SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Holland & Barrett Dandelion Capsules GNC Live Well Dandelion Capsules Lifecycle Dandelion Capsules Nature’s Garden Dandelion Capsules Nature’s Bounty Dandelion Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 339mg of extract (as dry extract) from Dandelion root (Taraxacum officinale Weber) (equivalent to 1018mg - 1696mg of Dandelion root).

Extraction solvent: Ethanol 60% 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 to

• Relieve the symptoms of mild digestive disorders, such as dyspepsia and flatulence and temporary loss of appetite.

• Increase the amount of urine for the purpose of flushing the urinary tract to assist in minor urinary complaints.

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 2 times daily. Swallow the whole capsule with water.

To ensure an increase of the amount of urine, adequate fluid intake is required during the treatment.

Not for use in children and adolescents under 18 years (see section 4.4 Special warning and precautions for use)

Duration of use

If symptoms worsen or persist after 2 weeks of using the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to Dandelion, or to plants of the Asteraceae (Compositae) family or any of the excipients

Obstruction of the biliary or intestinal tract, liver disease, cholangitis, gallstones and or active peptic ulcer

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 is not recommended due to lack of adequate data.

If symptoms such as fever, dysuria, spasms or blood in the urine occur during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

If the symptoms worsen or persist after 2 weeks of using the product a doctor or qualified healthcare practitioner should be consulted

Concomitant treatment with diuretics is not recommended

The use in patients with renal failure and/or diabetes and/or heart failure should be avoided because of the risk of hyperkalemia.

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.

Tests 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.

4.8 Undesirable effects

Mild gastrointestinal effects such as epigastric pain and hyperacidity. 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 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.

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.

Shelf life

2 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 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: 50 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 21710/0026

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

DATE OF REVISION OF THE TEXT

07/12/2011