Summary of medicine characteristics - NATURES GARDEN LEMON BALM CAPSULES,HOLLAND & BARRETT LEMON BALM CAPSULES,GNC LIVE WELL LEMON BALM CAPSULES,LIFECYCLE LEMON BALM CAPSULES,NATURES BOUNTY LEMON BALM CAPSULES
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 green 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.
4.2 Posology and method of administration
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 worsen or persist after 2 weeks 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.
If symptoms worsen or persist after 2 weeks during the use of this medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
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.
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.
No studies on the effects on fertility have been performed.
4.7 Effects on ability to drive and use machines
May impair the ability to drive and use machines. 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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(I)(a)(iii) of Directive 2001/83/EC amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(I)(a)(iii) of Directive 2001/83/EC amended.
5.3 Preclinical safety data
5.3 Preclinical safety dataReverse mutation assays (Ames test) on bacteria indicated that the extract in product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation.
Tests on reproductive toxicity 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
Store in the original container
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
6.6 Special precautions for disposalNo special requirements
7 MARKETING AUTHORISATION HOLDER
Holland & Barrett International 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 THEAUTHORISATION
21/02/2020