Summary of Product Characteristics (SmPC) - Nelsons Sootha Cough syrup
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 CLINICAL PARTICULARS
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 of suspected adverse reactions
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
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Honey
Sorbitol (E420)
Purified water
Lemon juice
Methyl parahydroxybenzoate (E218)
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
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
7 MARKETING AUTHORISATION HOLDER
A Nelson & Co Limited
5-9 Endeavour Way
Wimbledon
London
SW19 8UH
UK
8 MARKETING AUTHORISATION NUMBER(S)
NR 01175/0422
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/04/2017
10 DATE OF REVISION OF THE TEXT
05/04/2017