Natures Garden Lemon Balm Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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
5.3
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