SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

AquaBan Herbal Coated Tablets Boots Water Relief Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

75 mg Uva ursi leaf (Arctostaphylos uva-ursi (L.) Spreng., folium)

75 mg Clivers herb (Galium aparine L. herba)

50 mg Burdock root (Arctium lappa L. radix)

Each coated tablet contains 125 mg of sucrose

(See Section 4.4 ‘Special warnings and precautions for use’)

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Coated tablet.

Yellow circular biconvex sugar coated 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 : The recommended dose is 2 tablets three times a day before meals.

The tablets should be swallowed whole with some water or other liquid.

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.’)

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 or to plants of the Asteraceae (Compositae) family or to any of the excipients.

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.

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 the elderly, children and adolescents under 18 years of age is not recommended due to lack of adequate data.

Contains 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

No interaction studies have been performed.

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 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 effects on the ability to drive or operate machines have been performed.

4.8 Undesirable effects

Nausea, vomiting, stomach ache have been reported with Uva ursi leaf. Anaphylactic shock has been reported with Burdock root.

The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

No cases of overdose have been reported.

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

Core:

Magnesium Stearate Maize Starch Parsley Root Powder Pregelatinised Maize Starch Silicon Dioxide Sucrose

Coating:

Acacia

Calcium Carbonate

Mastercote Yellow SP0142G (containing Yellow Iron Oxide E172, Titanium Dioxide E171, Talc, Sucrose)

Opaglos 6000 (White Beeswax, Carnauba Wax, Shellac, Ethanol)

Talc

Shellac Varnish Sucrose

Titanium Dioxide E171

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2    years (blister packs)

3    years (bottles)

6.4 Special precautions for storage

Do not store above 25°C.

Store in original package.

6.5 Nature and contents of container

60, 80, 100, 160 and 200 tablets packaged into securitainers fitted with tamper evident caps.

60, 80 and 160 tablets packaged into amber glass bottles (USP Type III glass) fitted with white HDPE tamper evident caps.

60 tablets packaged into PVDC-aluminium/polyethylene laminate blister packs.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

G. R. Lane Health Products Limited

Sisson Road

Gloucester

GL2 0GR

United Kingdom

Tel: +44 (0)1452 524012

Fax: +44 (0)1452 507930

Email: info@laneshealth.com

8    MARKETING AUTHORISATION NUMBER(S)

THR 01074/0232

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/03/2013

10    DATE OF REVISION OF THE TEXT

08/03/2013