Granupas 5,52 g Oral Solution

GRANUPAS is used to treat resistant tuberculosis (TB) in combination with other medicines. It is used in patients with Multi-drug Resistant TB (MDR-TB) or in situations in which therapy with isoniazid and rifampicin is not possible due to a combination of resistance and/or intolerance.

Do not take GRANUPAS:

• If you are hypersensitive (allergic) to p-aminosalicylic acid, other salicylates, or any of the other ingredients of GRANUPAS (listed in section 6).
• If you have moderate or severe kidney insufficiency.
• If you have severe liver insufficiency.
• If you have severe heart failure.
• If you have stomach ulcer and duodenal ulcer.
• If you have myxoedema (chronic disease caused by weak activity of thyroid gland).
• If you have amyloidosis (disorders in protein metabolism).
• If you have phenylketonuria.
• If you are pregnant or breastfeeding your baby.

Warnings and precautions

Take special care with GRANUPAS:

• If you have a kidney activity disorder.
• If you have liver function disorders. Patients with liver disease may not tolerate GRANUPAS as well as normal patients.
• If you have heart failure.
• If you have a glucose-6-phosphate dehydrogenase deficiency.
• If you have phenylketonuria.
• If you are lactose intolerant.
• If you have a stomach ulcer.
• If you are hypersensitive to any other salicylate, including methylsalicylate (wintergreen oil) and medicines called sulphonamides.
• If you have any thyroid problems.
• If you have been advised to restrict your daily salt (sodium) intake.
• If you suffer from certain nutritional problems, such as Vitamin B12 deficiency, iron deficiency or malabsorption syndrome. GRANUPAS may aggravate these conditions. You may need to take vitamin B12 supplements.

Other medicines and GRANUPAS

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor if you are taking any of the following medicines. Co-administration with GRANUPAS may increase the risk of side effects or may cause the medicines to be less effective:

• Isoniazid and ethionamide (antibiotics used to treat tuberculosis)
• Probenecid or sulfinpyrazone (used to treat gout)
• Aminobenzoate (used to treat muscle or skin conditions)
• Anticoagulants (blood thinners)
• Rifampicin (antibiotic). GRANUPAS and rifampin should be taken at least 6 hours apart.
• Digoxin (used to treat heart failure or irregular heartbeat)

Vitamin B12: GRANUPAS may impair the absorption of vitamin B12 from the gastrointestinal tract. You may need to take Vitamin B12 supplements while being treated with GRANUPAS.

Laboratory tests: GRANUPAS has been reported to interfere technically with certain laboratory tests. Inform your doctor or healthcare provider that you are taking GRANUPAS when you are scheduled to have your blood or urine tested.

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 healthcare provider for advice before taking GRANUPAS. You must not take GRANUPAS if you are pregnant. The active ingredient in GRANUPAS is excreted in breast milk. You should not breastfeed your baby if you are taking GRANUPAS.

Driving and using machines

Do not drive or use machinery before you know how GRANUPAS affects you. GRANUPAS contains sodium, aspartame and lactose.

Do not share medicines prescribed for you with any other person. Always take GRANUPAS exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long your treatment with GRANUPAS will last. Do not stop treatment early because your condition may worsen, and you may become resistant to this medicine. If you have the impression that the effect of GRANUPAS is too strong or too weak, tell your doctor or pharmacist.

GRANUPAS is used in combination with other medicines for the treatment of tuberculosis. The usual dose for adults is:

• Two sachets (8 g) to 3 sachets (12 g), divided into 2 or 3 single doses.

If you have a body weight of less than 50 kg or you experience difficulty tolerating the medicine, your doctor may decrease the dose to:

• One (4 g) or two (8 g) sachets a day.

The usual dose for children is:

• The dosage should be adapted to the patient’s weight: 200 – 300 mg/kg/day, divided into 2 to 4 single doses. The maximum daily dose is 12 g (3 sachets).

Instructions on taking GRANUPAS

You should take GRANUPAS after meals to lower the irritating effect on your stomach. Dissolve the content of the sachet in 100 ml of cooled, boiled water and drink it immediately.

If you take more GRANUPAS than you should

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

If you forget to take GRANUPAS

If you miss a dose of GRANUPAS, take it as soon as possible. If it is almost time for your 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.

Effects when treatment with GRANUPAS is stopped

Do not stop treatment early because your condition may worsen, and you may become resistant to this medicine.

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

If any of the following happens, stop taking GRANUPAS 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
• rash, hives, or itching
• fainting
• dark urine, yellowing of the skin and eyes called jaundice.

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

Tell your doctor if you notice any of the following:

Frequent side effects

• Diarrhoea, nausea, stomach pain, vomiting, loss of appetite
• Skin redness or rash

Less frequent side effects

• Blood deficiencies, Vitamin B12 deficiency: fatigue, fainting, weakness, drowsiness, dizziness, pins and needles feeling in hands and feet, red sore tongue, mouth ulcers
• confusion, mental or mood changes
• headache
• fast or irregular heartbeat, tremors
• pale skin
• Infectious disease with symptoms such as fever, malaise, sore throat, swollen glands
• Decrease in thyroid gland function
• Changes in cholesterol levels
• Serious mental illness with loss of contact with reality
• Inflammation of the blood vessels
• Bloating, abnormally foul-smelling or loose stools, severe right-sided stomach pain (steatorrhoea)
• Joint pain
• Crystals in urine that cause kidney irritation

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 GRANUPAS.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 30 °C. Protect from light and moisture. 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).