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SANOFI

Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: iemedinfo@sanofi.com


Summary of Product Characteristics last updated on medicines.ie: 28/11/2013
SPC Solpadol 500mg/30mg Tablets



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1. NAME OF THE MEDICINAL PRODUCT

Solpadol Caplets 500mg/30mg Tablets


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol

500.0mg

Codeine Phosphate Hemihydrate

30.0mg

For excipients see 6.1.


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3. PHARMACEUTICAL FORM

Tablet.

White to off-white capsule-shaped tablet with flat sides marked 'SOLPADOL' on one side and blank on the reverse.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of severe pain.

Solpadol 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).


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4.2 Posology and method of administration

Solpadol should be used at the lowest effective dose for the shortest period of time. This dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose of codeine should not exceed 240mg.

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.

Adults

Two tablets not to be taken more frequently than every six hours up to a maximum of eight tablets in any 24 hour period.

Elderly

The initial dosage should be reduced to half the recommended dosage and should be titrated to the individuals need and overall medical condition.

Paediatric Population

Children aged 12 years to 18 years:

The recommended Solpadol dose for children 12 years and older should be one to two tablets not to be taken more frequently than every six hours up to a maximum of eight tablets in any 24 hour period.

Children aged less than 12 years:

Solpadol 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).

In patients with renal failure (creatinine clearance lower than 10 ml/min), the interval between two doses should be at least 8 hours.

Solpadol Caplets are for oral administration.


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4.3 Contraindications

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.

In patients hypersensitive to paracetamol or codeine, or hypersensitivity to any of the other constituents.

In patients with acute asthma, respiratory depression, acute alcoholism, head injuries, raised intra-cranial pressure and following biliary tract surgery.

In patients currently receiving or within 14 days of stopping monoamine oxidase inhibitor therapy.


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4.4 Special warnings and precautions for use

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% to 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 ultrarapid or extensive metabolisers in their ability to metabolise codeine to morphine.

Children with compromised respiratory function

Solpadol 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 only be used with great care in any patient whose condition may be exacerbated by opioids, particularly the elderly, who may be sensitive to its central and gastro-intestinal effects, those who are on concurrent CNS drugs, those with prostatic hypertrophy or those with inflammatory or obstructive bowel disorders.

Care should also be observed if prolonged therapy is contemplated.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease. In patients with kidney failure (creatinine clearance lower than 10 ml/min): the interval between doses should be increased (minimum 8 hours). See section 4.2.

Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short treatment duration and in patients without pre-existing liver dysfunction (See Section 4.8)

Caution is advised in patients with underlying sensitivity to aspirin and/or to non-steroidal anti-inflammatory drugs (NSAIDs).

Patients should be advised not to exceed the recommended dose and not take other paracetamol containing products concurrently.

Consumption of alcohol during treatment is not recommended since the drug contains codeine.

Tolerance and dependence can occur, especially with prolonged high dosage of codeine.

The risk-benefit of continued use should be assessed regularly by the prescriber.

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 (see Section 4.8).

In patients with intracranial hypertension, codeine may increase the severity of this hypertension. Solpadol is contraindicated for use in these patients. Section 4.3.

In patients who have had a cholecystectomy, codeine may induce acute biliary or pancreatic abdominal pain, which usually occurs with abnormal laboratory results, suggesting a spasm of the sphincter of Oddi. Solpadol is contraindicated for use in these patients. Section 4.3.

If the patient has a productive cough, codeine may impede expectoration.

Elderly patients: the initial dosage should be reduced to half the recommended dosage; this may be later increased based on patient tolerance and needs. See section 4.2

In ultra-rapid opiate/codeine metabolisers, there is an increased risk of developing opioid toxicity even at low doses. 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.


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4.5 Interaction with other medicinal products and other forms of interaction

Paracetamol may increase the elimination half-life of chloramphenicol. Oral contraceptives may increase its rate of clearance. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), rifampicin and alcohol.

Paracetamol may increase the risk of bleeding in patients taking warfarin, antivitamin K and other coumarins. These patients should be monitored for appropriate coagulation and bleeding complications.

Co-administration of flucloxacillin with paracetamol may lead to metabolic acidosis, particularly in patients presenting risk factors of glutathione depletion, such as sepsis, malnutrition or chronic alcoholism.

Treatment with paracetamol may interfere with the assay of blood uric acid by the phosphotungstic acid method.

Treatment with paracetamol may interfere with the assay of blood glucose when concentrations are abnormally high.

Inadvisable combinations with codeine

Morphine agonists-antagonists (buprenorphine, nalbuphine, pentazocine): Reduced analgesic effect due to competitive receptor blockade, with a risk of withdrawal syndrome.

Naltrexone: Risk of reduced analgesic effect. The doses of the morphine derivative should be increased if necessary.

Combinations to be taken into account:

The effects of CNS depressants (including alcohol) may be potentiated by codeine.

