Natures Garden Dandelion Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Holland & Barrett Dandelion Capsules GNC Live Well Dandelion Capsules Lifecycle Dandelion Capsules Nature’s Garden Dandelion Capsules Nature’s Bounty Dandelion Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 339mg of extract (as dry extract) from Dandelion root (Taraxacum officinale Weber) (equivalent to 1018mg - 1696mg of Dandelion root).
Extraction solvent: Ethanol 60% 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
• Relieve the symptoms of mild digestive disorders, such as dyspepsia and flatulence and temporary loss of appetite.
• 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 the elderly
Take 1 capsule 2 times daily. Swallow the whole capsule with water.
To ensure an increase of the amount of urine, adequate fluid intake is required during the treatment.
Not for use in children and adolescents under 18 years (see section 4.4 Special warning and precautions for use)
Duration of use
If symptoms worsen or persist after 2 weeks of using the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to Dandelion, or to plants of the Asteraceae (Compositae) family or any of the excipients
Obstruction of the biliary or intestinal tract, liver disease, cholangitis, gallstones and or active peptic ulcer
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 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.
If the symptoms worsen or persist after 2 weeks of using the product a doctor or qualified healthcare practitioner should be consulted
Concomitant treatment with diuretics is not recommended
The use in patients with renal failure and/or diabetes and/or heart failure should be avoided because of the risk of hyperkalemia.
4.5 Interaction with other medicinal products and other forms of interaction
None reported
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.
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
Mild gastrointestinal effects such as epigastric pain and hyperacidity. 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.
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
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
2 years
6.4 Special precautions for storage
Do not store above 25°C.
Keep in the original container.
Keep the bottle tightly closed.
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: 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 21710/0026
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATE OF REVISION OF THE TEXT
10
07/12/2011