Vicks Cough Syrup with Honey for Dry Coughs (2011)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	Procter & Gamble (Health & Beauty Care) Ltd
Διεύθυνση	The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK

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Name of the medicinal product

Vicks Cough Syrup with Honey for Dry Coughs.

Qualitative and quantitative composition

ACTIVE INGREDIENTS: %w/v Specification Dextromethorphan hydrobromide 0.133 Ph. Eur.

Pharmaceutical form

Syrup for oral administration.

Therapeutic indications

Cough suppressant to relieve acute non-productive cough associated with upper respiratory tract infection and soothe the throat.

Posology and method of administration

Adults and children over 12 years: 3 5ml spoonfuls Children (6-12 years): 1 5ml spoonful Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor, seek medical ...

Contraindications

Not to be used in children under the age of 6 years. Hypersensitivity to the active substance(s) or to any of the excipients. Severe liver disease. Patients currently receiving monoamine oxidase inhibitors ...

Special warnings and precautions for use

Do not exceed the stated dose. Ask a doctor before use if you suffer from liver disease, chronic or persistent cough, if you have asthma, suffering from an acute asthma attack or where cough is accompanied ...

Interaction with other medicinal products and other forms of interaction

Not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome (pyrexia, hypertension, arrhythmias) when MAOIs are taken in combination with dextromethorphan. ...

Pregnancy and lactation

Due to insufficient evidence on the use of the product in pregnancy and lactation, use of the product should be avoided unless on the advice of a physician.

Effects on ability to drive and use machines

None expected.

Undesirable effects

In general no severe undesirable effects are expected. Nervous system disorders: Drowsiness or dizziness may occur rarely. Gastrointestinal disorders: Gastrointestinal disturbances that may rarely occur ...

Overdose

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs. Symptoms: These include nausea and vomiting, CNS depression, ...

Pharmacodynamic properties

Dextromethorphan hydrobromide is a cough suppressant with a central action on the cough centre of the medulla.

Pharmacokinetic properties

Dextromethorphan HBr is well absorbed from the gastrointestinal tract, metabolised in the liver and is excreted in the urine as unchanged dextromethorphan and demethylated metabolites.

Preclinical safety data

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

List of excipients

Sucrose Sodium saccharin Propylene glycol Ethanol 96% Sodium citrate, hydrous Citric acid, anhydrous Carboxymethylcellulose sodium Polyethylene oxide Black cherry flavour RF 1195 Levomenthol Menthoxypropanediol ...

Incompatibilities

None known.

Shelf life

Shelf life (unopened): 2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Amber cylindrical glass bottle (pharmaceutical type III) with a high density polyethylene screw thread closure. Bottles containing 15ml, 30m1, 100ml, 120m1, 180m1 and 250ml of product are available.

Special precautions for disposal and other handling

No specific instructions required.

Marketing authorization holder

Procter & Gamble (Health & Beauty Care) Ltd. The Heights Brooklands Weybridge Surrey KT13 0XP

Marketing authorization number(s)

PL 00129/0079

Date of first authorization / renewal of the authorization

31 June 1984 / 13 February 1995

Date of revision of the text

30/04/2011