Rifapentine Film-Coated Tablets

RIFAPENTINE 300 ADCO contains rifapentine which belongs to the rifamycin class of antibiotics. RIFAPENTINE 300 ADCO is used with other anti-tuberculosis (TB) medicines such as isoniazid to treat inactive (latent) tuberculosis infection and to prevent its progression to active tuberculosis disease in people aged 2 years and older who are at risk. RIFAPENTINE 300 ADCO should not be used in people with active TB.

Do not take RIFAPENTINE 300 ADCO:

• if you are hypersensitive (allergic) to rifapentine, to a group of medicines called rifamycins (e.g. rifampicin and rifabutin), or to any of the ingredients of RIFAPENTINE 300 ADCO (see section 6)
• if you have a condition called porphyria (a group of disorders that can cause nerve or skin problems (blisters and itching) due to a problem with the production of blood pigment and red blood cells within the body)
• if you have acute or chronic liver disease.

Warnings and precautions

Take special care with RIFAPENTINE 300 ADCO: Before you are given RIFAPENTINE 300 ADCO tablets tell your doctor or health care provider if you:

• have liver problems. Your doctor may do a blood test to check your liver function before and during your treatment (see Do not take RIFAPENTINE 300 ADCO)
• have active TB disease
• take medicines to treat HIV infection or take oral contraceptives as taking these medicines with RIFAPENTINE 300 ADCO may make them less effective (see Other medicines and RIFAPENTINE 300 ADCO)
• use a medicine called digoxin (used to make the heart beat stronger and with a more regular rhythm). Your doctor will monitor and may change your dose of digoxin as RIFAPENTINE 300 ADCO may affect the way digoxin works. Even small changes need to be monitored to prevent serious side effects from occurring (also see Other medicines and RIFAPENTINE 300 ADCO)
• are pregnant or breastfeeding your baby, or if you are planning to become pregnant or to breastfeed (see Pregnancy and breastfeeding)
• wear contact lenses or dentures. RIFAPENTINE 300 ADCO may change the normal colour of your skin, mouth and body fluids and cause your skin, teeth, tongue, urine, stools, saliva, sputum, tears, sweat, and breast milk to turn a red-orange colour. Contact lenses or dentures may become permanently stained.

Do not share medicines prescribed for you with any other person. Always use RIFAPENTINE 300 ADCO exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are unsure.

RIFAPENTINE 300 ADCO should be taken once-weekly in combination with another anti-TB medicine, isoniazid, for 12 weeks as directly observed therapy (DOT). DOT is a way of helping people during their treatment, this means your treatment will be monitored weekly by visiting your local clinic, hospital or nurse so they can make sure you take your treatment correctly.

Your doctor will calculate the number of tablets you should take weekly based on your weight. This dose will therefore be calculated for you personally. It is important to take all of your RIFAPENTINE 300 ADCO and your other TB medicine (isoniazid) regularly and you do not skip doses. Missing doses may cause RIFAPENTINE 300 ADCO to not work as well and may increase the chance that your TB will not be treatable by RIFAPENTINE 300 ADCO or other medicines.

Take RIFAPENTINE 300 ADCO and isoniazid with food. This may help prevent nausea, vomiting or stomach upsets due to the medication. It is preferable to take antacids at least 1 hour before or 2 hours after your dose of RIFAPENTINE 300 ADCO tablets. If you cannot swallow tablets whole, they can be crushed and mixed with a small amount of semi-solid food. Be sure to immediately take all of the semi-solid food with RIFAPENTINE 300 ADCO crushed into it. Your doctor will tell you how long your treatment with RIFAPENTINE 300 ADCO will last.

RIFAPENTINE 300 ADCO can have side effects. Not all side effects reported for RIFAPENTINE 300 ADCO are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using RIFAPENTINE 300 ADCO, please consult your healthcare provider for advice.

If any of the following happens, stop using RIFAPENTINE 300 ADCO 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

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to RIFAPENTINE 300 ADCO. 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:

• flu-like syndrome (weakness, extreme tiredness, muscle pain, nausea and vomiting, headache, fever, chills, aches, rash, itching, sweats, dizziness, shortness of breath, chest pain, cough, fainting, fast heartbeat) (see Take special care with RIFAPENTINE 300 ADCO)
• hepatitis (inflammation of the liver) and liver problems (symptoms may include: nausea, vomiting, stomach pain, loss of appetite, tiredness, yellowing of the skin or whites of your eyes, dark urine) (see Take special care with RIFAPENTINE 300 ADCO)
• diarrhoea called Clostridium difficile -associated diarrhoea (CDAD) which may occur during or after taking this medicine. The severity of CDAD can range from mild diarrhoea to severe diarrhoea that may cause death (fatal colitis) (see Take special care with RIFAPENTINE 300 ADCO)
• pancreatitis (inflammation of the pancreas) (symptoms may include upper abdominal pain that radiates into the back; swollen and tender abdomen; nausea and vomiting, fever and increased heart rate)
• pneumonia (infection of the lungs; symptoms may include fever and chills, cough, difficulty breathing, shortness of breath when you climb stairs)
• blistering, peeling or bleeding on any part of your skin with or without a rash (including your lips, eyes, mouth, nose, genitals, hands or feet), flu-like symptoms (fever, chills or aching muscles) which are symptoms of a serious skin reaction (Steven Johnson Syndrome) which could be fatal
• a serious reaction (DRESS) with flu-like symptoms, a widespread rash with a high body temperature and enlarged lymph nodes. Abnormal blood test results may include increased levels of liver enzymes and an increase in a type of white blood cell (eosinophilia).

Store all medicines out of reach of children. Store below 25 °C. Protect from excessive heat and moisture. Keep blisters in carton until required for use. 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).