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Holland & Barrett Herbal Water Relief Tablets

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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