JACKSONS THE ORIGINAL ALL FOURS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Jackson's The Original All Fours

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Guaifenesin BP 50mg/5ml

Excipients of known effect:

Each 5 ml contains: Sucrose 0.36 g, Ethanol 42.5 mg (85 mg per 10 ml dose), Methyl

Parahydroxybenzoate (E219) 10 mg.

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Syrup

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of chesty coughs

4.2 Posology and method of administration

Oral administration according to the following posology:-

Adults:                        10–20 ml at bedtime or at four-hourly intervals.

Children:                      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 one or more of the ingredients.

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 0.36g of sucrose per 5ml dose. This should be taken into account in patients with diabetes mellitus.

This medicine contains up to 85mg of ethanol per 10ml 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 E219 which may cause allergic reactions (possibly delayed).

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 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 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

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

Black Treacle

Liquorice Liquid Extract

Ethanol 96%

Sodium Methyl Hydroxybenzoate E219

Capsicum Tincture

Anise Oil

Peppermint Oil

Purified Water

6.2 Incompati­bilities

None known

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

200ml amber glass bottle and polypropylene/HDPE child resistant closure with a saranex faced EPE liner and LDPE tamper-evident band

6.6 Special precautions for disposal and other handling

Consumers are advised not to accept the product if the cap seal is broken and to keep all medicines out of the reach of children.

OTC Concepts Limited

2 Park Street

Woburn

Bedfordshire

MK17 9PG

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 20338/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

4 September 2003