| Anti-Rheumatic Drug, Antimicrobial |
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Leflunomide
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| INFORMATION FOR USE OF A MEDICALPRACTITIONER, HOSPITAL OR LABORATORY |
| Each film-coated tablet contains Leflunomide 10mg |
PHARMACOLOGICAL CLASSIFICATION |
| Anti-Rheumatic Drug (disease-modifying anti-rheumatic drug"-DMARD) |
| ARTHO TECH is an isoxazole immunomodulatory agent which inhibits dihydroorotate dehydrogenase (an enzyme involved in de novo pyrimidine synthesis) and has antiproliferative activity. Several in vivo and in vitro experimental models have demonstrated an anti-inflammatory effect. |
Following oral administration, ARTHO TECH is metabolized to an active metabolite A77 1726 (hereafter referred to as M1) which is responsible for essentially all of its activity in vivo. Plasma levels of Leflunomide are occasionally seen, at very low levels. Studies of the pharmacokinetics of Leflunomide have primarily examined the plasma concentrations of this active metabolite. |
ARTHO TECH is indicated for the treatment of adult patients with: |
| • Active rheumatoid arthritis as a "disease-modifying anti-rheumatic drug" (DMARD) • Active psoriatic arthritis |
BEFORE YOU TAKE ARTHO TECH |
Make sure you have told your doctor if you: |
· are pregnant, trying for a baby or breast-feeding · suffer from liver or kidney problems · suffer from blood pressure problems · have ever suffered from tuberculosis |
| · suffer from blood or bone marrow disorders such as anaemia, leucopenia or thrombocytopenia · have ever had an allergic reaction to this or any other medicine · are taking any other medicines, including those available to buy without a prescription, herbal and complementary medicines |
You must take your medicine as the doctor tells you. It is important to take ARTHO TECH Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. The usual doses for adults are The dose is 10 or 20mg daily orally once a day. Clinical improvement usually starts after 4 to 6 weeks. Further improvement may be seen after 4 to 6 months. Lower doses may be advisable in the elderly. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally. Do not take a double dose to make up for the dose that you missed. If you miss more than one dose, or you are not sure what to do, ask your doctor or pharmacist.
WHAT TO DO IF AN OVERDOSE IS TAKEN |
In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department.In general, an overdose may lead to increased symptoms as described under side effects. In the event of overdose, special drug treatment may be administered by your doctor in order to speed up the elimination of ARTHO TECH from your body. If you are taking Tolbutamide, Phenytoin or Warfarin, you will need additional monitoring to ensure that your blood levels remain stable. You can continue to take: |
| · The contraceptive pill.· Pain killers and non-steroidal anti-inflammatory drugs prescribed for you. |
Like all medicines, ARTHO TECH can sometimes cause unwanted side effects. If the following happens, stop taking ARTHO TECH and tell your doctor immediately. |
· Mild to moderate diarrhea
| · Rash or itchy skin.· Mild to moderate hair loss. This will resolve when treatment is stopped.· Raised blood pressure.· Headache.· Nausea.· Heartburn or stomach discomfort.· Mouth ulcers. |
| · Keep all medicines out of the reach of children. · Store in a cool dry place, away from direct heat and light. |
| Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice. |
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