Summary of medicine characteristics - EM PHARMA MARSHMALLOW COUGH SYRUP
1 NAME OF THE MEDICINAL PRODUCT
EM Pharma Marshmallow Cough Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml (13.1 g) of syrup contains 4.71 g of macerate from Marshmallow root (Althaea officinalis L., radix) (DER 5:36) Extraction solvent: water: ethanol (47.9:1)
Each 10 ml of syrup also contains 131 mg of ethanol, 13.1 mg of benzoic acid and 8.4 g sucrose. (See Section 4.4 ‘Special warnings and precautions for use’)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
A viscous, clear liquid with a characteristic smell and taste.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of symptoms associated with a dry, irritating cough, based on traditional use only.
4.2 Posology and method of administrationDosage:
For oral use only.
Adults, elderly & children over 12 years of age: Using the measuring cup provided take 10 mls every 4 to 6 hours a day.
Repeat the dose depending on the symptoms up to a maximum of 4 times a day.
Maximum daily dose: 40mls
The use in children under 12 years of age is not recommended (See Section 4.4 ‘Special warnings and precautions for use.’)
Duration of use:
Do not use for more than 7 days.
If symptoms worsen, or do not improve after 7 days, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensivity to the active substance or to any of the excipients
4.4 Special warnings and precautions for use
Do not exceed the stated dose
Contains sucrose. This should be taken into account in patients with diabetes. 10 ml of syrup contains 8.4 g of sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains not more than 1.26% v/v ethanol (alcohol), i.e. up to 131 mg per 10 ml dose equivalent to. 2.772 ml beer, or 1.155 ml wine per 10 ml dose.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Absorption of concomitantly administered medicines may be delayed. As a precautionary measure, the product should not be taken ^ to 1 hour before or after intake of other medicinal products.
The use in children under 12 years of age is not recommended because data is not sufficient and medical advice should be sought.
If symptoms worsen, or do not improve after 7 days, a doctor or a qualified healthcare practitioner should be consulted
If dyspnoea, fever or purulent sputum occurs, a doctor or qualified healthcare practitioner should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction None reported.
Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).
4.6 Fertility, pregnancy and lactation
The safety of the product 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.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
This product contains alcohol (see Section 2 and Section 4.4 ).
4.8 Undesirable effects
None reported.
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.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
Each bottle (125 g) contains up to 1.25 g of ethanol equivalent to 11.02 mls of wine or 26.45 mls of beer.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
5.3 Preclinical safety dataTests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Excipients of the herbal preparation
Purified water
Ethanol
Benzoic acid
Excipients of the herbal product
Sucrose
Benzoic acid (E 210)
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf life unopened:3 years
Shelf life after opening: 28 days
6.4 Special precautions for storage
Do not store above 25oC.
Keep the bottle in the outer carton in order to protect from light.
6.5 Nature and contents of container
A brown glass bottle or brown polyethylene terephthalate bottle with aluminium screw cap with gasket made of polyethylene and with measuring cup with 2.5 ml to 15 ml scale packed into a carton
Pack size: 95ml (125g)
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
7 MARKETING AUTHORISATION HOLDER
Gemi Pharma Ltd
Unit 2A, Old Dalby Trading Estate Old Dalby, Leicestershire
LE14 3NJ, UK
8 MARKETING AUTHORISATION NUMBER(S)
THR 45296/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/09/2018