What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: THR02855/0242.

Urostemol femina capsules

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.

What is in this leaflet

1. What UROSTEMOL® femina is and what it is used for
2. What you need to know before you take UROSTEMOL® femina
3. How to take UROSTEMOL® femina
4. Possible side effects
5. How to store UROSTEMOL® femina
6. Contents of the pack and other information

1. WHAT UROSTEMOL® FEMINA IS AND WHAT IT IS USED FOR

UROSTEMOL® femina is a traditional herbal medicinal product 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.

3. HOW TO TAKE UROSTEMOL® 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 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 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 (Cucurbita 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: RRR-alpha-Tocopheryl acetate, partially hydrogenated soya-bean oil, yellow beeswax, gelatin, glycerol, glucose liquid (spray dried), lecithin, maltodextrin, titanium dioxide (E 171), iron oxide red (E 172) and iron oxide yellow (E 172).

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
SW1V 2SA
UK

Manufacturer

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

THR 02855/0242

This leaflet was last revised in 11/2015.

LF-2557C /1000007241