Summary of medicine characteristics - BUTTERCUP BRONCHOSTOP COUGH PASTILLES
1 NAME OF THE MEDICINAL PRODUCT
Buttercup Bronchostop Cough Pastilles
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pastille contains 59.5 mg of extract (as dry extract) from Thyme herb (Thymus vulgaris L. and Thymus zygis L., herb ) (DER 7–13:1) extraction solvent: water
Excipient(s) with known effect:
Each pastille contains: 523 mg sorbitol (E420), 300 mg fructose, 5.53 mg propylene-glycol (E1520) and 0.0018 mg benzyl-alcohol (E1519)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hexagonal, brown pastilles with a fruity taste.
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
Adults, the elderly and children over 12 years:
1 – 2 pastilles to be taken every 4 hours, 4 times a day. If required, up to a maximum of 12 pastilles can be taken per day.
Method of administration:
For oral use (allow to dissolve in the mouth through sucking).
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 Thyme or 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 Pastilles 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.
This medicine contains 523 mg fructose and 300 mg sorbitol in each pastille, corresponding to approximately 0.1 carbohydrate unit. This should be considered in patients with diabetes mellitus. Patients with rare hereditary fructose intolerance (HFI) should not take this medicinal product. The additive effect of concomitantly administered products containing fructose or sorbitol and dietary intake of fructose or sorbitol should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
The medicine contains 5.53 mg of propylene-glycol in each pastille.
This medicine contains 0.0018 mg benzyl-alcohol (E1519) in each pastille. Benzylalcohol (E1519) may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per pastille, that is to say essentially ‘sodium-free’.
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, 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 effectsTabulated 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 | Anaphylactic reaction1 |
| disorders | |
| Gastrointestinal disorders | Oral mucosal blistering, abdominal pain, diarrhoea, nausea, vomiting |
| Respiratory, thoracic and mediastinal disorders | Dyspnoea, exacerbation of asthma |
including 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 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
4.9 OverdoseNo case of overdose has 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
5.3 Preclinical safety dataTests on genotoxicity have been performed with different thyme herb extracts and thyme essential oil. 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 preparation
Maltodextrin
Arabic gum
Excipients of the herbal product
Arabic gum
Fructose
Sorbitol liquid 70% non-crystallising (E420)
Citric acid anhydrous
Saccharin sodium
Aronia (chokeberry) flavour (which contains propylene glycol (E1520))
Fruit of the forest (berry) aroma flavour (which contains propylene glycol
(E1520) and benzyl-alcohol (E1519))
Paraffin, light liquid
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
Store blister in the original package in order to protect from light.
6.5 Nature and contents of container
6.5 Nature and contents of containerPVC / PE / PVdC Alu blister packs with 10, 20 or 40 pastilles.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
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 02855/0337
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
27/01/2014