VICKS 1,33 % expectorant syrup guaifenesin honey adult Fl/180mL

Guaifenesin ............................................................................................................................... 1,333 g

Excipients with known effect: ethanol, sucrose, sodium, sodium benzoate and propylene glycol.

This medicine is recommended for adults and children over 15 years in cases of recent respiratory conditions with difficulty expectorating (difficulty expelling bronchial secretions by coughing them up).

Dosage

Reserved for adults and children over 15 years

The duration of treatment must be short (limited to 5 days).

In adults the usual dosage is 200 to 400 mg of guaifenesin per dose (i.e. 1 to 2 tablespoons of syrup).

In all cases, doses should be spaced at least 4 hours apart without exceeding 1600 mg per day (i.e. 8 measuring spoons).

15 ml = 200 mg = 1 tablespoon.

Method of administration

Oral use.

Children under 15 years.

Hypersensitivity to guaifenesin or to any of the excipients mentioned in the section Composition

In case of chronic (long-term) disease of the bronchi or lungs, medical advice is essential.

Caution is advised when administering guaifenesin to patients suffering from persistent or chronic cough, as is the case in smoking, chronic bronchitis, emphysema or cough with excess mucus, in order to avoid prolonged self-medication and masking of symptoms requiring more complex treatment.

The patient should accompany the treatment with voluntary coughing efforts to allow expectoration.

Combining bronchial mucomodifiers with antitussives and/or with secretion-drying substances (anticholinergics) is irrational.

If symptoms persist beyond 5 days and/or fever, the course of action should be re-evaluated by a physician.

This medicine contains 5,55 g of sucrose per tablespoon (15 ml). This should be taken into account for patients with diabetes mellitus.

Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) must not take this medicine.

This medicine contains 27,9 mg of sodium per 15 ml. This is equivalent to 1,40 % of the maximum recommended daily dietary intake of sodium by the WHO of 2 g of sodium per adult.

This medicine contains 15 mg of sodium benzoate per dose.

This medicine contains 5,256 % alcohol (ethanol) by volume, i.e. up to 597 mg per tablespoon of 15 ml, which is equivalent to 15 ml of beer or 6 ml of wine per dose. The small amount of alcohol contained in this medicine is not likely to cause any noticeable effect.

This medicine contains 1650 mg of propylene glycol per dose. Medical monitoring is required in patients suffering from renal insufficiency or liver function disorders, as various adverse effects attributed to propylene glycol have been reported, such as renal dysfunction (acute tubular necrosis), acute renal failure and hepatic dysfunction.

Pregnancy

Although propylene glycol has not demonstrated reproductive or developmental toxicity in animals or humans, it can reach the foetus and has been observed in milk. Consequently, the administration of propylene glycol to pregnant or breastfeeding patients should be considered on a case-by-case basis.

There are no teratogenicity studies of guaifenesin available in animals.

In clinical practice, the relatively widespread use of guaifenesin has apparently not revealed any malformative or fetotoxic effect to date.

However, epidemiological studies are needed to verify the absence of risk.

Consequently, as a precautionary measure due to the presence of guaifenesin, it is preferable not to use this medicine during pregnancy.

The safety of guaifenesin during pregnancy and breastfeeding has not been fully established. The product should be used during pregnancy or breastfeeding only if the potential benefit outweighs the risks.

Breast-feeding

During breastfeeding, the use of this product is not recommended.

Fertility

The available information is insufficient to determine whether guaifenesin is likely to impair fertility.

VICKS EXPECTORANT GUAIFENESINE 1,33 % ADULTS HONEY, syrup has no or negligible influence on the ability to drive vehicles and use machines.

Undesirable effects are classified by system organ class and by frequency using the following conventions: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); frequency not known (cannot be estimated from the available data).

In this case, it is advised to discontinue treatment.

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

A mild to moderate overdose may cause dizziness or vertigo, drowsiness and gastrointestinal disorders such as nausea and vomiting.

Very high doses may cause symptoms such as excitation, confusion and respiratory depression.

Urinary calculi have been reported in patients consuming large quantities of guaifenesin.

Treatment is symptomatic with digestive evacuation and general emergency measures.

Pharmacotherapeutic class: P1 - EXPECTORANTS, ATC code: R05C.

(R: respiratory system).

By modifying bronchial secretions, this medicine facilitates their evacuation by coughing.

Absorption

Guaifenesin is rapidly absorbed and metabolised in the liver.

Elimination

Its elimination, mainly urinary, is practically complete 24 hours after oral administration.

3 years

Store at a temperature not exceeding 25°C.

Shake well before use.