SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Buttercup Original Cough Syrup

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of syrup contains:

3.1 microlitres of extract (as liquid extract) from Squill bulb (Drimia maritima (L.) Stearn.) (1:1)

Extraction solvent: Ethanol 65% v/v

2.5 microlitres of tincture from Capsicum Oleoresin (Capsicum annuum L. var. minimum (Miller) Heiser) (1:10)

Extraction solvent: Ethanol 96% v/v

5 ml of syrup also contains 91 mg of ethanol, 4.41g of sucrose, fructose and glucose (as Partial Invert Syrup), 3.5mg of sodium methyl hydroxybenzoate (E219), 1.5 mg of sodium propyl hydroxybenzoate (E217) carmoisine E122 and Sunset Yellow E110. (See Section 4.4 ‘Special warnings and precautions for use.’)

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Syrup

Reddish-brown oral liquid.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of coughs, colds and sore throats, based on traditional use only.

4.2    Posology and method of administration

For oral use only

Adults, the elderly and children over 12 years: Two 5 ml spoonfuls three times a day and at bedtime, if the cough is 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.’)

Duration of use:

Do not use for more than one week.

If symptoms worsen or persist after one week, consult a doctor or qualified healthcare practitioner.

4.3 Contraindications

Hypersensitivity to any of the active ingredients, or menthol or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or persist after one week, consult a doctor or qualified healthcare practitioner.

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

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

Contains sucrose, glucose and fructose (as Partial Invert Syrup). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains 4.6% v/v ethanol (alcohol), i.e. up to 182 mg per 10ml dose, equivalent to 4.6 ml beer, 1.8 ml wine per 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.

Contains Sunset yellow (E110 and Carmoisine E122. May cause allergic reactions.

Contains Sodium methyl hydroxybenzoate (E219) and Sodium propyl hydroxybenzoate (E217). May cause allergic reactions (possibly delayed).

4.5 Interaction with other medicinal products and other forms of interaction

No interactions studies have been performed.

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

Safety during pregnancy and lactation has not been established. Due to the lack of 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 or operate machines have been performed.

Contains alcohol. See Section 2.

4.8    Undesirable effects

None reported.

If other adverse reactions occur, a doctor or a qualified healthcare practitioner 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 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.

4.9    Overdose

No cases reported.

Very high doses of Squill would be emetic and could be cardioactive. Overdose of this product may result in alcohol intoxication and should be treated accordingly. The amount of alcohol in a full bottle is:

1.4 g in 75 ml, equivalent 34.1 ml beer or 14.2 ml wine 2.7 g in 150 ml, equivalent 68.3 ml beer or 28.4 ml wine 3.6 g in 200 ml, equivalent 91 ml beer or 37.9 ml wine

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

Tests on reproductive toxicity, carcinogenicity and genotoxicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Acacia Powder Caramel Colour (E150)

Ethanol Levomenthol Clove Oil Peppermint Oil

Sodium methyl hydroxybenzoate (E219)

Sodium propyl hydroxybenzoate (E217)

Potassium sorbate Aniseed Flavour Purified Water Carmoisine (E122)

Sunset Yellow (E110)

Strong Ginger Tincture (ginger, ethanol, water) Acetic Acid Saccharin Sodium

Partial Invert Syrup (sucrose, fructose and glucose)

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years (unopened).

28 days (after first opening the bottle)

Special precautions for storage

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

Nature and contents of container

Clear glass bottle with aluminium tamper-evident screw-cap: 75 ml, 150 ml, 200 ml, 300 ml

Amber glass bottle with aluminium tamper-evident screw-cap: 300 ml Not all pack sizes may be marketed

Special precautions for disposal

There are no special precautions for disposal.

MARKETING AUTHORISATION HOLDER

Omega Pharma Ltd.

1^st Floor

32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom

24/07/2014