Panadol Extra Soluble Tablets
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Panadol Extra Soluble Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol Ph.Eur. 500.0 mg and Caffeine Ph.Eur. 65.0 mg.
3. PHARMACEUTICAL FORM
Effervescent tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Panadol Extra is a mild analgesic and antipyretic formulated to give extra pain relief. The soluble tablets are recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, backache, toothache, colds and influenza, sore throat, rheumatic pain and dysmenorrhoea.
4.2. Posology and method of administration
Panadol Extra should be dissolved in at least half a tumblerful of water.
Adults:
Two tablets up to four times daily. Do not exceed 8 tablets in 24 hours.
Elderly:
As for adults.
Children:
Not recommended for children under 12 years.
Method of Administration
Panadol Extra Soluble Tablets are for oral administration only.
4.3. Contraindications
Hypersensitivity to paracetamol, caffeine or any of the other constituents.
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.
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
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-containing products concurrently.
Each 2 tablet dose of Panadol Extra Soluble Tablets contains 854 mg of sodium and should not be taken by patients on a low sodium diet.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.
Patient Information 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. Interactions 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.
4.6 Pregnancy and Lactation
Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.
Caffeine in breast milk may potentially have a stimulating effect on breast fed infants.
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
None.
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 class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia Agranulocytosis |
|
Immune system disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
|
Hepatobiliary disorders |
Hepatic dysfunction |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
|
Caffeine | |
|
Central Nervous system |
Nervousness Dizziness |
|
When the recommended paracetamol-caf caffeine intake, the resulting higher dose caffeine-related adverse effects such as in headaches, gastrointestinal disturbances a |
feine dosing regimen is combined with dietary of caffeine may increase the potential for isomnia, restlessness, anxiety, irritability, nd palpitations. |
4.9 Overdose
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
Overdose of caffeine may result in epigastric pain, vomitting, diuresis, tachycardia or cardia 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 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 Cope Sachets requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of codeine and caffeine toxicity being managed symptomatically.
Sodium bicarbonate
High doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia; electrolytes should be monitored and patients managed accordingly.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
The combination of paracetamol and caffeine is a well established analgesic combination.
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 exclusively 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 and 1-methylxanthine.
5.3. Pre-clinical 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
|
Sodium bicarbonate |
Ph Eur |
|
Sorbitol powder |
Ph Eur |
|
Saccharin sodium |
BP |
|
Sodium lauryl sulphate |
Ph Eur |
|
Citric acid (anhydrous) |
Ph Eur |
|
Sodium carbonate (anhydrous) |
BPC |
|
Polyvidone |
Ph Eur |
|
Dimeticone (Silicone Fluid 200/350) |
Ph Eur |
6.2. Incompatibilities
None.
6.3 Shelf-life
48 months.
6.4. Special precautions for storage
The product should be stored below 30°C.
6.5. Nature and contents of container
PPFP laminate sachets in cardboard carton outers containing 4, 6, 12, 18, 24, 30, 48 or 60 tablets.
6.6. Instructions for use/handling
None.
7. MARKETING AUTHORISATION HOLDER
SmithKline Beecham (SWG) Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS.
8. MARKETING AUTHORISATION NUMBER
PL 00071/0379
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
23.08.91
10 DATE OF REVISION OF THE TEXT
14/04/2010