Potters Watershed Plus Mixture
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Watershed Plus Mixture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral liquid contains: -
0.63 ml of extract (as liquid extract) from Wild Carrot herb (Daucus carota L.) (1:1) (equivalent to 0.63 g Wild Carrot herb)
Extraction Solvent: Water
0.63 ml of extract (as liquid extract) from Pellitory herb (Anacyclus pyrethrum L.) (1:1) (equivalent to 0.63 g Pellitory herb)
Extraction Solvent: Water
0.56 ml of extract (as liquid extract) from Buchu leaf (Agathosma betulina (1:2.5) (equivalent to 0.22 g Buchu leaf)
Extraction Solvent: Ethanol 25% v/v
0.35 ml of extract (as liquid extract) from Juniper berry (Juniperus communis L.)
(1:1) (equivalent to 0.35 g Juniper berry)
Extraction Solvent: Water
0.35 ml of extract (as liquid extract) from Clivers herb (Galium aparine L.) (1:1) (equivalent to 0.35 g Clivers herb)
Extraction Solvent: Water
Excipients:
5 ml of oral liquid contains approximately 0.725 ml ethanol, 0.08 ml glucose, 0.463 g sucrose and also sorbitol. (See section 4.4 ‘Special warnings and precautions for use’.)
For full list of excipients see Section 6.1
3 PHARMACEUTICAL FORM
Oral Liquid.
A brown liquid.
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 one or two 5ml teaspoonful three or four times daily.
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 the 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.
Severe renal disease including infectious interstitial nephritis, pyelitis and pyelonephritis.
Conditions where reduced fluid intake is recommended (e.g. severe cardiac diseases).
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
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.
If symptoms worsen or persist after one week, or if symptoms such as fever, spasms, dysuria or blood in the urine occur, a qualified healthcare practitioner should be consulted.
This medicinal product contains 14.5% v/v ethanol (alcohol), i.e. up to 1.16 g per dose (10 ml), equivalent to 29 ml beer, 12.1 ml wine per dose.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
This medicinal product contains glucose, sucrose and sorbitol.
Patients with rare hereditary problems of fructose intolerance, glucose-glactose malabsorption or sucrase-isomaltase insufficiency 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.
Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).
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
May impair ability to drive and use machines. If affected, patients should not drive or operate machinery.
This product contains alcohol and therefore may impair ability to drive or operate machines. If affected do not drive or operate machines (See Section
4.4 ‘Special warnings and precautions for use’.)
4.8 Undesirable effects
Allergic skin reactions have been reported with Juniper Berry. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care 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
In case of prolonged use and overdose of Juniper Berry, urine will smell of violets. There may be renal irritation and pain in and near the kidney, strong diuresis, albuminuria, haematuria, purplish urine, gastrointestinal upsets, accelerated heartbeat and blood pressure. Rarely symptoms of central stimulation like convulsions occur as well as metrorrhagia and abortion.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (17.4 g in 150 ml; 23.2 g in 200 ml, equivalent to 0.73 and 0.97 large glass of wine, respectively) may result in intoxication and should be treated accordingly.
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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glucose Liquid Sucrose Syrup Glycerol
Cardamom Compound Tincture (cochineal E120, cardamom oil, caraway oil, cinnamon bark oil, glycerol, water)
Nutmeg Oil Clove Oil
Cinnamon Bark Oil
Liquorice Liquid Extract (liquorice root, sorbitol, ethanol, water)
Ethanol
Caramel (E150)
Water
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
Amber glass bottle with child-resistant tamper evident EPE cap contained in cardboard carton: 150 ml and 200 ml.
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 44893/0019
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/04/2013
10
DATE OF REVISION OF THE TEXT
28/09/2015