It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Chefaro Ireland Ltd

Chefaro Ireland Ltd

Summary of Product Characteristics last updated on medicines.ie: 25/6/2015

Buttercup Bronchostop Berry Flavour Cough Pastilles

1. NAME OF THE MEDICINAL PRODUCT

Buttercup Bronchostop Berry Flavour Cough Pastilles

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each pastille contains:

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

Excipients with known effect:

Each pastille contains 300 mg of fructose and 523 mg of sorbitol (E420).

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Pastille.

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, dry, tickly, irritating coughs and catarrh exclusively based on long standing use.

4.2 Posology and method of administration

For oral short-term use only.

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 Professional e.g. a doctor or pharmacist 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 Professional should be consulted.

If dyspnoea, fever or purulent sputum occurs, a doctor or qualified Healthcare Professional should be consulted.

Contains 0.6 g of fructose per maximum single dose (2 pastilles). This should be taken into account in patients with diabetes mellitus.

Contains fructose and sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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 edema) as well as stomach disorders have been observed in connection with medicinal products containing thyme. The frequency is not known.

If other adverse reactions not mentioned above occur, a qualified Healthcare Professional e.g. a doctor or pharmacist 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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

Herbal Preparation:

Maltodextrin

Acacia

Pastille:

Acacia

Fructose

Sorbitol (E420)

Anhydrous Citric Acid

Saccharin Sodium

Aronia (chokeberry) aroma flavour

Fruit of the forest (berry) aroma flavour

Light Liquid Paraffin

White Beeswax

Purified Water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 30°C. Store the 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

1160 Vienna

Austria

8. MARKETING AUTHORISATION NUMBER(S)

TR2006/001/002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first Authoristation: 13 March 2015

10. DATE OF REVISION OF THE TEXT

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.