SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Watershed Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains:

88 mg of extract (as dry extract) from Uva Ursi leaf (Arctostaphylos uva-ursi (L.) Spreng) (5:2) (equivalent to 220 mg Uva Ursi leaf)

Extraction Solvent: Water

55 mg Buchu Leaf (Agathosma betulina (Berg.) Pillans)

For full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Tablet.

A pale blue round film 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 use only.

Adults: Take two tablets three times a day.

Not recommended for use in the elderly, children and adolescents under 18 years of age. (see section 4.4 “Special warnings and precautions for use”).

If the symptoms worsen or persist after using this product for one week, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients or any of the excipients.

Renal disorders.

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 coloration of the urine.

Not recommended for use in the elderly, children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

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

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.

Studies on fertility have not been carried out.

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

Allergic skin reactions have been reported with Juniper Berry.

The frequency is not known.

If any adverse reactions occur, a doctor or a qualified healthcare practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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.

6.1 List of excipients

Calcium Hydrogen Phosphate Microcrystalline Cellulose Stearic Acid Capsicum Powder Colloidal Anyhdrous Silica Croscarmellose Sodium Magnesium Stearate Maltodextrin Juniper Berry Oil

Tablet coating containing hypromellose, glycerol and hydroxypropyl cellulose

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original container.

6.5 Nature and contents of container

Tamper evident polyethylene/polypropylene pot packed in a cardboard box: 36, 60, 84 and 100 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7 MARKETING AUTHORISATION HOLDER

Soho Flordis UK Limited 1 Botanic Court,

Martland Park,

Wigan,

WN5 0JZ,

UK.

Trading as: Potters, Wigan WN5 0JZ

8    MARKETING AUTHORISATION NUMBER(S)

THR 44893/0020

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/02/2013

10 DATE OF REVISION OF THE TEXT

28/09/2015