Urispas 200mg Tablets
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 FO
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.
POM
PL No: 17805/0190
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.