SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

•    Holland & Barrett Echinacea Cold and Flu Capsules

•    GNC Live Well Echinacea Cold and Flu Capsules

•    Lifecycle Echinacea Cold and Flu Capsules

•    Nature’s Garden Echinacea Cold & Flu Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 140mg of extract (as dry extract) from (Echinacea purpurea root) (equivalent to 838mg - 1117mg of Echinacea purpurea (L.) Moench, root).

Extraction solvent: Ethanol 75% v/v.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Capsule, hard

Two piece hard hypromellose capsules with light brown powder fill.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza type infections. This is based on traditional use only.

4.2    Posology and method of administration

For oral use only.

Adults, elderly and children over 12 years:

Take one capsule twice daily . Swallow the whole capsule with water.

Start at the first sign of a common cold.

Do not exceed the stated dose.

Duration of use:

Do not use this product for more than 10 days.

If symptoms worsen or persist for more than 10 days, a Doctor or a qualified Healthcare Practitioner should be consulted.

Not for use in children under 12 years (see section 4.4 Special warning and precautions for use)

4.3 Contraindications

• Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family

Because of its immunostimulating activity, Echinacea must not be used in cases of progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g. collangenoses, multiple sclerosis), immunodeficiencies (e.g. HIV infection, AIDS), immunosuppression (e.g. onocological cytostatic therapy, history of organ or bone marrow transplant) and diseases of the white blood cell system (e.g. agranulocytosis, leukaemias) and allergic diathesis (e.g. urticaria, atopic dermatitis, asthma)

4.4 Special warnings and precautions for use

•    Do not exceed the stated dose

•    If symptoms worsen or do not improve or high fever occurs during the use of this product or if symptoms persist for more than 10 days, a Doctor or qualified Healthcare Practitioner should be consulted

•    Not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.

•    There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their Doctor or qualified Healthcare Practitioner before using Echinacea

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used concomitantly with immunosuppressant medications such as ciclosporin and methotrexate

4.6 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.

Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available. To date, no other relevant epidemiological data are available. The potential risk for humans is unknown.

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.

4.8 Undesirable effects

Hypersensitive reactions (skin reactions rash, urticaria, Stevens-Johnson Syndrome, angiodema of the skin, Quicke edema, bronchospasm with obstruction, asthma and analphylactic shock) have been reported.

Echinacea can trigger reactions in atopic patients. Association with autoimmune diseases (encephalitis disseminate, erythema nodosum, immunothrombocytopenia,

Evans Syndrome, Sjogren syndrome with renal tubular dysfunction) has been reported. Leucopenia may occur in long-term use (more than 8 weeks)

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 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

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product.

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

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C.

Keep in the original container.

6.5 Nature and contents of container

Container:

Green Polyethylene terephthalate (PET) bottles with a polypropylene chiffon green hinge cap with an inner seal liner designed to lift ‘n’ peal. The inner seal (polyester film, polymer adhesive layer, polyester tab, polyolefin foam, aluminium foil and sealable polyester film) acts as a tamper evident seal under the cap

Pack size: 30 capsules, 60 capsules or 100 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 7HR, United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 21710/0006

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25/02/2011

10    DATE OF REVISION OF THE TEXT

12/02/2013