1.3 - Product Information    May 2013

1.3.1 - Labelling    Page 4 / 8

DiaUrtica, film-coated tablets - THR 42340/0007

Module 1.3.1 Package Leaflet

Patient Information Leaflet DiaUrtica Tablets, film-coated tablets

Nettle root extract 460 mg

In this leaflet:

1: What DiaUrtica Tablets are and what they are used for

2: Before you take DiaUrtica Tablets

3: How to take DiaUrtica Tablets

4: Possible side effects

5: How to store DiaUrtica Tablets

6: Further information

1: What DiaUrtica Tablets are and what they are used for

This product is a traditional herbal medicinal product containing Nettle root extract.

DiaUrtica Tablets is 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.

Used to relieve symptoms including:

-    Feeling like you need to pass urine more often, especially at night

-    When you pass urine, the flow of urine is weak or interrupted

-    Feeling that you cannot empty your bladder completely

Enlargement of the prostate is also termed benign prostatic hyperplasia (BPH). The prostate gland is only present in men and is located just below the bladder. This gland may be enlarged as men get older and cause urinary discomfort.

2: Before you take DiaUrtica Tablets

Do not take DiaUrtica Tablets if you:

•    are allergic (hypersensitive) to Nettle root or any of the other ingredients of DiaUrtica Tablets (see section 6 for a full list of ingredients)

•    are under 18 years of age. This product is not suitable for this age group.

Take special care with DiaUrtica Tablets

Before you take DiaUrtica Tablets a doctor must have told you that you have an enlarged prostate (benign prostatic hyperplasia or BPH).

Other serious conditions should have been ruled out by your doctor.

You should consult your doctor if symptoms of urinary discomfort worsen or persist.

Contact your doctor immediately:

•    in particular if difficulty in passing urine

•    if there is blood in your urine

•    if you have a fever

Surgery

If you are due to undergo surgery, tell your doctor that you are taking DiaUrtica Tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are already taking medicines for an enlarged prostate (BPH) consult your doctor before taking DiaUrtica Tablets as they may not be suitable for you.

No interactions with other medicines are known yet.

Pregnancy and breast-feeding

Do not use this product. It is for use in men only.

Driving and using machines

This product has no known effect on your ability to drive or use machines. Make sure you know how it affects you before you drive or use machinery. If affected do not drive.

Important information about some of the ingredients of DiaUrtica Tablets

These tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3: How to take DiaUrtica Tablets

Always take DiaUrtica Tablets exactly as specified in this package leaflet. You should check with your doctor or pharmacist if you are not sure.

For oral use only.

Adults and the elderly

Take 1 tablet daily. Swallow the tablet whole with a little liquid. Do not chew the tablet.

Do not exceed the stated dose.

Use in children

Not for use in children and adolescents less than 18 years old.

Duration of use

You should contact your doctor or qualified healthcare practitioner if your symptoms worsen or do not improve.

If you take more DiaUrtica Tablets than you should

If you take more than the recommended dose, speak to a doctor and take this leaflet with you.

If you forget to take DiaUrtica Tablets

Continue to take your usual dose at the usual time; it does not matter if you have missed a dose. Do not take a double dose to make up for a forgotten dose.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

4: Possible side effects

Like all medicines, this product can have side effects. These are listed below.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Remember to see your doctor:

-    if your symptoms of urinary discomfort worsen or persist

-    in particular if difficulty in passing urine

-    if there is blood in your urine

-    if you have a fever

5: How to store DiaUrtica Tablets

Keep the tablets out of the reach and sight of children.

Do not use DiaUrtica Tablets after the expiry date. The expiry date is printed on the box and the blister pack. The expiry date refers to the last day of that month.

Return any out-of-date tablets to your pharmacist, who will dispose of them for you.

Store the tablets in a cool dry place.

Do not store above 30° C.

Keep your tablets in the blister pack until it is time to take them.

6: Further information

What DiaUrtica Tablets contain

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.

This product also contains the following ingredients:

Tablet core: cellulose, powdered, colloidal anhydrous silica, lactose monohydrate, croscarmellose sodium, sodium starch glycollate (type A), stearic acid, talc

Film-coating: basic butylated methacrylate copolymer (Eudragit E 100), talc, titanium dioxide (E171) Each film-coated tablet contains 65 mg of lactose monohydrate.

What DiaUrtica Tablets look like and contents of the pack

DiaUrtica Tablets are white, biconvex film-coated tablets. Each pack contains 30, 60, 90, 100 or 120 film-coated tablets. Not all packs maybe marketed.

Registration holder and manufacturer of this product

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

1.3 - Product Information    May 2013

1.3.1 - Labelling    Page 8 / 8

DiaUrtica, film-coated tablets - THR 42340/0007

Traditional herbal registration number: THR 42340/0007

Certification Mark

If you would like further information about this product, please contact:

Diapharm GmbH & Co. KG

Wurzburger Str. 3

26121 Oldenburg

Germany

Telephone: +49 (0)441 - 98344-0 Email: info@diapharm.de

This leaflet was prepared in 10/03/2011.

You can help to make medicines safer by reporting any side effects to the Yellow Card Scheme at www.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday to Friday).