Urispas 200mg Film-Coated Tablets
1. What Urispas is and what it is used for
2. Before you take Urispas
3. How to take Urispas
PATIENT INFORMATION LEAFLET
Urispas® 200mg Film-coated Tablets
(flavoxate hydrochloride)
Your medicine is available by the above name,
but will be referred to as Urispas throughout the
remainder of this 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.
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 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 breastfeeding 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.
POM
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, diarrhoea, 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.aov.uk/vellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not store above 30°C.
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.
If the tablets become discoloured or show any signs of deterioration you should seek the advice of your pharmacist.
Further information
What Urispas contains
Each tablet contains 200mg flavoxate hydrochloride. The other ingredients are:
Lactose, polyvinylpyrrolidone,carboxymethylcellulose, talc, magnesium stearate, aerosil, avicel, sepifilm, titanium dioxide and polyethylene glycol.
What Urispas looks like and contents of the pack
White, round, biconvex, film-coated tablets with no markings on either side.
Urispas is available in blister packs containing 60 and 90 tablets.
Manufacturer:
RECORDATI, S.p.A., Milan, Italy.
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ. Product Licence Holder: Sam Pharma Ltd, Unit 20, Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
PL 33902/0447
Urispas® 200mg Film-coated Tablets
This leaflet was last approved: 05/12/2014
Urispas0 is a registered trademark of Recordati Ireland Limited.
S0447-SP-PIL-05.12.2014