URISPAS 200MG SUGAR COATED TABLETS

Active substance: FLAVOXATE HYDROCHLORIDE

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Ref: 1153/191012/1/F

®

Urispas 200mg Sugar Coated Tablets
(flavoxate hydrochloride)
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 on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Urispas 200mg Sugar Coated Tablets but will be
referred to as Urispas throughout this leaflet.
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

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.

What Urispas is and what it is used for

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
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.

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 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 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.

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

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)

Ref: 1153/191012/1/B

®

Urispas 200mg Sugar Coated Tablets
(flavoxate hydrochloride)
Patient Information Leaflet (continued)
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

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 your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
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.

6

Further Information

What Urispas contains
Each coated tablet contains 200mg of flavoxate hydrochloride as the active
ingredient.
Urispas also contain the inactive ingredients: lactose, sodium starch
glycollate, povidone, talc, magnesium stearate, microcrystalline cellulose,
shellac, castor oil, gelatin, acacia, colloidal silicon dioxide, spermaceti,
sucrose, titanium dioxide and magnesium carbonate.

What Urispas looks like and contents of the pack
Urispas is a white, round coated tablet with no-markings. Urispas are
available in packs of 90 tablets.
Manufacturer and Licence Holder
Urispas are manufactured by Nycomed BV, Postbus 31, Hoofddorp, 2130
AA, The Netherlands and is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
Urispas is a registered trademark of Recordati Ireland Limited.

POM

PL 15184/1153

Leaflet revision date: 19/10/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 1153/191012/2/F

Flavoxate Hydrocholride 200mg Sugar Coated Tablets
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 on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Flaxovate Hydrochloride 200mg Sugar Coated
Tablets but will be referred to as Flaxovate Hydrochloride throughout this
leaflet.
In this leaflet:
1 What Flaxovate Hydrochloride is and what it is used for
2 Before you take Flaxovate Hydrochloride
3 How to take Flaxovate Hydrochloride

Take special care with Flaxovate Hydrochloride
Before you start taking Flaxovate Hydrochloride, 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.
Flaxovate Hydrochloride is not recommended for use during breast-feeding
as it is not known if this medicine passes into breast milk.

4 Possible side effects

Ask your doctor or pharmacist for advice before taking any medicine.

5 How to store Flaxovate Hydrochloride

Driving and using machines
Do not drive or operate machinery if you experience drowsiness, blurred
vision or vertigo whilst taking Flaxovate Hydrochloride.

6 Further information

1

What Flaxovate Hydrochloride is and what it is used
for

Flaxovate Hydrochloride 200mg Film-coated Tablets belong to a group of
medicines which relieve and prevent muscle spasms. Flaxovate
Hydrochloride contains an anti-spasmodic which works by inhibiting bladder
contractions in the urinary tract in addition to reducing associated pain.
Flaxovate Hydrochloride is used to treat muscle spasms of the urinary tract
which may be a result of inflammation of the bladder, prostate gland or
urethra. Flaxovate Hydrochloride 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 Flaxovate Hydrochloride

Do not take Flaxovate Hydrochloride
* if you are allergic (hypersensitive) to flavoxate hydrochloride or any of the
other ingredients of Flaxovate Hydrochloride
* 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)
Flaxovate Hydrochloride is not recommended for children under 12
years of age

Important information about some of the ingredients of Flaxovate
Hydrochloride
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
Flaxovate Hydrochloride.

3

How to take Flaxovate Hydrochloride

Always take Flaxovate Hydrochloride 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.
Flaxovate Hydrochloride should be taken whole with water.
If you take more Flaxovate Hydrochloride than you should
If you accidentally take too many Flaxovate Hydrochloride tablets, contact
your doctor or hospital immediately.
If you forget to take Flaxovate Hydrochloride
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, Flaxovate Hydrochloride can cause side effects, although
not everybody gets them.

Ref: 1153/191012/2/B

Flavoxate Hydrochloride 200mg Sugar Coated Tablets
Patient Information Leaflet (continued)
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

5

How to store Flaxovate Hydrochloride

Do not store above 25°C
Store in the original package
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not use Flaxovate Hydrochloride after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
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.

6

Further Information

What Flaxovate Hydrochloride contains
Each coated tablet contains 200mg of flavoxate hydrochloride as the active
ingredient.
Flaxovate Hydrochloride also contain the inactive ingredients: lactose,
sodium starch glycollate, povidone, talc, magnesium stearate,
microcrystalline cellulose, shellac, castor oil, gelatin, acacia, colloidal silicon
dioxide, spermaceti, sucrose, titanium dioxide and magnesium carbonate.

What Flaxovate Hydrochloride looks like and contents of the pack
Flaxovate Hydrochloride is a white, round coated tablet with no-markings.
Flaxovate Hydrochloride are available in packs of 90 tablets.
Manufacturer and Licence Holder
Flaxovate Hydrochloride are manufactured by Nycomed BV, Postbus 31,
Hoofddorp, 2130 AA, The Netherlands and is procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1153

Leaflet revision date: 19/10/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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