Details for: LEFLUNOMIDE
Company: SANIS HEALTH INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02351668 | LEFLUNOMIDE | LEFLUNOMIDE | 10 MG | TABLET | ORAL |
| 02351676 | LEFLUNOMIDE | LEFLUNOMIDE | 20 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
LEFLUNOMIDE is used to treat adult patients who have active rheumatoid arthritis.
What it does
In rheumatoid arthritis, the immune system (body’s
defenses against infection and foreign substances) turns
against a patient’s own joint tissue. This causes
inflammation and the patient can have pain, stiffness, and
swelling, which over many months can lead to deformities
of the joints.
LEFLUNOMIDE works in rheumatoid arthritis by reducing
or suppressing to a certain extent the abnormal activation
and multiplication of cells responsible for the
inflammation.
From the results of studies in patients with rheumatoid
arthritis you can expect LEFLUNOMIDE to reduce your
arthritis signs and symptoms. It may take about 4 weeks
until you start to feel an improvement in your symptoms.
When it should not be used
Tell your doctor and do not start treatment with LEFLUNOMIDE:
- if you suspect that you may be pregnant, you must inform your doctor and you must not start taking LEFLUNOMIDE. LEFLUNOMIDE may increase the risk of having a baby with a birth defect.
- if you are of childbearing age, it must be confirmed with a pregnancy test that you are not pregnant just before you begin treatment with LEFLUNOMIDE. There is also a risk that male patients taking LEFLUNOMIDE might father a deformed baby. Both male and female patients should read below in the WARNINGS AND PRECAUTIONS section “What are the risks of birth defects with LEFLUNOMIDE?”.
- if you have a disease of the liver. Otherwise, your disease may get worse;
- if you have ever had an allergic reaction to leflunornide (especially a serious skin reaction, for example red rash, skin peeling, blisters) or to any of the other ingredients (see below “What the nonmedicinal ingredients are:”);
- if you suffer from a disease (for example, AIDS) which decreases the strength of your body’s defenses against infection. Otherwise the weakening of your body’s defenses against infection worsen;
- if your bone marrow does not work well or if the number of red cells, white cells, or platelets in your blood is very much decreased. Again LEFLUNOMIDE could worsen this problem;
- if you are suffering from a serious infection, as your infection may be more difficult to treat;
- if you have a disease of the kidney, because the kidney plays a role in the elimination of LEFLUNOMIDE.
- if you are nursing your baby, as LEFLUNOMIDE passes into breast milk and its effect on the nursing infant are not known;
- if you are younger than 18 years of age, it is not recommended that you take LEFLUNOMIDE. This is because there is not enough experience of its use in children and adolescents.
What the medicinal ingredient is
The tablets contain the active drug, leflunomide.
What the non-medicinal ingredients are
Lactose monohydrate impalpable, lactose anhydrous, povidone, crospovidone, prege1atinized starch, colloidal silicon dioxide, talc, magnesium stearate, titanium dioxide, hydroxypropyl methylcellulose and polyethylene glycol. Additional non-medicinal ingredients in the 10 mg tablet are po1ydextrose and triethyl citrate. Additional nonmedicinal ingredients in the 20 mg tablet are polysorbate 80, and iron oxide yellow.
What dosage form it comes in
10mg and 20mg film-coated tablets
10mg: white to off-white, round film-coated tablets,
engraved N on one side and 10 on the other side
20mg: cream, triangular shaped film-coated tablets,
engraved N on one side and 20 on the other side
Warnings and precautions
The medication can stay in your body for a long period of
time. Therefore some precautions and side effects may
follow from this characteristic of the drug.
WHAT ARE THE RISKS OF BIRTH DEFECTS
WITH LEFLUNOMIDE?
For female patients:
You may be at high risk of having a deformed baby if
you do not follow the following instructions:
If you are pregnant, or suspect that you may be, you must
tell your doctor and you must not start taking
LEFLUNOMIDE.
If you are of childbearing age (women who might get
pregnant), it must be confirmed with a pregnancy test that
you are not pregnant just before beginning your treatment.
Women must use reliable birth control methods when
taking LEFLUNOMIDE. If you are of childbearing age,
discuss methods to avoid becoming pregnant with your
doctor.
