GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Panadol Cold & Flu Hot Lemon Powder for Oral Solution

Paracetamol 600mg

Ascorbic Acid 40mg

Excipients: each 6g powder sachet contains 3700mg sucrose and approximately 113mg sodium.

For a full list of excipients, see section 6.1.

Powder for oral solution

Sachets containing an off white free flowing powder with an odour of lemon.

The relief of symptoms of influenza and feverish colds including headache, and aches and pains. Also effective in the relief of menstrual pain, toothache and musculoskeletal disorders.

Directions for use

Empty contents of sachet into mug. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.

Recommended Dose and Dosage Schedule

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

One sachet to be taken every four hours, if necessary, up to a maximum of six sachets in any 24 hours.

Not to be given to children under 12 years of age except on medical advice.

Do not take more often than every 4 hours.

Do not take more than 6 sachets in any 24 hours.

Hypersensitivity to any of the ingredients. Severe hepatic or renal impairment.

Caution is advised in the administration of paracetamol to patients with impaired renal and hepatic function or if they are taking other drugs that affect the liver. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Keep out of the reach and sight of children.

If symptoms persist consult your doctor.

Prolonged use except under medical supervision may be harmful.

Do not take with other products containing paracetamol.

Contains paracetamol.

Do not exceed the stated dose.

This product should only be used when clearly necessary.

Patients with rare hereditary problems of fructose intolerance, glucose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Contains 113mg sodium per dose. To be taken into account by patients on a sodium-controlled diet.

Paracetamol is reported to increase the half-life of chloramphenicol.

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. The hepatotoxicity of paracetamol may be potentiated by other drugs that affect the liver.

Use during pregnancy and lactation is not contraindicated. However caution should be exercised and use during pregnancy should be on the advice of a doctor.

None.

The following convention has been utilised for the classification of undesirable effects: very common (1/10), common (1/100, <1/10), uncommon (1/1,000, <1/100), rare (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.

Paracetamol

Paracetamol

Symptoms and Signs

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. 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.

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.

Ascorbic acid

High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort.

Effects of overdose of ascorbic acid would be subsumed by serious liver toxicity caused by paracetamol overdose.

ATC code/pharmacotherapeutic group: N02BE51.

Paracetamol: Provides the analgesic and antipyretic actions.

Ascorbic acid is commonly included in combination cold products to compensate for vitamin C losses that may occur in the initial stages of acute viral infections, including the common cold.

Paracetamol - is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.

Ascorbic acid - is readily absorbed from the GI tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic acid in excess of the body's needs is eliminated in the urine as metabolites.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Sucrose

Sodium citrate

Citric acid (anhydrous)

Sodium cyclamate

Saccharin sodium

Colloidal anhydrous silica

Lemon flavour (containing maltodextrins)

Natural curcumin (E 100)

Maize Starch (dried)

Not applicable.

3 years.

Do not store above 25°C.

The product is packed in laminate sachets comprising paper / polythene / aluminium foil / polythene. Five or ten sachets may be contained in a box board carton.

Not all pack sizes may be marketed.

No special requirements.

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

Stonemasons Way

Rathfarnham

Dublin 16

PA 678/11/1

Date of first authorisation: 20 October 1987

Date of last renewal: 20 October 2007

April 2010