Pflanzenwissen.
Mit Herkunft.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1, 2
    Well-established use                                    Traditional use

                                                            With regard to the registration application of Article
                                                            16d(1) of Directive 2001/83/EC
                                                            Arctostaphylos uva-ursi (L.) Spreng., folium
                                                            (bearberry leaf)

                                                            i) Herbal substance

                                                            Not applicable

                                                            ii) Herbal preparations

                                                            a) Comminuted herbal substance

                                                            b) Powdered herbal substance

                                                            c)   Dry extract (DER 3.5-5.5:1), extraction solvent
                                                                 ethanol 60% V/V, containing
                                                                 23.5-29.3% of hydroquinone derivatives
                                                                 calculated as anhydrous arbutin
                                                                 (spectrophotometry)

                                                            d) Dry extract (DER 2.5-4.5:1), extraction solvent
                                                                 water, containing 20-28% of hydroquinone
                                                                 derivatives calculated as anhydrous arbutin
                                                                 (spectrophotometry)

                                                            e) Liquid extract (DER 1:1), extraction
                                                                 solvent ethanol 25% V/V



3. Pharmaceutical form
    Well-established use                                    Traditional use

                                                            Comminuted herbal substance as herbal tea for oral
                                                            use.

                                                            Herbal preparations in liquid or solid dosage forms for



1
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
    The material complies with the Ph. Eur. monograph (ref.: 1054)



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 Well-established use                                       Traditional use

                                                            oral use.

                                                            The pharmaceutical form should be described by the
                                                            European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                       Traditional use

                                                            Traditional herbal medicinal product used for relief of
                                                            symptoms of mild recurrent lower urinary tract
                                                            infections such as burning sensation during urination
                                                            and/or frequent urination in women, after serious
                                                            conditions have been excluded by a medical doctor.

                                                            The product is a traditional herbal medicinal product
                                                            for use in the specified indication exclusively based
                                                            upon long-standing use.


4.2. Posology and method of administration 3

 Well-established use                                       Traditional use

                                                            Posology

                                                            Female adults and elderly

                                                            a) Comminuted herbal substance

                                                            Herbal tea: 1.5-4 g of the comminuted herbal
                                                            substance in 150 ml of boiling water as a herbal
                                                            infusion or in 150 ml of water as a macerate 2 to 4
                                                            times daily
                                                            Maximum daily dose: 8 g

                                                            b) Powdered herbal substance

                                                            Single dose: 700 – 1050 mg twice daily
                                                            Maximum daily dose: 1.75 g

                                                            c) and d) Dry extracts

                                                            Single dose: the dose corresponding to 100–210 mg
                                                            of hydroquinone derivatives calculated as anhydrous
                                                            arbutin 2–4 times daily

                                                            Daily dose: the dose corresponding to 200–840 mg of
                                                            hydroquinone derivatives calculated as anhydrous


3
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium
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 Well-established use                                       Traditional use

                                                            arbutin

                                                            e) Liquid extract

                                                            Single dose: 1.5–4 ml up to three times daily
                                                            Maximum daily dose: 8 ml

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

                                                            The use in men is not recommended (see section 4.4
                                                            ‘Special warnings and precautions for use’).

                                                            Duration of use

                                                            Not to be used for more than one week.

                                                            If the symptoms persist for more than 4 days during
                                                            the use of the medicinal product, a doctor or a
                                                            qualified health care practitioner should be consulted.

                                                            Method of administration

                                                            Oral use

                                                            The macerate should be used immediately after
                                                            preparation.

Contraindications

4.3. Contraindications

 Well-established use                                       Traditional use

                                                            Hypersensitivity to the active substance.
                                                            Kidney disorders

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                       Traditional use

                                                            The use in children and adolescents under 18 years of
                                                            age is not recommended because of concerns
                                                            requiring medical advice.

                                                            The use in men is not recommended because of
                                                            concerns requiring medical supervision.

                                                            If the symptoms worsen or if complaints such as
                                                            fever, dysuria, spasms, or blood in urine occur during
                                                            the use of the medicinal product, a doctor or a
                                                            qualified health care practitioner should be consulted.

                                                            Uvae ursi folium may cause a greenish-brown
                                                            coloration of the urine.



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 Well-established use                                       Traditional use

                                                            For extracts containing ethanol, the appropriate
                                                            labelling for ethanol, taken from the ‘Guideline on
                                                            excipients in the label and package leaflet of
                                                            medicinal products for human use’, must be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                       Traditional use

                                                            None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                       Traditional use

                                                            Nausea, vomiting, stomach-ache have been reported.
                                                            The frequency is not known.

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