Cystitis Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Antitis Cystitis Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains: -
80 mg of extract (as dry extract) from Uva Ursi leaf (Arctostaphylos uva-ursi (L.) Spreng) (5:2) (equivalent to 200 mg Uva Ursi leaf)
Extraction Solvent: Water
60 mg Buchu leaf (Agathosma betulina (Berg.))
23.4 mg of extract (as dry extract) from Buchu leaf (Agathosma betulina (Berg.)) (100:39) (equivalent to 60 mg Buchu leaf)
Extraction Solvent: Water
16.8 mg of extract (as dry extract) from Clivers herb (Galium aparine L.) (100:28) (equivalent to 60 mg Clivers herb)
Extraction solvent: Water
12 mg of extract (as dry extract) from Couchgrass rhizome (Agropyron repens Beauvais) (5:1) (equivalent to 60 mg Couchgrass)
Extraction solvent: Water
12 mg of extract (as dry extract) from Horesetail herb (Equisetum arvense L.)
(5:1)
(equivalent to 60 mg Horsetail herb)
Extraction solvent: Water
12 mg of extract (as dry extract) from Shepherd’s Purse herb (Capsella bursa-pastoris L.) (5:1) (equivalent to 60 mg Shepherd’s Purse herb)
Extraction solvent: Water
Excipient(s):
Each tablet contains 29.1 mg sucrose and 46.7 mg lactose. (See section 4.4 Special warnings and precautions for use.)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A greenish-grey sugar coated tablet.
CLINICAL PARTICULARS
4
4.1 Therapeutic indications
A traditional herbal medicinal product used to help flushing of the urinary tract and to assist in minor urinary complaints associated with cystitis in women, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adult women over 18 years: Two tablets three times a day after meals.
It is important to drink plenty of fluids.
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
If symptoms worsen or do not improve after 1 week, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Conditions where a reduced fluid intake is recommended (e.g. severe cardiac or renal diseases).
Impaired renal function
Oedema secondary to heart failure
Current or previous kidney disease
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use of this product is not recommended in children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.
If complaints or symptoms such as fever, acute urinary retention, a micturition disorder, urinary incontinence or blood in the urine occur during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
If symptoms worsen or do not improve after 1 week, a doctor or a qualified healthcare practitioner should be consulted.
Uva ursi leaf may cause a greenish-brown coloration of the urine.
This product contains sucrose and lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, 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 known.
4.6 Fertility, Pregnancy and lactation
Safety during pregnancy and lactation has not been established. The use of Uva ursi leaf should be avoided during pregnancy (see section 5.3 ‘Preclinical safety data).
In the absence of sufficient data the use 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
No studies 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.
Mild gastrointestinal complaints and allergic reactions (e.g. rash) have been reported with Horsetail herb use. The frequency is not known.
If other adverse reactions occur, a doctor or a qualified healthcare 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
No cases of overdose have been reported.
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 water and ethanolic extracts 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 fetal 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 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethylcellulose
Colloidal Anhydrous Silica
Lactose
Sucrose
Calcium Hydrogen Phosphate Croscarmallose Sodium Talc
Sodium Starch Glycolate Magnesium Stearate Shellac Kaolin Light Titanium Dioxide (E171) Black Iron Oxide (E172) Yellow Iron Oxide (E172) Maltodextrin
6.2 Incompatibilities
None known.
6.3 Shelf life
3 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
Tamper evident polyethylene/polypropylene pot with polyethylene/polypropylene cap packed in a cardboard box: 50, 60, 84, 100 and 120 tablets.
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 44893/0029
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/04/2013
10
DATE OF REVISION OF THE TEXT
28/09/2015