Uva-Ursi & Echinacea Cystitis Oral Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Uva-ursi & Echinacea Cystitis oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral liquid contains:
715 mg of tincture from fresh Uva-ursi herb (Arctostaphylos uva-ursi (L.) Spreng, herb) (1:4)
Extraction solvent: Ethanol 43% m/m
240 mg of tincture from fresh Echinacea purpurea herb (Echinacea purpurea (L.) Moench herb) (1:12)
Extraction solvent: Ethanol 57.3% m/m 1ml is equivalent to 30 drops.
1 ml of tincture contains approximately 426 mg ethanol (alcohol) equivalent to 10.8 ml of beer or 4.5 ml of wine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution.
Clear to opalescent brown-yellow to brown liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to help relieve minor urinary complaints associated with cystitis in women, such as burning sensation during urination and/or frequent urination, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adult women over 18 years: Take 15 drops in a little water 2-5 times daily.
Not recommended for children or adolescents under 18 years (see section 4.4 ‘Special warnings and precautions for use’).
It is advisable to drink plenty of liquids while taking this medicine.
4.3 Contraindications
Hypersensitivity to the active substances, to plants of the Asteraceae (Compositae) family or to any of the excipients.
Because of their immunostimulating activity, Echinacea must not be used in cases of progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g. collagenoses, multiple sclerosis), immunodeficiencies (e.g HIV infection, AIDS), immunosuppression (e.g. oncological cytostatic therapy; history of organ or bone marrow transplant), diseases of the white blood cell system (e.g. agranulocytosis, leukaemias) and allergic diathesis (e.g. urticaria, atopic dermatitis, asthma).
Patients with:
• Impaired renal function.
• Oedema secondary to heart failure or impaired renal function.
• Current or previous kidney disorders.
• Conditions where a reduced fluid intake is recommended e.g. severe cardiac or renal diseases.
4.4 Special warnings and precautions for use
Do not exceed stated dose.
The use in children and adolescents under 18 years is not recommended because of concerns requiring medical advice.
If complaints or symptoms such as fever, spasms, acute urinary retention, dysuria, urinary incontinence, or blood in urine occur during the use of this product, a doctor or a qualified healthcare practitioner should be consulted.
Uva ursi leaf may cause a greenish-brown coloration of the urine.
There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using Echinacea.
If symptoms worsen, or do not improve after 7 days, a doctor or qualified healthcare practitioner should be consulted, in order to exclude any underlying medical condition.
This product contains 54 vol % ethanol (alcohol).
This corresponds to 213 mg alcohol equivalent to 5.4 ml beer or 2.25 ml wine (15 drops).
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.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Not to be used concomitantly with immunosuppressant medications such as ciclosporin and methotrexate.
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 should be avoided (see section 5.3 ‘Preclinical safety data’). In the absence of such data, the use during lactation is not recommended.
Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available. To date, no other relevant epidemiological data are available. The potential risk to humans is unknown.
Studies on fertility have not been carried out.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed. This product contains alcohol (see section 4.4 for details of alcohol content).
4.8 Undesirable effects
Gastrointestinal symptoms (e.g. nausea, vomiting and stomach ache have been reported).
Hypersensitivity reactions (rash, urticaria, Stevens-Johnson Syndrome, angioedema of the skin, Quincke edema, bronchospasm with obstruction, asthma and anaphylactic shock) may occur.
Echinacea may trigger allergic reactions in atopic patients. Association with autoimmune diseases (encephalitis disseminata, erythema nodosum, immunothrombocytopenia, Evans Syndrome, Sj rgen Syndrome with renal tubular dysfunction) has been reported. Leucopenia may occur in long-term use (more than 8 weeks).
The frequency of adverse reactions is not known.
If other adverse reactions not mentioned above occur, a doctor or 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 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 case of overdose has been reported.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (21.3 g in 50 ml: equivalent to 2 glasses of wine) may result in intoxication and should be treated accordingly.
PHARMACOLOGICAL PROPERTIES
5
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
Reverse mutation assays (Ames test) conducted with Uva-ursi & Echinacea on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 1535, TA 1537, TA 100 and TA 102) mutation assays with or without metabolic activation. The product was positive in TA98 with or without metabolic activation however this was considered due to the presence of quercetin.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
2 years unopened.
After first opening the container: 4 months
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Brown glass dropper bottles (Type III glass) with a two part dropper (PE-LD)/dispenser cap (PP) and ring (PE-HD).
Pack sizes: 50 ml
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Bioforce (UK) Ltd
2 Brewster Place
Irvine, Ayrshire
KA11 5DD, United Kingdom
Tel: 01294 277344
8 MARKETING AUTHORISATION NUMBER(S)
THR 13668/0030
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/10/2015
10 DATE OF REVISION OF THE TEXT
07/10/2015