The risk of giving birth to a deformed baby can best be
estimated by the amount of LEFLUNOMIDE remaining in
your body when you become pregnant. If you plan to
become pregnant after stopping LEFLUNOMIDE, it is
important to inform your doctor beforehand. Once you stop
taking LEFLUNOMIDE, you must wait a period of 2 years
before trying to get pregnant. However, this waiting period
may be shortened to a few weeks by taking a certain
medicine that will speed up the elimination of
LEFLUNOMIDE from your body. If this option is chosen,
inform your doctor if you are taking an oral contraceptive
pill. The medicine that speeds up the elimination of
LEFLUNOMIDE may lower the effect of your
contraceptive pill and you may need another contraceptive
method during this period. In either case it should be
confirmed by two blood tests two weeks apart that
LEFLUNOMIDE has been sufficiently eliminated from
your body before you try to become pregnant. Your doctor
can give you more information about the options available
to reach low blood levels of LEFLUNOMIDE. For
information regarding blood levels measurements, please
also contact your doctor.
If you are currently taking LEFLUNOMIDE, or if you have
taken it within the last 2 years and you believe that you
may be pregnant, it is VERY IMPORTANT that you
contact your doctor immediately. You must have a
pregnancy test at the first delay of your period, and if the
test confirms that you are pregnant, discuss with your
doctor the risk of the treatment to your baby. Your doctor
may propose at the first delay of your period to rapidly start
the treatment which speeds up elimination of
LEFLUNOMIDE from the body, as this may decrease the
risk to your baby.
For male patients:
You may be at high risk of fathering a deformed baby if
you do not follow the following instructions:
Once you start taking LEFLUNOMIDE, you should take
every precaution to avoid getting your partner pregnant.
You should use a reliable birth control as recommended by
your doctor, during LEFLUNOMIDE therapy. If you have
any questions about reliable birth control methods, consult
your doctor.
If you wish to father a child after having stopped
LEFLUNOMIDE, it is important to inform your doctor
beforehand. Once you stop taking LEFLUNOMIDE, you
must wait a period of 2 years before trying to father a child.
However, this waiting period may be shortened to a few
weeks by taking a certain medicine that will speed up the
elimination of LEFLUNOMIDE from your body. In either
case it should be confirmed by two blood tests that
LEFLUNOMIDE has been sufficiently eliminated from
your body and you should then wait for another 3 months
before you try to get your partner pregnant. Your doctor
can give you more information about the options available
to reach low blood levels of LEFLUNOMIDE. For
information regarding blood level measurements, please
also contact your doctor.
If you are currently taking LEFLUNOMIDE, or if you have
taken it within the last 2 years and your partner suspects
that she may be pregnant you must both immediately
contact your doctors. Your partner must have a pregnancy
test at the first delay of her period, and if the test confirms
that she is pregnant, you should discuss with your doctors
the risk of the treatment to the baby.
WHAT ARE OTHER PRECAUTIONS WITH
LEFLUNOMIDE?
All patients:
Before you start to take LEFLUNOMIDE, and also while
you are taking LEFLUNOMIDE, your doctor will carry out
blood tests to monitor your blood cells and your liver at
regular intervals. Similarly, your blood pressure will need
to be checked regularly. It is important to keep your
medical appointments.
Tell your doctor if you have ever suffered from
tuberculosis. If you have ever had tuberculosis, your doctor
will carefully monitor you, in order to be able to treat you
without delay in case it becomes active again.
In certain circumstances (serious side effects, changing
antirheumatic treatment or in case of a desired pregnancy)
your doctor will decide that you should take a certain
medicine which speeds up the elimination of
LEFLUNOMIDE from your body.
Tell your doctor if you experience symptoms that can cause
numbness, tingling or burning in the hands and feet, muscle
weakness or other altered sensations while taking
LEFLUNOMIDE. Your doctor will give you a medication
which can speed up the elimination of LEFLUNOMIDE
from your body.
Interactions with this medication
Drinking alcohol with LEFLUNOMIDE:
It is not recommended to drink alcohol during treatment
with LEFLUNOMIDE. Drinking alcohol while taking
LEFLUNOMIDE may result in harm to your liver more
than you would usually expect.
Taking other medicines together with
LEFLUNOMIDE:
Medication to relieve pain and inflammation such as
nonsteroidal anti-inflammatory drugs (NSAIDs) or
cortisone can be taken together with LEFLUNOMIDE.
However, your doctor will give you specific instructions
about these medicines.
