Herbal Classics Water Retention Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
HRI Water Balance Tablets
Herbal Classics Water Retention Tablets
Forza Herbals Waterflow Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
100 mg of dandelion root (Taraxacum officinale).
18 mg of extract (as dry extract) from uva-ursi leaf (Arctostaphylos uva-ursi L) (equivalent to 45 mg of uva-ursi leaf).
Extraction solvent: methanol (30 % v/v).
15 mg of extract (as dry extract) from buchu leaf (agathosma betulina L) (equivalent to 45 mg of buchu leaf).
Extraction solvent: water
Excipients:
Each tablet also contains 160 mg of sucrose.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet.
Dark grey round biconvex tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Traditional herbal medicinal product used to relieve symptoms of mild water retention, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults
Two tablets to be taken twice a day after meals.
The use in children and adolescents under 18 years of age, and the elderly is not recommended (See Section 4.4 Special warnings and precautions for use).
If symptoms worsen or persist after one week, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substances, plants of the Asteraceae (Compositae) family or any of the excipients.
Obstructions of the bile ducts, cholangitis, liver diseases, gallstones, active peptic ulcer and any other biliary diseases.
Conditions where a reduced fluid intake is recommended (e.g cardiac or renal disease).
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use of this product in children and adolescents under 18 years of age, and the elderly is not recommended due to lack of adequate data.
Do not take on an empty stomach.
If symptoms worsen or persist after one week or if symptoms such as fever, spasms, dysuria or blood in the urine occur, a doctor or a qualified healthcare practitioner should be consulted.
Uva ursi leaf may cause a greenish-brown colouration of the urine.
The use in patients with renal failure, and/or diabetes and/or heart failure should be avoided due to the risk of hyperkalaemia.
This product contains sucrose. One tablet contains 160 mg sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
Additive effects with diuretics cannot be excluded and therefore concomitant treatment is
not recommended.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation had not been established.
In the absence of sufficient data the use in pregnancy and lactation is not recommended.
Studies on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Nausea, vomiting, stomach ache have been reported with Uva ursi leaf. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor, pharmacist 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
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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
Available tests on genotoxicity of Uva ursi leaf are inadequate. Reproductive toxicity has
not been studied. Available carcinogenicity studies have been negative.
Arbutin, the principal component of Uva ursi leaf, displayed some maternal and foetal toxicity in rats after subcutaneous administration of 400 mg/kg/day. No effect on reproduction has been observed at doses of 100 mg/kg/day.
Toxicity tests with hydroquinone, a hydrolysis product of arbutin, have demonstrated some evidence of genotoxicity and carcinogenicity. Risks posed by the exposure of hydrquinone during the short-term treatment with Uva ursi leaf preparations are considered minimal.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet Core
Calcium hydrogen phosphate Sucrose
Acacia, spray dried Croscarmellose sodium Magnesium stearate Stearic acid
Colloidal hydrated silica
Tablet Coating Sucrose
Calcium carbonate Purified Talc Shellac
Acacia, spray dried
Mastercote cream FP9002 (Beeswax, Shellac, Carnauba wax)
Mastercote dark grey SP0993 (Sucrose, Black Iron Oxide (E172), Titanium Dioxide (E171)) Titanium dioxide (E171)
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Glass bottles: Do not store above 25 °C. Store in the original packaging. Blister strip: Do not store above 25 °C. Store in the original packaging.
6.5 Nature and contents of container
Amber glass bottle with foil tamper evident seal and white polypropylene screw cap. Pack sizes: 30, 40, 45, 50, 60, 80, 100
Al/PVC/PVDC blister strip
Pack sizes: 30, 40, 45, 50, 60, 80, 100
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Jessup Health Limited (trading as Jessup Marketing)
27 Old Gloucester Street
London
WC1N 3XX
8 MARKETING AUTHORISATION NUMBER(S)
THR 14404/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/03/2013
10 DATE OF REVISION OF THE TEXT
05/10/2015