Buttercup Bronchostop Cough Pastilles: Clinical Particulars

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 (as listed in section 6.1)

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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. Benzyl-alcohol (E1519) may cause allergic reactions.

This medicine contains less than 1 mmol sodium (23 mg) per pastille, that is to say essentially 'sodium-free'.

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.

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 effects

Hypersensitivity reactions (including one case of anaphylactic shock and one case of Quincke's oedema) and stomach disorders have been observed with medicinal products containing thyme. The frequency is not known.

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 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

Tests 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

Beeswax, white

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

PVC / PE / PVdC Alu blister packs with 10, 20 or 40 pastilles.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Kwizda Pharma GmbH

Effingergasse 21

A-1160 Vienna

Austria

8. Marketing authorisation number

THR 16467/0002

9. Date of first authorisation/renewal of the authorisation

21^st February 2014 / 31^st July 2019

10. Date of revision of the text

02 September 2020