LEFLUNOMIDE 10 mg Tabletki Powlekane

Treść ulotki

1. Leflunomide Zentiva 10 mg film-coated tablets
   1. What is Leflunomide Zentiva and what is it used for
   2. What you need to know before taking Leflunomide Zentiva
   3. How to take Leflunomide Zentiva
   4. Possible side effects
   5. How to store Leflunomide Zentiva
   6. Package contents and other information
2. Leflunomide Zentiva 20 mg film-coated tablets
   1. What is Leflunomide Zentiva and what is it used for
   2. What you need to know before taking Leflunomide Zentiva
   3. How to take Leflunomide Zentiva
   4. Possible side effects
   5. How to store Leflunomide Zentiva
   6. Package contents and other information
3. Leflunomide Zentiva 100 mg film-coated tablets
   1. What is Leflunomide Zentiva and what is it used for
   2. What you need to know before taking Leflunomide Zentiva
   3. How to take Leflunomide Zentiva
   4. Possible side effects
   5. How to store Leflunomide Zentiva
   6. Package contents and other information

Leflunomide Zentiva 10 mg film-coated tablets

leflunomide

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Leflunomide Zentiva is and what it is used for
• 2. What you need to know before you take Leflunomide Zentiva
• 3. How to take Leflunomide Zentiva
• 4. Possible side effects
• 5. How to store Leflunomide Zentiva
• 6. Contents of the pack and other information

1. What is Leflunomide Zentiva and what is it used for

Leflunomide Zentiva belongs to a group of medicines called antirheumatic drugs.
Leflunomide Zentiva is used to treat adult patients suffering from active rheumatoid arthritis or active
psoriatic arthritis.
The symptoms of rheumatoid arthritis include inflammation of the joints, swelling, difficulty of
movement and pain. Other symptoms that can affect the whole body include loss of
appetite, fever, loss of strength and anemia (reduction in the number of red blood cells).
The symptoms of active psoriatic arthritis include inflammation of the joints, swelling, difficulty of
movement, pain and red, scaly skin patches (skin lesions).

2. What you need to know before taking Leflunomide Zentiva

Do not takeLeflunomide Zentiva:

• if you have already experienced an allergicreaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red skin patches or blisters, for example Stevens-Johnson syndrome) or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis),
• if you have any liver problems,
• if you have severe or moderate kidney problems,
• if you have an extremely low number of proteins in your blood(hypoproteinemia),
• if you suffer from any condition that affects your immune system(e.g. AIDS),
• if you have any bone marrowproblems or if the number of red blood cells or white blood cells is low or if the number of platelets in your blood is reduced,
• if you suffer from a severe infection,
• if you are pregnant,planning to become pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Leflunomide Zentiva

• if you have ever suffered from lung inflammation(interstitial lung disease).
• if you have ever had tuberculosisor if you have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis.
• if you are maleand intend to father a child. Because it cannot be ruled out that Leflunomide Zentiva passes into the seminal fluid, a reliable contraceptive method must be used during treatment with Leflunomide Zentiva. Men who intend to father a child should contact their doctor, who may advise them to stop treatment with Leflunomide Zentiva and to take certain medications to remove Leflunomide Zentiva quickly and sufficiently from the body. After that, they must have a blood test to ensure that Leflunomide Zentiva has been sufficiently removed from the body, and then wait at least another 3 months before attempting to conceive.
• if you are to undergo a specific blood test (calcium level). Falsely low calcium levels may occur.
• if you are undergoing or have recently undergone major surgery or if you still have an unhealed wound following surgery. Leflunomide Zentiva may impair wound healing.

Rarely Leflunomide Zentiva can cause problems with the blood, liver, lungs or
nerves of the arms or legs. Leflunomide Zentiva can also cause some serious allergic reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]), or
increase the incidence of serious infections. For more information, read section 4 (Possible
side effects).
DRESS syndrome initially manifests with flu-like symptoms and a rash on the face, then widespread rash with fever, increased levels of liver enzymes and a type of white blood cells (eosinophilia)
in blood tests and enlarged lymph nodes.
Before starting to take Leflunomide Zentiva and during treatment, your doctor will prescribe you regular blood teststo monitor blood cells and the liver. The doctor
will also check your blood pressure regularly as Leflunomide Zentiva can cause an
increase in blood pressure.
Tell your doctor if you have unexplained chronic diarrhea. The doctor may perform additional tests for
differential diagnosis.
Tell your doctor if a skin ulcer appears during treatment with Leflunomide Zentiva
(see also section 4).

