SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

AsParFlow Film-coated Tablets.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

200 mg asparagus root (Asparagus officinalis L.), and

200 mg parsley herb (Petroselinum crispum (Mill.) A. W. Hill)

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablets.

Green, convex, round film-coated tablets.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to increase the amount of urine for the purpose of flushing the urinary tract to assist in minor urinary complaints, based on traditional use only.

4.2 Posology and method of administration

For oral administration.

The tablets should be swallowed whole before meals with 1-2 glasses of water. It is important to drink plenty of fluids while taking this medicine. Do not chew the tablets.

Adults and the elderly

Take 2 tablets three times daily.

Children and adolescents under 18 years of age

This medicine is not recommended for children and adolescents under 18 years of age (see Section 4.4 Special warnings and precautions for use).

Duration of use

The product is used traditionally over a period of 2 to 4 weeks (see Section 4.4

Special warnings and precautions for use).

If the symptoms persist or worsen during the use of the product a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to asparagus root, parsley herb or to any of the excipients. Patients with:

•    impaired renal function,

•    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.

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

The use in children and adolescents under 18 years of age is not recommended because of lack of available experience.

Patients on anticoagulant therapy should tell their doctor that they are taking the product due to the vitamin K content of parsley herb.

If the symptoms persist or worsen during the use of the product a doctor or a qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

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.

No studies on the effects on fertility have been performed.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Allergic reactions of the skin or mucosa may occur. Phototoxic reactions are possible, especially in patients with fair or sensitive skin.

The frequency is not known.

If other adverse effects not mentioned above 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 website www.mhra.gov.uk/yellowcard.

4.9 Overdose

No cases of overdose have been reported.

Supportive and symptomatic treatment should be provided as appropriate.

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 and carcinogenicity have not been performed. In a genotoxicity test (Salmonella typhimurium bacterial reverse mutation assay) no mutagenic potential of the product was observed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core:

Colloidal anhydrous silica Macrogol 6000 Stearic acid 50

Tablet coating: Ethylcellulose

6.2 Incompatibilities

Not applicable.

Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

PVC/PVDC-Al blister strips in cardboard carton.

Packs of 50, 60, 100 and 200 film-coated tablets.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Grunwalder Gesundheitsprodukte GmbH Ruhlandstr. 5, 83646 Bad Tolz, Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 18457/0012

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

20/06/2016

10    DATE OF REVISION OF THE TEXT

20/06/2016