Rumalef 100mg Tablet 3'S

Introduction About RUMALEF 100MG TABLET

RUMALEF 100MG TABLET contains Leflunomide which belongs to the group of
medicines called Anti-rheumatics. It is indicated in adults for the management
of active rheumatoid arthritis. Rheumatoid arthritis is an auto-immune chronic
inflammatory disorder which affects many joints including those in the hands and
feet. Symptoms include inflammation of joints, swelling, difficulty moving and
pain, loss of appetite, fever, loss of energy and anaemia (lack of red blood
cells).

RUMALEF 100MG TABLET is also used in adults to manage active psoriatic
arthritis. Active psoriatic arthritis refers to a condition where psoriasis, a
skin condition is present along with arthritis. Symptoms include inflammation of
joints, swelling, difficulty in moving, pain and patches of red and scaly skin
(skin lesions).

Before starting management with RUMALEF 100MG TABLET, your doctor might ask you
to take a few blood tests to understand the existing condition and to use this
medicine safely.

RUMALEF 100MG TABLET is not recommended for use in patients having liver or
moderate to severe kidney disease, any problem which affects the immune system
(like AIDS), bone marrow problems, serious infections, severely low levels of
proteins in the blood (hypoproteinaemia) and reduced levels of white or red
blood cells and platelet count.

RUMALEF 100MG TABLET should be used with caution in patients who have
interstitial lung disease, tuberculosis and if you are a male who wishes to
father a child and chronic diarrhoea. Avoid consum
management with this medicine as it may increase the risk of liver damage.

RUMALEF 100MG TABLET is not recommended for use in pregnant women or women who
become pregnant during management with this medicine and it is not recommended
for use in breastfeeding women. RUMALEF 100MG TABLET is not recommended for use
in children and adolescents (below 18 years of age).

The most common side effects of taking RUMALEF 100MG TABLET are loss of
appetite, tiredness, headache, dizziness, diarrhoea, nausea, vomiting,
inflammation of the mouth or mouth ulcers, abdominal pain and increased hair
loss. Consult your doctor if any of the side effects worsen.

Uses Of RUMALEF 100MG TABLET

Manages,

• active rheumatoid arthritis
• active psoriatic arthritis

How RUMALEF 100MG TABLET Works

RUMALEF 100MG TABLET acts by inhibiting an enzyme which results in stopping the
activated and autoimmune white blood cells. This inhibition leads to
anti-inflammatory and immunomodulatory effects, reducing inflammation due to
arthritis.

How to use RUMALEF 100MG TABLET

Take RUMALEF 100MG TABLET as advised by your doctor. 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 RUMALEF 100MG TABLET

Common

• mild allergic reactions
• loss of appetite, weight loss
• tiredness
• headache, dizziness
• abnormal skin sensations like tingling (paraesthesia)
• mild increase in blood pressure
• diarrhoea, inflammation of the colon
• nausea, vomiting
• mouth ulcers or swelling of the mouth
• abdominal pain
• increased hair loss
• eczema, dry skin, rash, itching
• tendonitis (pain in feet or hands caused by inflammation in the membrane surrounding the tendons)
• problems affecting the nerves of the arms or legs

Uncommon

• anxiety
• taste disturbances
• urticaria (nettle rash)
• tendon rupture

Rare

• severe increase in blood pressure
• inflammation of the lung (interstitial lung disease)
• hepatitis and jaundice (yellowing of the skin or white of the eyes)
• sepsis (severe infection)

Stop taking RUMALEF 100MG TABLET and contact your doctor immediately if you
experience any of the following side effects:

• serious allergic reaction (signs include weakness, light-headedness or dizziness or have difficulty breathing)
• skin rash and ulcers in the mouth (Drug Reaction with Eosinophilia and Systematic Symptoms (DRESS), stevens-johnson syndrome and toxic epidermal necrolysis)
• blood disorders (signs include pale skin, tiredness, bruising)
• signs of liver failure (signs include tiredness, abdominal pain and jaundice)
• signs of infection (signs include cough, fever and sore throat)
• coughing or breathing problems (signs include interstitial lung disease or pulmonary hypertension)
• signs of peripheral neuropathy (unusual tingling, weakness or pain in the hands or feet)

How To Manage Side Effects

Nausea or vomiting:

Stick to simple meals while taking this medicine. Avoid eating oily rich, fried
or spicy foods. Do not lie down or sleep immediately after eating. Consult your
doctor if the symptom does not improve.

