Boots Headache and Upset Stomach Relief

1. Name Of The Medicinal Product

Headache and Upset Stomach Relief.

Andrews Plus+

Paramed Headache and Upset Stomach Relief

Asda Headache and Upset Stomach Relief

Boots Headache and Upset Stomach Relief

Tesco Recovery Effervescent Powder

2. Qualitative And Quantitative Composition

Each sachet contains; 1000 mg Paracetamol, Anhydrous citric acid 1185 mg, Sodium bicarbonate 808 mg, Potassium bicarbonate 715 mg, Anhydrous sodium carbonate 153 mg.

3. Pharmaceutical Form

Effervescent powder.

A free-flowing creamy/white powder with a characteristic orange odour. Free from large aggregates and particulate contamination.

4. Clinical Particulars

4.1 Therapeutic Indications

Recommended for the relief of headache with gastric upset, particularly associated with over-indulgence in food or drink or both.

4.2 Posology And Method Of Administration

For oral administration.

Dissolve the contents of the sachet in a glass of water (150 – 200 ml) before taking.

Adults, elderly and children aged 16 years and over:

One sachet every 4 hours as required. Do not take more than 4 sachets in any 24 hours.

Not to be given to children under 16 years of age.

The elderly may take the normal adult dose.

4.3 Contraindications

Known hypersensitivity to any of the ingredients. Hepatic or severe renal impairment. Patients on sodium-restricted diets. Patients on potassium-restricted diets

4.4 Special Warnings And Precautions For Use

Concomitant use of other paracetamol-containing medicines should be avoided. Consult your doctor if you are taking warfarin.

“Sachet warnings: Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with other paracetamol containing products”.

“Carton label: 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 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. The hepatototoxicity of paracetamol may be potentiated by excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metaclopramide or domperidone and absorption reduced by colestyramine. These interactions are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.

The acid neutralising capacity of the product may alter the absorption profile of pH specific drugs given concomitantly.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

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

4.9 Overdose

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 and any patient who had ingested around 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration or oral methionine on intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

Symptoms of paracetamol overdosage 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Liver damage is possible in adults who have taken 10 g or more of paracetamol.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code NO2B E01

Paracetamol – antipyretic and mild analgesic actions.

Ascorbic acid – replaces lost Vitamin C.

Citric acid

Sodium bicarbonate

Potassium bicarbonate

Sodium carbonate

Sodium and potassium citrates are formed by effervescent reaction with water. These provide acid neutralising and buffering actions against acidic gastric contents.

5.2 Pharmacokinetic Properties

Paracetamol is readily and rapidly absorbed from the gastro-intestinal 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 gastro-intestinal 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.

Antacid combination provides an immediately available, local buffering effect in the stomach. Absorbed sodium, potassium and citrate ions will be handled and excreted by normal metabolic routes.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

6. Pharmaceutical Particulars

6.1 List Of Excipients

orange flavour (including malto-dextrin, gum arabic, triacetin and alpha-tocopherol)

acesulfame potassium (E950)

aspartame (E951)

quinoline yellow (E104)

sunset yellow (E110)

ascorbic acid

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Not applicable.

6.5 Nature And Contents Of Container

This product is packed in laminate sachets comprising paper/polyethylene/aluminium foil/ polyethylene or paper/polyethylene/aluminium foil/Surlyn.

Five or ten sachets are contained in a boxboard carton.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Wrafton Laboratories Limited, Wrafton, Braunton, North Devon EX33 2DL.

8. Marketing Authorisation Number(S)

PL 12063/0033.

9. Date Of First Authorisation/Renewal Of The Authorisation

12 June 2003.

10. Date Of Revision Of The Text

June 2007.