Purderal P 100 mg Tablets

PURDERAL P belongs to a group of medicines called anti - tuberculosis medicines and is used for the treatment of tuberculosis (TB) in combination with other anti - tuberculosis medication.

Do not take PURDERAL P :

• if you are hypersensitive (allergic) to ethambutol or any of the other ingredients of PURDERAL P (listed in section 6).
• if you have kidney problems.
• if you have eye disorder caused by inflammation of nerves in your eye (optic neuritis, retrobulbar neuritis).

Warnings and precautions

Take special care with PURDERAL P:

• If you experience a decrease in sharpness of vision (vision acuity) tell your doctor about it, as it may be due inflammation of the nerve leading to the eye (optic neuritis).
• If you experience changes in ability to see from one eye or both eyes, tell your doctor about it as this effect may be related to the dose and duration of the treatment with PURDERAL P. This effect is generally reversible when administration of the medicine is discontinued promptly. However, irreversible blindness has been reported. As a precaution, each eye must be tested separately and both eyes together.
• If you are the caregiver of a child, as testing of changes in sharpness of vision (vision acuity) in children may be difficult.
• If you experience any changes in sharpness of vision or the ability to distinguish between colours when you start PURDERAL P, therapy will be stopped by your doctor, if your vision deteriorates.
• Your doctor will check your kidney function and uric acid levels before starting your treatment with PURDERAL P.

Children and adolescents

PURDERAL P is not recommended for children under 13 years of age.

Other medicines and PURDERAL P

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:

• Antacid medicines that contain aluminium hydroxide. PURDERAL P should be taken 4 hours before or 4 hours after taking antacid.

Pregnancy, breastfeeding and fertility

The safety of PURDERAL P in pregnancy and lactation has not been established. 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 PURDERAL P.

Driving and using machines

PURDERAL P can cause problems with eyesight, dizziness, disorientation or tingling/numbness in hands or feet which may influence your ability to drive, use machinery or perform any tasks that require concentration. It is not always possible to predict to what extent PURDERAL P may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which PURDERAL P affects you (see section 4).

PURDERAL P contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking PURDERAL P.

Do not share medicines prescribed for you with any other person. Always take PURDERAL P exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you exactly how to take PURDERAL P as your dosage will be calculated specially for you. Your doctor will tell you how long your treatment with PURDERAL P will last. Do not stop treatment early. If you have the impression that the effect of PURDERAL P is too strong or too weak, tell your doctor or pharmacist.

If you take more PURDERAL P than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take PURDERAL P

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of PURDERAL P, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

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

If any of the following happens, stop taking PURDERAL P 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,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens - Johnson Syndrome (SJS).

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

• Blurred vision, inability to see red - green, sudden changes in vision, bleeding in the eye,
• kidney problems with symptoms of lower back pain, burning or difficulty when you pass urine or blood in your urine, deterioration of kidney function (interstitial nephritis, nephrotoxicity),
• liver problems which may result in pale stools, dark urine, or make your skin or eyes look slightly yellow (jaundice).

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

Tell your doctor if you notice any of the following:

• Less frequent side effects:
• Thrombocytopenia, leucopenia, neutropenia.
• reduced levels of platelets and white blood cells in the body (eosinophilia),
• increased levels of uric acid in the blood (hyperuricaemia),
• a result of damage to the nerves outside of the brain and spinal cord (peripheral neuropathy), numbness, headache, dizziness,
• tingling and prickling (paraesthesia) weakness (hands and feet), burning pains, disorientation, involuntary body movements (tremor),
• decreased visual acuity, loss of vision, scotoma, colour blindness, visual disturbance, visual field defect, eye pain,
• inflammation of the lungs (pneumonitis, pulmonary infiltrates, with or without eosinophilia)
• decreased/loss of appetite (anorexia), nausea, vomiting, abdominal pain, diarrhoea
• excess amount of air/gas in the stomach (flatulence), metallic taste,
• hepatic reactions with hepatitis, yellowing pigmentation of skin and eyes (jaundice),
• abnormal liver function test values, and very rarely hepatic failure,
• joint pains,
• general feeling of discomfort, illness (malaise), raised body temperature or fever (pyrexia).

Side effects with an unknown frequency:

• Pain or swelling in your joints (especially big toe) with tender hot skin over effected joints (gout),
• mental confusion, disorientation, seeing or hearing things that are not really there (hallucinations).

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: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E - mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of PURDERAL P.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Keep in the original packaging until required for use.

• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).