INTRODUCTION

HANSEPRAN contains Clofazimine which belongs to the group of medicines called Antimycobacterial agents. It is used to treat lepromatous leprosy (including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum) in combination with other anti-leprosy drugs.

Leprosy is a chronic and contagious infection caused by mycobacterium leprae which affects the skin, nerves outside the brain and spinal cord including upper respiratory tract’s mucosa, and eyes. It is generally characterized by symptoms such as discoloured skin patches with loss of sensations, numbness or tingling sensation (in hands, feet, arms and legs), painless wounds/burns (typically on hands and feet) and muscle weakness.

HANSEPRAN is not recommended for use if you have a personal or family history of heart disease such as congenital long QT syndrome (a type of hereditary heart disease). It should be used with caution in patients with frequent stomach pain, continuous vomiting or diarrhoea, hepatitis B or C (liver infection), liver, kidney or other heart problems. HANSEPRAN should be used with caution in pregnant women and it is not recommended for use in breastfeeding women.

HANSEPRAN is recommended for use in children and adolescents (aged 10 to 14 years) and it should be used with caution in children (aged below 10 years). Also, it should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking HANSEPRAN. The common side effects associated with the use of HANSEPRAN are reversible reddish dark-brown discolouration of skin, hair and eyes, discolouration of body fluids (such as sweat, saliva, tears, urine, and stools), abdominal pain, diarrhoea, nausea, vomiting and dryness of skin. Consult your doctor if any of the symptom worsens.

USES OF HANSEPRAN

Used in combination with other anti-leprosy drugs to treat:

• lepromatous leprosy
• dapsone-resistant lepromatous leprosy
• lepromatous leprosy complicated by erythema nodosum leprosum

HOW HANSEPRAN WORKS

HANSEPRAN induces membrane dysfunction in the bacterial cell which also works by blocking the production of certain cells (responsible for causing inflammation) in the body that results in destruction of bacterial cell and prevention of inflammatory reaction in the body thus helps to treat lepromatous leprosy and its associated symptoms.

DIRECTIONS FOR USE

Take HANSEPRAN as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF HANSEPRAN

HOW TO MANAGE SIDE EFFECTS

Diarrhoea:

Drink lot of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhoea and consult your doctor if the symptom gets worse.

Nausea and vomiting:

Try to take HANSEPRAN with or just after a meal or a snack. Stick to simple meals. Avoid eating oily, fried or spicy foods. Consult your doctor if the symptom gets worse.

Itchy Skin:

Try to pat or tap your skin instead of scratching it. Hold a damp towel to cool your skin. Wear loose clothing and avoid tight clothes, or clothes made from wool or synthetic fabrics. Avoid using perfumed soaps, deodorants or moisturizers and use a skin softener regularly. Consult your doctor if the symptom gets worse.

Headache:

Apply hot or cold-water bag on your head. Try taking rest in a quiet and dark room. Apply pain relieving balm on your forehead if necessary. Drink sufficient amount of fluids and avoid skipping meals. Consult your doctor if the symptom does not improve.

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals and drink plenty of fluids. Exercise more regularly and stay active. Consult your doctor if the symptom gets worse.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interactions

Before taking HANSEPRAN, inform your doctor, if you are taking any of the following medicines:

• other medicines used to treat leprosy Ex. dapsone
• medicines used to treat tuberculosis and leprosy Ex. rifampicin, isoniazid, bedaquiline and delamanid
• azithromycin, clarithromycin and fluoroquinolones such as levofloxacin (used to treat bacterial infections)
• amprenavir, delaviridine, efavirenz, etravirine, indinavir, nelfinavir, raltegravir, rilpivirine, simeprevir, maraviroc (used to treat HIV infection)
• medicines to lower blood cholesterol levels Ex. simvastatin, lovastatin
• medicines used to treat high blood pressure Ex. losartan, verapamil, diltiazem, nitrendipine, amlodipine, nislodipine, nifedipine, eplerenone, felodipine, lercanidipine
• medicines to reduce blood sugar levels Ex. pioglitazone, repaglinide, saxagliptin
• phenytoin, fosphenytoin (used to control seizures)

Overdosage:

If you or anyone else accidentally takes too much of HANSEPRAN, consult your doctor immediately or visit the nearby hospital if you experience any unusual symptoms.

