Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Urispas 200mg Film-coated Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Flavoxate hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR What Urispas is Urispas 200 mg 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.
What you need to know before you take it
E 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. 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. Urispas contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.
How to take it
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. XXXXXXXX A
DRAFT N.: 2 DATE: 20/02/2024 DESCRIPTION: URISPAS-United Kingdom-LEAFLET-200mg COUNTRY: United Kingdom PACK TYPE: LEAFLET MANUFACTURING SITE: RECORDATI SPA COMPONENT CODE: XXXXXXXX A
PRINTABLE COLORS
NON PRINT
COLOR 1: K
PROFILE TECHNICAL INFO
IF APPLICABLE
EXTERNAL CODE: N/A DRAWING REFERENCE: N/A SIZE (mm): 150 x 279,40 MARKET SEGMENT: N/A FONT TYPE TEXT: Helvetica Neue Condensed FONT MINIMUM SIZE: 8 pt PHARMACODE LAETUS: N/A BRAILLE TEXT: N/A COPYRIGHT / PROPRIETÀ Recordati S.p.A
BACK DO NOT TAMPER / VIETATA LA MANOMISSIONE
BAR PRINTS 70 mm @ 100%
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.
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 (Erythema). 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.
How to store it
URISPAS Keep this medicine out of the sight and reach of children Do not store above 30°C Keep the blister strips in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. Do not use this medicine if you notice that it is damaged or the pack shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Urispas contains
- The active substance is flavoxate hydrochloride. Each film-coated tablet contains flavoxate hydrochloride 200mg.
- The other ingredients are: Lactose monohydrate, sodium starch glycolate, povidone, talc, magnesium stearate, cellulose microcrystalline, hypromellose, macrogol 6000, macrogol stearate, magnesium stearate, titanium dioxide. What Urispas looks like and contents of the pack Urispas are white, film-coated tablets with "F200" embossed. They are available in PVC/aluminium foil blisters packed in cartons in packs of 84, 90, 100 and 250 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Recordati Pharmaceuticals Limited Breakspear Park, Breakspear Way, Hemel Hempstead, HP2 4TZ, United Kingdom Manufacturer RECORDATI Industria Chimica e Farmaceutica S.p.A. Via M. Civitali 1 – 20148 Milan, Italy This leaflet was last revised in 02/2024 XXXXXXXX A
Frequently asked questions about Urispas 200mg Film-coated Tablets
How do I take Urispas 200mg Film-coated Tablets?
Urispas 200mg Film-coated Tablets comes as tablet containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Urispas 200mg Film-coated Tablets?
The active substance in Urispas 200mg Film-coated Tablets is flavoxate hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Urispas 200mg Film-coated Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Urispas 200mg Film-coated Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: flavoxate hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Urispas is indicated for the symptomatic relief of dysuria, urgency, nocturia, vesical supra- pubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethro- cystitis and urethrotrigonitis.
In addition, the preparation is indicated for the relief of vesico-urethral spasms due to catheterisation, cystoscopy or indwelling catheters; prior to cystoscopy or catheterisation; sequelae of surgical intervention of the lower urinary tract.
4.2. Posology and method of administration
Posology
Adults (elderly included)
The recommended adult dosage is one tablet three times a day for as long as required.
Paediatric population
The safety and efficacy of Urispas in children aged <12 years have not yet been established.
Method of administration
Oral administration.
The tablets should be taken after a meal in order to prevent nausea.
4.3. Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1;
- Gastrointestinal obstructive conditions or ileus
- Gastro-intestinal haemorrhage
- Achalasia
- Urinary retention
- Glaucoma
- Myasthenia gravis
4.4. Special warnings and precautions for use
The use in children below the age of <12 years is not recommended.
Since the renal clearance of the active metabolite accounts more than 50% of the dose, renal impairment may significantly affect the product kinetics. Caution is therefore required in patients with renal impairment.
Urispas contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Urispas contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium- free'.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies has been performed.
4.6. Fertility, pregnancy and lactation
Fertility
There are no data on the effect of flavoxate on human fertility. Flavoxate has no effect on animal fertility.
Pregnancy
There are no or limited amount of data from the use of flavoxate in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Urispas during pregnancy.
Lactation
It is unknown whether flavoxate (metabolites) is excreted in human milk. A risk to the suckling child cannot be excluded. Urispas should not be used during breast-feeding.
4.7. Effects on ability to drive and use machines
Urispas 200 mg film-coated tablet has minor influence on the ability to drive and use machines.
Patients should be informed that if somnolence or blurred vision occur they should not drive or use machines.
4.8. Undesirable effects
The source of the below ADRs frequencies is represented by data collected through clinical trials, observational studies, and spontaneous reporting.
In the table below, adverse reactions are reported and listed by MedDRA system organ class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from available data). Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness.
System Organ Class
Frequency
Preferred Terms
Immune system disorders
Not known
Hypersensitivity, anaphylactic reaction, anaphylactic shock*
Psychiatric disorders
Not known
Confusional state*
Nervous system disorders
Uncommon
Somnolence
Eye disorders
Uncommon
Not known
Visual impairment
Glaucoma*
Cardiac disorders
Not known
Palpitations
Gastrointestinal disorders
Uncommon
Common
Vomiting, dry mouth, dyspepsia
Nausea
Hepatobiliary disorders
Not known
Jaundice, liver disorder, hepatic enzyme abnormal*
Skin and subcutaneous tissue disorders
Uncommon
Rare
Not known
Rash
Urticaria, pruritus
Erythema*
Renal and urinary disorders
Rare
Urinary retention
General disorders and administration site conditions
Rare
Fatigue
*Adverse reactions from spontaneous reporting in the worldwide post-marketing experience.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No risk following overdose has been identified in the post-marketing experience
💬 Ask about this leaflet
Ask anything about Urispas 200mg Film-coated Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.