SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Headache and Upset Stomach Relief.

Asda Headache and Upset Stomach Relief Boots Headache and Upset Stomach Relief Superdrug Headache and Upset Stomach Relief Tesco Recovery Effervescent Powder Boots 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 cholestyramine. 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.

Very rare cases of serious skin reactions have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

PARACETAMOL

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

5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a,    Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.

Or

b,    Regularly consumes ethanol in excess of recommended amounts.

Or

c,    Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

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, 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.

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

36 months.

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.    Instruction for use and handling

Not applicable.

7. MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon EX33 2DL United Kingdom

MARKETING AUTHORISATION NUMBER

PL 12063/0033

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12 June 2003

10 DATE OF REVISION OF THE TEXT

20/01/2016