Details for: ACCEL-LEFLUNOMIDE
Company: ACCEL PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02478862 | ACCEL-LEFLUNOMIDE | LEFLUNOMIDE | 10 MG | TABLET | ORAL |
| 02478870 | ACCEL-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
ACCEL-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.
ACCEL-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 ACCEL-LEFLUNOMIDE:
- if you suspect that you may be pregnant, you must inform your doctor and you must not start taking ACCEL-LEFLUNOMIDE. ACCEL-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 ACCEL-LEFLUNOMIDE. There is also a risk that male patients taking ACCEL-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 ACCEL-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 ACCEL-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 ACCEL-LEFLUNOMIDE.
- if you are nursing your baby, as ACCEL-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 ACCEL-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
Cellulose microcrystalline, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, povidone, pregelatinized starch, silica colloidal anhydrous, talc, titanium dioxide
What dosage form it comes in
ACCEL-LEFLUNOMIDE comes as tablets of 2 different strengths:
- 20 mg film-coated tablet, yellow, round, biconvex tablets.
- 10 mg film-coated tablet, white, round biconvex tablets.
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 ACCEL-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
ACCEL-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 ACCEL-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 ACCEL-LEFLUNOMIDE remaining in your body when you
become pregnant. If you plan to become pregnant after stopping ACCEL-LEFLUNOMIDE, it is
important to inform your doctor beforehand. Once
you stop taking ACCEL-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
ACCEL-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 ACCEL-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 ACCEL-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
ACCEL-LEFLUNOMIDE. For information
regarding blood levels measurements, please also
contact your doctor.
If you are currently taking ACCEL-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 ACCEL-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 ACCEL-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
ACCEL-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
ACCEL-LEFLUNOMIDE, it is important to inform
your doctor beforehand. Once you stop taking
ACCEL-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 ACCEL-LEFLUNOMIDE from your
body. In either case it should be confirmed by two
blood tests that ACCEL-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 ACCEL-LEFLUNOMIDE. For information regarding blood
level measurements, please also contact your doctor.
If you are currently taking ACCEL-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
ACCEL-LEFLUNOMIDE?
All patients:
Before you start to take ACCEL-LEFLUNOMIDE,
and also while you are taking ACCEL-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 ACCEL-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 ACCEL-LEFLUNOMIDE. Your
doctor will give you a medication which can speed up
the elimination of ACCEL-LEFLUNOMIDE from
your body.
Interactions with this medication
Drinking alcohol with ACCEL-LEFLUNOMIDE:
It is not recommended to drink alcohol during
treatment with ACCEL-LEFLUNOMIDE. Drinking
alcohol while taking ACCEL-LEFLUNOMIDE
may result in harm to your liver more than you would
usually expect.
Taking other medicines together with ACCEL-LEFLUNOMIDE:
Medication to relieve pain and inflammation such as
nonsteroidal anti-inflammatory drugs (NSAIDs) or
cortisone can be taken together with ACCEL-LEFLUNOMIDE. However, your doctor will give
you specific instructions about these medicines.
You must not receive any type of live vaccinations
while treated with ACCEL-LEFLUNOMIDE or
within 6 months after stopping ACCEL-LEFLUNOMIDE. Check ahead with the clinic if
you have to be vaccinated.
Before you start taking ACCEL-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 ACCEL-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 ACCEL-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
ACCEL-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.
ACCEL-LEFLUNOMIDE is supplied as filmcoated tablets of 10 mg and 20 mg strengths. Your
doctor will usually want you to build up the amount
of ACCEL-LEFLUNOMIDE in your body. For
doing so, you will usually start the treatment by
taking 100 mg 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 ACCEL-LEFLUNOMIDE over long periods of time.
However, your doctor will advise you if and when
you need to stop taking ACCEL-LEFLUNOMIDE.
You can take ACCEL-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 ACCEL-LEFLUNOMIDE from your
body.
Missed Dose
If you forget to take a tablet of ACCEL-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, ACCEL-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 ACCEL-LEFLUNOMIDE
or may want you to stop the medication.
ACCEL-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 lifethreatening skin reactions such as painful blister,
red rash spreading and skin peeling. They may,
therefore, require discontinuation of ACCEL-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 ACCEL-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 ACCEL-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, ACCEL-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 ACCEL-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 ACCEL-LEFLUNOMIDE. However, simply
stopping ACCEL-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
ACCEL-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 ACCEL-LEFLUNOMIDE tablets and consult
your doctor immediately.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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, dizziness, chest pain | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ACCEL-LEFLUNOMIDE, contact your doctor or pharmacist.
How to store
Store this medicine at temperatures between 15°C and 30°C. As with all medicines, you should keep ACCEL-LEFLUNOMIDE tablets out of the reach and sight of children. Do not use the tablets in this package after the expiry date shown on the container label.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. 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
visiting the manufacturer's website
www.accelpharma.com or by calling the sponsor at
1-877-822-2235.
This leaflet was prepared by Accel Pharma Inc.
Date Prepared: July 12, 2018