iMedi.co.uk

Boxs Herbals Cystitis Relief

Informations for option: Boxs Herbals Cystitis Relief, show other option

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Napiers Herbal Cystitis Relief Box's Herbals Cystitis Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains: -

0.875 ml of extract (as liquid extract) from Couch Grass Herb (Agropyron repens (L) Beauv.) (1:1) Extraction solvent: Water

0.5 ml of extract (as liquid extract) from Marshmallow Root (Althaea officinalis L.) (1:1)

Extraction solvent: Water

1.125 ml of (as liquid extract) from Buchu leaf (Agathosma betulina (Berg) Pillans) (1:2.5)

Extraction solvent: Ethanol 25% v/v

0.16 ml of extract (as liquid extract) from Uva Ursi leaf (Arctostaphylos uva-ursi (L.) Spreng.) (1:1)

Extraction solvent: Water

0.16 ml of extract (as liquid extract) from Juniper berries (Juniperus communis) (1:1)

Extraction solvent t: Water

0.16 ml of extract (as liquid extract) from Clivers herb (Galium aparine) (1:1) Extraction solvent: Water

5 ml of oral liquid contains approximately 0.7 ml of ethanol and 363 mg of sucrose and 7.3 mg of glucose. (See section 4.4 ‘Special warnings and precautions for use’.)

For a full list of excipients, see section 6.1.

3


PHARMACEUTICAL FORM

Oral liquid.

Dark brown slightly viscous liquid.

4    CLINICAL PARTICULARS

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 only, based on traditional use only.

4.2    Posology and method of administration

For oral use only.

Adult women over 18 years old: Take one 5ml teaspoonful three times a day. Appropriate fluid intake is recommended.

The use in children and adolescent under 18 years is not recommended (see section 4.4 ‘Special warnings and precautions for use’).

Duration of use:

If the symptoms worsen or do not improve during the use of the product, a doctor or a qualified healthcare practitioner should be consulted

4.3    Contraindications

Hypersensitivity to the active ingredients to any of the excipients.

Patients with:

•    impaired renal function,

•    Severe renal disease including infectious interstitial nephritis, pyelitis and pyelonephritis.

•    oedema secondary to heart failure,

•    current or previous kidney disease,

•    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 the stated dose.

The use is not recommended in children and adolescent under 18 years of age due to the lack of adequate data.

Patients experiencing_fever, acute urinary retention, a micturition disorder, urinary incontinence or any blood in the urine should seek advice from a doctor.

If symptoms worsen or do not improve during the use of the product, a doctor or a qualified healthcare practitioner should be consulted.

Absorption of concomitantly administered medicines may be delayed. As a precautionary measure, the product should not be taken 'A to 1 hour before or after intake of other medicinal products.

Uva ursi leaf may cause a greenish-brown coloration of the urine.

This medicinal product contains 14.5 % v/v ethanol (alcohol), i.e. up to 725 mg per dose, equivalent to 14.5 ml beer, 6.04 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 product contains sucrose and glucose. Patients with rare hereditary problems of 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

No studies have been carried out to determine if drug interactions occur with this product

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. In the absence of sufficient data the use during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machines

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

Nausea, vomiting and stomach ache have been reported with Uva ursi leaf. The frequency is not known.

Allergic skin reactionshave been reported with Juniper berries. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or qualified health care practitioner should be consulted.

4.9 Overdose

No cases have been reported with this product.

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (14.1 g in 100 ml; 28.2g in 200 ml: equivalent to 0.48 or 0.96 large glasses of wine respectively or 1.16 or 2.32 glasses of beer, 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.

Available tests on genotoxicity of water and ethanolic extracts of Uvae ursi folium are inadequate. Reproductive toxicity has not been studied. Available carcinogenicity studies have been negative.

Arbutin, the principal component of Uvae ursi folium, 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 hydroquinoneduring the short-term treatment with Uvae ursi folium preparations are considered minimal.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Syrup (sucrose)

Glucose liquid Glycerol

Tincture Cardamon Co. (Cardamom oil, Caraway oil, Cinnamon oil, Beetroot powder, glycerol, ethanol and water)

Nutmeg oil Clove oil Cinnamon oil

Liquorice Liquid Extract (Liquorice, ethanol and water)

Caramel E150a Ethanol Water Sorbitol

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

3 years.

6.4    Special precautions for storage

Do not store above 25oC. Store in the original container.

6.5    Nature and contents of container

Amber glass bottle with polypropylene child- resistant cap packed in a cardboard box: 100ml, 200ml

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

There are no special precautions for disposal.

7    MARKETING AUTHORISATION HOLDER

Highland Herbs Limited 10 Payne Street Glasgow G4 0LF

8    MARKETING AUTHORISATION NUMBER(S)

THR 43751/0009

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/03/2013

10


DATE OF REVISION OF THE TEXT

19/01/2015