OUTER LABELLING

CARDBOARD BOX

1. PRODUCT NAME

Diuretic herbs

Species diureticae

• ACTIVE SUBSTANCE CONTENT

Sachet composition:

Goldenrod herb (Solidaginis virgaureae herba) – 0.750 g

Birch leaf (Betulae folium) – 0.375 g

Lovage root (Levistici radix) – 0.375 g

Equisetum stem (Equiseti herba) – 0.250 g

Bean pericarp (Phaseoli pericarpium) – 0.250 g

Dandelion root (Taraxaci radix) – 0.250 g

Dandelion herb (Taraxaci herba) – 0.250 g

One sachet contains 2.5 g of herbs, with at least 0.3% of flavonoids expressed as quercetin.

• LIST OF EXCIPIENTS

• PHARMACEUTICAL FORM AND CONTENTS

Herbs for brewing in sachets.

30 sachets po 2.5 g                                                     EAN UCC: 5909990021994

• METHOD OF ADMINISTRATION

Method of administration: Oral.

Posology: Adults and adolescents over 12 years – 2 sachets, pour 1.5 glass of water and heat slowly up to boiling point, do not boil. Leave covered for 10-15 minutes. Drink a glass of decoction 2-3 times a day. Only use fresh decoction.

• WARNING FOR STORAGE

Keep away from children.

• OTHER SPECIAL WARNINGS (if necessary)

Do not use after expiry date.

Contraindications:

Hypersensitivity to any of the ingredients. Do not use in case of edema caused by heart or kidney disease.

Warnings and precautions:

Due to lack of safety data, not recommended for use in children under 12 years.

Interactions:

None observed.

Pregnancy and lactation:

Due to lack of safety data, not recommended for use during pregnancy and lactation.

Impact on ability to drive vehicles and operate machinery:

None.

Adverse effects:

None observed.

Reporting adverse effects:

In case of any adverse effect, including those not stated on the packaging, notify a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Adverse Drug Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.

Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects allows for more safety information to be gathered on a medicinal product.

Overdose:

None observed.

Dose omission:

Do not use double doses to supplement omitted doses.

• EXPIRY DATA

Expiry date:

• STORAGE CONDITIONS

Storage:

Store closed in max. 30 °C.

1. SPECIAL PRECAUTIONS FOR DISPOSAL OF MEDICINAL PRODUCT OR ITS WASTE (if applicable)

1. NAME AND ADDRESS OF MARKETING AUTHORIZATION HOLDER

Marketing authorization holder:

Laboratorium Farmaceutyczne Labofarm Sp. z o.o.

ul. Lubichowska 176 b

83-200 Starogard Gdański

tel. 58 561 20 08

e-mail: poczta@labofarm.com.pl

1. MARKETING AUTHORIZATION NUMBER

Marketing authorization number: IL-5780/LN

1. BATCH NUMBER

Batch number:

1. GENERAL CLASSIFICATION

Non-prescription medicinal product – OTC

1. INSTRUCTION FOR USE

Indications for use:

Medicinal product used to increase the amount of urine and improving urine flow in the urinary tract.

1. INFORMATION IN BRAILLE

Diuretic herbs

1. UNIQUE IDENTIFICATION – 2D CODE

Not applicable.

1. UNIQUE IDENTIFICATION – HUMAN READABLE DATA

Not applicable.

1. OTHER

Date of information approval: 2016.08.25