SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

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

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 171mg of extract (as dry extract) from Lemon Balm leaf (Melissa officinalis L.) (equivalent to 684mg - 1026mg of Lemon Balm leaf). Extraction solvent: Ethanol 50% v/v.

3 PHARMACEUTICAL FORM

Capsule, hard

Two piece clear hard capsules with greenish brown powder fill.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms of mild anxiety, to aid sleep and for mild digestive complaints, such as bloating and flatulence, based on traditional use only.

For oral use only

Adults and elderly:

Take 2 capsule 3 times daily.

Swallow the whole capsule with water.

The use in children or adolescents under 18 years is not recommended (see section 4.4 ‘Special Warnings and Precautions for use’).

Duration of use:

If symptoms persist during the use of this medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to Lemon Balm or any of the excipients

4.4 Special warnings and precautions for use

Do not exceed stated dose.

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.

4.5 Interaction with other medicinal products and other forms of interaction

No data is available.

Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor.

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

4.7    Effects on ability to drive and use machines

May impair the ability to drive and use machines. If affected, patients should not drive or operate machinery.

4.8    Undesirable effects

None known.

If adverse reactions 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 amended.

5.2    Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC amended.

Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium hydrogen phosphate dihydrate 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

Three years

6.4 Special precautions for storage

Store below 25°C.

Keep the bottle tightly closed.

6.5 Nature and contents of container

Container.

Green Polyethylene terephthalate (PET) bottles with a green flip 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 21710/0004

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/04/2011

10    DATE OF REVISION OF THE TEXT

02/01/2013