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Dry Cough Syrup

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Dry Cough Syrup

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

UNIT    Dose

mg    15 ml


INGREDIENT    QTY

Dextromethorphan    15

Hydrobromide

3.    PHARMACEUTICAL FORM

Liquid

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Cough suppressant for relief of acute non-productive cough associated with upper respiratory tract infection.

4.2. Posology and method of administration

Adults, the Elderly and Children over 12 years: 15 ml in dosing cup provided.

Children 6 - 12 years: 7.5 ml in dosing cup provided.

Not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child’s condition deteriorates during treatment.

This product is contraindicated in children under the age of 6 years (see section 4.3).

The dose should not be repeated more frequently than every 6 hours and not more than 3 doses should be taken in a 24 hour period.

Do not exceed the stated dose.

Keep all medicines out of the reach and sight of children.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Not to be used in children under the age of 6 years.

Dextromethorphan should not be given to subjects in, or at risk of developing respiratory failure.

Patients taking monoamine oxidase inhibitors MAOIs) or within 14 days of stopping such treatment (see section 4.5).

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

4.4. Special warnings and precautions for use

Keep all medicines out of the reach and sight of children.

If symptoms persist consult your doctor.

Should be used with caution by patients with liver disease.

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

Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, suffering from an acute asthma attack or where cough is accompanied by excessive secretions.

Do not take with any other cough and cold medicine.

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

4.5. Interactions with other medicinal products and other forms of interaction

Not to be used in patients taking mono-amine oxidase inhibitors, 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 thiordazine, should be borne in mind.

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

4.6. Pregnancy and Lactation

There are no data on the use of dextromethorphan in pregnancy or when lactating.

There are no reports of problems from its use in pregnancy, but as with all medicines, its use is contra-indicated in early pregnancy unless absolutely essential.

4.7. Effects on Ability to Drive and Use Machines

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When taking this medicine, patients should be told:

•    The medicine is likely to affect your ability to drive

•    Do not drive until you know how the medicine affects you

•    It is an offence to drive while under the influence of this medicine

•    However, you would not be committing an offence (called ‘statutory defence’) if:

o The medicine has been taken to treat a medical or dental problem and

o You have taken it according to the information provided with the medicine and

o It was not affecting your ability to drive safely

4.8. Undesirable effects

The following side effects may be associated with the use of dextromethorphan:

Occasional drowsiness, dizziness, excitation, mental confusion, convulsions, respiratory depression, vomiting, gastrointestinal disturbances (nausea and diarrhoea) and skin reactions including rash.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9. Overdose

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychtropic drugs.

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. Gastic lavage may be of use. Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethophan in children (0.01 mg/kg body weight).

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Mechanism of action/effect

Dextromethorphan Hydrobromide is a well known cough suppressant which has a central action an the cough centre in the medulla. Although structurally related to morphine it has no analgesic and sedative properties.

5.2. Pharmacokinetic Properties

Absorption and Fate:

Dextromethorphan Hydrobromide is absorbed from the gastro-intestinal tract. It is metabolised and excreted in the urine as unchanged dextromethorphan and demethylated metabolites including dextorphan which exhibits some cough suppressant activity.

5.3. Pre-clinical Safety Data

Not applicable.

6.


PHARMACEUTICAL PROPERTIES

6.1.    List of Excipients

Carrageenan Menthol NF Alcohol 96% BP

Sorbitol 70% Solution Non-Crystallising EP

Potassium Sorbate BP

Sodium Cyclamate EP

Sodium Saccharin EP

Flavour Mix

Caramel E150

Purified Water BP

6.2.    Incompatibilities

None.

6.3. Shelf-Life

Three years.

6.4. Special Precautions for Storage

Do not store above 25°C.

6.5. Nature and Content of Container

Lightweight amber glass bottles with polypropylene/polythene caps containing 150ml of the product.

6.6. Instructions for Use, Handling and Disposal

Shake well before use.

7. MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited Wrafton

Braunton North Devon EX33 2DL

8.    MARKETING AUTHORISATION NUMBER(S)

PL 12063/0024

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

07 March 1997

10 DATE OF REVISION OF THE TEXT

30/06/2015