Patient leaflet - Urispas 200 mg film-coated tablets
1. What Urispas is and what it is used for What Urispas is
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.
What Urispas is used for
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. What you need to know before you take Urispas
Do not take Urispas
- If you are allergic to flavoxate hydrochloride or any of the other ingredients of this medicine (listed in section 6);
- If you have a gastrointestinal disease that affects the normal passage of food (obstruction);
- If you have an gastro-intestinal bleeding
- If you have a muscular inability to swallow (achalasia)
If you are not able to completely empty your bladder (urinary retention)
- If you are being treated for an eye disease called glaucoma
- If you have a disease which causes general weakness and fatigability of the muscles (myasthenia gravis)
Warnings and precautions
Talk to your doctor or pharmacist before taking Urispas:
- If you have impaired kidney function.
Children
Urispas should not be used in children younger than 12 years of age.
Taking other medicines and Urispas
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of this medicine in pregnancy and lactation has not been established. If you are pregnant or breast-feeding this medicine is not recommended.
Driving and using machines
Do not drive or operate machinery if you experience somnolence or blurred vision whilst taking Urispas.
Urispas contains lactose
If you have been told by your doctor or pharmacist that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Urispas
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 200 mg film-coated tablet three times a day, by oral administration.
Do not break the tablet but swallow it whole, preferably with a glass of water.
The tablets should be taken after a meal in order to prevent nausea.
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 a double dose to make up for a forgotten tablet.
If you stop taking Urispas
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines this medicine 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:
Common (may affect up to 1 in 10 people) Nausea
Uncommon (may affect up to 1 in 100 people) Somnolence
Visual impairment
Vomiting, dry mouth, gastric pain and upset stomach (dyspepsia)
Rash
Rare (may affect up to 1 in 1,000 people) Hives, pruritus
Inability to completely empty the bladder (urinary retention)
Fatigue
Not known (frequency cannot be estimated from the available data)
Hypersensitivity, anaphylactic reaction, anaphylactic shock
Confusional state
Glaucoma
Fast or irregular heartbeats (called palpitations) Yellowing of the skin and eyes (Jaundice), liver disorders, abnormal results of liver function tests (hepatic enzyme abnormal)
Redness (of the skin).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Urispas
Keep out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
6. Contents of the pack and other information
What Urispas contains
Each tablet contains 200mg flavoxate hydrochloride. The other ingredients are:
Lactose, povidone (E-1201), modified carboxymethylcellulose (E-466), talc (E-533b), magnesium stearate (E-572), colloidal silica (E-551), microcrystalline cellulose (E-460).
Coating excipients:
Hydroxypropyl methylcellulose, polyethylene glycol 300, titanium dioxide (E-171), polyethylene glycol 6000, magnesium stearate (E-572).
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 Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali, 1, 20148 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
This leaflet was last approved: 08/11/2019
Urispas® is a registered trade mark of Recordati Ireland Limited.
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S0447-SP-PIL-08.11.2019 POM