SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

English Herbal Medicines Chamomile Bloating and Flatulence Relief Napiers Chamomile Digestive Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains 2.5ml of liquid extract from dried Roman Chamomile flower (Chamaemelum nobile L.) (1:1). Extraction solvent: ethanol 70% v/v.

Each 5 ml of oral liquid also contains approximately 1.8 g Ethanol (alcohol) equivalent to 45 ml of beer or 19 ml of wine (See Section 4.4. special warnings and precautions for use.’)

For a full list of excipients see Section 6.1.

3    PHARMACEUTICAL FORM

Oral Liquid. Dark brown liquid.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of flatulence, bloating and mild upset stomach, based on traditional use only.

4.2    Posology and method of administration

Adults and elderly

Take one to two 5ml spoonfuls before each main meal, in water, or other liquid according to taste.

Maximum daily dose: 30mls (3 doses)

The use is not recommended for children and adolescents under 18 years. (see Section

4.4. Special warnings and precautions for use)

If symptoms worsen or persist for more than 2 weeks, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to Roman Chamomile or to plants of the Asteraceae (Compositae) family, or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Contains alcohol - up to 1.8g ethanol per 5 ml dose (equivalent to 45 ml of beer or 19 ml of wine).

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver-disease, or epilepsy.

The use of this product is not recommended in children and adolescents below the age of 18 years because data are not sufficient and medical advice should be sought.

If symptoms worsen or persist for more than 2 weeks, a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

No studies have been carried out to determine if drug interactions occur with this product.

Contains alcohol, and should therefore be avoided in patients taking other medication known to interact with alcohol (e.g. metronidazole)

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy 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 effect of this product on the ability to drive or use machinery have been performed.

This product contains alcohol (see Section 2).

4.8 Undesirable effects

Roman Chamomile may cause allergic reactions or exacerbate existing symptoms. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

4.9 Overdose

No case of overdose has been reported.

Overdose of this product may result in alcohol intoxication and should be treated accordingly. Amount of ethanol in a full bottle:

36g in 100 ml equivalent to 2.18 large glasses of wine;

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 reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Ethanol

Glycerol

Water

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

3 years.

6.4    Special precautions    for storage

Do not store above 25^oC. Store in the original container.

6.5    Nature and contents    of container

Glass bottle with polypropylene screwcap: 100ml and 200ml.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Rutland Biodynamics Ltd,

Town Park Farm,

Brooke, Rutland,

LE15 8DG.

8    MARKETING AUTHORISATION NUMBER(S)

THR 28255/0030

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25/03/2013

10    DATE OF REVISION OF THE TEXT

25/03/2013