Robitussin Dry Cough Medicine

1. Name Of The Medicinal Product

Robitussin Dry Cough Medicine

2. Qualitative And Quantitative Composition

Active Ingredient

Dextromethorphan Hydrobromide Ph Eur 7.5mg per 5ml

For full list of excipients see section 6.1

3. Pharmaceutical Form

Bright pink clear liquid for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of persistent dry irritant coughs.

4.2 Posology And Method Of Administration

Oral administration.

Adults, the elderly and children over 12 years: One 10ml measure up to four times daily.

Children under 12 years: Do not use

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Patients taking a prescription monoamine oxidase inhibitor (MAOI) or for 14 days after stopping the MAOI drug. (See section 4.5).

Use in children under 12 years.

4.4 Special Warnings And Precautions For Use

Patients suffering from chronic cough, asthma or patients suffering from an acute asthma attack, or where cough is accompanied by excessive secretions should be advised to consult a Healthcare Professional before use.

Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/ treated. Stop use and ask your healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash or persistent headache.

Keep out of the sight and reach of children.

Do not exceed recommended dose.

Excipient warnings:

- Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains Sorbitol and Maltitol.

- This product contains Amaranth (E123), which may cause allergic reactions.

- This medicinal product contains 2.5% v/v ethanol (alcohol), up to196 mg per dose, (equivalent to approx 1.6 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not to be used in patients taking monoamine inhibitors or within 14 days of stopping treatment as there is a risk of hyperpyrexic crisis when MOAI are taken in combination with dextromethorphan.

Quinidine can increase serum concentrations of dextromethorphan markedly and some patients have experienced symptoms of dextromethorphan toxicity when the two agents have been used together.

Amiodarone appears to be able to increase serum concentrations of dextromethorphan.

4.6 Pregnancy And Lactation

Although dextromethorphan has been in widespread use for many years without apparent illconsequence, there are no specific data on its use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment against any possible hazards. It is not known whether dextromethorphan or its metabolites are excreted in human milk.

4.7 Effects On Ability To Drive And Use Machines

Dextromethorphan hydrobromide has no adverse effects on the patients ability to drive and to use machines.

4.8 Undesirable Effects

Adverse effects are rare, however the following side effects may be associated with dextromethorphan hydrobromide:

Gastrointestinal Disorders

Rare: Gastrointestinal upset

Nervous System Disorders

Rare: Dizziness

4.9 Overdose

Symptoms:

These include nausea and vomiting, CNS depression, dizziness, dysarthria (slurred speech), nystagmus, somnolence (drowsiness), excitation, mental confusion, psychotic disorder (psychosis), and respiratory depression.

Management:

Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Dextromethorphan hydrobromide is a cough suppressant which has a central action on the cough centre in the medulla. It has no analgesic properties and little sedative activity.

Dextromethorphan

Pharmacotherapeutic group: Cough suppressant

ATC code: R05DA09

5.2 Pharmacokinetic Properties

Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine as unchanged dextromethorphan and demethylated metabolites including dextrorphan, which has some cough suppressant activity.

5.3 Preclinical Safety Data

There is no relevant information additional to that already contained elsewhere in the SmPC or of relevance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol

Sodium Carboxymethyl Cellulose

Sodium Benzoate

Disodium Edetate

Maltitol (E965)

Ethanol (96%)

Citric Acid Anhydrous

Amaranth (E123)

Caramel (E150)

Levomenthol

Cherry/Grenadine Flavour

Sorbitol Solution 70%

Sodium Cyclamate

Acesulfame Potassium Salt

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep out of reach and sight of children.

6.5 Nature And Contents Of Container

PET bottles containing 100ml with PET lined PP/HDPE screw caps.

A clear polypropylene measuring cap also included.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00165/0100

9. Date Of First Authorisation/Renewal Of The Authorisation

01 September 1993

10. Date Of Revision Of The Text

October 2011