Benylin Herbal Chesty Coughs Sugar Free Syrup is a traditional herbal medicinal product used to relieve chesty coughs associated with the common cold, based on traditional use only.

Posology

Adults, the elderly, and children aged 12 years and over

The recommended dose is 4 ml of syrup two to three times daily using the graduated measuring spoon provided

The use in children under 12 years of age is not recommended (see section 4.4 Special warnings and precautions for use).

Method of administration

For oral use only.

Shake the bottle well before each use.

If the symptoms worsen, or persist longer than one week during the use of Benylin Herbal Chesty Coughs Sugar Free Syrup, a doctor or qualified healthcare practitioner should be consulted.

The product should not be used for more than 2 weeks.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Do not exceed the stated dose.

The use of this product in children under 12 years of age is not recommended because data are not sufficient and medical advice should be sought.

If dyspnoea, fever or purulent sputum occurs, a doctor should be consulted.

If the symptoms worsen, or persist longer than one week during the use of Benylin Herbal Chesty Coughs Sugar Free Syrup, a doctor or qualified healthcare practitioner should be consulted.

Concomitant use with antitussives such as codeine or dextromethorphan is not recommended without medical advice.

Caution is recommended in patients with gastritis or gastric ulcer.

Benylin Herbal Chesty Coughs Sugar Free Syrup contains sorbitol.

The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Each 4 ml of syrup contains 2832 mg of sorbitol (E 420).

Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

None reported

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Fertility

No studies on the effect on fertility have been performed.

No studies on the effect on the ability to drive and use machines have been performed.

Gastrointestinal reactions (nausea, vomiting, and diarrhoea) have been reported. The frequency is not known.

Allergic reactions (urticaria, skin rash, dyspnoea) have been reported. The frequency is not known.

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.

Overdose can provoke nausea, vomiting, diarrhoea and agitation.

One case of a 4-year old child who developed aggressivity and diarrhoea after accidental intake of an ivy extract corresponding to 1.8 g herbal substance has been reported.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Reverse mutation assays (Ames test) on bacteria indicated that the herbal preparation was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) mutation assays with or without metabolic activation

Adequate tests on reproductive toxicity and carcinogenicity have not been performed.

Sorbitol, liquid (non-crystallising) (E 420)

Xanthan gum

Potassium sorbate

Citric acid, anhydrous

Purified water

Not applicable.

Unopened: 3 years.

Opened: 3 months.

This medicinal product does not require any special storage conditions.

After first opening do not store above 25 ° C.

This medicinal product is available in 100 ml bottles made of brown glass. The bottles are closed with white screw caps (HDPE) with cone sealing.

The bottle is further packed into cartons together with a measuring spoon (with graduation 2 and 4 ml).

No special requirements.