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Chefaro Ireland Ltd

4th Floor Hamilton House , Mabledone Place, Bloomsbury, London, WC1H 9BB, UK
Telephone: +44 (0)207 554 8888
E-mail: omega@professionalinformation.co.uk
Medical Information Direct Line: +44 (0)1748 828 860


Summary of Product Characteristics last updated on medicines.ie: 30/04/2014
SPC Solpadeine Capsules



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1. NAME OF THE MEDICINAL PRODUCT

Solpadeine Capsules

Paracetamol 500mg

Codeine Phosphate Hemihydrate 8mg

Caffeine 30mg


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains paracetamol 500 mg, codeine phosphate hemihydrate 8 mg and caffeine 30 mg.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Capsule, hard

Gelatin capsules with a red, opaque cap and a white, opaque body with 'SOLPADEINE' printed in black.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone.

In the management of symptoms of headache, including migraine, toothache, backache, common cold, influenza, menstrual pain, musculoskeletal pain.


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4.2 Posology and method of administration

For oral administration only.

Adults (including the elderly) and children aged 12 years and over:

The usual dose is two capsules three to four times in a 24 hour period as required.

The dose should not be repeated more frequently than every 4 hours.

A maximum of 8 capsules in 24 hours should not be exceeded.

Do not exceed the stated dose.

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.

Paediatric population:

Children aged less than 12 years:

Codeine 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).

Should not be used with other paracetamol or codeine containing products.

Renal Impairment

Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication.

Hepatic Impairment

Patients who have been diagnosed with liver impairment must seek medical advice before taking this medication


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4.3 Contraindications

Hypersensitivity to paracetamol, codeine, caffeine or any of the other constituents.

Acute asthma.

In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions (see section 4.4).

In women during breastfeeding (see section 4.6).

In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.


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4.4 Special warnings and precautions for use

Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking paracetamol or codeine. Underlying liver disease increases the risk of paracetamol-related liver damage.

The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Care should be observed in administering the product to any patients whose condition may be exacerbated by opioids, particularly the elderly, who are especially sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs and those with prostate hypertrophy.

Excessive intake of caffeine (e.g. tea, coffee and some canned drinks) should be avoided while taking this product.

Patients with inflammatory or 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.

Prolonged regular use, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in withdrawal symptoms, such as restlessness and irritability once the drug is stopped.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of 'medication overuse headache' should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

CYP2D6 metabolism

Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.

General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.

Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:

Population

Prevalence %

African/Ethiopian

29%

African American

3.4% to 6.5%

Asian

1.2% to 2%

Caucasian

3.6% to 6.5%

Greek

6.0%

Hungarian

1.9%

Northern European

1%-2%

Post-operative use in children

There have been reports in the published literature that codeine given post-operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events including death (see also section 4.3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.

Children with compromised respiratory function

Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.

This product should be used only when clearly necessary.

Prolonged use without medical supervision may be harmful.

Do not take for more than 3 days without consulting a doctor.

Do not exceed the stated dose.

If symptoms persist, consult your doctor.

Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver damage.

Keep out of the reach and sight of children.

CONTAINS PARACETAMOL.

Do not take with other paracetamol or codeine containing medicines.

Contains Carmoisine (E122). May cause allergic reactions.


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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 cholestyramine. 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.


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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 on foetal development and should be avoided during pregnancy due to the possible increased risk of spontaneous abortion associated with caffeine consumption.

Lactation

Codeine should not be used during breastfeeding (see section 4.3).

At normal therapeutic doses codeine and its active metabolite 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 metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.

Paracetamol and caffeine are excreted in breast milk but not in a clinically significant amount.

Although significant caffeine toxicity has not been observed in breastfed infants, caffeine may have a stimulating effect on the infant.


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4.7 Effects on ability to drive and use machines

Patients should be advised not to drive or operate machinery if affected by drowsiness.


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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 Organ Class and frequency.

Frequencies are defined as: very common (2:1/10), common (2:1/100, <1/10), uncommon (2:1/1,000, <1/100), rare (2:1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

Adverse event frequencies have been estimated from spontaneous reports received through post marketing data and are considered to be very rare.

