JACKSONS EXTRA STRENGTH ALL FOURS, JACKSONS MAX STRENGTH CHESTY COUGH 100 MG / 5ML ORAL EMULSION - summary of medicine characteristics

Summary of medicine characteristics - JACKSONS EXTRA STRENGTH ALL FOURS, JACKSONS MAX STRENGTH CHESTY COUGH 100 MG / 5ML ORAL EMULSION

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Jackson’s Extra Strength All Fours

Jackson’s Max Strength Chesty Cough 100mg/5ml Oral Emulsion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml contains Guaifenesin 100 mg

Excipients with known effect:

Each 5 ml contains: Sucrose 1.6 g, Ethanol 270 mg.

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral emulsion

Viscous, hazy olive green liquid with a characteristic balsam odour

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of bronchial catarrh and chesty coughs.

4.2 Posology and method of administration

Oral administration according to the following posology

Adults: 5 to 10 ml at bedtime or at four hourly intervals.

Children: Over 12 years of age, as for adults. Not to be used in children under 12 years of age.

Elderly: As for adult dose.

Pregnant/lactating women: As for adult dose.

4.3 Contraindications

Known hypersensitivity to guaifenesin, or one of the other excipients.

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

4.4 Special warnings and precautions for use

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

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.

Do not take with a cough suppressant.

Caution should be exercised when using the product in the presence of severe renal or severe hepatic impairment.

If symptoms persist consult your doctor.

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine as it contains sucrose.

This medicine contains approximately 1.6g of sucrose per 5ml dose. This should be taken into account in patients with diabetes mellitus.

This medicine contains up to 270mg ethanol per 5ml dose and may be harmful for those suffering from alcoholism. This should be taken into account in pregnant or breastfeeding women, children and high risk groups such as patients with liver disease or epilepsy.

This medicine contains less than 1mmol sodium (23mg) per 5ml, that is to say essentially “sodium-free”.

4.5 Interaction with other medicinal products and other forms of interaction

If urine is collected within 24 hours of a dose of this medicine 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 Fertility, Pregnancy and lactation

For guaifenesin no clinical data on exposed pregnancies are available. Caution should be exercised when prescribing to pregnant women.

Guaifenesin is excreted in breast milk. However, at therapeutic doses of the medicine no effects on the suckling child are anticipated. The medicine can be used during breastfeeding.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Modern clinical data on which to base adverse event frequencies are lacking for guaifenesin.

Gastrointestinal disorders: frequency unknown: Nausea, vomiting, diarrhoea, abdominal pain upper.

Immune system disorders: Hypersensitivity reactions including pruritis, urticaria, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Excessive doses may cause nausea and vomiting. Treat symptomatically.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

R05C A03 – Expectorants

Guaifenesin is an expectorant, and has been reported to reduce cough frequency and intensity.

5.2 Pharmacokinetic properties

Guaifenesin is readily absorbed from the gastro-intestinal tract. It is rapidly metabolised and excreted in the urine.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Glycerol

Ethanol (96%)

Tolu flavoured solution

Compound benzoin tincture Powdered tragacanth E413 Acetic acid (80%) E260 Capsicum Tincture

Caramel E150

Saccharin sodium

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

As packaged for sale, 36 months.

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original container.

6.5 Nature and contents of container

Amber glass bottle and polypropylene/HDPE child resistant closure with a saranex faced EPE liner and LDPE tamper-evident band.

Pack sizes of 100ml, 150ml and 200ml.

Not all pack sizes may be marketed