Resolve Extra (SSL International plc)

1. Name Of The Medicinal Product

Resolve Extra.

2. Qualitative And Quantitative Composition

Each sachet contains Paracetamol 1g, Sodium Bicarbonate 1.408g and Caffeine 60mg.

3. Pharmaceutical Form

Effervescent granules.

4. Clinical Particulars

4.1 Therapeutic Indications

Recommended for the relief of headache, including tension headache and migraine, with gastric upset, particularly associated with over-indulgence in food or drink or both. Resolve Extra contains an extra strength pain relieving formula with an antacid to settle the stomach. It is also recommended for the treatment of toothache, neuralgia, sore throat, period pains and symptomatic relief of rheumatic aches and pains, colds and influenza.

4.2 Posology And Method Of Administration

Method of Administration: Oral Administration. Resolve Extra should be dissolved in a glass of water. Adults: One sachet up to four times daily. Do not exceed 4 sachets in 24 hours. The Elderly: As for adults. Children: Not recommended for children under 18 years.

4.3 Contraindications

Hypersensitivity to paracetamol, caffeine, sodium bicarbonate or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Excessive intake of tea or coffee should be avoided while taking this product. This product contains dextrose (glucose) and patients should consult their physician if they are suffering from diabetes before using this product. Do not exceed stated dose. Patients should be advised not to take other paracetamol-containing products concurrently. If symptoms persist, consult your doctor. Keep out of reach of children.

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 daily 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 and caffeine used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol and caffeine are 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

None.

4.8 Undesirable Effects

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

4.9 Overdose

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

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 7.5g 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 for up to at least 48 hours after the overdose may be required. General supportive measures must be available.

Overdose of caffeine may product nervousness, restlessness, insomnia, excitement, diuresis, facial flushing, muscle twitching, GI disturbance, tachycardia or cardiac arrhythmia, “rambling” flow of thought and speech, psychomotor agitation, or periods of inexhaustibility.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of paracetamol and caffeine is a well-established analgesic combination.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.

Caffeine is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65-80% of administered caffeine is excreted in the urine as I-methyluric acid and 1-methylxanthine.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric Acid (anhydrous); Sodium Carbonate (anhydrous); Sodium Lauryl Sulphate; Polyvinylpyrrolidone K25; Saccharin Sodium; Dextrose (anhydrous); Lemon Durarome;

Purified Water

6.2 Incompatibilities

None.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Polythene/foil laminate sachets in cardboard carton outers containing 5 or 10 sachets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

SSL International PLC. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 17905/0081

9. Date Of First Authorisation/Renewal Of The Authorisation

13/06/2006

10. Date Of Revision Of The Text

13/06/2006