PACKAGE LEAFLET: INFORMATION FOR THE USER

UROSTEMOL

femina capsules

pumpkin seed oil, dry extract of Fragrant Sumach bark, and dry extract of Hop strobile

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.

jwhat is in this leaflet

jl.WhatUROSTEMOL®femina is and

| what it is used for

(2. What you need to know before you

j take UROSTEMOL® femina

|3. How to take UROSTEMOL® femina

|4. Possible side effects

Jj. How to store UROSTEMOL® femina

i5. Contents of the pack and other

; information

il.WHAT UROSTEMOL® FEMINA IS | AND WHAT IT IS USED FOR

! UROSTEMOL® femina is a traditional l .herbaLmodicmaJproduct used for__

the relief of lower urinary tract symptoms in women 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® FEMINA

Do not take UROSTEMOL® femina:

•    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).

•    If you are allergic to peanut or soya.

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

•    vaginal discharge

•    loin, back or stomach pain

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® femina 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® femina

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® femina 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

UROSTEMOL® femina may cause drowsiness. If you are affected, do not drive or operate machinery.

UROSTEMOL® femina contains glucose and soya-bean oil

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you are allergic to peanut or soya, do not use this medicinal product.

57HOW TO TAKE OrOSTE'MOL® FEMINA

! 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 times a day.

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

! Do not exceed the stated dose.

| 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®femina is not ; recommended for patients under ! 18 years of age.

; If you take more UROSTEMOL®

! femina than you should

; Contact your doctor or a pharmacist ! if you have accidently taken more

■    than the recommended dosage of ! UROSTEMOL® femina.

| If you forget to take UROSTEMOL®

! femina

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

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

jfl. POSSIBLE SIDE EFFECTS

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

j 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 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® FEMINA

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

Do not store above 25°C. Store 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® femina contains

•    Each hard capsule contains 227.3 mg Pumpkin seed oil

(Cucurbits pepo L. convar. citrullina I. Greb. var. styriaca I.

Greb), 56 mg of extract (as dry extract) of Fragrant Sumach bark [Rhus aromatica Aiton) (5-7:1), extraction solvent water, 18 mg of extract (as dry extract) of Hop strobile (Humulus lupulus L.)

(5.5—6.5:1), extraction solvent water.

• The other ingredients are: fl/?/?-alpha-Tocopheryl acetate, partially hydrogenated soya-bean oil, yellow beeswax, gelatin, glycerol, glucose liquid (spray dried), lecithin, maltodextrin, titanium dioxide (E171), iron oxide red (E 172) and iron oxide yellow (E172).

What UROSTEMOL® femina looks like and contents of the pack

UROSTEMOL® femina are red-brown, gelatin capsules, in a PVC/PE/ PVdC-aluminium-blister

Pack sizes: 30,60 or 120 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

THR

THR 02855/0242

This leaflet was last revised in 11/2015.

LF-2557C/1000007241

Athena reference nr.: 764912-001

Pass date: