Holland & Barrett Herbal Water Retention Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutrition Warehouse Herbal Water Retention Tablets Holland & Barrett Herbal Water Retention Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
64.8 mg of extract (as dry extract) from Boldo leaf (Peumus boldus L.) (4:1) Extraction solvent: Ethanol 50%v/v
24.4 mg Dandelion root (Taraxacum officinale Weber ex Wigg..)
32.4 mg of extract (as dry extract) from Uva Ursi leaf (Arctostaphylos uva ursi L.) (2.5-4.5:1)
Extraction solvent: Water
45.8 mg of extract (as dry extract) from Bladderwrack thallus (Fucus vesiculosus L.) (1.7-3:1)
Extraction solvent: Acidic Water
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Brown round biconvex tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve symptoms in mild cases of water retention, based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
Adults: One or two tablets daily with water.
To ensure an increase of the amount of urine, adequate fluid intake is required during treatment.
The use in the elderly and children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use.’)
Duration of use
If symptoms worsen or persist after using the product for 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, iodine or to any of the excipients.
Obstruction of bile duct, cholangitis, liver disease, gallstones, active peptic ulcer and any other biliary disorders that require medical supervision and advice.
Kidney disorders
Conditions where a reduced fluid intake is recommended (e.g. cardiac or renal disease).
Patients with a thyroid disorder.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
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.
The use in patients with renal failure and/or diabetes, and /or heart failure should be avoided because of possible risks due to hyperkalemia.
The use in the elderly, children and adolescents under 18 years of age is not recommended due to lack of adequate data.
Do not take with other medicines or dietary supplements containing iodine.
Uva ursi leaf may cause a greenish-brown colouration of the urine
4.5 Interaction with other medicinal products and other forms of interaction
Additive effects with diuretics cannot be excluded and therefore concomitant treatment is not recommended.
Do not take with other medicines or dietary supplements containing iodine.
Do not take with medicines for thyroid disorders.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Studies 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 has been reported with Burdock root. The frequency is not known.
Hypersensitivity (anaphylaxis) has been reported with Boldo leaf. The frequency is not known.
Bladderwrack may cause diarrhoea. The frequency is not known.
Allergic reactions, epigastric pain and hyperacidity may occur with Dandelion root. The frequency is not known.
Nausea, vomiting, stomach ache have been reported with uva ursi leaf. The frequency is not known.
If other adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.
4.9 Overdose
No cases of overdose have not been reported.
An overdose of Bladderwrack may lead to thyroid disorders such as hyperthyroidism, thyrotoxicosis, subclinical hypothyroidism, Hashimoto’s thyroiditis.
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.
Tests on reproductive toxicity have been performed with a dry ethanolic extract of boldo
leaf and boldine administered orally to pregnant rats. Results showed anatomical alterations in the fetus and a few cases of abortion at high doses. Tests on genotoxicity and carcinogenicity have not been performed with preparations of boldo leaf.
Available tests on genotoxicity of water and ethanolic extracts 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 fetal 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 hydroquinone during the short-term treatment with Uva ursi leaf preparations are considered minimal.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipients Maltodextrin
Colloidal anhydrous silica
Tablet core
Calcium Phosphate Dibasic
Potato Starch
Talc
Magnesium Stearate Stearic Acid Ethylcellulose N100
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Blister pack of hard tempered aluminium foil and food quality PVC enclosed in cardboard outer.
Pack size: 60 tablets
6.6 Special precautions for disposal
There are no special precautions for disposal
7 MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Limited
Samuel Ryder House
Barling Way
Eliot Park
Nuneaton
Warwickshire
CV10 7RH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 14010/0045
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/04/2013
10 DATE OF REVISION OF THE TEXT
19/04/2013