Benylin Herbal Cough & Cold Sugar Free Syrup

A traditional herbal medicinal product used to relieve symptoms associated with the common cold such as coughs, sore throat and blocked or runny nose. Based on traditional use only.

Posology

Start at first signs of common cold.

Children between 6 and 12 years of age:

Using the measuring spoon provided take 2.5 ml, 2-times per day.

Adolescents over 12 years of age, adults, and elderly:

Using the measuring spoon provided take 2.5 ml, 3-times per day.

The use in children under 6 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').

Do not use for more than 10 days.

Method of administration

For oral use only.

Shake the bottle before use.

If the symptoms worsen or persist longer than 1 week during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

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

Severe hepatic or renal disease.

Do not exceed the stated dose.

The use in children under 6 years of age has not been established due to lack of adequate data.

Hepatotoxicity and hepatitis cases were reported in association with the administration of the medicinal product. In case signs of hepatotoxicity occur (such as fatigue, anorexia, yellowing of the skin and eyes or severe stomach pain with nausea and vomiting or dark urine), the administration of the medicinal product should be stopped immediately, and a medical doctor should be consulted.

If symptoms worsen, or do not improve after one week, a doctor or qualified healthcare practitioner should be consulted.

If fever, shortness of breath or blood in the sputum occurs, a doctor or qualified healthcare practitioner should be consulted.

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.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

None reported.

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

Studies on the effects on fertility have not been performed.

No studies on the effects on the ability to drive and use machines have been performed. However, dizziness has been reported. Affected patients should not drive or operate machinery.

In very rare cases serious hypersensitivity reactions with swelling of the face, dyspnoea and decrease in blood pressure have been reported.

Hepatotoxicity (including hepatitis, liver dysfunction of different origin) has been reported. Dizziness and flushed skin have also been reported. The frequency is not known.

Gastrointestinal complaints (such as diarrhoea, epigastric discomfort, nausea or vomiting, dysphagia), mild nasal and gingival bleeding and hypersensitivity reactions (e.g. Dermatitis, rash, rash erythematous, exanthema, urticaria, pruritus of skin and mucous membranes) have been reported. The frequency was very rare.

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.

No case of overdose 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.

A bacterial reverse mutation assay (Ames test) indicated that the Pelargonium root dry extract in the product was not mutagenic.

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

Extract:

Maltodextrin

Syrup:

Sorbitol, liquid

Maltitol, liquid

Potassium sorbate

Citric acid anhydrous

Purified water

None.

3 years

After first opening: 3 months.

Store in the original container. This medicinal product does not require any special temperature storage conditions.

100 ml brown glass bottle with white PE screw cap. A measuring spoon made from polypropylene, graduated with 2.5 ml and 5 ml, is placed in cardboard box.

No special requirements

Any unused product or waste material should be disposed of in accordance with local requirements.