SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

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

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 455mg of extract (as dry extract) from Nettle leaf (Urtica dioica L.) (equivalent to 3636mg - 4545 mg of Nettle leaf).

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 greenish brown fill.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of minor aches and pains in the joints. 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.

This product is not for use in children or adolescents under 18 years (see section 4.4 Special warning and precautions for use)

Duration of use

This product is not to be used for more than 4 weeks

If symptoms worsen or persist after using the product for 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

•    Hypersensitivity to the active ingredient or to any of the excipients in this product.

•    Conditions where a reduced fluid intake is recommended (e.g. severe cardiac or renal disease)

4.4 Special warnings and precautions for use

• Do not exceed the stated dose

Not recommended for children or adolescents under 18 years of age because data are not sufficient and medicinal advice should be sought.

If symptoms worsen or persist after using the product for 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

Consult a Doctor or a qualified Healthcare Practitioner if joint pain is accompanied by swelling of the joint, redness or fever.

4.5 Interaction with other medicinal products and other forms of interaction

None known

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 machines have been performed.

4.8    Undesirable effects

Mild gastrointestinal complaints (e.g. nausea, vomiting, diarrhoea)

Allergic skin reactions (e.g. itching, exanthema, hives) may occur. 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.

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

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

36 months

6.4    Special precautions for storage

Do not store above 25°C.

Store in the original container.

6.5    Nature and contents of 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 21710/0032

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/01/2012

10    DATE OF REVISION OF THE TEXT

02/09/2013