RESOLVE - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Resolve

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3   PHARMACEUTICAL FORM

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.

Oral administration.

4.2 Posology and method of administration

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

Adults 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.

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 Label:

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 hepatotoxicity 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 Fertility, Pregnancy and lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, and hence paracetamol is not contraindicated during pregnancy. However patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk but not in clinically significant amounts. Available published data do not contraindicate breast feeding.

4.7 Effects on ability to drive and use machines None stated.

4.8 Undesirable effects

The active ingredients are usually well tolerated in normal use. Adverse effects of paracetamol are rare, but hypersensitivity including skin rashes and other allergies may occur.

4.9 Overdose

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

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 has ingested around 7.5 g 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. General supportive measures must be available.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol –

Ascorbic acid –

Citric acid             }

Sodium bicarbonate }

Potassium bicarbonate }

Sodium carbonate }

analgesic

replaces lost vitamin C

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 safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this summary.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Povidone 30

Anhydrous glucose

Polyethylene glycol 6000

Lemon flavour

Saccharin sodium

Sodium cyclamate

Quinoline yellow (E104)

6.2 Incompatibilities

None known

6.3 Shelf life

Three years

6.4 Special precautions for storage

Not applicable

6.5 Nature and contents of container

The product is packed in laminate sachets comprising paper/polythe­ne/aluminium foil/polythene.

A trial size sample consists of a single attached to a cardboard backing.

Two, three, four, five or ten sachets may be contained in a boxboard carton.

6.6 Special precautions for disposal Not applicable.