Diarrhoea:

Drink lot of fluids, such as water to keep yourself hydrated. Avoid eating
high-fat or spicy foods. Try to avoid taking any medicine on your own to manage
diarrhoea and consult your doctor if the symptom gets worse.

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to have smaller meals more
frequently. Keep a heating pad on your stomach. If the symptom does not improve,
consult your doctor.

Headache:

Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to
be relaxed and stress-free. Apply pain relieving balm on your forehead if
necessary. Consult your doctor if the symptom does not improve.

Loss of appetite:

Eat when you feel hungry. Eat smaller meals frequently than usual. Snack only
when you're hungry. Eat a nutritious snack which is rich in calories and
protein, such as dried fruits and nuts. Consult your doctor if the symptom does
not improve.

Warning & Precautions

!### Pregnancy

RUMALEF 100MG TABLET is not recommended for use in pregnant women or women who
become pregnant during management with this medicine, as it may increase the
risk of serious birth defects in the baby. Women of childbearing potential
should not take RUMALEF 100MG TABLET without using reliable contrace
measures. If you plan to become pregnant after stopping management with this
medicine and it is necessary to ensure that all traces of the medicine have left
your body, this may take up to 2 years. Consult your doctor before taking
RUMALEF 100MG TABLET.

!### Breastfeeding

RUMALEF 100MG TABLET is not recommended for use in breastfeeding women as it
passes through the breast milk. Consult your doctor before taking RUMALEF 100MG
TABLET.

!### Driving and Using Machines

Do not drive or operate any machines if you feel dizzy after taking RUMALEF
100MG TABLET.

!### Alcohol

Avoid consum
increase the chances of liver damage.

!### Kidney

RUMALEF 100MG TABLET is not recommended for use in patients with moderate to
severe kidney problems. Consult your doctor before taking RUMALEF 100MG TABLET.

!### Liver

RUMALEF 100MG TABLET is not recommended for use in patients with any liver
problems. Consult your doctor before taking RUMALEF 100MG TABLET.

!### Allergy

Do not take RUMALEF 100MG TABLET if you are allergic to Leflunomide or any other
ingredients of this medicine.

!### Lungs

RUMALEF 100MG TABLET should be used with caution in patients who have suffered
with interstitial lung disease or if you ever had tuberculosis. Consult your
doctor before taking RUMALEF 100MG TABLET.

Others

RUMALEF 100MG TABLET is not recommended for use if you:

• have any problem which affects the immune system (like AIDS)
• have bone marrow problems or reduced white blood or red blood cells and platelets
• have serious infections
• have hypoproteinaemia (severely low levels of proteins in the blood)

Before taking RUMALEF 100MG TABLET, inform your doctor if you:

• are a male who wishes to father a child
• are due to have a specific blood test (calcium test)
• unexplained chronic diarrhoea

Use in paediatrics:

RUMALEF 100MG TABLET is not recommended for use in children and adolescents
(below 18 years of age). Consult your child’s doctor for advice.

