NELSONS SOOTHA COUGH SYRUP - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Nelsons Sootha Cough Syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of syrup contains:

Active ingredient Bryonia 6C

Excipients of known effect

Honey                   ­57.56 %w/w  3727 mg/5ml

Sorbitol                    2­0.77 %w/w   941 mg/5ml

Methyl parahydroxybenzoate  0.15 %w/w    9.7 mg/5ml

See ‘Section 4.4. Special warnings and precautions for use’.

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Syrup

Golden yellow to brown colour

4.1 Therapeutic indications

A Homeopathic Medicinal Product used within the homeopathic tradition for the symptomatic relief of dry or chesty coughs.

4.2 Posology and method of administration

For oral use

For adults, the elderly & children aged 12 years and over

One 5ml spoonful 3 times a day.

(It is recommended that the last dose is taken at bedtime when the cough may be more troublesome)

This product is not recommended for use in children under 12 years of age (See

Section 4.4 Special warnings and precautions for use.’)

4.3 Contraindications

Hypersensitivity to Bryonia dioica preparations or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the symptoms worsen, or persist after 7 days of using this product, a doctor or qualified healthcare professional should be consulted.

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

This product contains sorbitol and honey. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product contains Methyl parahydroxybenzoate (E218). May cause allergic reactions (possibly delayed).

This product is not recommended for use in children under 12 years of age and medical advice should be sought.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Fertility, pregnancy and lactation

Pregnancy and lactation: There is no evidence of the safety of the product in human pregnancy or lactation, nor is there any evidence from animal studies. Although no adverse events have been observed, the use of this product during pregnancy and lactation should be avoided unless under the guidance of a doctor.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

Studies on the effects on the ability to drive or use machinery have not been performed.

4.8 Undesirable effects

None known

If any adverse reactions occur, a doctor or pharmacist should be consulted.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk 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

4.9 Overdose

No reports

6   PHARMACEUTICAL PARTICULARS

6.4 Special precautions for storage

Do not store above 25°C. Store in the original packaging. Do not refrigerate.

6.5 Nature and contents of container

Polyethylene terephthalate bottle with a Polypropylene tamper-evident child-resistant cap incorporating a polystyrene measuring spoon. This is packed into a cardboard carton.

Pack Size: 150ml

100ml

6.6 Special precautions for disposal

There are no special precautions for disposal

A Nelson & Co Limited 5–9 Endeavour Way Wimbledon

London

SW19 8UH

UK