Tubramak 50 mg/100 mg Film-Coated Tablets

TUBRAMAK is used to treat tuberculosis (TB) when the disease has become resistant to other antibiotics. This is called multi-drug resistant pulmonary tuberculosis. TUBRAMAK is used together with other medicines for treating tuberculosis.

TUBRAMAK is also used for the treatment of leprosy (Hansen's disease) in combination with other antibiotic medicines dapsone and rifampicin.

Do not take TUBRAMAK:

• if you are hypersensitive (allergic) to Clofazimine or to any of the ingredients of TUBRAMAK.
• If you have a personal or family history of a heart problem called ‘congenital long QT syndrome’.
• If you are taking other medicines known to prolong QTc interval up to the time intervals known to cause serious heart rhythm disorders (dysrhythmias).

Warnings and precautions

Take special care with TUBRAMAK:

• TUBRAMAK may accumulate over time in the stomach lining causing obstruction, nausea, vomiting, stomach upset, diarrhoea, bleeding and even death. If you experience nausea, vomiting, stomach upset and diarrhoea while receiving TUBRAMAK inform your doctor or pharmacist.
• TUBRAMAK may cause abnormal discolouration of the conjunctiva, tear fluid, sweat, sputum, urine, faeces, sperm, breast milk, hair and reddish to dark brown discolouration of the skin. After you stop taking TUBRAMAK, your skin and eye colour should return to normal, however, this can take several months or years. If the discolouration becomes bothersome or makes you depressed or you have thoughts of suicide, please notify your doctor.
• TUBRAMAK can cause irregular heart rhythms (referred to as a prolongation of the QT- interval, diagnosed by your doctor on an ECG) alone or when taken in combination with other medicines that cause irregular heart rhythms.
• TUBRAMAK must be taken in combination with other medicines (rifampicin and dapsone) to treat leprosy. This is called multi drug therapy (MDT) to ensure that the bacteria causing leprosy does not develop resistance to treatment.
• Always take TUBRAMAK in combination with other medicines prescribed by your doctor to treat tuberculosis.

Take all your medicines for treatment of leprosy or tuberculosis regularly as prescribed by your doctor as poor compliance can delay healing or make it incomplete or you could become a source for infecting other people.

Other medicines and TUBRAMAK

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines).

Inform your doctor or pharmacist if you are taking any of the following:

• Rifampicin (used to treat tuberculosis or leprosy) - clofazimine in TUBRAMAK may reduce rifampicin absorption in leprosy patients.
• Dapsone (used to treat leprosy) – may reduce the anti-inflammatory activity of TUBRAMAK. If leprosy-associated inflammatory reactions develop when taking dapsone and TUBRAMAK, it is still advisable to continue treatment with both medicines.
• Isoniazid- If you are taking high doses of TUBRAMAK (150 mg daily) and isoniazid (300 mg daily), there may be higher than normal levels of clofazimine in your blood plasma and urine.
• TUBRAMAK may increase the QT interval of your electrocardiogram (ECG) causing heart rhythm disturbances. Tell your doctor if you think this is happening to you.
• QT prolonging medicines such as bedaquiline, azithromycin and fluoroquinolones. Caution is recommended when TUBRAMAK is taken with other medicines with known QT interval prolonging potential.
• Caution should be exercised when taking TUBRAMAK together with medicines such as TB medicines (bedaquiline, delamanid, clarithromycin), selected unboosted anti-retrovirals (amprenavir, delaviridine, efavirenz, etravirine, indinavir, nelfinavir, raltegravir, rilpivirine, simeprevir, maraviroc), medicines to lower your blood pressure and cholesterol (simvastatin, lovastatin, losartan, verapamil, diltiazem, nitrendipine, amlodipine, nislodipine, nifedipine, eplerenone, felodipine, lercanidipine), medicines to reduce blood sugar levels (pioglitazone, repaglinide, saxagliptin).

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

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

• Your doctor will tell you how long your treatment with TUBRAMAK will last. Do not stop treatment early.

• If you have the impression that the effect of TUBRAMAK is too strong or too weak, tell your doctor or pharmacist.

• Stay under a healthcare provider’s care when taking TUBRAMAK. Do not change your treatment or stop treatment without first talking with your healthcare provider.

• TUBRAMAK should be taken with food or with a glass of milk to ensure maximum absorption.

