Details for: SANDOZ LEFLUNOMIDE
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02283964 | SANDOZ LEFLUNOMIDE | LEFLUNOMIDE | 10 MG | TABLET | ORAL |
| 02283972 | SANDOZ 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
Sandoz 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.
Sandoz 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 Sandoz 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 Sandoz Leflunomide:
- If you suspect that you may be pregnant, you must inform your doctor and you must not start taking Sandoz Leflunomide. Sandoz 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 Sandoz Leflunomide. There is also a risk that male patients taking Sandoz 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 SANDOZ 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 worsens.
- 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 Sandoz 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 Sandoz Leflunomide.
- If you are nursing your baby, as Sandoz 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 Sandoz 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
What dosage forms it comes in: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and yellow ferric oxide (20 mg tablet only).
What dosage form it comes in
Sandoz Leflunomide comes as film-coated tablets of 2 different strengths:
- 10 mg.
- 20 mg.
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
SANDOZ 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
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
Sandoz 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 Sandoz Leflunomide remaining in your body
when you become pregnant. If you plan to become pregnant after
stopping Sandoz Leflunomide, it is important to inform your
doctor beforehand. Once you stop taking Sandoz 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
Sandoz 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 Sandoz
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 Sandoz 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 Sandoz Leflunomide. For information
regarding blood level measurements, please also contact your
doctor.
If you are currently taking Sandoz 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 treatment which speeds up the elimination of Sandoz
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 Sandoz 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
Sandoz 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 Sandoz
Leflunomide, it is important to inform your doctor beforehand.
Once you stop taking Sandoz 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 Sandoz
Leflunomide from your body. In either case it should be
confirmed by two blood tests that Sandoz 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 Sandoz Leflunomide. For
information regarding blood level measurements, please also
contact your doctor.
If you are currently taking Sandoz 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 SANDOZ
LEFLUNOMIDE?
All patients:
Before you start to take Sandoz Leflunomide, and also while you
are taking Sandoz 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 Sandoz 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 Sandoz
Leflunomide. Your doctor will give you a medication which can
speed up the elimination of Sandoz Leflunomide from your body.
Interactions with this medication
Drinking alcohol with Sandoz Leflunomide: It is not
recommended to drink alcohol during treatment with Sandoz
Leflunomide. Drinking alcohol while taking Sandoz Leflunomide
may result in harm to your liver more than you would usually
expect.
Taking other medicines together with Sandoz Leflunomide:
Medication to relieve pain and inflammation such as nonsteroidal
anti-inflammatory drugs (NSAIDs) or cortisone can be taken
together with Sandoz Leflunomide. However, your doctor will
give you specific instructions about these medicines.
You must not receive any type of live vaccinations while treated
with Sandoz Leflunomide or within 6 months after stopping
Sandoz Leflunomide. Check ahead with the clinic if you have to
be vaccinated.
Before you start taking Sandoz 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 Sandoz
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 Sandoz 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
Sandoz 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.
Sandoz Leflunomide is supplied as film-coated tablets of 10 and
20 mg strengths. Your doctor will usually want you to build up
the amount of Sandoz 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 Sandoz Leflunomide over long periods of time.
However, your doctor will advise you if and when you need to
stop taking Sandoz Leflunomide.
You can take Sandoz 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 Sandoz Leflunomide from your body.
Missed Dose
If you forget to take a tablet of Sandoz 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, Sandoz 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 Sandoz Leflunomide or
may want you to stop the medication.
Sandoz 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 Sandoz 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 some 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 Sandoz 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 Sandoz 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 Sandoz 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, Sandoz 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 Sandoz 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 Sandoz 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 Sandoz Leflunomide. However, simply
stopping Sandoz 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 Sandoz
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 Sandoz 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 seek immediate emergency medical attention |
|---|---|---|---|
| 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 heartbeat) | ✔ | ||
| 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 Sandoz Leflunomide, contact your doctor or pharmacist.
How to store
Do not expose Sandoz Leflunomide tablets to light or moisture. Store this medicine between 15°C and 30°C. As with all medicines, you should keep Sandoz Leflunomide tablets out of 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 help improve the safe use of health products for
Canadians by reporting serious and unexpected side effects to
Health Canada. Your report may help to identify new side
effects and change the product safety information.
3 ways to report:
- Report online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting
Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
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 obtained by contacting the sponsor,
Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
or by e-mail at:
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: February 29, 2016