Lifecycle Burdock Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Holland & Barrett Burdock Capsules GNC Live Well Burdock Capsules Lifecycle Burdock Capsules Nature’s Garden Burdock Capsules Nature’s Bounty Burdock Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 399mg of extract (as dry extract) from Burdock Root (Arctium lappa L.) (equivalent to 798mg - 1596mg of Burdock Root). Extraction solvent: Ethanol 70% 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 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 elderly:
Take 2 capsules 3 times daily. Swallow the whole capsule with water.
Do not exceed the stated dose.
Duration of use:
If symptoms worsen or do not improve after 2 weeks, a doctor or a qualified healthcare practitioner should be consulted.
Not for use in children and adolescents under 18 years (see section 4.4 Special warning and precautions for use)
4.3 Contraindications
Hypersensitivity to Burdock or to plants of the Asteraceae (Compositae) family or any of the excipients
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 the symptoms worsen during the use of the medicinal product a doctor or qualified healthcare practitioner should be consulted
If complaints of 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
Concomitant treatment with diuretics is not recommended
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
4.6 Pregnancy and lactation
Safety during pregnancy and lactation has not been established. Due to the lack of data, the 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
Anaphylactic shock and mild gastrointestinal effects may be experienced. The frequency is not known.
If adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.
4.9 Overdose
No cases of overdose have 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
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product.
Adequate 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.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Do not store above 25°C.
Keep in the original container.
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. 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 21710/0016
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/07/2011
10 DATE OF REVISION OF THE TEXT
19/08/2013