You must not receive any type of live vaccinations while
treated with LEFLUNOMIDE or within 6 months after
stopping LEFLUNOMIDE. Check ahead with the clinic if
you have to be vaccinated.
Before you start taking LEFLUNOMIDE, be sure to tell
your doctor about all medicines you are taking or have
taken recently including any that you bought without a
prescription or any natural products. This is because the
effects of LEFLUNOMIDE or the other medicines may be
changed or you might get side effects. Furthermore, do not
start any new medicine, whether prescription, non-prescription
or natural products without first checking with
your doctor.
Examples of drugs that may interact with LEFLUNOMIDE
are:
- activated charcoal
- azathioprine
- cholestyramine
- cimetidine (stomach acid medicine)
- D penicillamine
- duloxetine (anti-depressant)
- gold
- methotrexate
- phenytoin
- teriflunomide
- theophylline (asthma medicine)
- tizanidine (muscle relaxant medicine)
- warfarin
- medicines used to treat diabetes, such as: repaglinide, pioglitazone, rosiglitazone, nateglinide or tolbutamide
- oral contraceptives
- some medicines used to treat infections such as: antimalarial drugs, cefaclor, ciprofloxacin, penicillin G, rifampin, rifampicin, zidovudine
- medicines used to lower blood cholesterol, such as: rosuvastatin, atorvastatin, simvastatin, pravastatin
- anti-inflammatory drugs, such as: indomethacin, ketoprofen, sulfasalazine
- diuretics (water losing pills), such as: furosemide
- some medicines to treat cancer such as: paclitaxel, methotrexate, topotecan, daunorubicin, doxorubicin
LEFLUNOMIDE can stay in your body for a long period of time after you stop taking it. Therefore, when LEFLUNOMIDE is stopped and another drug (for example methotrexate) is started to treat your rheumatoid arthritis, there is a possibility of increased risks of adverse events. Your doctor may give you a certain medicine that will speed up the elimination of LEFLUNOMIDE from your body before starting the other drug.
Proper use of this medication
Usual Dose
LEFLUNOMIDE has been prescribed for you alone. Do
not share it with anyone else, even if their symptoms are
the same as yours, as it may bring more harm than good.
LEFLUNOMIDE is supplied as film-coated tablets of
10mg, 20 mg strengths. Your doctor will usually want you
to build up the amount of LEFLUNOMIDE in your body.
For doing so, you will usually start the treatment by taking
100 mg once daily for the first 3 days. Thereafter, your
doctor will usually reduce the dose to a tablet of 20 mg to
be taken once daily. For some people, their doctor will
instead prescribe a tablet of 10 mg once daily.
You should always follow your doctor’s instructions. Do
not take any more or any less tablets than what your doctor
says. You will normally take LEFLUNOMIDE over long
periods of time. However, your doctor will advise you if
and when you need to stop taking LEFLUNOMIDE.
You can take LEFLUNOMIDE during meals or at any time
between meals. However, it works best if you take it at the
same time every day. Swallow the tablet whole with a glass
of water or another fluid.
Overdose
If you accidentally take more than one tablet, nothing is
likely to happen. If possible, take your tablets or the box
with you to show the doctor.
In general, an overdose may lead to increased symptoms as
described under “SIDE EFFECTS AND WHAT TO DO
ABOUT THEM”. Should this happen, it is possible that
medicine may be administered by your doctor in order to
speed up the elimination of LEFLUNOMIDE from your
body.
Missed Dose
If you forget to take a tablet of LEFLUNOMIDE take it as soon as you remember, unless it is nearly time for your next dose. Do not double-up on the next dose to make up for the one missed.
Side effects and what to do about them
As with any medication, LEFLUNOMIDE can cause some side effects. It may, however, affect different people in different ways. Just because side effects have occurred in other people does not mean you will get them. In studies of patients with rheumatoid arthritis, common side effects included: diarrhea, loss of appetite, nausea (queasiness), vomiting, abdominal pain, weight loss (usually mild), headache, dizziness, weakness, abnormal skin sensations like tingling, inflammation of a tendon sheath, increased hair loss, eczema, and dry skin. Should these side effects occur and be bothersome, please consult
your doctor. Your doctor may decide to decrease the dose of LEFLUNOMIDE or may want you to stop the medication.
LEFLUNOMIDE can also increase blood pressure (usually mildly) and your blood pressure will need to be checked regularly.
