Solpadeine Max Soluble Tablets

1. Name Of The Medicinal Product

Solpadeine Max Soluble Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph. Eur. 500 mg, Codeine Phosphate Hemihydrate Ph. Eur. 12.8 mg and Caffeine Ph Eur 30 mg.

3. Pharmaceutical Form

Effervescent tablet.

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 Max Soluble Tablets are recommended for the relief of headache, migraine, dental pain, period pain, strains & sprains, backache, arthritic & rheumatic pain and sciatica.

4.2 Posology And Method Of Administration

For oral administration

Adults (including the elderly)

2 tablets dissolved in at least half a tumbler of water up to four times a day if necessary.

Do not take more than 8 tablets in 24 hours.

Children

Not recommended for children under 12 years of age.

Do not take for more than 3 days continuously without medical review.

4.3 Contraindications

Solpadeine Max Soluble Tablets are contraindicated in patients with hypersensitivity to paracetamol, codeine, caffeine or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Solpadeine Max Soluble Tablets contain 427 mg sodium in each tablet. This should be taken into account where the patient has been placed on a restricted sodium intake e.g. patients with hypertension, cardiac or renal insufficiency, oedema or pregnancy.

Care is advised in the administration of Solpadeine Max Soluble Tablets to patients with severe renal or severe 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 not to take other paracetamol-containing or codeine-containing products concurrently.

• If symptoms persist consult your doctor

• Keep out of the reach of children.

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.

The label will state:

Front of pack

• Can cause addiction

• Use for 3 days only

Back of pack

• Solpadeine Max Soluble Tablets 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, arthritic & 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 medicinec ontains 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

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 Max Soluble Tablets 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, dental pain, period pain, strains & sprains, backache, arthritic & 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.

• Usually it is safe to take this medicine while breast feeding 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.

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

• 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 10 am – 2 pm 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

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 (MAOI) and for two weeks after stopping MAOI treatment. Opioid analgesics may antagonise the gastrointestinal effects of metoclopromide and domperidone and may delay the absorption of mexiletine. The effect of CNS depressants such as alcohol, anxiolytics, hypnotics, tricyclic antidepressants and antipsychotics may be potentiated by codeine; these interactions are unlikely to be significant at the dosage involved.

4.6 Pregnancy And Lactation

Do not use this product if pregnant or breast feeding without medical advice.

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

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 effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Codeine may cause constipation, nausea, vomiting, vertigo, difficulty with micturition, dry mouth, rashes, urticaria, dizziness and drowsiness according to dosage and individual susceptibility.

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

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. Symptons 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

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.

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. The CNS effects of overdose may be treated with intravenous sedatives.

Summary

Treatment of overdose with Solpadeine Max Soluble Tablets 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 a well established analgesic.

Caffeine has a stimulatory effect on the central nervous system and possesses a weak diuretic action.

Codeine phosphate has moderate analgesic and weak cough-suppressant effects.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration of the drug in plasma reaches a peak in 30 – 60 minutes and the plasma half-life is 1- 4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.

Codeine phosphate is well absorbed after administration and distributes widely throughout the body. 86% of an oral dose is excreted in the urine within 24 hours, 40–70% of this being free or conjugated codeine, 5-15% free or conjugated morphine, 10-20% free or conjugated norcodeine.

Caffeine is rapidly but irregularly absorbed after oral administration, absorption is pH-related. After an oral dose of 100 mg, peak plasma concentration of 1.5-2 μg/ml are attained within 1-2 hours. Plasma half-life is between 4-10 hours. Caffeine rapidly distributes throughout the body water, and is approximately 15% bound to plasma proteins. In 48 hours, 45% of a dose is excreted in the urine as 1methylxanthine and 1-methyluric acid.

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

Sorbitol

Sodium saccharin

Sodium bicarbonate

Sodium lauryl Sulphate

Citric acid

Sodium carbonate

Polyvidone

Silicone fluid.

6.2 Incompatibilities

None known.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

The product should be protected from light and moisture.

6.5 Nature And Contents Of Container

Laminate strips packed into cardboard cartons containing 8, 16, 20, 24 or 32 tablets.

Not all pack sizes may be marketed

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 GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS.

8. Marketing Authorisation Number(S)

PL 00071/0234

9. Date Of First Authorisation/Renewal Of The Authorisation

19/01/1984 / 28/02/2003

10. Date Of Revision Of The Text

07/11/2011