SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

LOWATER

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

30 mg of extract (as dry extract) from Buchu leaf (Agathosma betulina (Berg) Pillans ( 4:1)

Extraction solvent: Ethanol 70% v/v

30 mg of extract (as dry extract) from Uva Ursi leaf (Arctostaphylos uva-ursi (L.) Spreng. (25 - 45:1)

Extraction solvent: Water

50 mg of extract (as dry extract) from Dandelion root (3 -5:1) (Taraxacum officinale Weber ex Wigg.)

Extraction solvent: Ethanol 60% v/v

Each tablet contains 228 mg of sucrose and 68 mg lactose

(See section 4.4 special warnings and precautions for use).

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet. Grey bi-convex tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve bloating associated with premenstrual water retention, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only

Adults: Two tablets to be taken in the morning and two tablets in the evening.

The tablets should be taken before the period is expected to start.

The use in children and adolescents under 18 years of age and the elderly 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 qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substances or plants of the Asteraceae (Compositae) or to any of the excipients

Obstructions of the bile ducts, cholangitis, liver diseases, gallstones, active peptic ulcer and other biliary diseases.

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 do not improve after one week or if symptoms such as fever, spasm, dysuria or blood in the urine occur, a doctor or qualified healthcare practitioner should be consulted.

The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data. The use in the elderly is not relevant to the indication.

The use in patients with renal failure and/ or diabetes, and /or heart failure should be avoided because of possible risks due to hyperkalaemia.

Uva ursi leaf may cause a greenish-brown colouration of the urine.

Contains lactose monohydrate and sucrose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption 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. Due to the lack of data, 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. Allergic reactions, epigastric pain and hyperacidity may occur with Dandelion Root. The frequency is not known.

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

4.9    Overdose

No cases of overdose have 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    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Extract excipients Maltodextrin

Colloidal anhydrous silica

Tablet core Sucrose,

Lactose monohydrate.

Talc

Magnesium Stearate Sodium Starch Glycolate Cayenne

Tablet coat

Titanium Dioxide (E171)

Iron Oxide Black (E172)

Syrup

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C. Store in the original package

6.5 Nature and contents of container

Plastic container with tamper evident cap - 60 tablets. Plastic container with tamper evident cap - 30 tablets

6.6 Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

Kerbina Limited

T/A Bio-Health Limited

Culpeper Close

Medway City Estate

Rochester

Kent

ME2 4HU

8    MARKETING AUTHORISATION NUMBER(S)

THR 00904/0002

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/03/2013 27/03/2013