Clofazimine 50 mg/100 mg Film-Coated Tablets

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

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

Do not take CLOFAZIMINE TABLETS MACLEODS:

• if you are hypersensitive (allergic) to Clofazimine or to any of the ingredients of CLOFAZIMINE TABLETS MACLEODS.
• 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 CLOFAZIMINE TABLETS MACLEODS:

• CLOFAZIMINE TABLETS MACLEODS 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 CLOFAZIMINE TABLETS MACLEODS inform your doctor or pharmacist.
• CLOFAZIMINE TABLETS MACLEODS 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 CLOFAZIMINE TABLETS MACLEODS, 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.
• CLOFAZIMINE TABLETS MACLEODS 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.
• CLOFAZIMINE TABLETS MACLEODS 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 CLOFAZIMINE TABLETS MACLEODS 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.

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

• Always take CLOFAZIMINE TABLETS MACLEODS 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 CLOFAZIMINE TABLETS MACLEODS will last. Do not stop treatment early.

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

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

• CLOFAZIMINE TABLETS MACLEODS 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 CLOFAZIMINE TABLETS MACLEODS under supervision once a month and 50 mg CLOFAZIMINE TABLETS MACLEODS once daily, together with other medicines against leprosy. Children (10 to 14 years) usually take 150 mg CLOFAZIMINE TABLETS MACLEODS 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.

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

If any of the following happens, stop taking CLOFAZIMINE TABLETS MACLEODS 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 CLOFAZIMINE TABLETS MACLEODS.

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).