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FLAVOXATE HYDROCHLORIDE 200MG TABLETS

Active substance(s): FLAVOXATE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
URISPAS® 200mg TABLETS
FLAVOXATE HYDROCHLORIDE 200mg TABLETS
(flavoxate hydrochloride)
This product is available as either of the above names but will be referred to as
Urispas throughout the following:
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it onto others. It may
harm them, even if their symptoms are the same as yours.
• If any side effects get serious, or if you notice any side effects not in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Urispas is and what it is used for
2. Before you take Urispas
3. How to take Urispas
4. Possible side effects
5. How to store Urispas
6. Further information
1. WHAT URISPAS IS AND WHAT IT IS USED FOR
Urispas belong to a group of medicines which relieve and prevent muscle spasms.
Urispas contains an anti-spasmodic which works by inhibiting bladder contractions
in the urinary tract in addition to reducing associated pain.
Urispas is used to treat muscle spasms of the urinary tract which may be a result of
inflammation of the bladder, prostate gland or urethra.
Urispas can also be used to relieve symptoms which may occur as a result of
surgery, cystoscopy or catheterisation such as painful urination, excessive urination
at night and the inability to control urine flow.
2. BEFORE YOU TAKE URISPAS
Do not take Urispas
• if you are allergic (hypersensitive) to flavoxate hydrochloride or any of the other
ingredients of Urispas
• if you have a history of, suffer from or think you may have a blockage of the
stomach, bowel or urinary tract
• if you have or have recently had intestinal lesions or bleeding
• if you have a muscular inability to swallow (achalasia)
Urispas is not recommended for children under 12 years of age
Take special care with Urispas
Before you start taking Urispas, tell your doctor:
• if you suffer from or think you may have glaucoma (a disease associated with
increased eye pressure)
• if you have any urinary infections
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.
Pregnancy and breast-feeding
The safety of this medicine for use during pregnancy has not been established. It is
not recommended for use if you are pregnant, think you are pregnant or are
planning on becoming pregnant.
Urispas is not recommended for use during breast-feeding as it is not known if this
medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or operate machinery if you experience drowsiness, blurred vision or
vertigo whilst taking Urispas.
Important information about some of the ingredients of Urispas
This product contains lactose. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking Urispas.
3. HOW TO TAKE URISPAS
Always take Urispas exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The recommended dose is one 200mg tablet three times a day.
Urispas should be taken whole with water.
If you take more Urispas than you should
If you accidentally take too many Urispas tablets, contact your doctor or hospital
immediately.
If you forget to take Urispas
If you miss a dose do not worry, take the next dose at the usual time. Do not take
more than one dose to make up for a forgotten tablet.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Urispas can cause side effects, although not everybody gets
them.
If any of the below side effects get serious, or if you notice any side effects not
listed below, please tell your doctor or pharmacist:
Heart disorders:
Increased heart rate (tachycardia), sensation of heart pounding (palpitations)
Eye disorders:
Blurred vision, increased pressure in the eye (ocular tension)
Blood disorders:
Increase or decrease in the number of white blood cells
Gastrointestinal disorders:
Indigestion, diarrhea, nausea, difficulty in swallowing (dysphagia), vomiting, dry
mouth
Nervous system disorders:
Headache, dizziness, mental confusion, nervousness, vertigo, drowsiness
Skin disorders:
Itching, skin redness, rash, rapid swelling of the skin (angioedema, urticaria)
Urinary disorders:
Painful urination
Other:
Allergic reactions (hypersensitivity), tiredness, fever
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 on the Yellow Card Scheme website: 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 URISPAS
• Do not store above 25°C. Store in the original package.
• Keep out of the sight and reach of children.
• Do not use Urispas after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month.
• If the tablets become discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist who will advise you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
The name of this medicine is Urispas. Each tablet contains 200mg flavoxate
hydrochloride as the active ingredient. Each white, round coated tablet has no
markings.
Urispas also contain the following inactive ingredients:
Lactose, microcrystalline cellulose, talc, povidone, magnesium stearate, sodium
starch glycollate, castor oil, gelatin, sucrose, colloidal anhydrous silica, acacia, light
magnesium carbonate, titanium dioxide (E171), shellac and wax.
Urispas are available as blister packs of 90 or 100 tablets.
Flavoxate hydrochloride is one of a group of drugs called antispasmodics which
relieve or prevent muscle spasms including spasms of the urinary tract. Urispas has
also been shown to relieve pain.
PL No: 17805/0190
POM
This product is manufactured by Nycomed Oranienburg GmbH, Lehnitzstrabe 7098, 16515 Oranienburg, Germany OR Takeda GmbH, Lehnitzstrabe 70-98, 16515
Oranienburg, Germany and procured from within the EU by the Product Licence
holder Delta Pharma (Europe) Ltd, 1 Colonial Way, P.O. Box 233, North Watford,
Herts WD24 4EW and repackaged by O.P.D. Laboratories Ltd, Watford, Herts
WD24 4PR.
Leaflet revision and issue date (Ref.) 01.05.2015.
Urispas is a registered Trade Mark of Recordati group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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