Urispas 200

Urispas 200mg Film-coated tablets

Flavoxate hydrochloride

Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What is Urispas 200mg Film-coated Tablets?

Urispas 200mg Film-coated Tablets contain the active ingredient flavoxate hydrochloride.

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.

Urispas 200mg Film-coated Tablets also contain the ingredients lactose, sodium starch glycollate, povidone, talc, cellulose microcrystalline, magnesium stearate, hypromellose, macrogol, macrogol stearate and titanium dioxide (E171).

Each white, film coated tablet is embossed with 'F 200' and contains 200mg flavoxate hydrochloride.

The pack contains 90 tablets, which is enough for about 4 weeks treatment at the normal dose of one tablet three times a day.

The Marketing Authorisation holder is

Recordati Pharmaceuticals

Isis House

43 Station Rd

Henley on Thames

OXON

RG9 1AT

Tel: 01491 576336

What is Urispas 200mg Film-coated Tablets used for?

Urispas is used to treat conditions which cause muscle spasms of the urinary tract. These muscle spasms may be due to inflammation of the bladder, prostate gland or urethra (tube from bladder to outside). In addition, Urispas can be used to treat the 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.

If you have a urine infection as well, your doctor will probably also prescribe medicine to treat this at the same time.

When must Urispas not be used?

If you have a condition which causes a blockage of the stomach, bowel or urinary tract or if you suffer from bleeding from the stomach or bowel.

If you are allergic to Urispas 200mg Film-coated Tablets or any of the ingredients they contain.

In children under 12 years of age.

When should you be extra careful while taking Urispas 200mg Film-coated Tablets?

Make sure your doctor knows if you have, or suspects you have, the eye condition glaucoma.

This medicine may cause drowsiness, blurred vision or dizziness. If it does you should not operate a motor vehicle or machinery.

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

May Urispas be used during pregnancy or while breast feeding?

Before starting treatment, tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should take the medicine.

Many drugs pass into breast milk, therefore, if you are breast feeding, this medicine should be avoided. Your doctor will be able to discuss this with you.

How should Urispas 200mg Film-coated Tablets be taken?

Always take the tablets as your doctor tells you to. A normal dose is one tablet three times a day for as long as is required.

If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

If you forget to take your tablets:

Take the normal dose when you remember unless it is almost time for your next dose.

DO NOT TAKE A DOUBLE DOSE OF TABLETS TO MAKE UP FOR A MISSED DOSE.

What are the possible unwanted effects of Urispas 200mg Film-coated Tablets?

In addition to the beneficial effects of Urispas, it is possible that unwanted effects will occur during treatment such as:

• feeling or being sick, dry mouth or diarrhoea.


• indigestion or difficulty swallowing.


• vertigo, headache, confusion (especially in the elderly), drowsiness, tiredness, dizziness or nervousness.


• allergic reaction such as rash, itching, skin redness, sneezing, difficulty in breathing and swelling of the throat. if any of these occur stop taking the tablets and see your doctor immediately.


• heart beat irregularities.


• disturbances to your vision or eye pain.


• painful urination.


• low white blood cell count.

If you are concerned about these or any other unwanted effects, talk to your doctor.

How should Urispas 200mg Film-coated Tablets be stored?

Do not store above 30°C. In order to protect your medicine from light, keep the blister strips in the outer carton.

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

This medicine must not be used after the expiry date printed on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.

REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

Further Information

You can get more information on Urispas 200mg Film-coated Tablets from your doctor or pharmacist.

Date of Preparation: April 2007

41894313 A