RIFABACT

SCHEDULING STATUS:

S4

RIFABACT (FILM-COATED TABLETS)

Each tablet contains:
Rifampicin 150 mg
Isoniazid 75 mg
Pyrazinamide 400 mg
Ethambutol 275 mg.
Sugar Free

WHAT RIFABACT IS AND WHAT IT IS USED FOR:

RIFABACT belongs to a group of medicines called antituberculosis medicines. RIFABACT works by killing the bacteria that causes tuberculosis and therefore is a medicine used to treat TB. It is important that you take your medicine on a daily basis and complete the treatment.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIFABACT

Do not take RIFABACT:

• If you are allergic (hypersensitive) to RIFABACT or to any of the ingredients. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue (see POSSIBLE SIDE EFFECTS).
• If you have any kind of liver disease.
• If you suffer from any eye disease e.g. optic neuritis (eye nerve damage which may cause pain and loss of vision in the eye).
• If you are an alcoholic or are in remission.Do not take RIFABACT :
• You suffer from porphyria (a hereditary condition causing your skin to blister or darken the colour of your urine).
• If the patient is a child under 13 years of age.
• If you suffer from acute gout (pain or swelling in the joint).
• You are taking any protease inhibitor, including saquinavir, lopinavir, tipranavir, darunavir, atanzanavir, nelfinavir, indinavir or ritonavir for an HIV infection.
• You are taking voriconazole (used for fungal infections).

Tell your doctor before taking RIFABACT if:

• You have liver problems including hepatitis (inflammation of the liver), especially if you are aged over 35 years or are elderly as your doctor may need to monitor your liver enzymes in your blood more carefully.
• You have kidney problems.
• You have problems with your eyes or eyesight.
• You have weakness, numbness and pain, usually in your hands and feet, but also in other areas of your body (peripheral neuropathy). If you are underweight or malnourished, an alcoholic, pregnant, elderly, have kidney problems, or suffer from HIV infection, you may be at risk to develop peripheral neuropathy. Your doctor may advise that you use pyridoxine (vitamin B6) to prevent or treat this.
• You have or have ever had gout (pain or swelling in the joints) and if you are using medicine to treat gout.
• You have previously had ‘fits’ or suffer from epilepsy.
• You have or have ever had mental health problems (such as depression, schizophrenia or psychosis).
• You have diabetes. Your diabetes may become more difficult to control while taking this medicine.
• You are using oral contraceptives (birth control tablets). RIFABACT may make oral contraception (‘the Pill’) less effective and it is important that you use an alternative barrier method of contraception or the ‘coil’ whilst taking RIFABACT. If you have any questions or are unsure about this, talk to your doctor, pharmacist or other healthcare professional.
• You are using anticoagulants (medicines to thin your blood e.g. warfarin) (also see: Taking other medicines with RIFABACT).
• You drink alcohol every day or you are an alcoholic.
• You develop or have previously developed thrombocytopenic purpura (easy or excessive bruising and superficial bleeding into the skin causing a rash of pinpoint sized reddish-purple spots) after using RIFABACT or rifampicin.
• You wear contact lenses. Taking RIFABACT may permanently stain soft contact lenses (see: Important information about some of the ingredients of  RIFABACT.
• If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking RIFABACT.

Take special care with RIFABACT:

• It is very important that you take RIFABACT exactly as your doctor has told you. There is a chance of you developing a severe and dangerous allergic reaction if you do not take RIFABACT each day as you are told. You must keep taking RIFABACT until your doctor tells you to stop.
• While taking RIFABACT you must visit your doctor at least once a month. Tell your doctor if you experience any problems with your RIFABACT treatment.
• Blood tests: Your doctor will need to check your blood before you take RIFABACT. This will help your doctor to know if any changes happen to your blood after taking RIFABACT. You may also need to have regular blood tests to check how your liver is working especially if you are older than 35 years of age, suffer from chronic liver disease of use drink alcohol regularly.
• Eye tests: Your doctor may suggest that regular eye tests are performed while using RIFABACT. Inform your doctor immediately if you experience any visual disturbances.
• RIFABACT may make your teeth and body fluids (urine, sweat, sputum and tears) a yellow, orange, red or brown colour. Do not worry – this is normal and not harmful. Teeth may be stained permanently. (See POSSIBLE SIDE EFFECTS and Important information about some of the ingredients of RIFABACT.)

