Benylin dry Coughs (Non-Drowsy)

1. Name Of The Medicinal Product

BENYLIN DRY COUGHS (NON DROWSY)

2. Qualitative And Quantitative Composition

BENYLIN DRY COUGHS (NON DROWSY) contains -

Dextromethorphan hydrobromide Ph Eur 7.5 mg in each 5 ml

3. Pharmaceutical Form

Pale brown coloured, peach flavoured syrup.

4. Clinical Particulars

4.1 Therapeutic Indications

BENYLIN DRY COUGHS (NON DROWSY) is indicated as an antitussive, for the relief of persistent, dry, irritating cough.

4.2 Posology And Method Of Administration

Adults and Children aged 12 years and over:

Oral. 10 ml syrup (15 mg dextromethorphan) 4 times a day.

Maximum daily dose: 40 ml syrup (60 mg dextromethorphan)

Children under 12 years:

BENYLIN DRY COUGHS (NON DROWSY) is contraindicated in children under the age of 12 years (see section 4.3).

The Elderly (over 65 years)

As for adults above.

Hepatic/renal dysfunction

Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of moderate to severe hepatic impairment (see Pharmacokinetics).

Do not exceed the stated dose.

Keep out of the reach and sight of children.

4.3 Contraindications

BENYLIN DRY COUGHS (NON DROWSY) is contraindicated in individuals with known hypersensitivity to the product or any of its components.

BENYLIN DRY COUGHS (NON DROWSY) is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors, can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.

Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to subjects in, or at risk of developing respiratory failure.

Not to be used in children under the age of 12 years.

4.4 Special Warnings And Precautions For Use

BENYLIN DRY COUGHS (NON DROWSY) should not be administered to patients with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.

There have been no specific studies of BENYLIN Dry Coughs (Non Drowsy) in renal or hepatic dysfunction. Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.

4.6 Pregnancy And Lactation

Although dextromethorphan has been in widespread use for many years without apparent ill consequence, there is insufficient information on the effects of administration during human pregnancy. In addition, it is not known whether dextromethorphan or its metabolites are excreted in breast milk.

BENYLIN DRY COUGHS (NON DROWSY) should therefore only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing foetus or suckling infant.

4.7 Effects On Ability To Drive And Use Machines

Unlikely to produce an effect.

4.8 Undesirable Effects

Side effects attributed to dextromethorphan are uncommon; occasionally dizziness, nausea, vomiting, or gastro-intestinal disturbance may occur.

4.9 Overdose

Signs and symptoms

The effects of acute toxicity from BENYLIN DRY COUGHS (NON DROWSY) overdose may include drowsiness, lethargy, nystagmus, ataxia, respiratory depression, nausea, vomiting, hyperactivity.

Treatment

Treatment 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 is a non-opioid antitussive drug. It exerts its antitussive activity by acting on the cough centre in the medulla oblongata, raising the threshold for the cough reflex. A single oral dose of 10-20 mg dextromethorphan produces its antitussive action within 1 hour and lasts for at least 4 hours.

5.2 Pharmacokinetic Properties

Absorption

Dextromethorphan is well absorbed from the gut following oral administration. Due to individual differences in the metabolism of dextromethorphan, pharmacokinetic values are highly variable. After the administration of a 20 mg dose of dextromethorphan to healthy volunteers, the Cmax varied from < 1 mg/l to 8 mg/l, occurring within 2.5 hours of administration.

Distribution

Due to extensive pre-systemic metabolism by the liver, detailed analysis of the distribution of orally administered dextromethorphan is not possible.

Metabolism and Elimination

Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration. Genetically controlled O-demethylation is the main determinant of dextromethorphan pharmacokinetics in human volunteers. It appears that there are distinct phenotypes for this oxidation process resulting in highly variable pharmacokinetics between subjects. Unmetabolised dextromethorphan, together with the three demethylated morphinan metabolites dextrophan (also known as 3-hydroxy-N-methylmorphinan) 3-hydroxymorphinan and 3-methoxymorphinan have been identified as conjugated products in the urine. Dextrorphan, which also has antitussive action, is the main metabolite.

5.3 Preclinical Safety Data

Mutagenicity

There is insufficient information to determine whether dextromethorphan has mutagenic potential.

Carcinogenicity

There is insufficient information to determine whether dextromethorphan has carcinogenic potential, although such effects have not been associated with these drugs in animal studies.

Teratogenicity

There is insufficient information to determine whether dextromethorphan has teratogenic potential.

Fertility

There is insufficient information to determine whether dextromethorphan has potential to impair fertility.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid glucose

Sucrose

Sorbitol solution 70% non crystallising

Ethanol 96%

Glycerol

Saccharin sodium

Citric acid monohydrate

Sodium benzoate

Caramel T12

Imitation peach flavour

Levomenthol

Carbomer

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Store below 30°C

6.5 Nature And Contents Of Container

125 or 150 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyterephtalate ethylene faced aluminium/expanded polyethylene laminated wad.

6.6 Special Precautions For Disposal And Other Handling

None applicable

Administrative Data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Bershire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

15513/0051

9. Date Of First Authorisation/Renewal Of The Authorisation

Date Granted: 16 June 1997

10. Date Of Revision Of The Text

05 March 2010