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Procter & Gamble (Health & Beauty Care) Ltd.

The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK

Telephone: +44 (0)191 297 5000
Fax: +44 (0)191 297 6295
WWW: http://www.uk.pg.com
Customer Care direct line: +44 (0) 8000 850367 (UK)

Customer Care direct line: +353 (1) 800 509 301 (Ireland)

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Summary of Product Characteristics last updated on the eMC: 17/08/2009

SPC	Vicks Cold & Flu Care Medinite Complete Syrup

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Vicks Cold & Flu Care Medinite Complete Syrup.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

ACTIVE INGREDIENTS

	Percentage w/v	Specification
Dextromethorphan HBr	0.050	EP
Doxylamine succinate	0.025	USP
Paracetamol	2.000	EP
Pseudoephidrine HCl	0.200	BP

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3. PHARMACEUTICAL FORM

Syrup.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the treatment of symptoms of the common cold, accompanied by sneezing, headache, bodyache, sore throat, cough and nasal congestion.

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4.2 Posology and method of administration

Oral administration.

Adults & Children over 12 years: 30ml in measuring cup at bedtime.

Elderly patients: Adult dose applies.

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4.3 Contraindications

Cardiovascular disorders, thyroid disease, diabetes, monoamine oxidase inhibitor therapy, severe hepatic or renal insufficiency. Pregnancy. Hypersensitivity to any of the ingredients.

Not to be used in Children under 12 years of age

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

Do not exceed the recommended dose.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist, consult your doctor.

Keep out of the reach of children.

This preparation should not be administered to children under 10 years except on medical advice.

Contains paracetamol.

May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

If you are under the care of your doctor or are receiving prescribed medication or if you are pregnant, consult your doctor before using this product.

Prolonged use without medical supervision is not advisable.

Contains alcohol.

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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.

Paracetamol may cause a marginal increase in blood levels of chloramphenicol, monoamine oxidase inhibitors, antihypertensives, beta-blockers.

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4.6 Pregnancy and lactation

Epidemiological studies in human pregnancy have shown no effects due to paracetamol used in the recommended dosage. However, paracetamol should be avoided in pregnancy unless considered essential by the physician.

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

Regarding the product as a whole there is insufficient evidence to assure safe use in pregnancy and lactation.

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4.7 Effects on ability to drive and use machines

May cause drowsiness. Those affected should not drive or operate machinery.

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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, and of acute pancreatitis.

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4.9 Overdose

4.9.1 Symptoms

Paracetamol:

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 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.

Other symptoms may include CNS depression, cardiovascular effects and renal damage.

4.9.2 Treatment of overdose

Paracetamol:

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 preceeding 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.

Treatment of other symptoms is by symptomatic management.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Paracetamol:	Analgesic/antipyretic.
Dextromethorphan HBr:	Anti-tussive.
Doxylamine succinate:	Antihistamine, anticholinergic
Pseudoephidrine hydrochloride:	Sympathomimetic agent - nasal decongestant

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5.2 Pharmacokinetic properties

Paracetamol:	Metabolised in the liver and excreted in the urine as glucuronide and sulphate conjugates.
Dextromethorphan HBr:	Metabolised in the liver and excreted as unchanged dextromethorphan and demethylated morphinian compounds.
Doxylamine succinate:	Is believed to to be metabolised in the liver and excreted mainly as metabolites in the urine
Pseudoephidrine hydrochloride:	Is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine