Pyridium 100 mg Tablets

PYRIDIUM is used to relieve symptoms caused by irritation of the urinary tract such as pain, burning, and the feeling of needing to urinate urgently or frequently. This medicine does not treat the cause of the urinary irritation, but it can help relieve the symptoms while other treatments take effect. PYRIDIUM is a dye that works as a painkiller to soothe the lining of the urinary tract.

Do not take PYRIDIUM if:

• you are hypersensitive (allergic) to phenazopyridine hydrochloride or any of the other ingredients of PYRIDIUM (listed in section 6).
• you suffer from inflammation of blood vessels around the kidney (confirmed by urine testing), urea in the blood (progressive weakness and easy fatigue, loss of appetite due to nausea and vomiting)
• you suffer from impaired renal function
• you suffer from severe inflammation of the liver (hepatitis)
• PYRIDIUM should not be used for repeated or prolonged treatment without full diagnostic investigation
• you suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency. You are at an increased risk of severe haemolytic anaemia (blood disorder)
• you are pregnant or breastfeeding your baby.

Warnings and precautions

Take special care with PYRIDIUM:

• PYRIDIUM is for relief of symptoms and you should not delay the process of determining the underlying cause of your disease. Prompt appropriate treatment of the cause of pain must be instituted. Stop using PYRIDIUM if the symptoms are controlled.
• If PYRIDIUM is used concurrently with an antibiotic treatment, the duration of PYRIDIUM therapy should not exceed 2 days.
• If your symptoms persist or recur, a doctor should be consulted.
• PYRIDIUM produces an orange to red colour in the urine and faeces and may stain clothing. Staining of contact lenses has been reported.
• PYRIDIUM may affect the results of tests performed to determine the cause of your disease. Inform your doctor that you are taking PYRIDIUM prior to being tested.
• You should stop taking PYRIDIUM if your eyes and skin become discoloured.

Other medicines and PYRIDIUM

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines). PYRIDIUM may affect the results of tests performed to determine the cause of your disease. Inform your doctor that you are taking PYRIDIUM prior to being tested.

PYRIDIUM with food and drink

PYRIDIUM should be taken with or after meals.

Pregnancy, breastfeeding and fertility

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 healthcare provider for advice before taking this medicine. The safety and/or efficacy of the use of PYRIDIUM during pregnancy and breastfeeding have not been established (see section 2). No fertility studies have been conducted in humans.

Driving and using machines

PYRIDIUM does not appear to influence the ability to drive or use machines; however, it is known to cause visual disturbances. It is not always possible to predict to what extent PYRIDIUM 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 PYRIDIUM affects them.

PYRIDIUM contains lactose, sucrose and sodium starch glycolate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking PYRIDIUM.

PYRIDIUM contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take PYRIDIUM exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

Adults should take two tablets three times per day with or after meals. If PYRIDIUM is used concurrently with an antibiotic treatment, the duration of PYRIDIUM therapy should not exceed 2 days. PYRIDIUM is for oral use. Tablets should not be chewed.

If you take more PYRIDIUM than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison center. The following can occur with an overdosage:

• the presence of a higher-than-normal level of methemoglobin in your blood. The symptoms include shortness of breath, blue or purple colouration of the skin, mental status changes, headache, fatigue, exercise intolerance, dizziness and loss of hairlines
• abnormal breakdown of red blood cells characterised by pallor, fatigue, shortness of breath, and potential for heart failure
• impaired liver function and sometimes kidney failure.

Treatment of overdosage is symptomatic and supportive.

If you forget to take PYRIDIUM

If you forget to use a dose of PYRIDIUM, carry on with the next dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

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

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

• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing,
• a rash or itching,
• fainting,
• yellowing of the skin and eyes, also called jaundice.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to PYRIDIUM. 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:

• fever, headache and neck stiffness (meningitis).

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

Tell your doctor if you notice any of the following:

• headache
• nausea, vomiting and diarrhoea
• abdominal cramps or stomach pains
• skin discolouration
• tiredness, weakness
• visual disturbances
• crystal deposits in your urinary tract
• discolouration of urine and other body fluids.

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 PYRIDIUM.

• Store all medicines out of reach of children
• Store at or below 25 °C in a dry place.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).