Holland & Barrett Herbal Water Relief Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutrition Warehouse Herbal Water Relief Tablets Holland & Barrett Herbal Water Relief Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
50 mg of extract (as dry extract) from Bladderwrack thallus (Fucus vesiculosus L.) (1.7-3:1)
Extraction solvent: Acidic Water
25 mg of extract (as dry extract) from Burdock root (Arctium lappa L.) (2-4:1) Extraction solvent: Ethanol 70%v/v
25 mg of extract (as dry extract) from Ground Ivy leaf (Glechoma hederacea L.) (6-7:1)
Extraction solvent: Ethanol 40 %v/v
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 short term oral use only.
Adults: One to two tablets to be taken three times daily.
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 the symptoms worsen or persist for more than one week, a doctor or qualified health care practitioner should be consulted
4.3 Contraindications
Hypersensitivity to the active substances, plants of the Asteraceae (Compositae) family, plants of the Araliaceae family, iodine or to any of the excipients.
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 the elderly, children and adolescents under 18 years of age is not recommended due to lack of adequate data.
Concomitant use with antitussives such as codeine or dextromethorphan is not recommended without medical advice.
Caution is recommended in patients with gastritis or gastric ulcer.
Do not take with other medicines or dietary supplements containing iodine.
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.
Allergic reactions (urticaria, skin rash, couperoses, dyspnoea) and gastrointestinal reactions (nausea, vomiting, diarrhoea) have been reported with Ivy leaf. The frequency is not known.
Bladderwrack may cause diarrhoea. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified health care practitioner should be consulted.
4.9 Overdose
No cases of overdose have not been reported.
Overdose of Ivy leaf can provoke nausea, vomiting, diarrhoea and agitation.
An overdose of Bladderwrack may lead to thyroid disorders such as hyperthyroidism, thyrotoxicosis, subclinical hypothyroidism, Hashimoto’s thyroiditis.
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
Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
a-Hederin, B-hederin and 5-hederin isolated from Ivy leaf showed no mutagenic potential in the Ames test using Salmonella typhimurium strain TA 98, with or without S9 activation.
Data on genotoxicity, carcinogenicity and reproductive toxicity testing for Ivy leaf preparations are not available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipients Maltodextrin
Colloidal anhydrous silica Tablet core
Calcium Phosphate Dibasic Sago Flour
Magnesium Trisilicate 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 14010/0035
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/04/2013
10 DATE OF REVISION OF THE TEXT
19/04/2013