Children and adolescents
The use of Leflunomide Zentiva is not recommended in children and adolescents under
18 years of age.
Other medicines and Leflunomide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines you bought without a prescription.
This information is particularly important if you are taking:

• other medicines for the treatment of rheumatoid arthritissuch as antimalarials (e.g. chloroquine and hydroxychloroquine), gold salts administered by intramuscular or oral route, D-penicillamine, azathioprine and other immunosuppressant medicines (e.g. methotrexate) as these combinations are not recommended,
• warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine
• teriflunomide for multiple sclerosis
• repaglinide, pioglitazone, nateglinide or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, urinary incontinence or kidney disease in diabetics
• alosetron for managing severe diarrhea
• theophylline for asthma
• tizanidine, to relax muscles
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart disease (diuretic, water pill)
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• a medicine called cholestyramine (which is used to lower cholesterol) or activated charcoal as these medicines can decrease the amount of Leflunomide Zentiva absorbed by the body,

If you are already taking non-steroidal anti-inflammatorydrugs (NSAIDs) and/or corticosteroidsyou
can continue to take them after starting therapy with Leflunomide Zentiva.

Vaccinations
If you need to be vaccinated, ask your doctor for advice. Certain vaccinations should not be
given while you are taking Leflunomide Zentiva, and for a certain period of time after
stopping treatment.

Leflunomide Zentiva with food, drinks and alcohol
Leflunomide Zentiva can be taken with or without food.
It is recommended not to drink alcohol during treatment with Leflunomide Zentiva. Drinking alcohol while
taking Leflunomide Zentivamay increase the likelihood of liver damage.

Pregnancy and breastfeeding
Donot take Leflunomide Zentiva if you are pregnantor think you might be. If you are pregnant or become
pregnant during treatment with Leflunomide Zentiva, the risk of having a baby with serious
birth defects is increased. Women must not take Leflunomide Zentivawithout using
reliable contraceptive measures when they are of childbearing potential.
If you are planning to become pregnant after stopping treatment with Leflunomide
Zentiva, it is important to inform your doctor in advance, as they must ensure that every trace
of Leflunomide Zentiva has been eliminated from your body before attempting to become pregnant.
The elimination of Leflunomide Zentiva can take up to two years. This period can be reduced to
a few weeks by taking certain medicines that accelerate the removal of Leflunomide Zentiva from
your body.
In both cases, before you become pregnant, blood tests must
confirm that Leflunomide Zentiva has been eliminated from your body to a sufficient extent andafter
that you must wait at least another month.
For further information about laboratory tests, contact your doctor.
If you suspect you are pregnant during treatment with Leflunomide Zentiva or
within two years after stopping treatment, you must immediatelyinform your doctor
who will arrange for you to have a pregnancy test. If this confirms that you are pregnant, the
doctor will advise you to take treatment with certain medicines to remove Leflunomide Zentiva
quickly and sufficiently from your body, thus reducing the risk to your baby.

Donot take Leflunomide Zentiva during breastfeedingas leflunomide passes into
breast milk.

Driving and using machines
Leflunomide Zentiva may make you feel unsteady and this sensation may alter your ability to
concentrate and react. In this case, do not drive and do not use machines.

Leflunomide Zentiva contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Leflunomide Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.
The initial dose of Leflunomide Zentiva is usually 100 mg of leflunomide once a day for the
first three days. Afterwards, most patients need:

• for rheumatoid arthritis: a daily dose of 10 or 20 mg of Leflunomide Zentiva depending on the severity of the disease.
• for psoriatic arthritis: a daily dose of 20 mg of Leflunomide Zentiva.

Takethe tablet wholeand with plenty of water.
It may take about 4 weeks or more before you begin to feel an
improvement in your condition. Some patients may experience further improvements even
after 4-6 months of treatment.
Generally, Leflunomide Zentiva is taken for long periods of time.