SYNOPSIS

MORE INFORMATION

• Keep HANSEPRAN out of reach of children
• Store HANSEPRAN at room temperature

FAQs ABOUT HANSEPRAN

What is HANSEPRAN used for?

HANSEPRAN is used to treat lepromatous leprosy (including dapsone-resistant lepromatous leprosy and complicated by erythema nodosum leprosum) which is a chronic and contagious infection caused by a mycobacterium leprae, generally characterized by symptoms such as discoloured skin patches, numbness or tingling sensation, painless wounds/burns (typically on hands and feet) and muscle weakness.

What common side effects are seen with the use of HANSEPRAN?

The common side effects associated with the use of HANSEPRAN are reversible reddish dark-brown discolouration of skin, hair and eyes, discolouration of body fluids (such as sweat, saliva, tears, urine and stools), abdominal pain, diarrhoea, nausea, vomiting and dryness of skin. Consult your doctor if any of the symptom worsens.

Who should avoid taking HANSEPRAN?

HANSEPRAN is not recommended for use if you are allergic to clofazimine, peanuts or soya. It is not recommended for use if you have a personal or family history of heart problem such as congenital long QT syndrome (a type of hereditary heart disease). Consult your doctor before taking HANSEPRAN.

How does HANSEPRAN work?

HANSEPRAN induces membrane dysfunction in the bacterial cell which also works by blocking the production of certain cells (responsible for causing inflammation) in the body that results in destruction of bacterial cell and prevention of inflammatory reaction in the body thus helps to treat lepromatous leprosy and its associated symptoms.

What if I forget to take HANSEPRAN dose?

You should take HANSEPRAN immediately when you remember. If it is time for your next dose skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.

When to stop taking HANSEPRAN?

It is very important to keep taking HANSEPRAN for the full treatment period, even if you start feeling better after a few months. If you stop taking HANSEPRAN on your own without consulting your doctor may increase the risk of symptoms of leprosy to recurs. Consult your doctor if any of the side effect bothers you to stop taking HANSEPRAN.

Can HANSEPRAN cause diarrhoea?

HANSEPRAN may cause diarrhoea in some individuals. To manage this effect, drink lot of fluids such as water to keep yourself hydrated. Also, avoid eating high fat or spicy foods. Do not take any medicine on your own to treat diarrhoea and consult your doctor if the symptom gets worse.

REFERENCES

1. KD. Tripathi. Antileprotic Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page 781.

2. A. B. A. Karat, Anbu Jeevaratnam, S. Karat, P. S. S. Rao. Controlled Clinical Trial of Clofazimine in Untreated Lepromatous Leprosy. NIH National Library of Medicine. National Centre for Biotechnology Information. PMC PubMed Central. November 1971. [Accessed on 3rd August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1799776/

3. R Ganapati, V V Dongre. Clinical trial with clofazimine in leprosy. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. October 1976. [Accessed on 3rd August 2022] https://pubmed.ncbi.nlm.nih.gov/1026807/

4. Novartis Pharmaceuticals Corporation. U.S Food and Drug Administration (FDA). [Revised in July 2016] [Accessed on 3rd August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019500s013lbl.pdf

5. Novartis South Africa (Pty) Ltd. Lamprene. South African Health Products Regulatory Authority (SAHPRA) [Revised in November 2019] [Assessed on 3rd August 2022] https://www.sahpra.org.za/wp-content/uploads/2020/06/Lamprene_PIL_Novartis_MCC-Format04-November-2019.pdf

USEFUL DIAGNOSTIC TESTS

• Skin biopsy
• Nerve biopsy