Urispas 200 mg Film-Coated Tablets

URISPAS 200 contains flavoxate hydrochloride. It is a non-specific, direct-acting, smooth muscle relaxant. URISPAS 200 is therefore an anti-spasmodic which works by inhibiting contractions in the urinary tract, thereby reducing urinary symptoms and associated pain.

URISPAS 200 is used for its antispasmodic (preventing or relieving spasms) action in urological disorders (disorders of or relating to urinary tract.)

Do not take URISPAS 200:

• if you are hypersensitive (allergic) to flavoxate hydrochloride or any of the other ingredients of URISPAS 200 listed in section 6.
• if you have a history of, suffer from or think you may have a blockage of the stomach, bowel, or urinary tract; or if you suffer from bleeding from the stomach or bowel.
• if you have an inability to swallow (achalasia).
• if you are or think that you might be pregnant or if you are breastfeeding.
• if you suffer from urinary retention (the inability to empty the bladder completely).
• if you have glaucoma (increased pressure of the fluid inside the eye).
• if you have a muscle disorder called myasthenia gravis (disorder causing weakness in the skeletal muscles).

URISPAS 200 is not recommended for use in children under 12 years of age.

Warnings and precautions

Take special care with URISPAS 200:

• if you have kidney problems.
• if you think you may have glaucoma (increased pressure of the fluid inside the eye).
• if you have serious, uncontrolled disorders that is causing a blockage of the lower urinary tract.
• if you feel drowsy, you should wait longer before taking your next dosage. See also “Driving and using machines”.

Children

Do not give your child URISPAS 200, as the safety and efficacy of URISPAS 200 in children (aged < 12 years) have not been established.

Other medicines and URISPAS 200

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) No interaction studies have been performed on URISPAS 200. Please consult your doctor, pharmacist or other health care provider for advice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking URISPAS 200. Do not take URISPAS 200 during pregnancy or breastfeeding.

Driving and using machines

It is not always possible to predict to what extent URISPAS 200 may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which URISPAS 200 affects them.

Do not share medicines prescribed for you with any other person. Always take URISPAS 200 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is one tablet three times a day for as long as is required. Do not break the tablet but swallow it whole, preferably with a glass of water.

If you have the impression that the effect of URISPAS 200 is too strong or too weak, tell your doctor or pharmacist.

If you take more URISPAS 200 than you should

The most likely symptoms of overdose are blurred vision, dry mouth, drowsiness and diarrhoea or constipation. Treatment by your doctor or healthcare professional is symptomatic and supportive. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take URISPAS 200

If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

URISPAS 200 can have side effects. Not all side effects reported for URISPAS 200 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking URISPAS 200, please consult your health care provider for advice.

If any of the following happens, stop taking URISPAS 200 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to URISPAS 200. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Less frequent side effects:

• palpitations (rapid irregular action of the heart).
• tachycardia (increased rate of heartbeat).

Side effects with an unknown frequency:

• yellowing of the skin and eyes (also called jaundice), liver disorders, abnormal liver enzyme levels.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:

Frequent

• Nausea

Less frequent:

• blood disorders (increased or decreased white blood cell count).
• drowsiness, dizziness, headache, confusion (especially if you are elderly), nervousness, sleepiness, sensation of whirling and loss of balance (vertigo).
• blurred vision, visual impairment, eye disorders (disturbances in eye accommodation), increased eye tension.
• diarrhoea, dry mouth, dyspepsia (heartburn, indigestion), dysphagia (difficulty swallowing) and vomiting.
• urticaria (allergic skin rash), itch (pruritus) and other dermatoses (diseases of the skin).
• dysuria (painful or difficult urination), inability to completely empty the bladder.
• fatigue (unusual weakness or tiredness), and fever.

Side effects with an unknown frequency:

• feeling confused.
• glaucoma (increased pressure of the fluid inside the eye).
• redness of the skin.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of URISPAS 200.

• Store all medicines out of reach of children.
• Store at or below 30 °C.
• Protect from moisture and light.
• Keep the blister strips in the outer carton until required for use. Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).