Interactions

A. Drug – Drug Interactions:

Before taking RUMALEF 100MG TABLET, inform your doctor if you are taking any of
the following medicines:

• other medicines for rheumatoid arthritis (Ex. sulfasalazine), antimalarials (Ex. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine
• medicines used as immunosuppressants (Ex. azathioprine, methotrexate)
• medicines used as blood thinners (Ex. warfarin)
• medicines used to manage multiple sclerosis (Ex. teriflunomide)
• medicines used for the management of diabetes (repaglinide, pioglitazone, nateglinide, rosiglitazone)
• medicines used in the management of cancer (daunorubicin, doxorubicin, paclitaxel, topotecan)
• medicine used for depression, urinary incontinence or in kidney disease in diabetics (Ex. duloxetine)
• medicines used for the management of severe diarrhoea (Ex alosetron)
• medicines used to manage asthma (Ex. theophylline)
• medicines used as a muscle relaxant (Ex. tiz
• oral contrace
• medicines used for infections (Ex. cefaclor, benzylpenicillin (penicillin G), ciprofloxacin)
• medicines used for the management of pain or inflammation (Ex. indomethacin, ketoprofen)
• diuretics for heart disease (Ex. furosemide)
• medicines used in the management of HIV infection (Ex. zidovudine)
• medicines used in the management of high cholesterol (Ex. rosuvastatin, simvastatin, atorvastatin, colestyramine, pravastatin)
• activated charcoal (used to manage certain kinds of poisoning)
• vaccinations

Overdosage:

If you or anyone else accidentally takes too much of RUMALEF 100MG TABLET,
consult your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Leflunomide
Pharmacological Category	:	Disease-Modifying Antirheumatic Drug (DMARD)
Therapeutic Indication	:	Rheumatoid Arthritis, Active psoriatic arthritis
Dosage Forms	:	Tablet

More Information

• Keep RUMALEF 100MG TABLET out of reach of children
• Store the medicine at room temperature

FAQs About RUMALEF 100MG TABLET

What is RUMALEF 100MG TABLET and why is it given?

RUMALEF 100MG TABLET contains leflunomide which belongs to the group of
medicines called Anti-rheumatic medicines. It is used to manage active
rheumatoid arthritis and active psoriatic arthritis. Consult your doctor before
taking RUMALEF 100MG TABLET.

What type of drug is RUMALEF 100MG TABLET?

RUMALEF 100MG TABLET has leflunomide as the active agent which is a
disease-modifying antirheumatic drug (DMARDs). It acts by slowing the
progression of the condition and decreasing the inflammation which aids in
improving the physical activity of the people affected with rheumatoid
arthritis.

Can RUMALEF 100MG TABLET be taken by pregnant women?

RUMALEF 100MG TABLET is not recommended for use in pregnant women or women who
become pregnant during management with this medicine, as it may increase the
risk of serious birth defects in the baby. Women of childbearing potential
should not take RUMALEF 100MG TABLET without using reliable contrace
measures. If you plan to become pregnant after stopping management with this
medicine and it is necessary to ensure that all traces of the medicine have left
your body, this may take up to 2 years. Consult your doctor before taking
RUMALEF 100MG TABLET.

Does RUMALEF 100MG TABLET affects the liver?

RUMALEF 100MG TABLET is not recommended for use in patients who have liver
diseases. Inform your doctor if you notice any signs of liver injury (which
includes itching, yellowing of eyes or skin, loss of appetite, dark urine or
light-coloured stools). Your doctor may monitor your liver function test before
and during management with RUMALEF 100MG TABLET to manage the risk of liver
damage. Consult your doctor before taking RUMALEF 100MG TABLET.

Does RUMALEF 100MG TABLET has any effect on male fertility?

RUMALEF 100MG TABLET should be used with caution in a male who wishes to father
a child because it may pass into the semen. Effective contrace
exercised while on the course of RUMALEF 100MG TABLET. If you wish to father a
child and you are taking RUMALEF 100MG TABLET, ask for your doctor’s advice as
he may advise you to stop taking this medicine and take certain medications to
remove this medicine rapidly from the body. Consult your doctor for advice.

Useful Diagnostic Tests

• X-rays
• Complete Blood Count
• Liver Function Test
• Kidney Function Test