Rifampicin/Isoniazid/Pyrazinamide 60mg/30mg/150mg Tablets  Anti-tuberculous

COMPOSITION:

Each Tablet contains 60 mg rifampicin 30 mg isoniazid and 150mg pyrazinamide.

INDICATIONS:

Tablets is indicated for the initial treatment of tuberculosis in children weighing 5 to 20 kg.

Your child should not be given Rifampicin/Isoniazid/Pyrazinamide 60mg/30mg/150mg 
Dispersible Tablets: 
- if he/she is hypersensitive (allergic) to isoniazid, rifampicin, pyrazinamide, or any of the other 
ingredients of Rifampicin/Isoniazid/Pyrazinamide 60mg/30mg/150mg Dispersible Tablets (see 
section 6, What Rifampicin/Isoniazid/Pyrazinamide 60mg/30mg/150mg Dispersible Tablets 
contains). 
- if he/she has acute liver disease, 
- if he/she has drug induced liver disease, 
- if he/she has experienced liver damage linked to isoniazid, rifampicin or pyrazinamide before, 
- if he/she has experienced severe side effects of isoniazid or rifampicin, such as drug fever, chills 
or inflammation of the joints before. 
- if he/she presently has inflammation of the joints (arthritis) due to gout. 
- if he/she is using voriconazole (a medicine used to treat fungal infections) or a medicine against 
HIV infection that belongs to the class of protease inhibitors.

DOSAGE AND DIRECTIONS FOR USE:

The dose of Rifampicin/Isoniazid/Pyrazinamide 60mg/30mg/150mg Dispersible Tablets is decided on 
the basis of the body weight of your child. 
If your child weighs 5-7 kg: 1 tablet each day. 
If your child weighs 8-14 kg: 2 tablets each day. 
If your child weighs 15-20 kg: 3 tablets each day. 
Disperse the required number of Rifampicin/Isoniazid/Pyrazinamide 60mg/30mg/150mg Dispersible 
Tablets in approximately 50 ml water and make the child drink the entire dispersion. The reconstituted 
preparation (tablets dispersed in water) should be used within 10 minutes. 
 Tablets should be taken on an empty stomach (at least one hour prior to or two hours after a meal). 
 If the child has a kidney disease, the doctor may prescribe separate formulations of the component 
drugs in Rifampicin/Isoniazid/Pyrazinamide 60mg/30mg/150mg Dispersible Tablets. 
Tablets is not recommended for adults or children with a body weight of 21 kg or more. 
Tablets is usually given for 2 months at the beginning of tuberculosis therapy. The doctor will decide on the duration of treatment for your child.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The most important adverse effects of isoniazid, rifampicin and pyrazinamide are nerve injuries.

The most commonly reported side effects include sensations of tingling, pricking, or numbness of the skin, especially in the feet and hands.
Commonly reported side effects include a reddish discouloration of body fluids such as urine, sputum, tears, saliva and sweat. Further common side effects are diarrhoea, abdominal pain, loss of appetite, nausea and vomiting, as well as skin reactions with rash and/or itching, and disturbances of the menstrual cycle. 

Uncommon side effects  are inflammation of the liver (hepatitis) epileptic seizures, headache, inflammation of the brain, personality changes and memory impairment. 

STORAGE INSTRUCTIONS:

Store below 25°C in a dry place, out of reach of children.