1. What Urispas is and what it is used for

2. What you need to know before you take Urispas

3. How to take Urispas

4. Possible side effects

5. How to store Urispas

6. Contents of the pack and other information

1. what urispas is and what it is used for

What Urispas is

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.

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 200mg 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: 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.

Do not store above 30"C. Store in the original package in order to protect from light.

Do not take the tablets after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.

If the tablet becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.

Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

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. contents of the pack and other information

What Urispas contains

The active ingredient in the Urispas is flavoxate hydrochloride.

Each film-coated tablet contains 200mg flavoxate hydrochloride.

The other ingredients are: lactose, povidone, carboxymethyl­cellulose, talc, magnesium stearate, aerosol, avicel, sepifilm, 6000, titanium oxide (E171) and polyethylene glycol.

What Urispas looks like and contents of the pack

Urispas are white, round film-coated tablets which are plain on both sides.

They are available in blister strips containing 60 tablets.

Manufactured by: Recordati, S.p.A., Milan, Italy.

Procured from within the EU and repackaged by the Product Licence holder : B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Urispas ® 200mg film-coated tablets; PL 18799/2215 | POM |

Leaflet date: 28.08.2019

Urispas is a registered trademark of Recordati Ireland Limited.

Blind or partially sighted?

PACKAGE LEAFLET: INFORMATION FOR THE USER

Flavoxate hydrochloride 200mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Flavoxate hydrochloride 200mg film-coated tablets but will be referred to as Flavoxate hydrochloride throughout this leaflet.

In this leaflet:

1. What Flavoxate hydrochloride is and what it is used for

2. What you need to know before you take Flavoxate hydrochloride

3. How to take Flavoxate hydrochloride

4. Possible side effects

5. How to store Flavoxate hydrochloride

6. Contents of the pack and other information

1. what flavoxate hydrochloride is and what it is used for

What Flavoxate hydrochloride is

Flavoxate hydrochloride belong to a group of medicines which relieve and prevent muscle spasms. Flavoxate hydrochloride contains an antispasmodic which works by inhibiting bladder contractions in the urinary tract in addition to reducing associated pain.

What Flavoxate hydrochloride is used for

Flavoxate 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. Flavoxate 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. what you need to know before you take flavoxate hydrochloride

Do not take Flavoxate hydrochloride

• – 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 Flavoxate hydrochloride:

• – If you have impaired kidney function.

3. how to take flavoxate hydrochloride

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 200mg 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 Flavoxate hydrochloride than you should

If you accidentally take too many Flavoxate hydrochloride tablets, contact your doctor or hospital immediately.

If you forget to take Flavoxate hydrochloride

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 Flavoxate hydrochloride

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: 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 flavoxate hydrochloride

Keep out of the sight and reach of children.

Do not store above 30"C. Store in the original package in order to protect from light.

Do not take the tablets after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.

If the tablet becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.

Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

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. contents of the pack and other information

What Flavoxate hydrochloride contains

The active ingredient in the Flavoxate hydrochloride is flavoxate hydrochloride.

Each film-coated tablet contains 200mg flavoxate hydrochloride.

The other ingredients are: lactose, povidone, carboxymethyl­cellulose, talc, magnesium stearate, aerosol, avicel, sepifilm, 6000, titanium oxide (E171) and polyethylene glycol.

What Flavoxate hydrochloride looks like and contents of the pack

Flavoxate hydrochloride are white, round film-coated tablets which are plain on both sides.

They are available in blister strips containing 60 tablets.

Manufactured by: Recordati, S.p.A. Milan, Italy.

Procured from within the EU and repackaged by the Product Licence holder : B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Flavoxate hydrochloride 200mg film-coated tablets; PL 18799/2215

Leaflet date: 28.08.2019 POM |

Blind or partially sighted?

PACKAGE LEAFLET: INFORMATION FOR THE USER

Flavoxate hydrochloride 200mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Flavoxate hydrochloride 200mg film-coated tablets but will be referred to as Flavoxate hydrochloride throughout this leaflet.

In this leaflet:

• 1. What Flavoxate hydrochloride is and what it is used for

• 2. What you need to know before you take Flavoxate hydrochloride

• 3. How to take Flavoxate hydrochloride

• 4. Possible side effects

• 5. How to store Flavoxate hydrochloride

• 6. Contents of the pack and other information

1. what flavoxate hydrochloride is and what it is used for

What Flavoxate hydrochloride is

Flavoxate hydrochloride belong to a group of medicines which relieve and prevent muscle spasms. Flavoxate hydrochloride contains an antispasmodic which works by inhibiting bladder contractions in the urinary tract in addition to reducing associated pain.

What Flavoxate hydrochloride is used for

Flavoxate 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. Flavoxate 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. what you need to know before you take flavoxate hydrochloride

Do not take Flavoxate hydrochloride

• – 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 Flavoxate hydrochloride:

• – If you have impaired kidney function.