SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Holland & Barrett Euphrasia Sinus Relief Capsules GNC Live Well Euphrasia Sinus Relief Capsules Lifecycle Euphrasia Sinus Relief Capsules Nature’s Garden Euphrasia Sinus Relief Capsules Nature’s Bounty Euphrasia Sinus Relief Capsules

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each hard capsule contains 140mg of extract (as dry extract) from Eyebright herb (Euphrasia officinalis L.) (equivalent to 560mg - 980mg of Eyebright herb).

Extraction solvent: Ethanol 75% v/v.

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Capsule, hard

Two piece clear hard capsules with brown fill.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the    relief of blocked sinuses

and catarrh. This is based on traditional use only.

4.2 Posology and method of administration

For oral use only Adults and the elderly

Take 1 capsule 3 times daily. Swallow the whole capsule with water.

Do not exceed the stated dose.

Duration of use:

If symptoms worsen, or do not improve after 7 days, a Doctor or a qualified Healthcare Practitioner should be consulted.

4.3    Contraindications

Hypersensitivity to Euphrasia or any of the excipients

4.4    Special warnings and precautions for use

Do not exceed the stated dose

The use in children and adolescents under 18 years of age has not been established due to lack of adequate data

If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

None reported

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to the lack of data, 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 of machines have been performed.

4.8 Undesirable effects

None reported.

If adverse reactions occur, a Doctor or qualified Healthcare Practitioner 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 of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard

Overdose

No cases of overdose have been reported.

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

Studies on genotoxicity, carcinogenicity and reproductive toxicity have not been performed

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline cellulose Magnesium stearate Silica colloidal hydrated

Excipients in the extract:

Maltodextrin

Silica colloidal anhydrous

Capsule Shell:

Hypromellose

Incompatibilities

Not applicable

6.3    Shelf life

35 months

6.4    Special precautions for storage

Do not store above 25°C.

Keep in the original container Keep the bottle tightly closed

6.5 Nature and contents of container

Container:

Green Polyethylene terephthalate (PET) bottles with a chiffon green hinge cap (Polypropylene), with an inner seal liner designed to lift ‘n’ peel. The inner seal acts as a tamper evident seal under the cap. The Inner seal liner is made up of polyester film, polymer adhesive layer, polyester tab, polyolefin foam, aluminium foil and sealable polyester film Pack size: 30 capsules

6.6 Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

NBTY Europe Limited Samuel Ryder House Barling Way Nuneaton Warwickshire CV10 7RH United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 21710/0014

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 DATE OF REVISION OF THE TEXT