Ref: 0642/241115/1/F

Urispas® 200mg Tablets / Uronid® 200mg Tablets

(flavoxate hydrochloride)

Patient Information Leaflet

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.

Your medicine is called Urispas 200mg Tablets / Uronid 200mg Tablets but will be referred as Urispas.

In this leaflet:

What Urispas is and what it is used for Before you take Urispas ^ How to take Urispas ^ Possible side effects ^ How to store Urispas ^ Further information

What Urispas is and what it is used for

Urispas 200mg Film-coated Tablets 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.

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.

^ 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)

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.

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 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.

^ How to store Urispas

•    Do not store above 30°C.

•    Store in original package

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

•    Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

•    Do not use this medicine after the expiry date, which is shown on the carton. Return any left over medicine to your pharmacist.

^ Further Information What Urispas contains

Each film-coated tablet contains 200mg of flavoxate hydrochloride as the active ingredient. Inactive ingredients: Lactose, povidone, carboxymethyl cellulose, talc, magnesium stearate, aerosil, avicel, sepifilm, titanium dioxide and polyethylene glycol.

What Urispas looks like and contents of the pack

Urispas are round, white, film-coated, unmarked tablets. Each blister contains 15 tablets, which comes in boxes of 60 and 90 Tablets.

Manufacturer and Licence Holder

The tablets are manufactured by Recordati, S.p.A., Milan, Italy and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

Urispas is a registered trademark of Recordati Ireland Limited

I POM PL 15184/0642

Leaflet revision date: 24/11/15

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

Ref: 0642/241115/1/B