Co-Afaris Paed Dispersible Tablets

CO-AFARIS PAED 75/50/150 is an antimicrobial medicine used in the treatment of pulmonary tuberculosis (TB infection in the lungs) in children.

Do not give CO-AFARIS PAED 75/50/150 if your child suffers from any of the conditions mentioned below:

• If your child is hypersensitive (allergic) to rifamycins including rifampicin, isoniazid, pyrazinamide or other chemically-related medicines such as ethionamide and niacin or to any of the ingredients contained in CO-AFARIS PAED 75/50/150.
• If your child has any kind of liver disease or jaundice (yellowing of the eyes and skin).
• CO-AFARIS PAED 75/50/150 should not be given with nevirapine (used in HIV treatment).
• If your child has any kidney disease.
• If your child has porphyria.
• If your child has a history of gout.
• If your child is diabetic.
• If your child has epilepsy.
• If your child developed thrombocytopenia and purpura while taking CO-AFARIS PAED 75/50/150 (bruising, nosebleeds or bleeding in the mouth and gums, rash with pinpoint red spots).
• If your child is pregnant or breastfeeding her child.

If your child develops itching with swelling or skin rash or difficulty breathing, or if the skin and eyes turn yellow while taking CO-AFARIS PAED 75/50/150, do not give any more CO-AFARIS PAED 75/50/150 and tell your doctor immediately.

Do not share medicines prescribed for you with any other person. Always give CO-AFARIS PAED 75/50/150 exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of CO-AFARIS PAED 75/50/150 is too strong or too weak talk to your doctor or pharmacist.

CO-AFARIS PAED 75/50/150 is recommended in the intensive phase of the treatment of pulmonary tuberculosis. During this phase CO-AFARIS PAED 75/50/150 should be given on a continuous daily basis. Your doctor will prescribe the required number of tablets to be given on a daily basis based on your child’s body weight. The tablets can either be dispersed in as little as 5 ml of water, or chewed, and should preferably be taken on an empty stomach (30 minutes before or 2 hours after a meal) as a single dosage. CO-AFARIS PAED 75/50/150 should be given at least 1 hour before aluminium containing antacids are taken.

Do not stop giving CO-AFARIS PAED 75/50/150 because your child feels better. If the full treatment prescribed by your doctor is not completed, some of the bacteria causing the TB infection may not be killed. These bacteria may continue to grow and multiply so the TB infection may not clear completely or it may return.

CO-AFARIS PAED 75/50/150 can have side effects. Not all the side effects reported for CO-AFARIS PAED 75/50/150 are included in this leaflet. Should your child’s general health worsen or if your child experiences any untoward effects while taking CO-AFARIS PAED 75/50/150, please consult your doctor, pharmacist or healthcare professional for advice.

If any of the following happens, stop taking CO-AFARIS PAED 75/50/150 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 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 reaction to CO-AFARIS PAED 75/50/150. You may need urgent medical attention or hospitalisation.

Store at or below 25 °C. Keep the aluminium sachet in the HDPE container until required for use. Keep the blister in the carton until required for use. Store this medicine away from light and moisture. Do not store in the bathroom cabinet. Any expired or outdated medicines and unused medicines can be returned to your nearest pharmacy. STORE ALL MEDICINES OUT OF REACH OF CHILDREN.