Duopic Paed 75 mg/50 mg Dispersible Tablets

DUOPIC PAED contains rifampicin and isoniazid. They both belong to a group of medicines called tuberculostatics.

DUOPIC PAED is indicated for tuberculosis (also known as TB) of the lungs in children.

Do not give DUOPIC PAED:

• if your child is hypersensitive (allergic) or has a history of being hypersensitive to rifampicin, other rifampicins, isoniazid or any of the other ingredients of DUOPIC PAED (see section 6).
• if your child has yellowing of the skin or liver problems.
• if your child has kidney or liver problems, diabetes, history of gout, suffering from fits or a rare hereditary disease called porphyria, with symptoms like severe abdominal pain, constipation or diarrhoea, nausea and vomiting, red or brown urine.
• if you are taking medicine for HIV/AIDS called nevirapine or the combination of saquinavir and ritonavir.
• if you are pregnant or breastfeeding your baby.

Warnings and precautions

Take special care with DUOPIC PAED:

If your child has kidney or liver problems, your child should not be given DUOPIC PAED. If it is the only treatment option available, your doctor or healthcare provider will monitor your child’s liver function via blood tests every two to four weeks.

DUOPIC PAED may cause liver problems. You should be attentive to symptoms of liver damage, such as unexplained loss of appetite, nausea, vomiting, dark urine, yellow discolouration of the skin (jaundice), persistent fatigue of greater than 3 days duration and abdominal pain and tenderness in your child. If these occur, you should immediately report this to your child’s healthcare provider.

Your child’s urine, stool, saliva, sweat and tears may change colour, and soft contact lenses may be permanently stained as a result of being given DUOPIC PAED.

If your child develops kidney problems or a blood disorder, where the red blood cells are destroyed faster than they can be made, your child should discontinue the treatment.

DUOPIC PAED may enhance the functioning of certain hormones and vitamin D.

Your healthcare provider will monitor your child closely as there is a possibility that your child may develop an allergic reaction towards DUOPIC PAED. For this reason, do not interrupt the treatment if not advised by your healthcare provider.

If your child gets flu-like symptoms such as fever, headache, muscle aches, etc. you should report this to your child’s healthcare provider, since DUOPIC PAED may be the cause.

Your healthcare provider will monitor your child’s blood counts during treatment, as your child may develop certain blood disorders.

DUOPIC PAED may reduce the functioning of certain medicine like antiretrovirals (used to treat HIV/AIDS), medicine for epilepsy (fits/seizures), immunosuppressants (medicine used to lower the functioning of the immune system) and warfarin (medicine used to treat blood clots).

If your child is allergic to ethionamide (used to treat TB), pyrazinamide (used to treat TB) or niacin (vitamin B3), you should inform your child’s healthcare provider, because your child may also be allergic to DUOPIC PAED.

Tingling in the hands and feet (peripheral neuropathy) is the most common side effect of isoniazid, one of the active ingredients in DUOPIC PAED, particularly in HIV-positive and malnourished children being treated for TB. You should report any such symptoms to your child’s healthcare provider. A certain vitamin, pyridoxine, should be administered routinely at doses of 5-10 mg per day during treatment with DUOPIC PAED, as it reduces the risk of developing a nerve called neuropathy.

If your child has diabetes, your child should be closely monitored.

If your child has epilepsy or a history of psychiatric disease, you should report this to your child’s healthcare provider, as these conditions may affect your child’s ability to tolerate DUOPIC PAED.

If your child is taking cortisone or any cortisone-like medicine, you should report this to your child’s healthcare provider, as the cortisone dose may have to be increased whilst taking DUOPIC PAED.

If your child experiences reappearance or worsening of symptoms of tuberculosis (paradoxical drug reaction), you should inform your child’s healthcare provider immediately.

Do not share medicines prescribed for you with any other person. Always give DUOPIC PAED exactly as your healthcare provider has instructed you. You should check with your healthcare provider or pharmacist if you are unsure.

For the continuation phase of TB treatment: The dose of DUOPIC PAED is decided on the basis of your child’s body weight. The usual dose is:

Weight Number of dispersible tablets

• 4 - 7 kg 1 dispersible tablet
• 8 - 11 kg 2 dispersible tablets
• 12 - 15 kg 3 dispersible tablets
• 16 - 24 kg 4 dispersible tablets
• 25 kg + Adult dosages recommended

For children weighing 25 kg and above, adult dosages are recommended. Your healthcare provider will tell you how long your child’s treatment with DUOPIC PAED will last. Do not stop treatment early because your child’s infection may come back.

If you have the impression that the effect of DUOPIC PAED is too strong or too weak, tell your healthcare provider or pharmacist.

If you give your child more DUOPIC PAED than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of overdose may include:

• your child may also get a reddish-orange discolouration of the skin and mucous membranes, facial swelling and itching
• high blood glucose levels, vomiting, gastrointestinal disturbances, slurring of speech, fits/seizures, coma, hallucinations, difficulty breathing, central nervous system depression, fatalities.

If you forget to give your child DUOPIC PAED Give your child DUOPIC PAED as soon as you remember, then continue to give DUOPIC PAED at the usual times. Do not give a double dose to make up for forgotten individual doses.

