Lamprene ® 100 mg Capsules

LAMPRENE 50/100 mg soft gelatin capsules is an anti-mycobacterial medicine that stops the growth of mycobacteria in the body and/or eventually kills them. LAMPRENE 50/100 mg soft gelatin capsules is used to treat leprosy and is given together with other medicines for leprosy. LAMPRENE 50/100 mg soft gelatin capsules should never be used alone for the treatment of leprosy. Multidrug therapy (MDT) is necessary to prevent the emergence of drug resistance.

Multidrug resistant Tuberculosis (MDR-TB): LAMPRENE 50/100 mg soft gelatin capsules is used in the treatment of pulmonary multidrug-resistant tuberculosis, MDR-TB in adults and children 10 years and older including, rifampicin resistant tuberculosis (RR-TB). It is used in combination with anti-TB medicines.

Follow all the doctor’s instructions carefully. Do not take LAMPRENE 50/100 mg soft gelatin capsules:

• if you are hypersensitive or allergic to clofazimine or any of the other ingredients of LAMPRENE 50/100 mg soft gelatin capsules;
• If you are allergic (hypersensitive) to peanuts or soya, do not use LAMPRENE 50/100 mg soft gelatin capsules since it contains soybean oil;
• 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).

If any of these apply to you, tell your doctor without taking LAMPRENE 50/100 mg soft gelatin capsules. If you think you may be allergic, ask your doctor for advice.

Warnings and precautions:

• If you have frequent stomach pain
• If you have continuous diarrhoea or vomiting
• If you have heart, liver or kidney disease
• If you have hepatitis B or C
• If you are pregnant or breastfeeding your baby
• If you are taking QT-prolonging medicines such as bedaquiline, fluoroquinolones, delaminid, azithromycin, rilpivirine, lopinavir, atazanavir, nelfinavir, saquinavir.

If any of these apply to you, tell your doctor before taking LAMPRENE 50/100 mg soft gelatin capsules.

Do not share medicines prescribed for you with any other person. It may harm them. Always take LAMPRENE 50/100 mg soft gelatin capsules exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Do not exceed the recommended dose.

It is very important to keep taking LAMPRENE for the full treatment period, even if you begin to feel better after a few months. You may have to take it regularly for as long as 12 months, as prescribed by your doctor. If you stop taking LAMPRENE too soon, your symptoms may return.

Your doctor will prescribe the correct dosage for you, if there is uncertainty consult your doctor.

How much LAMPRENE 50/100 mg soft gelatin capsules to take

LAMPRENE 50/100 mg soft gelatin capsules should only be taken if prescribed by your doctor. He or she will tell you exactly how many capsules of LAMPRENE 50/100 mg soft gelatin capsules to take.

Leprosy: For the treatment of leprosy, adult patients usually take 300 mg LAMPRENE 50/100 mg soft gelatin capsules under supervision once a month and 50 mg LAMPRENE 50/100 mg soft gelatin capsules once daily, together with other medicines against leprosy. Children (10 to 14 years) usually take 150 mg LAMPRENE 50/100 mg soft gelatin capsules 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 patients 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.

When to take LAMPRENE 50/100 mg soft gelatin capsules: LAMPRENE 50/100 mg soft gelatin capsules work best when there is a constant amount of the active substance in the blood. To help keep the amount constant, do not miss any doses.

If you take more LAMPRENE 50/100 mg soft gelatin capsules 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. Show the pack of LAMPRENE 50/100 mg soft gelatin capsules. Medical treatment may be necessary.

If you forget to take LAMPRENE 50/100 mg soft gelatin capsules: If you have forgotten to take a dose of LAMPRENE 50/100 mg soft gelatin capsules as scheduled, take it as soon as you remember and then go back to your normal dosing schedule. However, if it is almost time for the next dose, do not take a double dose of LAMPRENE 50/100 mg soft gelatin capsules to make up the one that you missed and continue your treatment as usual.

How long to take LAMPRENE 50/100 mg soft gelatin capsules: It is very important to keep taking LAMPRENE 50/100 mg soft gelatin capsules for the full treatment period, even if you begin to feel better after a few months. You may have to take it regularly for as long as 12 months, as prescribed by your doctor. If you stop taking LAMPRENE 50/100 mg soft gelatin capsules too soon, your symptoms may return. Continue taking LAMPRENE 50/100 mg soft gelatin capsules as your doctor tells you. If you have questions about how long to take LAMPRENE 50/100 mg soft gelatin capsules, talk to your doctor or your pharmacist.

LAMPRENE 50/100 mg soft gelatin capsules can have side effects. Not all side effects reported for LAMPRENE 50/100 mg soft gelatin capsules are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LAMPRENE 50/100 mg soft gelatin capsules, please consult your doctor, pharmacist or other healthcare professional for advice.

Some effects could be serious: You could experience heart rhythm disturbances e.g.

• Irregular heartbeat (fast or slow)
• Dizziness and/or fainting
• Shortness of breath
• Severe tiredness
• If the skin and hair discolouration has a serious impact on your quality of life and makes you feel depressed
• If you experience upper stomach pain (you may also have fever, chills, chest and left shoulder pain, feel nauseous or vomit)
• If you have a blurred or cloudy vision
• If you have a bowel obstruction (blockage)
• If you have black stools (symptoms of stomach or intestine bleeding)
• If you feel generally unwell, nauseous, vomit, experience a loss of appetite, fever (symptoms of hepatitis)
• If you have serious skin reactions with flaking or peeling

If you experience any of these, tell your doctor straight away.

Some side effects are frequent:

• Reddish to dark-brown discolouration of the skin, hair and eyes (reversible)
• Discolouration of sweat, saliva, tears, urine and stools
• Gastrointestinal disorders (nausea, vomiting, diarrhoea)
• Stomach pain or discomfort
• Dry, rough or scaly skin
• If any of these affects you severely, tell your doctor.
• Dry, burning, itching, or irritated eyes
• Eyesight problems
• Skin rash and itching
• Weight loss
• If any of these affects you severely, tell your doctor.

Some side effects are less frequent:

• Headache
• Loss of appetite
• Increased sensitivity of the skin when exposed to sunlight
• Acne-like skin reactions
• Tiredness
• Swollen lymph nodes
• Dizziness
• Constipation
• Jaundice (yellowing of the skin and eyes)
• Fever

If any of these affects you severely, tell your doctor. If you notice any other 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 side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of LAMPRENE 50/100 mg soft gelatin capsules.

Store at or below 25 °C in the original package. Protect the capsules from moisture and heat. Store all medicines out of reach of children. Remember to take back any unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Do not use after the expiry date shown on the box.