Details for: TEVA-LEFLUNOMIDE
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02261251 | TEVA-LEFLUNOMIDE | LEFLUNOMIDE | 10 MG | TABLET | ORAL |
| 02261278 | TEVA-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
TEVA-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.
TEVA-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 TEVA-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 TEVA-LEFLUNOMIDE:
- if you suspect that you may be pregnant, you must inform your doctor and you must not start taking TEVA-LEFLUNOMIDE. TEVA-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 TEVA-LEFLUNOMIDE. There is also a risk that male patients taking TEVA-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 TEVA-LEFLUNOMIDE?”.
- if you have a disease of the liver. Otherwise, your disease may get worse;
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction, for example red rash, skin peeling, blisters), to teriflunomide, 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 TEVA-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 TEVA-LEFLUNOMIDE.
- if you are nursing your baby, as TEVA-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 TEVA-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 TEVA-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 TEVA-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 TEVA-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 TEVA-LEFLUNOMIDE
remaining in your body when you become pregnant. If you
plan to become pregnant after stopping TEVA-LEFLUNOMIDE,
it is important to inform your doctor
beforehand. Once you stop taking TEVA-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 TEVA-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 TEVA-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 TEVA-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 TEVA-LEFLUNOMIDE. For information
regarding blood levels measurements, please also contact
your doctor.
If you are currently taking TEVA-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 TEVA-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 TEVA-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 TEVA-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 TEVA-LEFLUNOMIDE,
it is important to inform your doctor
beforehand. Once you stop taking TEVA-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 TEVA-LEFLUNOMIDE
from your body. In either case it should
be confirmed by two blood tests that TEVA-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 TEVA-LEFLUNOMIDE. For
information regarding blood level measurements, please
also contact your doctor.
If you are currently taking TEVA-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 TEVA-LEFLUNOMIDE?
All patients:
Before you start to take TEVA-LEFLUNOMIDE, and also
while you are taking TEVA-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.
Tell your doctor if you have, or if you have had heart disease or lung disorders.
Tell your doctor if you have unexplained chronic diarrhea or weight loss.
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 TEVA-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 TEVA-LEFLUNOMIDE.
Your doctor will give you a medication
which can speed up the elimination of TEVA-LEFLUNOMIDE
from your body.
Interactions with this medication
Drinking alcohol with TEVA-LEFLUNOMIDE:
It is not recommended to drink alcohol during treatment
with TEVA-LEFLUNOMIDE. Drinking alcohol while
taking TEVA-LEFLUNOMIDE may result in harm to your
liver more than you would usually expect.
Taking other medicines together with TEVA-LEFLUNOMIDE:
Medication to relieve pain and inflammation such as
nonsteroidal anti-inflammatory drugs (NSAIDs) or
cortisone can be taken together with TEVA-LEFLUNOMIDE.
However, your doctor will give you
specific instructions about these medicines.
You must not receive any type of live vaccinations while
treated with TEVA-LEFLUNOMIDE or within 6 months
after stopping TEVA-LEFLUNOMIDE. Check ahead with
the clinic if you have to be vaccinated.
Before you start taking TEVA-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 TEVA-LEFLUNOMIDE or the other medicines
may be changed or you might get side effects. Furthermore,
do not start any new medicine, whether prescription, nonprescription
or natural products without first checking with
your doctor.
Examples of drugs that may interact with TEVA-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
Proper use of this medication
Usual Dose
TEVA-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.
TEVA-LEFLUNOMIDE is supplied as film-coated tablets
of 10mg, 20 mg strengths. Your doctor will usually want
you to build up the amount of TEVA-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 TEVA-LEFLUNOMIDE over
long periods of time. However, your doctor will advise you
if and when you need to stop taking TEVA-LEFLUNOMIDE.
You can take TEVA-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 TEVA-LEFLUNOMIDE from
your body.
Missed Dose
If you forget to take a tablet of TEVA-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, TEVA-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 TEVA-LEFLUNOMIDE or may want you to stop the
medication.
TEVA-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 very rare 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 TEVA-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 TEVA-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, TEVA-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 TEVA-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 TEVA-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 TEVA-LEFLUNOMIDE.
However, simply stopping TEVA-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
TEVA-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 TEVA-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 talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Hypertension (high blood pressure) | ✔ | ||
| Pain and swelling of the tendon | ✔ | ||
| 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 TEVA-LEFLUNOMIDE, contact your doctor or pharmacist.
How to store
Store between 15°C and 30°C. Protect from light and moisture. As with all medicines, you should keep TEVA-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,
Teva Canada Limited at:
1-800-268-4127 ext 1255005 (English);
1-877-777-9117 (French)
or druginfo@tevacanada.com
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, MIB 2K9
www.tevacanada.com
Last revised: February 29, 2016