PACKAGE LEAFLET: INFORMATION FOR THE USER

UROSTEMOL

I Men capsules I

Pumpkin seed, crushed. Pumpkin seed oil and Saw palmetto fruit extract

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or qualified healthcare practitioner has told you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor, pharmacist or qualified healthcare practitioner. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor or qualified healthcare practitioner if you do not feel better or if you feel worse.

What is in this leaflet

1. What UROSTEMOL™ Men is and what it is used for

2.    What you need to know before you take UROSTEMOL™ Men

3.    How to take UROSTEMOL™ Men

4.    Possible side effects

5.    How to store UROSTEMOL™ Men

6.    Contents of the pack and other information

I.WHAT UROSTEMOL™ MEN IS AND WHAT IT IS USED FOR

UROSTEMOL™ Men is a traditional herbal medicinal product used for

the relief of lower urinary tract symptoms in men related to an overactive bladder or bladder weakness. This is based on traditional use only.

Used to relieve symptoms such as:

•    frequent urination day and night

•    urgency to urinate

•    urinary incontinence/accidental leakage of urine

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE UROSTEMOL™ MEN

Do not take UROSTEMOL™ Men:

•    if you are allergic to the active ingredients, or other pumpkin-like plants (such as watermelon, courgettes, etc.), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

You must see your doctor, pharmacist or qualified healthcare practitioner if you have any of the following symptoms or if they occur during the use of this product:

•    a fever

•    bladder spasms

•    blood in your urine

•    pain when urinating

•    difficulty urinating

•    loin, stomach or back pain

If you are due to undergo surgery, you should stop taking this medicine and contact your doctor.

You must talk to a doctor, pharmacist or qualified healthcare practitioner if you feel worse after 7 days of using this product, or if your symptoms do not improve after 4 weeks of use.

Children and adolescents

The use of UROSTEMOL™ Men in children and adolescents under 18 years of age is not recommended, because lower urinary tract symptoms in these patients require medical supervision.

Other medicines and UROSTEMOL™ Men

Tell your doctor, pharmacist or qualified healthcare practitioner if you are taking or have recently taken any other medicines.

Pregnancy and breast-feeding

UROSTEMOL™ Men is not intended for use by women, therefore use during pregnancy and breast-feeding is not recommended.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. If you are affected, do not drive and do not use any tools or machines.

UROSTEMOL™ Men contains lactose

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 UROSTEMOL™ MEN

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or qualified healthcare practitioner has told you. Check with them if you are not sure

For oral use only.

Adults and the elderly: The

recommended dose is 1 capsule 3 times a day.

The capsules should be taken with sufficient water, ideally before meals.

Long-term use should be discussed with your doctor, pharmacist or qualified healthcare practitioner.

Use in children and adolescents under 18 years of age

UROSTEMOL™ Men is not recommended for patients under 18 years of age.

If you take more UROSTEMOL™ Men than you should

If you have accidently taken more than the recommended dosage of UROSTEMOL™ Men, you should contact your doctor or a pharmacist.

If you forget to take UROSTEMOL™ Men

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time as you would normally.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or qualified healthcare practitioner.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common

•    Mild stomach complaints such as stomach pain or discomfort, indigestion, feeling or being sick, swallowing problems, diarrhoea and belching have been reported.

There have been post marketing reports of

•    Allergic reactions such as skin rashes, hives, itching, fluid retention and anaphylactic shock. The frequency is not known.

If allergic reactions should occur, discontinue the use of this medicinal product and consult a doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE UROSTEMOL™ MEN

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions and should be stored in the original package.

Do not use this medicine after the expiry date which is stated on the blister and the carton after "EXP". The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What UROSTEMOL™ Men contains

•    Each hard capsule contains 400 mg Pumpkin seed, crushed {Cucurbits pepo L. convar. citrullina I. Greb. var. styriaca I. Greb), 340 mg Pumpkin seed oil (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb) and 75 mg of extract (as dry extract) from Saw palmetto fruit (Serenoa repens (Bartram) small fructus (Saba! serrulata (Michaux) Nichols fructus), extraction solvent ethanol 90 % (m/m)).

*    The other ingredients are: colloidal anhydrous silica, lactose monohydrate, gelatin. Iron oxide black (E172), Iron

oxide yellow (E172) and Iron oxide red (E172).

What UROSTEMOL™ Men looks like and contents of the pack

UROSTEMOL™ Men are brown, gelatin capsules in a PVC/ PVdC-aluminium blister.

Pack sizes: 30,60,120,150 or 200 hard capsules.

Not all pack sizes may be marketed.

Traditional Herbal Registration Holder

Omega Pharma Ltd.,

32 Vauxhall Bridge Road,

London, SW1V2SA,UK.

Manufacturer

Omega Pharma Manufacturing GmbH & Co. KG Benzstr. 25 71083 Herrenberg Germany

Certification Mark

THR

THR 02855/0240

This leaflet was last revised in 04/2015.

LF-2556A/1000004138