Co-Ripyso Paed Dispersible Tablets

CO-RIPYSO 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-RIPYSO 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 or other chemically-related medicines such as ethionamide and niacin or to any of the ingredients contained in CO-RIPYSO PAED 75/50/150. (listed in section 6).
• If your child has any kind of liver disease or jaundice (yellowing of the eyes and skin).
• CO-RIPYSO 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 develops thrombocytopenia and purpura while taking CO-RIPYSO 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-RIPYSO PAED 75/50/150, do not give any more CO-RIPYSO PAED 75/50/150 and tell your doctor immediately.

Warnings and precautions

Take special care with CO-RIPYSO PAED 75/50/150

• If your child developed thrombocytopenia and purpura while taking CO-RIPYSO PAED 75/50/150 (bruising, nosebleeds or bleeding in the mouth and gums, rash with pinpoint red spots).
• Before you give CO-RIPYSO PAED 75/50/150, tell your doctor if your child has epilepsy.
• CO-RIPYSO PAED 75/50/150 should not be given to children whose liver is not functioning normally, however, in cases where there are no other treatment options your doctor will monitor your child’s liver function before treatment and every two to four weeks during treatment with CO-RIPYSO PAED 75/50/150.

Do not share medicines prescribed for you with any other person. Always give CO-RIPYSO PAED 75/50/150 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure. CO-RIPYSO PAED 75/50/150 is recommended in the intensive phase of the treatment of pulmonary tuberculosis. During this phase CO-RIPYSO 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-RIPYSO PAED 75/50/150 should be given at least 1 hour before aluminium containing antacids are taken.

If you give more CO-RIPYSO PAED 75/50/150 than you should

In the event of overdosage consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison control center. Symptoms include nausea, vomiting, stomach pain, dizziness, high blood sugar levels, high levels of acid in the blood, hallucinations, difficulty in breathing and central nervous system depression with seizures and coma. Other signs of overdosage includes bright-red discolouration of the skin and mucous membranes, decreased mental alertness, swelling of the face and “puffy eyes” and generalised itching.

If any of the above symptoms occur, get medical help immediately by calling your nearest doctor or healthcare professional.

If you forget to give your child CO-RIPYSO PAED 75/50/150 give it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular scheduling. Never double the dose.

If you stop giving your child CO-RIPYSO PAED 75/50/150

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-RIPYSO PAED 75/50/150 can have side effects. Not all side effects reported for CO-RIPYSO 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-RIPYSO PAED 75/50/150, please consult your health care provider for advice.

If any of the following happens, stop taking CO-RIPYSO 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-RIPYSO PAED 75/50/150. 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:

• Red and/or itchy skin, blisters or pimples.
• Skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (symptoms of Stevens Johnson Syndrome).
• Widespread scaling of the skin with itching, skin redness and hair loss (symptoms of exfoliative dermatitis).
• Shortness of breath and wheezing.
• Lung disease causing coughing, difficulty breathing and wheezing (symptoms of pneumonitis).
• Scarring and thickening in the lungs with shortness of breath (symptoms of pulmonary fibrosis).
• Blood in the urine or any other urination disturbances.
• Fever, chills, headache or dizziness.
• Bone pain.
• Bruising, nosebleeds or bleeding in the mouth and gums, rash with pinpoint red spots.
• Fatigue, weakness, malaise (feeling unwell), anorexia (loss of appetite), nausea or vomiting.
• Abdominal pain, blood in the stool, ongoing bouts of diarrhoea that do not respond to over-the-counter (OTC) medicines or an unexplained fever lasting more than a day or two (symptoms of ulcerative colitis).
• Bleeding from the stomach wall with vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea.
• Inflammation of the pancreas with severe upper stomach pain, nausea and vomiting.

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

Tell your doctor immediately if your child has any of the following side effects, particularly if they occur several weeks after stopping treatment with CO-RIPYSO PAED 75/50/150:

• Severe stomach cramps.
• Watery and severe diarrhoea, which may also be bloody.
• Fever, in combination with one or both of the above.

Your child may have a serious condition affecting the bowel, which may need urgent medical attention. Do not give any diarrhoea medicine without first checking with your doctor.

Tell your doctor if you notice any of the following frequently occurring side effects:

• Heartburn, anorexia, nausea, vomiting, wind, cramps or diarrhoea, constipation, dry mouth.
• Skin reactions with flushing and itching, with or without a rash.
• Aching muscles, muscle tenderness or weakness, not caused by exercise.
• Reddish-orange to reddish-brown discolouration of the urine, faeces, saliva, sputum, sweat and tears.
• Soft contact lenses may be permanently stained.
• Numbness or weakness of the arms and legs.
• Increase in liver enzymes.

Less frequent side effects:

• Increase in some white blood cells (eosinophilia).
• Lack of white blood cells resulting in frequent infections such as fever, severe chills, sore throat or mouth ulcers (leucopenia).
• Tiredness, headaches, being short of breath when exercising, dizziness, looking pale and yellowing of the skin and/or eyes (haemolytic anaemia).
• High blood glucose levels.
• High levels of acid in the blood.
• Mental illness with strange or disturbing thoughts or moods.
• Loss of memory.
• Headache, dizziness, drowsiness, fatigue, inability to concentrate or confusion.
• Poor coordination, pain in the fingers or toes, or numbness, unusually increased reflexes or twitching.
• Fits or increase in fits if you are an epileptic patient.
• Blurred vision or loss of vision with or without eye pain, eye irritation.
• Menstrual disturbances.
• Oral contraceptives may become less effective.
• Temporary hearing loss.
• Vertigo (feeling dizzy with a spinning sensation).
• Skin rash, itchy rash, acne, hair loss sensitivity to the sun, allergic reactions.
• Enlarged breasts.
• Oral thrush - white, furry, sore tongue and mouth.
• Swelling of hands, ankles or feet.
• Aggravation of stomach ulcers.
• Difficulty going to the toilet (urinating).
• Fever, aches and pains in muscles, pain and swelling of joints (especially big toe, ankle and knee with tense, hot skin over affected joints).
• Unusual tiredness or weakness.

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 CO-RIPYSO PAED 75/50/150.

Store all medicines out of reach of children. 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.