Akurit Kid Dispersible Tablets

AKURIT KID 75/50 ODT contains rifampicin and isoniazid, one of a group of medicines called Tuberculostatics.

AKURIT KID 75/50 ODT is indicated for tuberculosis of the lungs in children.

Your child should not take AKURIT KID 75/50 ODT:

• if he/she is hypersensitive (allergic) or has a history of being hypersensitive to rifampicin, other rifampicins, isoniazid or any of the other ingredients of AKURIT KID 75/50 ODT (see section 6)
• if he/she has yellowing of the skin or liver problems
• if he/she has moderate to severe kidney or liver problems, diabetes, history of gout, suffering from fits and 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 and the combination saquinavir/ritonavir
• if you are pregnant or breastfeeding.

Warnings and precautions

Take special care with AKURIT KID 75/50 ODT:

If your child has kidney or liver problems, he/she should not be given AKURIT KID 75/50 ODT. If it is the only treatment option available, your doctor or healthcare provider will monitor his/her liver function via blood tests every two to four weeks.

AKURIT KID 75/50 ODT dispersible tablets 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 stained as a result of taking AKURIT KID 75/50 ODT.

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

AKURIT KID 75/50 ODT may enhance the functioning of certain hormones and vitamin D.

Your healthcare provider will monitor your child closely as there is a possibility that he/she may develop an allergic reaction towards AKURIT KID 75/50 ODT. 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 AKURIT KID 75/50 ODT dispersible tablets may be the cause.

Do not share medicines prescribed for you with any other person.

Always give AKURIT KID 75/50 ODT 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 AKURIT KID 75/50 ODT dispersible tablets is decided on the basis of your child’s body weight. The usual dose is:

Your healthcare provider will tell you how long your child’s treatment with AKURIT KID 75/50 ODT will last. Do not stop treatment early because your child’s infection may come back.

If you have the impression that the effect of AKURIT KID 75/50 ODT is too strong or too weak, tell your healthcare provider or pharmacist.

If you give your child more AKURIT KID 75/50 ODT than you should: In the event of overdosage, consult your healthcare provider or pharmacist. If neither is available, contact the nearest hospital or poison control 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 AKURIT KID 75/50 ODT: Give AKURIT KID 75/50 ODT as soon as you remember, then continue to give AKURIT KID 75/50 ODT at the usual times. Do not take a double dose to make up for forgotten individual doses.

If you stop giving AKURIT KID 75/50 ODT to your child: You should not stop giving this medicine to your child without checking with your child’s healthcare provider. Stopping tablets too early may no longer protect your child from the infection or cause it to come back.

AKURIT KID 75/50 ODT can have side effects. Not all side effects reported for AKURIT KID 75/50 ODT are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using AKURIT KID 75/50 ODT, please consult your healthcare provider, pharmacist, or other healthcare professional for advice.

If any of the following happens, stop using AKURIT KID 75/50 ODT 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 you have them, you may have had a serious allergic reaction to AKURIT KID 75/50 ODT. You 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 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. You may need urgent medical attention.

Tell your healthcare provider if you notice any of the following:

• 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 B 3 ). Symptoms include inflamed skin, diarrhoea, dementia, and sores in the mouth)
• urinary retention
• male breast enlargements.

The following side effects have been reported but the frequency for them to occur is not known:

• 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 you get side effects, talk to your healthcare provider or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug 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 AKURIT KID 75/50 ODT.

Store all medicines out of reach of children.

Store at or below 30 °C in original container. Protect from moisture and light. 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).