Priftin 150 mg Film-Coated Tablets

The active substance of PRIFTIN is rifapentine. Each film-coated tablet contains 150 mg rifapentine. PRIFTIN contains rifapentine which belongs to the rifamycin class of antibiotics. It is used with other anti-tuberculosis (TB) medicines 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. PRIFTIN should not be used in people with active TB. For the treatment of latent tuberculosis infection PRIFTIN must always be used in combination with the anti-tuberculosis medicine isoniazid.

Do not take PRIFTIN:

• If you are hypersensitive (allergic) to rifapentine or to a group of medicines called rifamycins (e.g. rifampicin and rifabutin), or to any of the ingredients of PRIFTIN.
• 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 haem (blood pigment) and red blood cells within the body).
• If you have acute or chronic liver disease.

Warnings and precautions

Take special care with PRIFTIN: Tell your doctor or health care provider before you are given PRIFTIN tablets:

• If you have liver problems. Your doctor may do a blood test to check your liver function before and while you take PRIFTIN (see Do not take PRIFTIN if).
• If you have active TB disease.
• If you know that you have TB that is resistant to treatment with some medicines.
• If you are pregnant or breastfeeding or if you are planning to become pregnant or to breastfeed (see Pregnancy and breastfeeding).
• If you take medicines to treat HIV infection or take oral contraceptives. Using these medicines with PRIFTIN may make them less effective (see Other medicines and PRIFTIN).
• If you use a medicine called digoxin (used to make the heart beat stronger and with a more regular rhythm). Your doctor will monitor your dose of digoxin as it could change due to PRIFTIN. Even small changes need to be monitored to prevent serious side effects from occurring (also see Other medicines and PRIFTIN).
• If you wear contact lenses or dentures. PRIFTIN 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.

If you experience any of the following after or while you are taking PRIFTIN, tell your doctor or health care provider immediately:

• If you experience symptoms of a hypersensitivity (allergic) reaction after taking PRIFTIN, e.g. low blood pressure, hives, swelling of the face, lips, tongue or throat, difficulty breathing, red eyes or 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). These may be symptoms of a serious allergic reaction and you must immediately stop taking PRIFTIN and go to the casualty department at your nearest hospital (see Possible side effects).
• PRIFTIN may cause serious liver problems. Stop taking PRIFTIN and call your doctor right away if you have any of the following signs and symptoms of liver problems: nausea, vomiting, stomach pain, loss of appetite, tiredness, yellowing of the skin or whites of your eyes, dark urine (see Possible side effects).
• Severe skin problems such as Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with the use of PRIFTIN.

Do not share medicines prescribed for you with any other person. Always take PRIFTIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• PRIFTIN 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, e.g. your treatment will be monitored weekly by visiting your local clinic, hospital or nurse and they will make sure that 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 PRIFTIN and your other TB medicine (isoniazid). Do not skip doses. Skipping doses may cause PRIFTIN to not work as well and may increase the chance that your TB will not be treatable by PRIFTIN or other medicines.
• Take PRIFTIN 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 PRIFTIN tablets.
• If you cannot swallow PRIFTIN tablets whole, they can be crushed and mixed with a small amount of semisolid food. Be sure to take all of the semisolid food with PRIFTIN in it immediately.

If you take more PRIFTIN than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Always take the labelled medicine package with you, whether there are any PRIFTIN tablets left or not.

If you forget to take PRIFTIN: Since your weekly dose of PRIFTIN will be given to you via directly observed therapy (DOT) which includes a visit to, for example, your local clinic or hospital, it is unlikely that you will forget to take a dose. However, if you have missed the visit to your local clinic or hospital, visit them as soon as possible and do not skip the whole week until the next appointment.

PRIFTIN can have side effects. Not all side effects reported for PRIFTIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PRIFTIN, please consult your health care provider for advice.

If any of the following happens, stop taking PRIFTIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Frequent: Hypersensitivity (allergic) reaction: this may present as a sudden life-threatening allergic reaction and the signs may include low blood pressure, hives, swelling of the face, lips, tongue or throat, difficulty breathing, red eyes or flu-like syndrome (see below).
• Less frequent: 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 PRIFTIN).
• 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 PRIFTIN).
• Diarrhoea called Clostridium difficile -associated diarrhoea (CDAD) which may occur during or after taking PRIFTIN. The severity of CDAD can range from mild diarrhoea to severe diarrhoea that may cause death (fatal colitis) (see Take special care with PRIFTIN).
• 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). These are all very serious side effects. If you have them, you may have had a serious reaction to PRIFTIN. 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:

• Less frequent: influenza (flu)
• upper abdominal pain
• skin reaction
• pain in one or more muscles (myalgia)
• chills
• fever
• abnormal physical weakness or lack of energy (asthenia).

Frequency unknown: SJS including the following symptoms: 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).

DRESS including the following symptoms: 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). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Less frequent: headache
• fatigue or extreme tiredness
• irritation of the oesophagus (the tube that carries food from your throat down to your stomach).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can report any side effects directly to Sanofi’s Pharmacovigilance Unit at [email protected] (email) or 011 256 3700 (tel). 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.

• Store at or below 30 °C.

• Protect from excessive heat and humidity.

• Do not expose the tablets to direct sunlight and do not remove the tablets from the blister strips until ready for use in order to protect them from excessive heat and moisture.

• STORE ALL MEDICINE OUT OF REACH OF CHILDREN.

• Do not use after the expiry date stated on the label.

• Return all unused medicine to your pharmacist.