Children:
Do not give RIFABACT to children under 13 years of age.

HOW TO TAKE RIFABACT

Adults and children over 13 years:

Do not share medicines prescribed for you with any other person.

Always take RIFABACT exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Treatment is based on the patients’ body weight and should be taken daily for the 2-month initial phase:

RIFABACT tablets should be taken with a full glass of water 1 hour before or 2 hours after a meal. If gastrointestinal irritation occurs, the tablets may be taken with food. Antacids, if required, should only be taken one hour after taking RIFABACT.

If you take more RIFABACT than you should:

Too much RIFABACT can cause side effects to occur. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison center.

If you forget to take RIFABACT:

If you have missed a dose of RIFABACT, take it as soon as you remember. However if it is almost time for your next dose, skip the missed dose and go back to your regular scheduling. Do not take a double dose to make up for forgotten individual doses.

If you stop taking RIFABACT

Always keep taking the tablets until the course is finished, even if you feel better. If you stop taking the tablets too soon, the infection may come back. Also, the bacteria may become resistant to the medicine, making it more difficult to treat the infection.

Possible Side Effects

RIFABACT can have side effects.

Not all side effects reported for RIFABACT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RIFABACT please consult your doctor, pharmacist or other health care professional for advice

If you have any of the following symptoms of a severe allergic reaction, stop taking this medicine and tell your doctor or healthcare provider immediately or go to the casualty department at your nearest hospital:

• Serious allergic reactions. Signs may be: a rash, swelling of your lips, face, throat or tongue which may cause swallowing or breathing problems, wheezing or collapse.
• You have a fever and yellowing of the skin or whites of the eyes, feel tired, weak or generally unwell, loss of appetite (anorexia), feel sick (nausea), being sick (vomiting). These may be early signs of liver problems.
• Blistering, peeling, bleeding, scaling or fluid-filled patches on any part of your skin. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may have a serious skin problem (pemphigoid).
• Severe extensive skin damage, e.g. separation of the epidermis and superficial mucous membranes (known as toxic epidermal necrolysis).
• Fever, unexplained tiredness or shortness of breath, cough, swollen glands, muscle pains, diarrhoea, a full feeling quickly while eating or a rash or itching, or liver problems (these may be symptoms of ‘DRESS syndrome’, a medicine hypersensitivity reaction which affects your internal organs, and increase the white cells in your blood).
• Blistering of the skin, mouth, eyes and genital area, red/purple rash, fever, headache, cough and joint pain (Stevens-Johnson syndrome).
• Blood in your urine or an increase or decrease in the amount of urine you produce. You may also get swelling, especially of the legs, ankles or feet, but also in any area of the body. This may be caused by serious kidney problems.
• A sudden severe headache. This could be a sign of bleeding in the brain.
• Shortness of breath and wheezing.
• You get confused, sleepy, cold clammy skin, shallow or difficult breathing, a racing heartbeat or your skin is paler than normal. These could be signs of shock.
• Abnormal blood clotting (signs may be chest pains, shortness of breath, leg pains or problems speaking) or bleeding from your nose, ear, gums, throat, skin or stomach (signs may include a feeling of tenderness and swelling in your stomach, purple spots on your skin and black or tar-like stools).

Less frequent:

Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis).
These are all very serious side effects. If you have them, you may have had a serious allergic reaction or side effect to RIFABACT. 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:
Frequent:

• Bruising more easily than usual or you may have a rash of dark red spots under the skin which do not go away when you press on them (purpura). These may be signs of blood disorders (e.g. thrombocytopenia) which are determined by blood tests.
• Weakness, numbness, pricking, tingling or pain, usually in your hands and feet, but also in other areas of your body (peripheral neuropathy). Your doctor may advise that you use pyridoxine (vitamin B6) supplement to prevent or treat this (see: Tell your doctor or pharmacist before taking RIFABACT.

Frequency unknown:

The following symptoms of blood disorders which your doctor may determine with blood tests:

• Getting infections more easily than normal, fever, sore throat, mouth ulcers or tiredness (low or abnormal number of white blood cells in your blood).
• Chills, tiredness, unusually pale skin colour, shortness of breath, fast heartbeat or dark coloured urine (low number of certain blood cells, e.g. red blood cells).
• Weight loss, night sweats and fever (eosinophilia).
• Immune system problems with symptoms that include tiredness, joint pain and skin rashes (called lupus-like syndrome).
• Mental problems with unusual thoughts and strange visions (hallucinations).
• Your stomach ulcer gets worse.
• Severe watery diarrhoea that will not stop and you are feeling weak and have a fever (called pseudomembranous colitis).
• Your fits get worse or you start to have fits.
• Flu-like symptoms including chills, fever and bone pains, including shortness of breath and wheezing.
• Vision problems such as loss of eyesight, distorted or reduced eyesight.
• These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you have any of the following:

Frequent:

feeling sick (nausea) or being sick (vomiting)

fever or chills

diarrhoea.

Less frequent:

• eye irritation or disturbances in your vision
• wollen glands.

Frequency unknown:

• headache
• dizziness
• feeling drowsy or sleepy
• movement problems such as loss of full control of bodily movements and may affect your manner of walking (ataxia)
• confusion or disorientation
• loss of feeling (numbness)
• unusual skin sensations such as feeling numb, tingling, pricking, burning or creeping on the skin (paraesthesia)
• memory loss
• vertigo (feeling off balance or as if your head is spinning)
• memory problems, diarrhoea, scaly skin rash – this may be due to vitamin B3 deficiency (pellagra)
• inflammation in your blood vessels (vasculitis)
• loss of appetite
• blurred vision
• skin flushing
• skin rash or itching
• blotchy red skin rash (erythema multiforme)
• skin conditions (including acne, lumpy red rash, hives, red/purple skin discolouration (purpura), itching and skin scaling)
• sensitivity of your eyes or skin to sunlight (photosensitivity)
• hair loss
• a yellow, orange, red or brown discolouration of your teeth, urine, sweat, phlegm (sputum), saliva or tears. This is quite common and you need not worry. However, the red colour may permanently stain soft contact lenses. The red colour in tears may last for some time after you have stopped having RIFABACT, while the discolouration of the teeth may be permanent.
• chronic or recurrent stomach pain (which may sometimes be alleviated by food)
• dry mouth
• metallic taste
• constipation
• muscle weakness or pain, loss of muscle reflexes, bone pain
• general feeling of discomfort or illness (malaise)
• irregular periods
• breast enlargement in men
• water retention (oedema) which may cause swollen face, stomach, arms or legs, fingers, toes or ankles
• lowering of blood pressure (which may make you feel lightheaded and faint, especially when you stand or sit up quickly)
• blood tests may show changes in the way your liver or kidneys are working
• feeling very tired and weak
• joint pains
• gout (inflammation of the joints caused by high levels of uric acid crystals). Symptoms include red, tender, hot, swollen and painful joints (inflamed joints). The big toe is often involved, but other joints may also be involved.
• pain or discomfort when passing urine or unable to pass urine
• increased thirst, urgency to pass water more often, feeling tired. Your blood sugar may be high.

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

Reporting of side effects
If you get side effects, talk to your doctor or pharmacist. 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 RIFABACT.

HOW TO STORE RIFABACT

Store at or below 30°C.
Protect from moisture and light
Keep out of reach of children

CONTENTS OF THE PACK AND OTHER INFORMATION

What RIFABACT contains

The active ingredients of RIFABACT are:

Rifampicin 150 mg, Isoniazid 75 mg, Pyrazinamide 400 mg, Ethambutol hydrochloride 275 mg

The other ingredients are:

Colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, maize starch, microcrystalline cellulose, purified talc and sodium starch glycolate, hydroxypropyl methylcellulose, iron oxide red, polyethylene glycol, purified talc and titanium dioxide.

What RIFABACT looks like and contents of the pack

RIFABACT are pinkish-brown, oblong, biconvex, film-coated tablets with a break-line on one side, supplied as:

Polypropylene bag, packed together with a silica gel desiccant in a white square HDPE bottle with aluminium induction seal and white polypropylene cap.

Pack size of 500 and 1000 tablets will be packed.

Red PVDC/aluminium blisters of 28 tablets. Pack sizes of 28, 56, 84, and 112 tablets will be packed.

Holder of Certificate of Registration

Epiglo Pharmaceuticals (Pty) Ltd
Allandale Building First Floor
23 Magwa Crescent
Waterfall City
Gauteng
1685

This leaflet was last revised in:

24/11/2020

Registration Number:

42/20.2.3/0682

Access to the corresponding Professional Information

The Professional Information may be found in the packaged product.