SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

English Herbal Medicines Herbal Indigestion Mixture Napiers Herbease Digestive Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains:-

0.21 ml of liquid extract from Oat seed* (Avena sativa L.) (1:1)

Extraction solvent: ethanol 25% v/v

0.21 ml of liquid extract from Peppermint leaf * (Mentha piperita L.) (1:1)

Extraction solvent: ethanol 45% v/v

0.21 ml of liquid extract from Lemon balm leaf * (Melissa officinalis L.) (1:1) Extraction solvent: ethanol 45% v/v

0.107 ml of liquid extract from Southern Prickly Ash berries (Zanthoxylum clava-herculis L.) (1:1).

Extraction solvent: ethanol 45% v/v

* Certified organically produced ingredients

5 ml of oral liquid also contains approximately: 255 mg ethanol (alcohol) equivalent to 6.4 ml of beer or 2.4 ml of wine, 18.8 pg liquid glucose 129 mg sodium bicarbonate and 100 mg sucrose

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oral Liquid. Dark brown liquid.

4    CLINICAL PARTICULARS

4.1

4.2 Posology and method of administration

Adults and the elderly:

Take one 5ml teaspoon three times a day. May be taken with water or fruit juice if desired.

Not recommended for children and adolescents under 18 years of age. (See section 4.4 “Special warnings and precautions for use.”)

If symptoms worsen or do not improve after one week, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to any of the active ingredients, Oats or Oat preparations, peppermintleaf preparations or to menthol or any of the excipients.

Caution advised when using the product in patients with coeliac disease because of the Oat content.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted.

Not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

Patients with gastro-oesophageal reflux (heartburn) should avoid peppermint leaf preparations, because heartburn may increase.

Patients with gallstones and any other biliary disorders should be cautious using peppermint leaf preparations

Caution is advised when used in coeliac disease because data on the protein content is not available.

Contains alcohol - up to 225 mg ethanol per dose (equivalent to 6.4 ml of beer or 2.4 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.

This medicinal product contains 35.5 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Contains glucose. Patients with rare hereditary problems of fructose intolerance, glucose - galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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

The safety of this product during pregnancy and lactation has not been established. Therefore the use of this product during pregnancy and lactation is not recommended.

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.

Lemon balm leaf preparations may impair ability to drive and use machines. Affected patients should not drive or use machines.

This product contains alcohol (see Section 2).

4.8 Undesirable effects

Skin reactions may occur in atopic patients and in patients with contact dermatitis with Oat

preparations. The frequency is not known.

The gastro-oesophageal reflux may worsen and heartburn may increase with Peppermint leaf preparations.

If other adverse reactions occur, a doctor or qualified healthcare practitioner should be consulted.

4.9 Overdose

No case of overdose has been reported.

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.

Data from in vitro and animal studies indicate that the water extract of Lemon balm leaf may inhibit the activity of thyroid stimulating hormone (TSH). The clinical relevance of these findings is not known

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Orange Oil

Concentrated Cinnamon Water (Cinnamon bark oil, ethanol and water)

Glycerol

Ethanol

Sodium Bicarbonate Liquid Glucose

Tincture Cardamon Compound (Water, Cinnamon bark, Caraway seed, Cardamom pods, Ethanol, Glyercol, Cochineal E120)

Nutmeg Oil Clove Oil

Liquorice Liquid Extract (Liquorice root, sorbitol, ethanol and water)

Caramel (E150)

Sucrose

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 in the original container

6.5    Nature and contents of container

Glass bottle with white opaque HDPE cap: 150ml, 200ml and 250ml.

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 28255/0031

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/04/2013

10    DATE OF REVISION OF THE TEXT

29/04/2013