PACKAGE LEAFLET: INFORMATION FOR THE USER

UROSTEMOL

capsules

pumpkin seed, crushed and Pumpkin iseed oil

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® is and what it is used for

2.    What you need to know before you take UROSTEMOL®

3.    How to take UROSTEMOL®

4.    Possible side effects

5.    How to store UROSTEMOL®

5. Contents of the pack and other information

I.WHAT UROSTEMOL® IS AND WHAT IT IS USED FOR

UROSTEMOL® is a traditional herbal medicinal product used for the relief

_qf_lower urinaryJtra_cJ_sympto_ms

related to an overactive bladder or bladder weakness. This is based on traditional use only.

Used to relieve symptoms such as:

•    urgency to urinate

•    urinary incontinence/urinary leakage

•    frequent urination

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE UROSTEMOL®

Do not take UROSTEMOL®:

•    if you are allergic to the active ingredient 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

•    painful urination

•    difficulty urinating

•    loin, stomach or back pain

•    vaginal discharge

You must talk to your 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® in children and adolescents under 18 years of age is not recommended, because !pwer_u_rjnary tract symptomsjn

these patients require medical supervision.

Other medicines and UROSTEMOL®

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

Pregnancy and breast-feeding

The use of UROSTEMOL® during pregnancy and breast-feeding is not recommended, because lower urinary tract symptoms in these patients requires medical supervision. If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. UROSTEMOL® does not contain any ingredients that are known to cause drowsiness.

3. HOW TO TAKE UROSTEMOL®

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 one capsule 3 to 5 times a day.

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

Do not exceed the stated dose.

"Lon'g-tVrffi'useVhouFd"be discussed"" with your doctor, pharmacist or qualified healthcare practitioner.

Use in children and adolescents under 18 years of age

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

If you take more UROSTEMOL® than you should

Contact your doctor or a pharmacist if you have accidently taken more than the recommended dosage of UROSTEMOL®.

If you forget to take UROSTEMOL®

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 and diarrhoea 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_eff_ects_direc_t|y_ _

viVthi 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®

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.

32 VauxhalFBFidge Road," " London, SW1V2SA,UK.

Manufacturer

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

THR

THR 02855/0239

This leaflet was last revised in 11/2015.

LF-2551B/1000007247

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What UROSTEMOL® contains

•    Each hard capsule contains 400 mg pumpkin seed crushed (Cucurbits pepoL convar. citrullina I. Greb. var. styriaca I. Greb) and 340 mg pumpkin seed oil (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb).

•    The other ingredients are: Gelatin, titanium dioxide (E 171) and iron oxide red (E172).

What UROSTEMOL® looks like and contents of the pack

UROSTEMOL® are red-brown, gelatin capsules in a PVC-aluminium blister.

Pack sizes: 50,100 or 160 hard capsules. Not all pack sizes may be marketed.

Traditional Herbal Registration Holder

Omega Pharma Ltd.,

Athena reference nr.: 764912-003

Pass date: