HERBAL CLASSICS WATER RETENTION TABLETS

Active substance: TARAXACUM OFFICINALE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT

HRI Water Balance Tablets

Herbal Classics Water Retention Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:
100 mg of Dandelion root (Taraxacum officinale Weber ex Wigg.).
18 mg of extract (as dry extract) from Uva-ursi leaf (Arctostaphylos uva-ursi L.)
(equivalent to 45 mg of Uva-ursi leaf).
Extraction solvent: methanol 30 % v/v.
15 mg of extract (as dry extract) from Parsley piert herb (Alchemilla arvensis L.)
(equivalent to 45 mg of Parsley piert herb).
Extraction solvent: ethanol 50 % v/v.
15 mg of extract (as dry extract) from Buchu leaf (agathosma betulina L.) (equivalent
to 45 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

PHARMACEUTICAL 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 sucraseisomaltase 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.

4.6
Fertility, pregnancy and lactation
Safety during pregnancy and lactation had not been established.
In the absence of sufficient data the use in pregnancy and lactation 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 on 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. The frequency is not
known.

If other 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 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
Tablet Core
Dicalcium phosphate
Sucrose
Powdered acacia
Croscarmellose sodium
Magnesium stearate
Stearic acid

Tablet Coating
Sucrose
Calcium carbonate
Talc
Shellac
Powdered acacia
Mastercote cream FP9002 (containing beeswax, shellac, carnauba wax, industrial methylated
spirit)
Mastercote dark grey SPO993-A
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 25 °C. Store in the original packaging.
Blister strip: Do not store above 25 °C. 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
Al/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

Jessup Health Limited
(trading as Jessup Marketing)
27 Old Gloucester Street
London
WC1N 3XX

8

MARKETING AUTHORISATION NUMBER(S)

THR 14404/0003

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/03/2013

10

DATE OF REVISION OF THE TEXT

22/03/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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