Summary of Product Characteristics (SmPC) - Jacksons the Original All Fours
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
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Not to be used in children under the age of 12 years.
4.4 Special warnings and precautions for use
This product should not be used for persistent or chronic cough, such as occurs with asthma, or where a cough is accompanied by excessive secretions, unless directed by a physician.
A persistent cough may be a sign of a serious condition. Stop use and ask a healthcare professional if your cough lasts for more than 7days, comes back, or is accompanied by a fever, rash or persistent headache.
The concomitant useof cough suppressants is not recommended.
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, glucose- galactose 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).
Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination is illogical and patients may be exposed to unnecessary adverse effects.
No interaction studies have been performed which revealed an interaction with guaifenesin.
4.6 Fertility, pregnancy and lactation Pregnancy
Pregnancy
For guaifenesin, no or limited clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to reproductive toxicity, (see section 5.3).
Jackson's The Original All Fours is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
Guaifenesin is excreted in breast milk in small amounts. There is insufficient information on the effects of guaifenesin in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Jackson's The Original All Fours therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.
4.7 Effects on ability to drive and use machines
Guaifenesin has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Summary of the safety profile
Anaphylaxis has been reported.
Modern clinical data on which to base adverse event frequencies are lacking for guaifenesin. The undesirable effects have been reported spontaneously during post marketing use. Due to limited clinical trial data, a frequency cannot be
estimated from the available data and is therefore classified as “not known”.’ The following side effects may be associated with the use of guaifenesin:
Gastrointestinal disorders: frequency unknown: Nausea, vomiting, diarrhoea, abdominal pain upper.
Immune system disorders: frequency unknown: Hypersensitivity reactions including pruritis, urticaria, rash. Anaphylactic reaction.
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
Symptoms and signs
The signs and symptoms of overdose may cause gastro-intestinal discomfort, nausea, drowsiness and vomiting.
When taken in excess, guaifenesin may cause renal calculi.
Management
Treatment should be symptomatic and supportive.
5. PHARMACOLOGICAL PROPERTIS
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Cough and Cold Preparations, Expectorants,
ATC Code: R05C A03
Guaifenesin is an expectorant, and has been reported to reduce cough frequency and intensity.
Mechanism of action
This product is thought to exert its pharmacological action by stimulating receptors in the gastric mucosa. This increases the output from secretory glands of the gastrointestinal system and reflexly increases the flow of fluids from glands lining the respiratory tract. The result is an increase in volume and decrease in viscosity of bronchial secretions. Other actions may include stimulating vagal nerve endings in bronchial secretory glands and stimulating certain centres in the brain, which in turn enhance respiratory fluid flow. Guaifenesin produces its expectorant action within 24 hours.
5.2 Pharmacokinetic properties
Special Populations
There is no information available on the pharmacokinetics of guaifenesin in special populations.
Absorption
Guaifenesin is well absorbed from the gastro-intestinal tract following oral administration, although limited information is available on its pharmacokinetics. After the administration of 600 mg guaifenesin to healthy adult volunteers, the Cmax was approximately 1.4 ug/ml, with tmax occurring approximately 15 minutes after drug administration.
Distribution
No information is available on the distribution of guaifenesin in humans.
Biotransformation and elimination
Guaifenesin appears to undergo both oxidation and demethylation. The drug is rapidly metabolized in the liver via oxidation to β-(2-methoxyphenoxy)-lactic acid. The demethylation of GGE (hydroxyguaifenesin) is performed by O-demethylase, localized in liver microsomes. Following an oral dose of 600 mg guaifenesin to 3 healthy male volunteers, the t½ was approximately 1 hour and the drug was not detectable in the blood after approximately 8 hours.
Guaifenesin is excreted predominantly in the urine. Approximately 40% of a dose is excreted as the metabolite beta-2-methoxyphenoxy-lactic acid in the urine within 3 hours. Following oral dosing of 400 mg guaifenesin, more than 60% of a dose is hydrolysed within 7 hours, with no parent drug detectable in the urine.
5.3 Preclinical Safety data
Carcinogenicity
There is insufficient information available to determine whether guaifenesin has carcinogenic potential.
Mutagenicity
There is insufficient information available to determine whether guaifenesin has mutagenic potential.
Teratogenicity
There is insufficient information available to determine whether guaifenesin has teratogenic potential.
Fertility
There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.
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
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.
7 MARKETING AUTHORISATION HOLDER
Kent Pharmaceuticals Limited,
2nd Floor, Connect 38,
1 Dover Place, Ashford,
Kent, TN23 1FB
8 MARKETING AUTHORISATION NUMBER(S)
PL 08215/0193
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
4 September 2003
10 DATE OF REVISION OF THE TEXT
19/11/2024