Urispas 200mg Film-Coated Tablets
S1253 LEAFLET Urispas 20150420
PACKAGE LEAFLET: INFORMATION FOR THE USER URISPAS® 200mg FILM-COATED TABLETS (flavoxate hydrochloride)
Your medicine is known as Urispas 200mg Film-coated Tablets but will be referred to as “Urispas” throughout the following patient information 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
1. WHAT URISPAS IS AND WHAT IT IS USED FOR?
Urispas belongs 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 via the Yellow Card Scheme at: 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
• 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 after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Urispas contains
• Each film-coated tablet contains 200mg of the active ingredient, flavoxate hydrochloride.
• Urispas also contains the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, carboxymethyl cellulose, purified talc, colloidal anhydrous silica, microcrystalline cellulose, sepifilm, macrogol and titanium dioxide (E171).
What Urispas looks like and contents of the pack
The tablets are white, round, film-coated with no markings on either side.
Urispas is available as blister packs of 60 or 90 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Recordati S.p.A, Milan, Italy.
| POM | PL 19488/1253 Leaflet revision date: 20 April 2015
Urispas is a registered trade mark of Recordati Ireland Limited, Ireland.
S1253 LEAFLET Urispas 20150420
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.
S1253 LEAFLET Flavoxate 20150420
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLAVOXATE HYDROCHLORIDE 200mg FILM-COATED TABLETS
Your medicine is known as Flavoxate Hydrochloride 200mg Film-coated Tablets but will be referred to as Flavoxate Tablets throughout the following patient information leaflet.
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. Flavoxate Tablets are 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 Flavoxate Tablets.
Important information about some of the ingredients of Flavoxate Tablets
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 Flavoxate Tablets.
In this leaflet:
1. What Flavoxate Tablets are and what they are used for
2. Before you take Flavoxate Tablets
3. How to take Flavoxate Tablets
4. Possible side effects
5. How to store Flavoxate Tablets
6. Further information
1. WHAT FLAVOXATE TABLETS ARE AND WHAT THEY ARE USED FOR?
Flavoxate Tablets belong to a group of medicines which relieve and prevent muscle spasms. Flavoxate Tablets contain an antispasmodic which works by inhibiting bladder contractions in the urinary tract in addition to reducing associated pain.
Flavoxate Tablets are used to treat muscle spasms of the urinary tract which may be a result of inflammation of the bladder, prostate gland or urethra.
Flavoxate Tablets 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 FLAVOXATE TABLETS
Do not take Flavoxate Tablets
- if you are allergic (hypersensitive) to flavoxate hydrochloride or any of the other ingredients of Flavoxate Tablets
- 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) Flavoxate Tablets are not recommended for children under 12 years of age
Take special care with Flavoxate Tablets
Before you start taking Flavoxate Tablets, 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.
3. HOW TO TAKE FLAVOXATE TABLETS
Always take Flavoxate Tablets 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. Flavoxate Tablets should be taken whole with water.
If you take more Flavoxate Tablets than you should
If you accidentally take too many Flavoxate Tablets, contact your doctor or hospital immediately.
If you forget to take Flavoxate T ablets
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, Flavoxate Tablets 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 via the Yellow Card Scheme at: 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 FLAVOXATE TABLETS
• 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 after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Flavoxate Tablets contain
• Each film-coated tablet contains 200mg of the active ingredient, flavoxate hydrochloride.
• Flavoxate Tablets also contain the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, carboxymethyl cellulose, purified talc, colloidal anhydrous silica, microcrystalline cellulose, sepifilm, macrogol and titanium dioxide (E171).
What Flavoxate Tablets look like and contents of the pack
The tablets are white, round, film-coated with no markings on either side.
Flavoxate Tablets are available as blister packs of 60 or 90 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Recordati S.p.A, Milan, Italy.
POM PL 19488/1253
Leaflet revision date: 20 April 2015
S1253 LEAFLET Flavoxate 20150420