If you stop giving you child DUOPIC PAED You should not stop giving your child DUOPIC PAED without speaking to your child’s healthcare provider. Stopping treatment with DUOPIC PAED too early may no longer protect your child from the infection and can cause it to come back.

DUOPIC PAED can have side effects. Not all side effects reported for DUOPIC PAED are included in this leaflet. Should your child’s general health worsen or if your child experiences any untoward effects while being given DUOPIC PAED, please consult your healthcare provider for advice.

If any of the following happens, stop giving your child DUOPIC PAED and tell your healthcare provider 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 or itching,
• fainting.

These are all very serious side effects. If your child has them, your child may have had a serious reaction to DUOPIC PAED. Your child may need urgent medical attention or hospitalisation.

Tell your healthcare provider immediately or go to the casualty department at your nearest hospital if you notice your child has any of the following:

• diarrhoea that is serious, lasts a long time or has blood in it with stomach pain or fever as this can be a sign of serious bowel inflammation,
• hepatitis (swelling and inflammation of the liver, characterised by symptoms such as, abdominal pain or distension, dark urine and pale or clay-coloured stools, fatigue, fever, general itching, yellowing of the skin or eyes, loss of appetite, nausea and vomiting), jaundice,
• inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis),
• Stevens-Johnson syndrome (a life-threatening skin disorder with symptoms such as a red-purplish rash and blisters),
• muscle weakness, involuntary twitching, poor decision making or concentration, trembling, difficulty speaking (toxic encephalopathy),
• renal failure,
• sudden increase in blood pressure (hyperreflexia), bleeding in the brain,
• toxic exfoliative dermatitis (a severe inflammation of the entire skin surface).

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

Tell your healthcare provider if you notice any of the following in your child: Frequent side effects:

• weakness, numbness and pain from nerve damage, usually in the hands and feet,
• redness of eyes, discoloration of soft contact lenses,
• diarrhoea, abdominal pain, nausea, loss of appetite, vomiting,
• elevated liver activity blood test results,
• disturbances of menstrual cycle,
• flushing, reddish discoloration of body fluids like urine, tears, saliva and sweat, lower blood pressure, shock,
• skin reactions which consist of redness and itching, with or without a rash,
• muscle weakness and muscle disease,
• constipation, dry mouth.

Less frequent side effects:

• worsening of porphyria (a rare hereditary disease in which there is abnormal metabolism of the blood pigment haemoglobin),
• impaired memory,
• medicine induces psychosis,
• headache, lack of energy, impaired balance or coordination, difficulty concentration, dizziness, seizures/fits,
• pink eye,
• stomach inflammation, swelling or inflammation of the large intestine,
• sun allergy, redness and peeling of the skin over large areas of the body, skin condition called pemphigoid (symptoms include itching skin, large blisters), a rash of purple spots due to small blood vessels leaking blood into the skin, joints, intestines or organ,
• inflammation of the kidney,
• several blood disorders,
• confusion, generalised numbness,
• blurred vision, eye irritation,
• loss of hearing,
• hypersensitivity skin reactions, an inflammation of the blood vessels that causes changes in the blood vessel walls, medicine-induced hypersensitivity reaction that presents with skin rash, involvement of internal organs like liver, lung, or kidney,
• flu syndrome, a fever reaction with flu-like symptoms, fungal overgrowth i.e. sore mouth or tongue,
• swollen lymph nodes, reactions which is similar to a disease called Lupus (an inflammatory disease caused when the immune system attacks its own tissues),
• a condition in which too much acid accumulates in the body,
• psychotic reactions (characterised by delusions, hallucinations and confusion), memory impairment,
• nerve condition associated with pins and needles, loss of tendon reflexes, increase in frequency of fits in epileptic patients,
• blurred vision or loss of vision, with or without eye pain,
• vertigo,
• pellagra (a disease caused by a lack of the vitamin niacin (vitamin B3). Symptoms include inflamed skin, diarrhoea, dementia, and sores in the mouth), acne,
• urinary retention,
• male breast enlargements.

Side effects with an unknown frequency:

• bleeding into the skin, bruising and slow blood clotting after an injury (thrombocytopenia),
• shortage of white blood cells, accompanied by sudden high fever, severe sore throat and ulcers in the mouth (agranulocytosis),
• hallucinations (strange visions or sounds),
• tremors, sleeplessness,
• vision problems due to death or inflammation of cells in your eye,
• flatulence, constipation,
• joint pain,
• a lung disease that occurs when lung tissue becomes damaged and scarred, inflammation of lung tissue, shortness of breath, wheezing,
• ulcerative colitis (chronic, inflammatory bowel disease that causes inflammation in the digestive tract), gastrointestinal bleeding,
• swelling of the face, arms and legs,
• hair loss, hives,
• rheumatic syndrome (autoimmune and inflammatory diseases that cause your immune system to attack your joints, muscles, bones and organs).

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

Reporting of side effects If your child gets side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of DUOPIC PAED.

• Store all medicines out of reach of children.
• Store at or below 30 °C.
• Protect from moisture and light.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).