1. Name Of The Medicinal Product
Solpadeine Plus Capsules
2. Qualitative And Quantitative Composition
Each capsule contains Paracetamol Ph Eur. 500 mg, Codeine Phosphate Hemihydrate Ph Eur 8 mg and Caffeine Ph Eur 30.0 mg.
3. Pharmaceutical Form
Capsule.
4. Clinical Particulars
4.1 Therapeutic Indications
For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
Solpadeine Plus Capsules are recommended for the relief of migraine, headache, backache, rheumatic pain, period pains, dental pain, strains & sprains and sciatica.
4.2 Posology And Method Of Administration
Adults (including the elderly)
2 capsules up to four times daily. Maximum 8 capsules in 24 hours. The dose should not be repeated more frequently than every 4 hours. Do not take for more than 3 days without consulting a doctor. For oral administration only.
Children
The product is not recommended for children under 12 years of age.
Do not take for more than 3 days continuously without medical review.
4.3 Contraindications
Hypersensitivity to paracetamol, caffeine, codeine, opioid analgesics or any of the other constituents.
Use of codeine containing products is contraindicated in mothers who are breast feeding unless prescribed by a doctor.
4.4 Special Warnings And Precautions For Use
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised not to take other paracetamol or codeine-containing products concurrently.
If symptoms persist, consult your doctor.
Keep out of the reach and sight of children.
Patients with obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product.
Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients.
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
The leaflet will state:
Headlines section (to be prominently displayed)
• This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked.
• 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.
Section 1: What the medicine is for:
• Solpadeine Plus Capsules are for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. They can be used for migraine, headache, dental pain, period pain, strains & sprains, backache, rheumatic pain and sciatica.
Section 2: Before taking
• 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.
Section 3: Dosage
• 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
• Possible withdrawal effects
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.
Section 4: Side effects
• 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?
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 your doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended dose
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
The label will state:
Front of pack
• Can cause addiction
• Use for 3 days only
Back of pack
• Solpadeine Plus Capsules are for the short term treatment of acute moderate pain when other painkillers have not worked. Wait at least four hours after taking any other painkiller before you take this medicine. For: migraine, headache, dental pain, period pain, backache, rheumatic pain, strains & sprains and sciatica.
• 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 continuously for more than 3 days. If you take this medicine for headaches for more than 3 days it can make them worse.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Opioid analgesics should be given with care to patients receiving monoamine oxidase inhibitors. The effect of CNS depressants (including alcohol) may be potentiated by codeine; these interactions are unlikely to be significant at the dosage involved.
4.6 Pregnancy And Lactation
Pregnancy
Use during pregnancy should be avoided, unless advised by a physician. This includes maternal use during labour because of the potential for respiratory depression in the neonate.
The safety of paracetamol-caffeine-codeine during pregnancy has not been established relative to the possible adverse effects of foetal development and should be avoided during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.
Lactation
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.
Although significant caffeine toxicity has been observed in breastfed infants, caffeine may have a stimulating effect on the infant.
Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.
4.7 Effects On Ability To Drive And Use Machines
Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.
4.8 Undesirable Effects
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system. The frequency of these adverse events is not known (cannot be estimated from available data).
Paracetamol
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* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Caffeine
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When the recommended paracetamol-caffeine-codeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.
Codeine
Adverse reactions identified during post-marketing use are listed below by MedDRA system organ class. The frequency of these reactions is not known.
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4.9 Overdose
Overuse of this product, defined as consumption of quantities in excess of the recommended dose, or consumption for a prolonged period of time may lead to physical or psychological dependency. Symptoms of restlessness and irritability may result when treatment is stopped.
Codeine
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
An overdose of codeine is characterised, in the first phase, by nausea and vomiting. An acute depression of the respiratory centre can cause cyanosis, slower breathing, drowsiness, ataxia and, more rarely, pulmonary oedema. Respiratory pauses, miosis, convulsion, collapse and urine retention. Signs of histamine release have been observed as well.
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.
Paracetamol
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors:
If the patient
Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
Regularly consumes ethanol in excess of recommended amounts.
Or
Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdose 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). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. 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. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Caffeine
Symptoms and signs
Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.
Management
Patients should receive general supportive care (e.g. hydration and maintenance of vital signs). The administration of activated charcoal may be beneficial when performed within one hour of the overdose, but can be considered for up to four hours after the overdose. The CNS effects of overdose may be treated with intravenous sedatives.
Summary
Treatment of overdose with Solpadeine Plus Capsules requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of codeine and caffeine toxicity being managed symptomatically.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol is an analgesic and antipyretic. Codeine phosphate is a moderate analgesic and has weak cough suppressant activity. Caffeine is a potent stimulator of the CNS.
5.2 Pharmacokinetic Properties
Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost completely renal, in the form of conjugated metabolites.
Caffeine is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65-80% of administered caffeine is excreted in the urine as 1-methyluric acid 1-methylxanthine.
Codeine phosphate is well absorbed after oral administration and is widely distributed. About 86% is excreted in the urine in 24 hours; 40-70% is free or conjugated codeine, 5-15% is free or conjugated morphine and 10-20% is free or conjugated norcodeine.
5.3 Preclinical Safety Data
There are no pre-clinical 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
Maize starch, magnesium stearate, titanium dioxide (E 171), erythrosine (E 127), patent blue V (E 131), quinoline yellow (E 104), gelatin. Printing Ink: shellac, propylene glycol and colour black iron oxide (E172).
6.2 Incompatibilities
None stated.
6.3 Shelf Life
60 months.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
PVC 250 µm / aluminium foil 30 µm blister strips in a cardboard carton, containing 6, 12, 16, 24, and 32 capsules.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
SmithKline Beecham (SWG) Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as Sterling Health or GlaxoSmithKline Consumer Healthcare or SmithKline Beecham International, Brentford, TW8 9GS.
8. Marketing Authorisation Number(S)
PL 00071/0186
9. Date Of First Authorisation/Renewal Of The Authorisation
09.05.83 / 21.04.95
10. Date Of Revision Of The Text
21.06.2011
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