Fripnit Plus 300 mg Film-Coated Tablets

FRIPNIT PLUS 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. FRIPNIT PLUS should not be used in people with active TB.

Do not take FRIPNIT PLUS

• if you are hypersensitive (allergic) to rifapentine, other rifamycins (e.g. rifampicin, rifabutin), isoniazid, ethionamide, pyrazinamide (used for TB), niacin (vitamin B 3), or other chemically-related medicines or to any of the ingredients of FRIPNIT PLUS (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
• alcoholism
• in patients with severe kidney failure
• if you have uncontrolled seizures
• if you are pregnant and breastfeeding
• if you are currently on antiretroviral therapy.

Warnings and precautions

Take special care with FRIPNIT PLUS

Tell your doctor or healthcare 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 FRIPNIT PLUS)
• take other medicines to treat HIV infection or take oral contraceptives as taking these medicines with FRIPNIT PLUS may make them less effective (see Other medicines and FRIPNIT PLUS)
• take 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 FRIPNIT PLUS 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 FRIPNIT PLUS)
• wear contact lenses or dentures. FRIPNIT PLUS 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.
• have diabetes as your diabetes may become more difficult to control while taking this medicine
• have epilepsy
• have or have ever had mental health problems (such as depression or schizophrenia)
• have any kidney problems

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

FRIPNIT PLUS should be taken once-weekly 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 FRIPNIT PLUS and any other TB medicine regularly and you do not skip doses. Missing doses may cause FRIPNIT PLUS to not work as well and may increase the chance that your TB will not be treatable by FRIPNIT PLUS or other medicines.

Take FRIPNIT PLUS with food. Take FRIPNIT PLUS with food if you suffer with stomach problems. This may help prevent nausea, vomiting or stomach upsets due to the medicine. It is preferable to take antacids at least 1 hour before or 2 hours after your dose of FRIPNIT PLUS 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 semisolid food with FRIPNIT PLUS crushed into it.

Your doctor will tell you how long your treatment with FRIPNIT PLUS will last. If you have the impression that the effect of FRIPNIT PLUS is too strong or too weak, tell your doctor or pharmacist.

If you take more FRIPNIT PLUS 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.

If you forget to take FRIPNIT PLUS

Since your weekly dose of FRIPNIT PLUS will be given to you via directly observed therapy (DOT), meaning you will visit, 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 for your dose. Do not skip the whole week until the next appointment.

If you stop taking FRIPNIT PLUS

Withdrawal symptoms, which may occur, include headache, insomnia, excessive dreaming, irritability and nervousness.

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

If any of the following happens, stop using FRIPNIT PLUS 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

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to FRIPNIT PLUS. 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 FRIPNIT PLUS)
• hepatitis (inflammation of the liver) and other liver problems including jaundice and liver failure (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 FRIPNIT PLUS)
• 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/ toxic epidermal necrolysis (TEN)) 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)
• skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious skin allergy called ‘erythema multiforme’
• peripheral neuritis or neuropathy, a result of damage to the nerves outside of the brain and spinal cord (peripheral nerves), often causes weakness, numbness and pain, usually in your hands and feet
• neurotoxicity- damage to brain or peripheral nervous system (this can alter the activity of the nervous system in ways that can disrupt or kill nerves).
• convulsions (fits)
• lupus-like syndrome: drug-induced lupus erythematosus (DIL) is a subset of lupus defined as a lupus-like syndrome that develops in temporal relation when you have taken some kind of medicine and resolves after you stop taking the medicine
• severe inflammation of the entire skin surface (exfoliative dermatitis)
• rheumatic diseases are characterized by inflammation that affects the connecting or supporting structures of the body (most commonly the joints, but also sometimes the tendons, ligaments, bones, and muscles) arthritis
• hepatitis and hepatitis prodromal symptoms (loss of appetite, nausea or vomiting, unusual tiredness or weakness)
• blood disorders which may make you more likely to get infections, get tired very easily, or bruise very frequently
• chills, tiredness, unusually pale skin colour, shortness of breath, fast heartbeat or dark coloured urine. These could be signs of a serious type of anaemia
• you bruise more easily than usual. Or you may have a painful rash of dark red spots under the skin which do not go away when you press on them (purpura). This could be because of a serious blood problem

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

Tell your doctor if you notice any of the following:

Frequent side effects:

• increase in liver enzymes
• nausea, vomiting, constipation, upper abdominal pain, dry mouth, stomach irritation

Less frequent side effects:

• influenza (flu)
• headache
• skin rash/reaction, hair loss and swelling of skin
• muscle pain
• high blood sugar levels (although you may not notice any symptoms)
• acidosis (upset of the acid balance in the body) which may make you feel or be sick, be drowsy or have breath that smells of “pear drops”
• overactive reflexes (being jumpy and overreacting)
• dizziness or feeling if the room is spinning round (vertigo)
• gynaecomastia (increased size of breasts in men)
• inflammation of an optic nerve, causing blurred vision
• pellagra (a disease caused by a lack of vitamin B 3 with symptoms including inflamed skin, diarrhoea, dementia, and sores in the mouth, constipation, dry mouth)
• acne-like eruptions
• difficulty passing urine.

The following side effects have been reported but the frequency for them to occur is not known:

• 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 side effects, talk to your doctor, pharmacist or nurse. You can also report any side effects to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FRIPNIT PLUS. You can also send an email directly to the company, [email protected] to ensure safety of the product.

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).