HRI Water Balance – SPC

water_balance_packDownload the Patient Information Leaflet here.

 

1. Name of the medicinal product

HRI Water Balance Tablets

2. Qualitative and quantitative composition

Each coated tablets contains:

100 mg of Dandelion herb with root (Taraxacum officinale F.H.Wigg).

9.7 mg of extract (as dry extract) from Uva-ursi leaf (Arctostaphylos uva-ursa L.) (equivalent to 29-58 mg of Uva-ursi leaf).

Extraction solvent:  Ethanol (50% v/v).

11.25 mg of extract (as dry extract) from Buchu leaf (Agathosma betulina L.) (equivalent to 30-60 mg of Buchu leaf).

Extraction solvent:  water

Excipients:

Each tablet also contains 160 mg of sucrose.

For full list of excipients, see section 6.1

3. Pharmeceutical form

Coated tablet.

Dark grey round biconvex tablet.

4. Clinical particulars

4.1 Therapeutic indications

Traditional herbal medicinal product used to relieve symptoms of mild water retention, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults

Two tablets to be taken twice a day after meals.

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).

If symptoms worsen or persist after one week, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

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

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

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

Do not take on an empty stomach.

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 patients with renal failure, and/or diabetes and/or heart failure should be avoided due to the risk of hyperkalaemia.

This product contains sucrose. One tablet contains 160 mg 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

None reported.

Additive effects with diuretics cannot be excluded and therefore concomitant treatment is not recommended.

Studies on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effects of the ability to drive and use machines have been performed.

4.8 Undesirable effects

Nausea, vomiting, stomach ache have been reported with Uva ursi leaf.

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

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 16 c (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 hydroquinone during the short-term treatment with Uva ursi leaf preparations are considered minimal.

6. Pharmeceutical particulars

6.1 List of excipients

Tablet Core

Calcium hydrogen phosphate

Sucrose

Acacia, spray dried

Croscarmellose sodium

Magnesium stearate

Stearic acid

Colloidal hydrated silica

Extract Excipients

Maltodextrin

Colloidal anhydrous silica

Tablet Coating

Sucrose

Calcium carbonate

Purified talc

Shellac

Acacia, spray dried

Mastercote cream FP9002 (beeswax, shellac, carnauba wax)

Mastercote dark grey SP0993 (Sucrose, Black Iron Oxide (E172), Titanium Dioxide (E171))

Titanium dioxide (E171)

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Glass bottles:  Do not store above 25oC.  Store in the original packaging.

Blister strip:  Do not store above 25oC.  Store in the original packaging.

6.5 Nature and contents of container

Amber glass bottle with foil tamper evident seal and white polypropylene screw cap.

Pack sizes:  30, 40, 45, 50, 60, 80, 100

A1/PVC/PVDC blister strip

Pack sizes:  30, 40, 45, 50, 60, 80, 100

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7. Marketing authorisation holder

The Herbal Research Company Limited

(trading as Jessup Marketing)

27 Old Gloucester Street

London

WC1N 3XX

8. Marketing authorisation number(s)

THR 02231/0014

9. Date of first authorisation / renewal of the authorisation

22/03/2013

10 Date of revision of the text

January 2017