Buttercup Bronchostop Berry Flavour Cough Pastilles

Buttercup Bronchostop Berry Flavour Cough Pastilles

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

Pastille.

Hexagonal, brown pastilles with a fruity taste.

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.

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.

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

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.

No interaction studies have been performed.

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.

No studies on the effects on the ability to drive and to use machines have been performed.

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.

No case of overdose has been reported.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

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.

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

Not applicable

3 years

Do not store above 30°C. Store the blister in the original package in order to protect from light.

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

Not all pack sizes may be marketed.

No special requirements

Kwizda Pharma GmbH

Effingergasse 21

1160 Vienna

Austria

TR2006/001/002

Date of first Authoristation: 13 March 2015