This information is intended for use by health professionals

1. Name of the medicinal product

Buttercup Bronchostop Cough Syrup

2. Qualitative and quantitative composition

15 ml of syrup (16.7 g) contains:

120 mg of extract (as dry extract) from Thyme herb (Thymus vulgaris L. and Thymus zygis L., herb) (DER 7-13:1) extraction solvent: water

and

830 mg of extract (as liquid extract) from Marshmallow root (Althaea officinalis L.) (DER 1:12-14) extraction solvent: water

Excipient(s) with known effect:

Each single dose (15 ml) contains

12.53 mg of methyl parahydroxybenzoate (E218), 6.68 mg of propyl parahydroxybenzoate (E216) and 4609.2 mg g xylitol (E967), 131 mg total sugars from raspberry juice concentrate (containing sucrose, glucose and fructose) and 33.3 mg propylene glycol (E1520) contained in raspberry aroma flavour (See 'Section 4.4 Special warnings and precautions for use')

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Oral Syrup

Brown-red, viscous liquid

4. Clinical particulars
4.1 Therapeutic indications

Traditional herbal medicinal product used for the relief of coughs, such as chesty coughs and dry, tickly, irritating coughs and catarrh based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults, the elderly and children over 12 years:

Using the measuring cup provided, 15 ml of syrup to be taken every 4 hours, 4 times per day.

If required, up to a maximum of 6 doses (90 ml) can be taken per day.

Method of administration:

Buttercup Bronchostop Cough Syrup may be administered undiluted or diluted in water or warm tea.

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:

If symptoms worsen, or persist after 7 days, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to marshmallow root, thyme, to other members of the Lamiaceae family or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children under 12 years of age is not recommended due to lack of data and because medical advice should be sought.

If symptoms worsen, or persist after 7 days, a doctor or qualified healthcare practitioner should be consulted.

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

Patients with asthma should consult their doctor before using Buttercup Bronchostop Cough Syrup as symptoms of asthma may worsen when taking this product.

There is a possible risk of severe hypersensitivity reactions in atopic patients. Atopic patients should consult their doctor before using this product.

Absorption of concomitantly administered medicines may be delayed. As a precautionary measure, the product should not be taken ½ to 1 hour before or after intake of other medicinal products.

The medicine contains the preservatives methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These may cause allergic reactions (possibly delayed).

The medicine contains raspberry juice concentrate which contains sucrose, glucose and fructose. Patients with rare hereditary problems of fructose intolerance (HFI), glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains 66 mg of fructose in each 15 ml of syrup which is equivalent to 4.4 mg/ml.

The additive effect of concomitantly administered products containing fructose (or sorbitol) and dietary intake of fructose (or sorbitol) should be taken into account.

The medicine contains 4.61 g of xylitol (E967) in each 15 ml of syrup which may have a laxative effect. Calorific value 2.4 kcal/g xylitol.

This medicine contains 33.3 mg of propylene glycol (E1520) in each 15 ml of syrup.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. Therefore, in the absence of sufficient data, the 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 to use machines have been performed.

4.8 Undesirable effects

Tabulated list of adverse reactions

The following list of adverse reactions is based on experience from postmarketing experience.

Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

System Organ Class

Frequency not known (cannot be estimated from available data)

Skin and subcutaneous tissue disorders

Pruritus, rash, urticaria, angioedema1,2

Immune system disorders

Anaphylactic reaction1

Gastrointestinal disorders

Oral mucosal blistering, abdominal pain, diarrhoea, nausea, vomiting

Respiratory, thoracic and mediastinal disorders

Dyspnoea, exacerbation of asthma

1Including severe reactions

2Swelling of the face, lips, mouth, tongue or throat

If other adverse reactions not mentioned above 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 or search for MHRA Yellow Card in Google Play or Apple App Store.

4.9 Overdose

No cases of overdose have been reported.

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 genotoxicity have been performed with several thyme herb extracts and thyme essential oil as well as with a marshmallow root dry extract. No mutagenicity was observed in the Ames tests conducted.

Tests on reproductive toxicity and carcinogenicity have not been performed.

6. Pharmaceutical particulars
6.1 List of excipients

Excipients of the herbal preparations

Maltodextrin

Acacia (E414)

Xylitol (E967)

Methyl parahydroxybenzoate (E218)

Purified water

Excipients of the herbal product

Raspberry juice concentrate (containing sucrose, glucose and fructose)

Xylitol (E967)

Methyl parahydroxybenzoate (E218)

Xanthan gum

Citric acid monohydrate

Propyl parahydroxybenzoate (E216)

Purified water

Raspberry aroma flavouring (synthetic and natural flavourings, propylene glycol (E1520))

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

After first opening: 4 weeks.

6.4 Special precautions for storage

Do not store above 25°C.

Store the bottle in the original package in order to protect from light. Close the bottle tightly after use.

6.5 Nature and contents of container

Brown glass bottles of hydrolytic class III with tamper evidence ring, with nozzle and polyethylene screw cap. Polypropylene measuring cup with 2.5 ml to 20 ml scale.

Pack sizes: 120 ml, 200 ml and 240 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Omega Pharma Ltd.

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

United Kingdom

8. Marketing authorisation number(s)

THR 02855/0336

9. Date of first authorisation/renewal of the authorisation

21st February 2014 / 31th July 2019

10. Date of revision of the text

11th November 2020