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

                                                                Vaccinium macrocarpon Aiton, fructus
                                                                (cranberry fruit)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                Expressed juice from the fresh fruit (DER 1: 0.6-
                                                                0.9)



3. Pharmaceutical form
 Well-established use                                           Traditional use

                                                                Herbal preparations in liquid dosage forms for
                                                                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

                                                                Indication 1)

                                                                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

1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal

quality guidance.
2 Detailed specifications for the herbal substance shall be given by references to bibliographic sources in absence of a

monograph in the European Pharmacopoeia, a national pharmacopoeia or national codex currently used officially in a
Member State.


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 Well-established use                                          Traditional use

                                                               urination in women, after serious conditions
                                                               have been excluded by a medical doctor.

                                                               Indication 2)

                                                               Traditional herbal medicinal product used for
                                                               prevention of recurrent uncomplicated lower
                                                               urinary tract infections 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

 Well-established use                                          Traditional use

                                                               Posology

                                                               Female adults and elderly

                                                               Indication 1)

                                                               50-60 ml expressed juice 2 - 4 times daily

                                                               Indication 2)

                                                               30 ml expressed juice once daily

                                                               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

                                                               Indication 1)

                                                               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.

                                                               Indication 2)

                                                               No restriction.

                                                               If the patient experience symptoms of urinary
                                                               tract infection during the use of the medicinal
                                                               product, a doctor or a qualified health care


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 Well-established use                                          Traditional use

                                                               practitioner should be consulted.

                                                               Method of administration

                                                               Oral use.

Contraindications

4.3. Contraindications

 Well-established use                                         Traditional use

                                                              Hypersensitivity to cranberry (Vaccinium
                                                              macrocarpon Ait.) fruit.

                                                              Patients with kidney disorders who experienced
                                                              recurrent urinary tract infections require medical
                                                              supervision.

                                                              Concomitant use with tacrolimus and warfarin
                                                              (see section 4.5 ‘Interactions with other
                                                              medicinal products and other forms of
                                                              interaction’).

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 data
                                                               is not sufficient and medical advice should be
                                                               sought.

                                                               The use in men and pregnant women is not
                                                               recommended because lower urinary tract
                                                               symptoms in these populations require medical
                                                               supervision.

                                                               Cranberry concentrate has a high content of
                                                               oxalate, and there may be an increased risk of
                                                               stone formation in the urinary tract in patients
                                                               with stone history.

                                                               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.




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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

                                                               Cranberry juice and other cranberry products
                                                               may potentiate the effect of warfarin and
                                                               therefore concomitant use should be avoided
                                                               (see section 4.3. ‘Contraindications’).

                                                               Decreased tacrolimus serum levels have been
                                                               reported from the concomitant use of cranberry
                                                               juice and tacrolimus in a renal allografted
                                                               patient. The concomitant use of cranberry
                                                               preparations and tacrolimus should be avoided
                                                               (see section 4.3. ‘Contraindications’).

Undesirable effects

4.8.     Undesirable effects

 Well-established use                                          Traditional use

                                                               Gastrointestinal disorders: nausea, diarrhoea
                                                               and dyspepsia. The frequency is not known.

                                                               Skin and subcutaneous tissue disorders:
                                                               urticaria and rash. The frequency is not known.

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




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