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PACKAGE LEAFLET : INFORMATION FOR THE USER

Urispas 200mg Film-coated Tablets

(flavoxate hydrochloride)

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

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.

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.

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.

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

Keep out of the sight and reach of children.

Do not store above 30°C.

In order to protect your medicine from light, keep the blister strips in the outer carton.

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.

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 protect the environment.

What Urispas contains

The active substance is flavoxate hydrochloride.    _

The other ingredients are:

Lactose, sodium starch glycollate, povidone, talc, magnesium stearate, cellulose microcrystalline, hypromellose, macrogol 6000, macrogol stearate, titanium dioxide (E171)

What Urispas looks like and contents of the pack

Urispas are white, film-coated tablets with ‘F 200’ printed on one side.

They are available in PVC/ aluminium blister strips in pack sizes of 84, 90, 100 and 250 tablets. Not all pack sizes may be marketed.

Marketing Authorisation holder Recordati Pharmaceuticals Limited

Isis House - 43 Station Road - Henley-on-Thames - Oxfordshire RG9 1AT - United Kingdom Manufacturer

RECORDATI Industria Chimica e Farmaceutica S.p.A.

Via M. Civitali 1 - 20148 Milan, Italy

This leaflet was last approved in 09/06/2010.

RECORDATI

41894316 A