SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

DiaUrtica Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

460 mg of extract (as dry extract) from Nettle root (Urtica dioica L. and/or Urtica urens L.) (7-14:1) (equivalent to 3.22-6.44 g of Nettle root).

Extraction solvent: Methanol 20% v/v

Excipients: each film-coated tablet contains 65 mg of lactose monohydrate.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

White, biconvex film-coated tablets.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of urinary tract discomfort in men who have been told that they have an enlarged prostate (benign prostatic hyperplasia or BPH), based on traditional use only.

Prior to treatment other serious conditions should have been ruled out by a doctor.

Posology and method of administration

For oral use.

For adults and the elderly: take 1 tablet daily. Tablets should be swallowed whole with a little liquid. The tablet should not be chewed.

This medicine is not indicated for use in children and adolescents less than 18 years old (see Section 4.4. Special warnings and precautions for use).

The patient should consult a doctor or qualified healthcare practitioner if symptoms persist or worsen, especially in cases of blood in the urine and acute urine retention.

4.3 Contraindications

Hypersensitivity to Nettle root or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

This product is intended for use in men who have had benign prostatic hypertrophy already diagnosed by a medical practitioner.

The patient should contact a doctor if symptoms worsen or persist.

Medical advice must be sought immediately if symptoms including blood in the urine, fever, or acute urine retention occurs.

Patients taking medication for Benign Prostatic Hyperplasia should consult their doctor before using DiaUrtica Tablets.

This product contains lactose monohydrate.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This product is not recommended for use in children and adolescents less than 18 years old since there is no relevant use in this age group.

Interaction with other medicinal products and other forms of interaction

None reported.

4.6 Fertility, Pregnancy and lactation

This product is for use in men only.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive or use machines have been performed.

4.8 Undesirable effects

Gastrointestinal complaints (nausea, heartburn, diarrhoea, feeling of repletion, flatulence) and allergic skin reactions, such as pruritus, rash and urticaria have been reported. The frequency is not known.

If other adverse reactions occur a doctor or qualified healthcare practitioner should be consulted.

4.9 Overdose

None reported.

5 PHARMACOLOGICAL PROPERTIES

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, genotoxicity and carcinogenicity have not been performed.

6.1 List of excipients

Tablet core

Cellulose, powdered Silica, colloidal anhydrous Lactose monohydrate Croscarmellose sodium Sodium starch glycollate (type A)

Stearic acid Talc

Film-coating

Basic butylated methacrylate copolymer (Eudragit E 100) Talc

Titanium dioxide E 171

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 30° C.

6.5 Nature and contents of container

Original packages contain 30, 60, 90, 100 or 120 film-coated tablets. Not all pack sizes maybe marketed.

DiaUrtica Tablets are packed in PVC/PVDC-aluminium blisters and inserted into a carton.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Diapharm GmbH & Co. KG Hafenweg 18-20 48155 Munster Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 42340/0007

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

07/06/2011

10 DATE OF REVISION OF THE TEXT

29/07/2013