Vicks Cough Syrup with Honey for Dry Coughs Ref.[2738] Active ingredients: Demorphan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2011  Publisher: Procter & Gamble (Health & Beauty Care) Ltd. The Heights Brooklands Weybridge Surrey KT13 0XP

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 (MAOIs) or within 14days of stopping such treatment

Patients with a productive cough.

Patients in, or at risk of developing respiratory failure.

Patients taking selective serotonin reuptake inhibitors (SSRIs, see section 4.5).

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 by excessive secretions

Should be used with caution in atopic children due to histamine release

Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

If symptoms persist, consult your doctor.

Keep out of reach and sight of children.

Children age 6-12: do not take with any other cough and cold medicine.

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.

Dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6; the possibility of interactions with inhibitors of this enzyme, including amiodarone, haloperidol, propafenone, quinidine, SSRIs, and thioridazine, should be borne in mind.

Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs.

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 include nausea, vomiting and diarrhoea.

Skin and subcutaneous disorders: Skin rashes have rarely been reported with dextromethorphan.

Excitation, mental confusion, respiratory depression or convulsions may occur very rarely under normal conditions of use or after overdosage (see Section 4.9)

Incompatibilities

None known.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.