SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nutrition Warehouse Herbal Indigestion Relief Tablets Holland & Barrett Herbal Indigestion Relief Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

4 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (56:1)

Extraction solvent: Ethanol 70%v/v

15 mg Fennel fruit (Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung)

20 mg Myrrh gum-resin(Commiphora molmol Engler)

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Tablet

Brown oval biconvex tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve symptoms of dyspepsia, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly:

One or two tablets to be taken after meals.

The use in children or adolescents under 18 years of age is not recommended (see section 4.4 Special warnings and precautions for use.’)

If symptoms worsen or persist after one week, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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 persist or worsen after one week, a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP1A2 or CYP 2E1 pathway has not been observed.

Additive effects with hypnotics and other sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution.

The effect of this product may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

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 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

May impair ability to drive and use machines. If affected patients should not drive or operate machines.

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea, abdominal cramps, may occur with Valerian root. The frequency is not known.

Allergic reactions to Fennel, affecting the skin or respiratory system may occur. The frequency is not known.

Allergic skin reactions have been reported with Myrrh. The frequency is not known.

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

4.9 Overdose

No case of overdose has been reported for this product.

Valerian root at a dose of approximately 20g caused benign symptoms (fatigue, abdominal cramp, chest tightness, light-headedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30g of the drug) withdrawal symptoms (delirium) have been reported.

No cases of overdose have been reported for the other ingredients in this product.

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

Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

A fennel aqueous extract was tested in an Ames test on Salmonella typhimurium strains TA98, TA100 and turned out as negative. Results from studies carried out in laboratory animals showed a weak mutagenic activity of anethole. The genotoxic risk4 related to estragole is not considered to be relevant in the specified conditions of use due to the small amount present in herbal infusions prepared from fennel.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Extract excipients Maltodextrin

Colloidal anhydrous silica

Tablet core Calcium Carbonate Calcium Sulphate Dihydrate Sago Flour

Dibasic Calcium Phosphate Magnesium Trisilicate Stearic Acid Ethyl Cellulose N100

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 package.

6.5    Nature and contents of    container

Rigid injection mould tablet container.

Pack size: 100 tablets.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Nutrition Warehouse Limited

Samuel Ryder House

Barling Way

Eliot Park

Nuneaton

Warwickshire

CV10 7RH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 14010/0040

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/04/2013

10    DATE OF REVISION OF THE TEXT

15/04/2013