SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Cystipret coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 coated tablet contains 18 mg of Centaury herb (Centaurium erythraea Rafn., herba), 18 mg of Lovage root (Levisticum officinale Koch., radix) and 18 mg of Rosemary leaf (Rosmarinus officinalis L., folium).

Excipient:

One coated tablet contains 45.0 mg lactose monohydrate, 60.4 mg sucrose and

1.1 mg glucose.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Coated tablet

The coated tablets are orange, round, biconvex with smooth surface.

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:

Take two coated tablets three times daily.

The coated tablets should be swallowed whole with some water or other liquid.

It is advisable to drink plenty of liquids while taking this medicine.

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

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

4.3 Contraindications

Patients with known hypersensitivity to centaury herb, lovage root, rosemary leaf or to any of the excipents.

Patients with a peptic ulcer.

Patients who have impaired renal function.

Patients with oedema secondary to heart failure or impaired renal function.

Patients with 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

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

One coated tablet contains 45.0 mg lactose monohydrate, 60.4 mg sucrose and 1.1 mg glucose. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The use in children and adolescents under 18 years of age is not recommended.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Pregnancy and lactation

The safety of Cystipret during pregnancy and lactation has not been established. Therefore this product should not be used during pregnancy or lactation.

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.

4.8 Undesirable effects

Common side-effects (affecting less than 1 in 10 but more than 1 in 100 patients) are gastrointestinal symptoms such as nausea, vomiting or diarrhoea.

In very rare cases (affecting less than 1 in 10,000 patients) allergic skin reactions have been reported.

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

4.9 Overdose

No cases of overdose have been reported.

In cases of overdose the patient should contact a doctor, pharmacist or a qualified health care practitioner. In case of overdose, management should be symptomatic and supportive.

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

The LD₅₀ test of acute toxicity in mice showed a lack of toxic effects at 15 g/kg body weight.

Investigations of reproductive toxicity in rats and rabbits have shown a lack of toxic effects on pregnant females and foetuses at doses 100 times higher than the recommended human dose.

In a genotoxicity test (Salmonella typhimurium bacterial reverse mutation assay) with the active ingredients of Cystipret no mutagenic potential of the combination could be observed.

Tests on carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Tablet core:

Lactose monohydrate Magnesium stearate Maize starch Povidone K25 Silica, colloidal anhydrous Tablet coating:

Calcium carbonate

Castor oil, virgin

Glucose syrup (dry substance)

Iron oxide, red (E 172)

Maize starch Maize starch, modified Montan glycol wax Povidone K30 Riboflavin (E 101)

Shellac

Sucrose

Talc

Titanium (IV) oxide (E 171)

6.2 Incompatibilities

None known

6.3 Shelf life

4 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Package containing 60 or 120 coated tablets.

Tablets are sealed in PVC/PVDC aluminium blisters which are packaged into a cardboard carton.

6.6 Special precautions for disposal

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

BIONORICA SE KerschensteinerstraBe 11-15 92318 Neumarkt Tel.: ++49 9181 231-90 Fax.: ++49 9181 231-265 email: info@bionorica.de

8    MARKETING AUTHORISATION NUMBER(S)

THR 26411/0003

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

06/08/2010

10 DATE OF REVISION OF THE TEXT

06/08/2010