Increased risk of respiratory depression in combination with morphine agonist analgesics, morphine-like antitussives, true opioid antitussives, benzodiazepines and related derivatives, barbiturates, methadone.


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4.6 Pregnancy and lactation

Solpadol should not be used in pregnancy and 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 ultrarapid 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.


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4.7 Effects on ability to drive and use machines

Patients receiving this medication should be advised not to drive or operate machinery if affected by dizziness or sedation.


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4.8 Undesirable effects

Paracetamol

Immune system disorders: Hypersensitivity, anaphylactic shock, angioedema.

Blood and lymphatic system disorders: thrombocytopenia, agranulocytosis, leukopenia, neutropenia, haemolytic anaemia in patients with underlying glucose 6-phosphate-deshydrogenase deficiency.

Other reactions may occur:

Skin and subcutaneous disorders: erythema, urticarial, rash, Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis, fixed drug eruption.

Cardiac disorders: Kounis syndrome.

Respiratory, thoracic and mediastinal disorders: bronchospasm (See section 4.5).

Hepatobiliary disorders: cytolytic hepatitis, which may lead to acute hepatic failure

Codeine:

At therapeutic doses, the adverse effects of Codeine can produce typical opioid effects but they are less frequent and more moderate including:

-

sedation, euphoria, dysphoria,

constipation, nausea, vomiting,

dizziness, light-headedness, confusion, drowsiness

-

hypersensitivity reactions (pruritus, urticaria and rash)

myosis, urinary retention.

-

bronchospasm, respiratory depression (see Section 4.3),

-

acute biliary or pancreatic abdominal pain, suggesting a spasm of the sphincter of Oddi and occurring mainly in patients who have had a cholecystectomy,

-

pancreatitis: very rare cases have been reported.

At supratherapeutic doses: there is a risk of dependence and withdrawal syndrome if treatment is suddenly discontinued. This may occur both in the patient and in the neonates of mothers with codeine intoxication.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via 'freepost', in addition to the traditional post-paid 'yellow card' option.

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: + 353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie


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4.9 Overdose

Paracetamol:

Liver damage is possible in adults who have taken 10g or more of paracetamol (150 mg/kg body weight in children). 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:

Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes,

Regularly consumes ethanol in excess of recommended amounts,

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. Overdosage with paracetamol may cause hepatic cytolysis which can lead to hepatocellular insufficiency, metabolic acidosis, encephalopathy, coma and death. Increased levels of hepatic transaminases, lactate deshydrogenase and bilirubin with a reduction in prothrombin level can appear 12 to 48 hours after acute overdosage. It can also lead to pancreatitis, acute renal failure and pancytopenia .

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 the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.

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 serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIC or a liver unit.

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 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 Drowsiness, rash, pruritis, ataxia, pulmonary edema (more rare) are possible.

Management:

Respiratory assistance: 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.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anilides, Paracetamol combinations.

ATC Code: N02B E51.

Paracetamol is an analgesic which acts peripherally, probably by blocking impulse generation at the bradykinin sensitive chemo-receptors which evoke pain. Although it is a prostaglandin synthetase inhibitor, the synthetase system in the CNS rather than the periphery appears to be more sensitive to it. This may explain paracetamol's lack of appreciable anti-inflammatory activity. Paracetamol also exhibits antipyretic activity.

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has 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.


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5.2 Pharmacokinetic properties

Following oral administration of two tablets (i.e. a dose of paracetamol 1000mg and codeine 60mg), the mean maximum plasma concentrations of paracetamol and codeine were 15.96µg/ml and 212.4ng/ml respectively. The mean times to maximum plasma concentrations were 0.88 hours for paracetamol and 1.05 hours for codeine.

The mean AUC for the 9 hours following administration was 49.05µg.ml-1.h for paracetamol and 885.0ng.ml-1.h for codeine.

The bioavailabilities of paracetamol and codeine phosphate when given as the combination are similar to those when they are given separately.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Pregelatinised starch

Maize starch

Povidone

Potassium sorbate

Microcrystalline cellulose

Stearic acid

Talc

Magnesium stearate

Croscarmellose sodium


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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. Store in the original package.


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6.5 Nature and contents of container

1) Amber glass bottles with tinplate screw cap with steran-faced pulpboard wad.

2) PVC/aluminium foil (250 μm/20 μm) or PVC/aluminium foil (250 μm/20 μm) / PVC (15 μm) blister packs or PVC/aluminium foil (250 μm/9 μm /Glassine paper (35 gsm). Packs of 4, 10, 60 and 100 tablets.

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

sanofi-aventis Ireland Ltd., T/A SANOFI

Citywest Business Campus,

Dublin 24,

Ireland.


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8. MARKETING AUTHORISATION NUMBER(S)

PA 540/159/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26th June 1991 / 1st November 2004


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10. DATE OF REVISION OF THE TEXT

20 November 2013



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Active Ingredients

 
   Paracetamol
   Codeine Phosphate Hemihydrate