SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

•    Holland & Barrett Celery Seed Capsules

•    GNC Live Well Celery Seed Capsules

•    Lifecycle Celery Seed Capsules

•    Nature’s Garden Celery Seed Capsules

•    Nature’s Bounty Celery Seed Capsules

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 112mg of extract (as dry extract) from Celery Seed (Apium graveolens L.) (equivalent to 449mg - 674mg of Celery Seed). Extraction solvent: Ethanol 50% v/v.

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Capsule, hard

Two piece clear hard capsules with light brown fill.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of rheumatic aches and pains, 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 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

The use in children under 18 years of age is not recommended (see section 4.4 Special warning and precautions for use)

4.3    Contraindications

Hypersensitivity to celery seed, to plants of the Apiaceae (Umbelliferae) amily or to carrots, mugwort, birch or dandelion.

Hypersensitivity to any of the excipients.

Patients with renal disease.

Patients taking anti-coagulant medicines.

4.4    Special warnings and precautions for use

If symptoms worsen or do not improve after 4 weeks, or if adverse effects not mentioned in the package leaflet occur, a doctor or a qualified healthcare practitioner should be consulted.

If articular pain accompanied by swelling of joint, redness or fever are present, a doctor should be consulted.

The use in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.

In some cases, particularly in fair-skinned individuals, sun burn type reactions on the skin areas exposed to strong sunlight may occur due to photosensitisation by Celery Seed. Individuals using this product should avoid excessive sunbathing or the use of sunbeds or solariums.

4.5    Interaction with other medicinal products and other forms of interaction

None reported. However, there is a theoretical risk that Celery seed may interact with anti-coagulant medicines and should therefore not be used in patients receiving anti-coagulant medicines.

4.6 Fertility, Pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.

Studies 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.

4.8    Undesirable effects

Allergic reaction in individuals sensitive to certain plants and species including wild carrots, mugwort, birch and dandelion.

Inflammation in individuals with renal disease.

Skin inflammation and sensitivity to sunlight The frequency is not known.

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

4.9 Overdose

No case of overdose has 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

Tests on reproductive toxicity, genotoxicity and carcinogenicity 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

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.

Keep the bottle tightly closed.

6.5    Nature and contents of container

Container:

Green Polyethylene terephthalate (PET) bottles with a 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 21710/0021

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/10/2011 08/05/2013