HRI Water Balance - SPC
1. Name of the medicinal product
HRI WATER BALANCE
2. Qualitative and quantitative composition
One tablet contains 100 mg of Dandelion root powder BHP; 15 mg Buchu powdered extract 3:1 (from 45mg Buchu); 15mg Parsley Piert powdered extract 3:1 (from 45mg Parsley Piert); 18mg Uva Ursi powdered extract 5:2 (from 45mg Uva Ursi).
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Dark grey round biconvex sugar coated tablet.
4. Clinical particulars
4.1. Therapeutic indications
A traditional herbal remedy to help relieve water retention and maintain a normal body fluid balance.
4.2. Posology and method of administration
For oral administration.
Adults, the elderly and children over 12 years: Two tablets to be taken twice a day after meals. Children under 12 years of age: Not recommended.
4.3. Contraindications
There are no known contra-indications to this product.
4.4. Special warnings and precautions for use
Do not exceed the stated dose or take on an empty stomach. If you accidentally take too many HRI Water Balance Tablets, consult your doctor.
Not to be taken by children under 12 years of age.
Store out of reach of children.
4.5. Interaction with other medicinal products and other forms of interaction
There are no known interactions with this product.
4.6. Pregnancy and lactation
Not to be taken during pregnancy or lactation without consulting your doctor.
4.7. Effects on ability to drive and use machines
There is no known effect.
4.8. Undesirable effects
There are no known undesirable effects.
4.9. Overdose
No special procedures or antidotes are likely to be needed in healthy adults.
5. Pharmacological properties
5.1. Pharmacodynamic properties
Dandelion Root is traditionally used to promote renal and digestive elimination functions and to promote the renal elimination of water.
Buchu is traditionally used to promote the renal elimination of water. Parsley Piert is traditionally used as a diuretic.
Uva Ursi is traditionally used to promote the renal elimination of water.
5.2. Pharmacokinetic properties
None stated.
5.3. Preclinical safety data
No remarks.
6 Pharmaceutical particulars
6.1. List of excipients
• Sucrose
• Dicalcium Phosphate
• Powdered Acacia BP
• Croscarmellose Sodium
• Magnesium Stearate Ph. Eur.
• Stearic Acid BP
• Shellac
• Purified Talc Ph. Eur
• Calcium Carbonate
• Titanium Dioxide Ph. Eur
• Iron Oxide Black
• Carnauba Wax
• Beeswax
6.2. Incompatibilities
None known.
6.3. Shelf life
Three years from date of manufacture.
6.4. Special precautions for storage
Store below 25°C in a dry place. Protect from light.
6.5. Nature and contents of container
The product container is a 60ml amber glass jar with a foil tamper-evident seal and white polypropylene screw cap, contained in a carton. Leaflet enclosed.
Each jar contains 50 tablets.
Carton: white backed folded box board and colour printed.
6.6. Instructions for Use/Handling
Do not use if tamper-evident seal is broken.
7. Marketing Authorisation Holder
Jessup Health Limited
(Trading as Jessup Marketing)
27 Old Gloucester Street
London WC1N 3XX
8. Marketing Authorisation number
PL 14404/0001
9. Date of revision of the text
July 2007

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