SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nutrition Warehouse Herbal Hayfever Tablets Holland & Barrett Herbal Hayfever Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

7.5    mg of extract (as dry extract) from White horehound herb (Marrubium vulgare L.) (10:1)

Extraction solvent: Ethanol 80% v/v

17.0    mg of extract (as dry extract) from Sage leaf (Salvia officinalis L.) (6-8:1) Extraction solvent: Water

17.0 mg of extract (as dry extract) from Yarrow herb (Achillea millefolium L.) (1217:1)

Extraction solvent: Water

17.0    mg of extract (as dry extract) from Vervain herb (Verbena officinalis L.) (5:1) Extraction solvent: Water

22.5    mg of Lobelia herb (Lobelia inflata L.)

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Tablet

Brown/Grey round biconvex tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2 Posology and method of administration

For oral use only.

Adults and the elderly

One or two tablets three times daily with water.

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

Duration of use

Do not use this product for more than 7 days.

If the symptoms worsen or do not improve within 7 days, a doctor or qualified healthcare practitioner should be consulted.

4.3    Contraindications

Hypersensitivity to the active ingredients, other plants of the Asteraceae (Compositae) family or any of the excipients.

Obstruction of the bile duct, cholangitis, liver disease, ileus.

4.4    Special warnings and precautions for use

Do not exceed the stated dose.

If the symptoms worsen or do not improve within 7 days, a doctor should be consulted.

Patients with active peptic ulcer, gallstones and any other biliary disorders should consult a doctor before using White horehound preparations.

4.5 Interaction with other medicinal products and other forms of interaction

None reported.

The intake of Sage leaf preparations might influence the effect of medicinal products acting via GABA receptor (e.g. barbiturates, benzodiazepines), even if not seen clinically. Therefore the concomitant use with such medicinal products is not recommended.

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

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

Sage leaf may impair the ability to drive and use machines. Affected patients should not drive or operate machines.

4.8 Undesirable effects

Lobelia can cause similar effects to nicotine and include nausea, vomiting, diarrhoea, coughing, tremors and dizziness. The frequency is not known.

Hypersensitivity reactions of the skin have been reported with Yarrow herb. The frequency is not known.

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

4.9 Overdose

No cases have been reported with this product.

Overdose of Lobelia could produce nausea, vomiting or diarrhoea, profuse diaphoresis, paresis, hypotension and coma. High doses could be cardioactive.

Overdose has been reported with a sense of heat, tachycardia, vertigo and epileptic form convulsions (seizures) after intake corresponding to more than 15 g of Sage leaf.

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.

Thujone present in Sage leaf is reported to be neurotoxic and chemotypes with low content of thujone should be preferred.

A daily intake of 5.0 mg/person is acceptable for a maximum duration of use of 2 weeks.

Tests on reproductive toxicity genotoxicity and carcinogenicity have not been performed with preparations of Sage leaf.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Extract excipients Maltodextrin

Colloidal anhydrous silica Tablet core

Calcium Phosphate Dibasic Stearic Acid Potato Starch Ethylcellulose N100

6.2    Incompatibilities

None known

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

Blister pack of hard tempered aluminium foil and food quality PVC enclosed in cardboard outer.

Pack size: 60 tablets.

6.6    Special precautions for disposal

There are no special precautions for disposal.

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 14010/0032

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/04/2013

10 DATE OF REVISION OF THE TEXT

22/04/2013