Leprosy:

For the treatment of leprosy, adult patients usually take 300 mg TUBRAMAK under supervision once a month and 50 mg TUBRAMAK once daily, together with other medicines against leprosy. Children (10 to 14 years) usually take 150 mg TUBRAMAK under supervision once a month and 50 mg every other day, together with other medicines against leprosy. For children less than 10 years, your doctor will decide on the most suitable dosage. Treatment of children below 10 years of age is possible only if dapsone tablets of 25 mg are commercially available.

Multidrug-Resistant (MDR) TB:

For the treatment of MDR-TB, adult’s patient weighing at least 30 kg, the recommended dosage is 100 mg/day and adults weighing less than 30 kg, the recommended dosage is 50 mg/day. Children (10 years of age and over) weighing at least 30 kg, usually are given 2-5 mg/kg/day, not exceeding 100 mg/day. For children weighing less than 30 kg, the recommended dosage is 2-5 mg/kg/day, not exceeding 50 mg/day. If a dose lower than 50 mg/day is required, the 50 mg dose can be given every other day.

If you take more TUBRAMAK 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. Symptoms of overdose may include a rapid heart rate of over 100 beats per minute leading to chest pain, fainting, dizziness and shortness of breath (torsade de pointes) and abnormal heart rhythm (QT prolongation).

If you forget to take TUBRAMAK

It is important to take your TUBRAMAK regularly as prescribed by your doctor. If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. In that case, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking TUBRAMAK

Take TUBRAMAK for as long as your doctor recommends. Do not stop taking TUBRAMAK unless your doctor tells you to. It is important that you complete the course of treatment even if you begin to feel better after a few days. If you stop taking TUBRAMAK too soon your infection may not be completely cured and the infection may return or your condition may get worse. The bacteria causing your infection may become resistant to TUBRAMAK.

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

If any of the following happens, stop taking TUBRAMAK 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. You may need urgent medical attention or hospitalization.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Feeling depressed with thoughts of suicide.
• Abnormal heart rhythm causing fainting and seizures (QT prolongation).
• Chest pain, fainting, dizziness and difficulty in breathing (symptoms of Torsades de pointe).
• General weakness, chills, fever, extreme exhaustion and development of infected ulcers in the mucous membranes that line the mouth, throat, and/or intestinal tract (symptoms that are associated with rapidly falling white blood cell levels (agranulocytosis))
• Vision problems (decreased sharpness or clarity of vision, loss of peripheral vision or “tunnel vision”, difficulty in adjusting to day and night vision).
• Bowel obstruction with symptoms of nausea or feeling sick, vomiting, abdominal pain or stomach pain and diarrhoea.
• Gastrointestinal bleeding (Bloody or black, tarry stools).
• Severe pain in the left upper quadrant of the abdomen due to crystals in spleen (Splenic infarction).
• Widespread scaling of the skin with itching, skin redness and hair loss (symptoms of exfoliative dermatitis).
• Metabolic acidosis (A condition in which too much acid accumulates in the body). Symptoms include nausea, vomiting, fast breathing and lethargy.

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

Tell your doctor if you notice any of the following:

Frequently occurring side effects:

• Staining of the conjunctiva and pigmentation of the cornea of the eye.
• Dryness of eyes and eye irritation
• Nausea (feeling sick), vomiting, abdominal pain or stomach pain, diarrhoea, stool discolouration
• Abnormal colour of sweat, skin discolouration, change of hair colour
• Dry, scaly or thickened skin, rash and itching
• Abnormal colouration of urine
• Colouring of breast milk
• Weight loss

Less frequently occurring side effects:

• Headache
• Dizziness
• Drowsiness (feeling sleepy)
• Significant vision loss due to colouration of the back of the eye
• Deposits on the protective layer of your eye (corneal deposits)
• Decreased tear production
• Irregular heartbeat
• Swelling of arms or legs
• Ejecting coloured mucus from the throat or lungs by coughing, hawking, or spitting.
• Hepatitis (inflammation of the liver), jaundice (yellowing of skin or white of eyes)
• Decreased appetite
• Inflammation of the intestine due to crystal deposition in the small intestine
• Taste disorders (reduced ability to taste)
• Pain or discomfort in the abdomen
• Constipation
• Increased sensitivity of the skin to the sun
• Acne like skin reaction with redness, swelling and small blisters resulting from direct irritation of the skin
• Fever
• Weakness and lack of energy
• Increased blood sugar levels

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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 TUBRAMAK.

Store all medicines out of reach of children.

Store at or below 30 ° C (room temperature).

Keep the blister in the carton until required for use.

Store all medicines out of reach of children.

Do not store in a bathroom.

Do not use after the expiry date stated on the label / carton / bottle.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).