SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Expectorant and Decongestant Cough Syrup

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

INGREDIENT	QTY	UNIT
Guaifenesin	200	mg/15ml
Pseudoephedrine Hydrochloride	60	mg/15m;

3. PHARMACEUTICAL FORM

Liquid

4 CLINICAL PARTICULARS

4.1. Therapeutic indications

Expectorant for the symptomatic relief of acute productive (chesty) cough. Also effective in the relief of nasal congestion and congestion of the mucous membranes of the upper respiratory tract associated with the common cold.

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.

Not more than 3 doses should be taken in any 24 hours. Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

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

4.3.    Contraindications

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

Porphyria.

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

Concomitant use of other sympathomimetic decongestants.

Cardiovascular disease including hypertension.

Diabetes mellitus.

Phaeochromocytoma.

Hyperthyroidism.

Closed angle glaucoma.

Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5).

Beta-blockers - (see section 4.5).

Severe renal impairment.

4.4.    Special warnings and precautions for use

Ask a doctor before use if you suffer from a chronic cough, if you have asthma or are suffering from an acute asthma attack.

Do not take with a cough suppressant.

Stop use and ask a healthcare professional if your cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache.

Use with caution in occlusive vascular disease.

If any of the following occur this product should be stopped:

•    Hallucinations

•    Restlessness

•    Sleep disturbances

Should be used with caution in patients with arrhythmias, prostatic hypertrophy, moderate to severe renal impairment, or severe coronary artery disease.

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

If symptoms persist consult your doctor.

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

•    MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis

•    Moclobemide: risk of hypertensive crisis

•    Antihypertensives (including adrenergic neurone blockers and beta-blockers): this product may block the hypotensive effects

•    Cardiac glycosides: increased risk of dysrhythmias

•    Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism

•    Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension

•    Oxytocin - risk of hypertension

•    Enhances effects of anticholinergic drugs (such as TCAs).

If urine is collected within 24 hours of a dose of this product, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

4.6. Pregnancy and Lactation

Pseudoephedrine is not teratogenic in animals and both pseudoephedrine and guaiphenesin have been in use for many years without any problems or teratogenicity or mutagenicity being reported. However, there have been no specific studies in human pregnancy and as with all medicines the use of Expectorant and decongestant Cough Syrup is contraindicated in early pregnancy unless absolutely necessary.

4.7. Effects on Ability to Drive and Use Machines

None stated.

4.8. Undesirable effects

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

Gastrointestinal disorders: Nausea, vomiting Immune system disorders: Hypersensitivity reactions.

Pseudoephedrine can cause:

Cardiovascular effects

•    Tacycardia/palpitations

•    Other cardiac dysrhythmias and hypertension.

CNS effects

•    Irritability

•    Anxiety

•    Restlessness

•    Excitability

•    Insomnia

•    Hallucinations and paranoid delusions

Skin reactions including rash.

Hypersensitivity reactions - including that cross-sensitivity may occur with other sympathomimetics.

Other reactions

•    Nausea and/or vomiting

•    Headache

•    Urinary retention.

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

Very large doses of Guaiphenesin can cause nausea and vomiting. Vomiting should be treated by fluid replacement and monitoring of electrolytes.

Because pseudoephedrine is rapidly absorbed, emetics and gastric lavage should be instituted within four hours of overdosage in order to be effective.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Mechanism of action/effect

Guaiphenesin is a well known expectorant. Such expectorants are known to increase the volume of secretions in the respiratory tract and therefore to facilitate their removal by cilary action and coughing.

Pseudoephedrine Hydrochloride is a well known decongestant. It has been stated that decongestants provide only minimal relief when used alone in allergic rhinitis and are more effective when combined with other agents. Pseudoephedrine Hydrochloride is categorised as sympathomimetic which stimulate a-adrenergic receptors and cause vasoconstriction of capillaries in the nasal mucosa and are therefore used as nasal decongestants.

5.2. Pharmacokinetic Properties

Absorption and Fate:

Guaiphenesin is absorbed from the gastro-intestinal tract. It is metabolised and excreted in the urine. Pseudoephedrine Hydrochloride is also absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged together with small amounts of its hepatic metabolite.

5.3. Pre-clinical Safety Data

Not applicable.

6. PHARMACEUTICAL PROPERTIES

6.1.    List of Excipients

Carrageenan Glycerine EP Alcohol 96% EP Menthol BP

Sorbitol 70% Solution Non-Crystallising EP Potassium Sorbate BP Sodium Cyclamate EP Sodium Saccharin EP Flavour Mix

Colour Ponceau 4R E124 Caramel Colour 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

Amber glass bottles with polypropylene/polythene caps containing 150 ml of 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 12063/0022

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

07 March 1997

10 DATE OF REVISION OF THE TEXT

11/11/2015