If you use more Leflunomide Zentiva than you should
If you take a quantity of Leflunomide Zentiva higher than you should, contact your doctor or
seek some other form of medical advice. If possible, bring the tablets or the
package with you to show the doctor.

If you forget to take Leflunomide Zentiva
If you forget to take a dose, take it as soon as you remember, unless it is
almost time to take the next dose. Do not take a double dose to make up for
forgetting the dose.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Leflunomide Zentiva and contact your doctor immediately:

• if you have experienced a feeling of weakness, lightheadedness or dizziness or if you have had difficulty breathingas these signs may indicate a serious allergic reaction,
• if you have developed skin rednessor mouth ulcersas these signs may indicate serious allergic reactions, sometimes even fatal (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.

Contact your doctor immediatelyif you experience:

• paleness, fatigueor bruisingas these may indicate blood disorders caused by an imbalance between the different types of cells that make up the blood,
• fatigue, abdominal painor jaundice(yellowing of the eyes or skin) as these manifestations may indicate serious conditions such as liver failure which can be fatal,
• any symptom of infectionsuch as fever, sore throator coughas this medicine may increase the incidence of serious infections that can be life-threatening,
• coughor breathing difficultiesas these may indicate problems with the lungs (interstitial lung disease or pulmonary hypertension),
• tingling, weakness or unusual pain in the hands or feet as these may indicate problems with the nerves (peripheral neuropathy).

Common side effects (may affect up to 1 in 10 people)

• a mild decrease in the number of white blood cells (leukopenia),
• moderate allergic reactions,
• loss of appetite, decrease in body weight (usually not significant),
• fatigue (asthenia),
• headache, dizziness,
• abnormal skin sensations such as tingling (paresthesia),
• moderate increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• inflammation of the mouth or mouth ulcers,
• abdominal pain,
• an increase in values in some liver function tests,
• increased hair loss,
• eczema, dry skin, redness, itching,
• tendinitis (pain caused by inflammation of the sheath covering the tendons generally of feet or hands),
• an increase in some blood enzymes (creatine phosphokinase),
• problems with the nerves of the arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

• a decrease in the number of red blood cells (anemia) and a decrease in the number of platelets (thrombocytopenia),
• a decrease in potassium levels in the blood,
• anxiety,
• taste disturbances,
• urticaria (redness with itching),
• tendon rupture,
• an increase in levels of fats in the blood (cholesterol and triglycerides),
• a decrease in levels of phosphate in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

• an increase in the number of blood cells called eosinophils (eosinophilia); a mild decrease in the number of white blood cells (leukopenia); a reduction in the number of all blood cells (pancytopenia),
• increased blood pressure,
• inflammation of the lung (interstitial lung disease),
• an increase in some liver function values that can lead to serious conditions such as hepatitis and jaundice,
• serious infections called sepsis that can be fatal,
• an increase in some enzymes in the blood (lactate dehydrogenase).

Very rare side effects (may affect up to 1 in 10,000 people)

• a marked decrease in some white blood cells (agranulocytosis),
• serious and potentially severe allergic reactions,
• inflammation of blood vessels (vasculitis, including necrotizing cutaneous vasculitis),
• inflammation of the pancreas (pancreatitis),
• serious liver damage such as liver failure or necrosis which can be fatal,
• serious, sometimes fatal reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects may also occur, with unknown frequency, such as kidney failure,
decrease in levels of uric acid in the blood, pulmonary hypertension, male infertility (which is
reversible when treatment with this medicine is stopped), cutaneous lupus (characterized
by rash/erythema of skin areas exposed to light), psoriasis (onset or worsening),
DRESS and skin ulcer (a round and open lesion in the skin through which it is possible
to see the underlying tissues).

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the
national reporting system indicated in Annex V .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Leflunomide Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging.
The expiry date refers to the last day of the month.
Blisters: store in the original packaging.
Bottle: keep the bottle tightly closed.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Leflunomide Zentiva contains

• The active ingredient is leflunomide. Each film-coated tablet contains 10 mg of leflunomide.
• The other ingredients are: corn starch, povidone (E1201), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate (E470b) and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171) and macrogol 8000 in the coating.