Ulceration or inflammation of the mouth and skin rash are common with leflunomide. However, tell your doctor without any delay if you develop skin rash or mucous membrane lesions (e.g. lesions in the mouth). This is because, in cases, such reactions may develop into severe, sometimes life-threatening skin reactions such as painful blister, red rash spreading and skin peeling. They may, therefore, require discontinuation of leflunomide and immediate action by your doctor.
Also common are mild allergic reactions and itching, whereas occurrence of hives is uncommon. Severe and potentially serious allergic reactions are very rare. Symptoms of severe allergic reactions to any medications include weakness, drop in blood pressure and difficult breathing. If such symptoms do occur, do not take any more LEFLUNOMIDE tablets and consult your doctor immediately.
Blood tests may often show a decrease in the number of white blood cells. However, a pronounced decrease in the number of white cells or of all blood cells may occur rarely in some patients. Tell your doctor without any delay if you have symptoms such as paleness, tiredness, if you bruise or bleed easily or if you have symptoms of infection such as fever, chills or sore throat. Such symptoms may be due to disorders of your blood cells. They may require discontinuation of LEFLUNOMIDE and other medications, and further action by your doctor.
Blood tests may also show an increase in some liver function test results. In very rare cases this may indicate an abnormality, which may develop into serious conditions such as hepatitis and liver failure, which may be fatal. Therefore, if you develop symptoms such as unusual tiredness, nausea, vomiting, abdominal pain, or jaundice (yellow discoloration of the eyes or skin) inform your doctor at once.
Like other antirheumatic medicines that to some extent reduce the immune defense, LEFLUNOMIDE may increase the susceptibility to infections. Tell your doctor without any delay if you have any symptoms of an infection (such as fever, sore throat, or cough). This is because some infections might become more severe and, therefore, they need to be treated early.
Cases of lung inflammation causing difficulty breathing
have occurred rarely in patients receiving LEFLUNOMIDE. Tell your doctor without delay if you experience new or worsening of shortness of breath and/or cough, with or without associated fever, at any time while you are taking LEFLUNOMIDE.
Your doctor will assess your condition and will decide on appropriate course of action. This may require additional tests, for example, blood analysis. In some cases your doctor may recommend to stop taking LEFLUNOMIDE. However, simply stopping LEFLUNOMIDE may not be enough to prevent further progression of the side effect. You may be required to take certain medicines, which speeds up the elimination of LEFLUNOMIDE from your body. Additional follow-up visits to the doctor and diagnostic tests may be needed to monitor your condition.
Please consult your doctor or pharmacist if you notice any of the side effects listed in this leaflet or any other undesired effects or unexpected changes. If sudden or severe reactions do occur, do not take any more LEFLUNOMIDE tablets and consult your doctor immediately.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Hypertension (high blood pressure) | ✔ | ||
| Inflammation of a tendon sheath | ✔ | ||
| Loss of appetite | ✔ | ||
| Skin rash | ✔ | ||
| Mouth sores | ✔ | ||
| Uncommon | |||
| Bruise or bleed easily | ✔ | ||
| Heart disorders (for example: chest pain, palpitation, fast heart beat) | ✔ | ||
| Eye disorders (for example: dimness of vision, eye infection, cataract) | ✔ | ||
| Infection or symptoms of infection such as fever (see text) | ✔ | ||
| Liver problem, if symptoms such as jaundice or other related symptoms (see text) | ✔ | ||
| Lung inflammation, if symptoms such as new or worsening of shortness of breath or other related symptoms (see text) | ✔ | ||
| Severe allergic reactions | ✔ | ||
| Unknown frequency | |||
| Colitis: abdominal pain, bloody stools, diarrhea, fever, rectal pain, bloating, weight loss | ✔ | ||
| Shortness of breath, fatigue, dissiness, chest pain | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking LEFLUNOMIDE, contact your doctor or pharmacist. Reporting Side Effects
How to store
Store between 15°C and 30°C. Protect from light and moisture. As with all medicines, you should keep LEFLUNOMIDE tablets out of the reach of children. Do not use the tablets in this package after the expiry date shown on the container label.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found by contacting Sanis Health Inc., at:
1-866-236-4076
Fax: 905-689-1465
or quality@sanis.com
This leaflet was prepared by:
Sanis Health Inc.
1 Presidents Choice Circle
Brampton, Ontario
L6Y 5S5
Last revised: December 20, 2016