SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Headache and Indigestion Relief

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient    mg/tablet

Paracetamol pdr    250.0

Paracetamol DC FP 272 GSR HSE    260.0*

Anhydrous caffeine (Alkd) 60 pdr    15.0

Sodium bicarbonate course granules    1.390 g

Anhydrous sodium carbonate BPC ’68    133.1

Citric acid monohydrate pdr    954.0

* Contains 10mg Gelatine

3 PHARMACEUTICAL FORM

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the effective relief of headache and rapid relief of indigi associated with over-indulgence in food or alcohol.

For oral administration.

Posology and method of administration

Adults and children over 12 years: one to two tablets.

Repeat the dose, three or four times daily at intervals of not less than four hours, up to a maximum of eight tablets in 24 hours if necessary.

Children 5 to 12 years: half to one tablet.

Repeat the dose, three or four times daily at intervals of not less than four hours, up to a maximum of four tablets in 24 hours if necessary.

These doses should be taken dissolved in half a tumbler of water.

Elderly: There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Severe liver disease.

4.4 Special warnings and precautions for use

Should be taken with caution by patients with impaired liver or kidney function, congestive heart failure or hypertension and patients on low sodium diets.

The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease.

Do not give for more than 3 days without consulting your doctor.

Do not give to children under 5 years without medical advice.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Contains paracetamol.

Do not take with any other paracetamol-containing products.

Keep all medicines out of the reach of children.

Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet or combined Label/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 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 use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy and lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Side effects are rare and usually mild and may include stomach cramps, flatulence, nausea, vomiting, insomnia, anxiety, restlessness, vertigo, palpitations, skin rashes and other allergic reactions. Very rarely there have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily casually related to paracetamol.

4.9 Overdose

Immediate treatment is essential in the management of paracetamol overdosage. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required.

Metabolic abnormalities should be corrected and convulsions controlled by the intravenous administration of diazepam. General supportive measures must be available.

Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion as liver function tests become abnormal. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe cases liver failure may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop with or without severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Additional symptoms associated with caffeine overdosage include maniacal behaviour, diuresis, tremor, delirium, hyperthermia, tachycardia, tachypnoea, electrolyte disturbances and convulsions.

Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol is an analgesic with antipyretic activity.

Caffeine is a central nervous system stimulant and contributes to the feeling of well being.

Sodium citrate arising from the reaction between sodium bicarbonate/carbonate and citric acid has antacid properties.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose dependent.

Caffeine is absorbed readily after oral administration and is widely distributed throughout the body. Caffeine passes readily into the CNS and into saliva. In adults, caffeine is metabolised almost completely via oxidation, demethylation and acetylation and is excreted in the urine as various metabolites with only about 1% being excreted unchanged. Elimination half life is approximately 3 to 6 hours in adults.

Sodium citrate causes neutralisation of gastric acid. Any sodium citrate not involved in that reaction is absorbed and converted in the liver to sodium bicarbonate. Less than 5% of sodium citrate is excreted unchanged.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride Sodium saccharin Sorbitol

Sodium benzoate

Peppermint flavour E4030 SDF and F

Gelatine

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months

6.4 Special precautions for storage

None

6.5 Nature and contents of container

Blisters of aluminium/polythene laminate backed with nylon/aluminium/polythene laminate in a carton.

Pack size: 12

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Max Remedies Limited 10 Town End View Holmfirth West Yorkshire HD9 1AX

8    MARKETING AUTHORISATION NUMBER(S)

PL 31308/0020

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 May 1985

DATE OF REVISION OF THE TEXT

19/02/2008