Description of the appearance of Leflunomide Zentiva and package contents
Leflunomide Zentiva 10 mg film-coated tablets are white or almost white and
round.
Imprinted on one side: ZBN.
The tablets are packaged in blisters or bottles.
Packs of 30 and 100 tablets are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
LABORMED- PHARMA S.A.
B-dul. Theodor Pallady no. 44B, sector 3
code 032266, Bucharest,
Romania
ZENTIVA S.A.
B-dul. Theodor Pallady no. 50, sector 3
code 032266, Bucharest,
Romania
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
[email protected]

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: +35924417136
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf.: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2034 1796
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS
Sími: +354 539 5025
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39 800081631
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

This leaflet was last updated on:
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu/ .

Leflunomide Zentiva 20 mg film-coated tablets

leflunomide

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful. If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Leflunomide Zentiva is and what it is used for
• 2. What you need to know before you take Leflunomide Zentiva
• 3. How to take Leflunomide Zentiva
• 4. Possible side effects
• 5. How to store Leflunomide Zentiva
• 6. Contents of the pack and other information

1. What is Leflunomide Zentiva and what is it used for

Leflunomide Zentiva belongs to a group of medicines called antirheumatic drugs.
Leflunomide Zentiva is used to treat adult patients suffering from active rheumatoid arthritis or active
psoriatic arthritis.
The symptoms of rheumatoid arthritis include inflammation of the joints, swelling, difficulty of
movement and pain. Other symptoms that can affect the whole body include loss of
appetite, fever, loss of strength and anemia (reduction in the number of red blood cells).
The symptoms of active psoriatic arthritis include inflammation of the joints, swelling, difficulty of
movement, pain and red, scaly skin patches (skin lesions).

2. What you need to know before taking Leflunomide Zentiva

Do not take Leflunomide Zentiva

• if you have already experienced an allergicreaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red skin patches or blisters, for example Stevens-Johnson syndrome) or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis),
• if you have any liver problems
• if you have severe or moderate kidney problems,
• if you have an extremely low number of proteins in your blood(hypoproteinemia),
• if you suffer from any condition that affects your immune system(such as AIDS),
• if you have any problems with your bone marrowor if the number of red blood cells or white blood cells is low or if the number of platelets in your blood is reduced,
• if you suffer from a severe infection,
• if you are pregnant,planning to become pregnant or are breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Leflunomide Zentiva

• if you have ever suffered from lung inflammation(interstitial lung disease).
• if you have ever had tuberculosisor if you have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis.
• if you are maleand intend to father a child. Because it cannot be ruled out that Leflunomide Zentiva passes into the semen, a reliable contraceptive method must be used during treatment with Leflunomide Zentiva. Men who intend to father a child should contact their doctor, who may advise them to stop treatment with Leflunomide Zentiva and take certain medications to remove Leflunomide Zentiva quickly and sufficiently from the body. After that, they must have a blood test to ensure that Leflunomide Zentiva has been sufficiently removed from the body, and then wait at least another 3 months before attempting to conceive.
• if you are to undergo a specific blood test (calcium level). Falsely low calcium levels may occur.
• if you are undergoing or have recently undergone major surgery or if you still have a wound that has not healed after surgery. Leflunomide Zentiva may impair wound healing.

Rarely, Leflunomide Zentiva can cause problems with the blood, liver, lungs or
nerves in the arms or legs. Leflunomide Zentiva can also cause some serious allergic reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]), or
increase the incidence of serious infections. For more information, read section 4 (Possible
side effects).
DRESS syndrome initially manifests with flu-like symptoms and a rash on the face, then widespread rash with fever, increased levels of liver enzymes and a type of white blood cells (eosinophilia)
in blood tests and enlarged lymph nodes.
Before starting to take Leflunomide Zentiva and during treatment, your doctor will prescribe you regular blood teststo monitor blood cells and the liver. The doctor
will also check your blood pressure regularly as Leflunomide Zentiva can cause an
increase in blood pressure.
Tell your doctor if you have unexplained chronic diarrhea. The doctor may perform additional tests for
differential diagnosis.
Tell your doctor if a skin ulcer appears during treatment with Leflunomide Zentiva
(see also section 4).