Paracetamol

Body System

Undesirable Effect

Blood and lymphatic system disorders

Thrombocytopaenia

Immune system disorder

Anaphylaxis

Cutaneous hypersensitivity reactions, including skin rashes, angioedema and Stevens Johnson syndrome

Respiratory, thoracic and mediastinal disorders

Bronchospasm in patients sensitive to aspirin and other NSAIDs

Hepatobiliary disorders

Hepatic dysfunction

Caffeine

Body System

Undesirable Effect

Central nervous system disorders

Nervousness

Dizziness

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 organ system class. The frequency of these reactions is not known.

Body System

Undesirable Effect

Psychiatric disorders

Drug dependency can occur after prolonged use of codeine at high doses

Gastrointestinal disorder

Constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis in patients with a history of cholecystectomy

Nervous system disorder

Dizziness, worsening of headache with prolonged use, drowsiness

Skin and subcutaneous tissue disorder

Pruritis, sweating


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4.9 Overdose

Paracetamol

Symptoms and Signs

Paracetamol overdose may cause liver failure. Ingestion of more than 12 g paracetamol (24 standard 500 mg tablets) or more than 150 mg paracetamol per kg bodyweight (9 g paracetamol in a 60 kg individual), whichever is the smaller, can cause severe liver damage. Liver damage (as demonstrated by a rise in plasma transaminase levels) may be apparent between 8 and 36 hours following overdose. Biochemical evidence of maximal damage, however, may not be attained until 72-96 hours after ingestion of the overdose.

Symptoms of paracetamol overdose in the first 24 hours may include pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Liver damage results when excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Treatment

Immediate medical attention (in-hospital, if possible) is required in the event of overdose, even if there are no significant early symptoms. There may be no early symptoms following a life-threatening overdose.

Intravenous N-acetylcysteine (NAC) is effective when initiated within 8 hours of the overdose. Efficacy declines progressively after this time, but NAC may provide some benefit up to and possibly beyond 24 hours. Oral methionine is also effective provided that it is given within 10 to 12 hours of the overdose. Activated charcoal should be considered if the dose of paracetamol ingested exceeds 12 g or 150 mg/kg, whichever is the smaller, and the procedure can be undertaken within 1 hour of the overdose. There is little evidence that undertaking gastric lavage will be of benefit to a patient in whom paracetamol is known to have been the only substance ingested.

Codeine

Effects of overdose due to codeine would be subsumed by serious liver toxicity caused by paracetamol overdose. Immediate medical management is required in the event of overdosage, even if symptoms of overdose are not present.

Symptoms and Signs

An overdose of codeine is characterized, 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.

Treatment

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 of codeine or a child more than 5mg/kg of codeine. Give naloxone if coma or respiratory depression is present. Observe for at least four hours after ingestion or eight hours for a sustained release formulation.

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.

Treatment

No specific antidote is available, but supportive measures such as beta adrenoreceptor antagonists to reverse the cardiotoxic effects may be used.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Paracetamol is an analgesic and antipyretic.

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through µ opioid receptors, although codeine has a low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain.

Caffeine is a potent stimulator of the CNS.


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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 l-methyluric acid l- 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.


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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.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Maize starch

Magnesium stearate

Capsule Shell

Titanium dioxide (E171)

Erythrosine (E127)

Patent blue (E131)

Quinoline yellow (E104)

Gelatin

Printing Ink

Shellac

Black iron oxide (E172)

Propylene glycol

Ammonium Hydroxide


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

5 years.


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

PVC/aluminium foil blister strip in a cardboard carton, containing 6, 12, 24, 32, 36, 48, 60, 72 or 96.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Chefaro Ireland Limited

First Floor

Block A

The Crescent Building

Northwood Office Park

Dublin 9

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 1186/011/002


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 24th August 1992

Date of last renewal: 24th August 2007


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10. DATE OF REVISION OF THE TEXT

December 2013



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Active Ingredients

 
   Paracetamol
   Caffeine
   Codeine Phosphate Hemihydrate