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.
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 N-acetylcysteine 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.
5. 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.
5.2 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 O- 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.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium metabisulphite
Magnesium stearate
Sodium starch glycolate
Sodium lauryl sulphate
Gelatine
Erythrosine (E127)
Indigo carmine (E132)
Water
6.2 Incompatibilities
None known
6.3 Shelf Life
18 Months
6.4 Special Precautions For Storage
None
6.5 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/9 micron soft temper aluminium foil.
Pack size: 8/12/16/24/32
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL 0014/0325
9. Date Of First Authorisation/Renewal Of The Authorisation
First authorisation: 5 March 1985
Last renewal: 08 February 2000
10. Date Of Revision Of The Text
November 2004
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