Children and adolescents
The use of Leflunomide Zentiva is not recommended in children and adolescents under
18 years of age.
Other medicines and Leflunomide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines you buy without a prescription.
This information is particularly important if you are taking:

• other medicines for the treatment of rheumatoid arthritissuch as antimalarials (e.g. chloroquine and hydroxychloroquine), gold salts administered by intramuscular or oral route, D-penicillamine, azathioprine and other immunosuppressant medicines (e.g. methotrexate) as these combinations are not recommended,
• warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine
• teriflunomide for multiple sclerosis
• repaglinide, pioglitazone, nateglinide or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, urinary incontinence or kidney disease in diabetics
• alosetron for the management of severe diarrhea
• theophylline for asthma
• tizanidine, to relax muscles
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart disease (diuretic, water pill)
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• a drug called cholestyramine (which is used to lower cholesterol) or activated charcoal as these medicines can decrease the amount of Leflunomide Zentiva absorbed by the body,

If you are already taking non-steroidal anti-inflammatory drugs(NSAIDs) and/or corticosteroidsyou
can continue to take them after starting therapy with Leflunomide Zentiva.

Vaccinations
If you need to be vaccinated, ask your doctor for advice. Certain vaccinations should not be
given while you are taking Leflunomide Zentiva, and for a certain period of time after
stopping treatment.

Leflunomide Zentiva with food, drinks and alcohol
Leflunomide Zentiva can be taken with or without food.
It is recommended not to drink alcohol during treatment with Leflunomide Zentiva. Drinking alcohol while
taking Leflunomide Zentiva may increase the likelihood of liver damage.

Pregnancy and breastfeeding
Donot take Leflunomide Zentiva if you are pregnantor think you might be. If you are pregnant or become
pregnant during treatment with Leflunomide Zentiva, the risk of having a baby with
serious birth defects is increased. Women must not take Leflunomide Zentiva without
using reliable contraceptive measures when they are of childbearing potential.
If you are planning to become pregnant after stopping treatment with Leflunomide
Zentiva, it is important to inform your doctor in advance, as they must be sure that all traces
of Leflunomide Zentiva have been eliminated from your body before attempting to become pregnant.
The elimination of Leflunomide Zentiva can take up to two years. This period can be reduced to
a few weeks by taking certain medicines that accelerate the removal of Leflunomide Zentiva from
your body. In both cases, before you become pregnant, blood tests must confirm that Leflunomide Zentiva has been eliminated from your body to a sufficient extent
and you must then wait at least another month.
For further information on laboratory tests, contact your doctor.
If you suspect you are pregnant during treatment with Leflunomide Zentiva or
within two years after stopping treatment, you must immediatelyinform your doctor
who will arrange for you to have a pregnancy test. If this confirms that you are pregnant, the
doctor will advise you on treatment with certain medicines to remove Leflunomide Zentiva
quickly and sufficiently from your body, reducing the risk to your baby.

Donot take Leflunomide Zentiva during breastfeedingas leflunomide passes into
breast milk.

Driving and using machines
Leflunomide Zentiva may make you feel unsteady and this feeling may impair your ability to
concentrate and react. In this case, do not drive and do not use machines.

Leflunomide Zentva contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Leflunomide Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.
The initial dose of Leflunomide Zentiva is usually 100 mg of leflunomide once a day for the
first three days. Afterwards, most patients need:

• for rheumatoid arthritis: a daily dose of 10 or 20 mg of Leflunomide Zentiva depending on the severity of the disease,
• for psoriatic arthritis: a daily dose of 20 mg of Leflunomide Zentiva

Takethe tablet wholeand with plenty of water.
It may take about 4 weeks or more before you start to feel an
improvement in your condition. Some patients may experience further improvements even
after 4-6 months of treatment.
Generally, Leflunomide Zentiva is taken for long periods of time.

If you use more Leflunomide Zentiva than you should
If you take a quantity of Leflunomide Zentiva higher than you should, contact your doctor or
seek some other type of medical advice. If possible, bring the tablets or the
package with you to show the doctor.

If you forget to take Leflunomide Zentiva
If you forget to take a dose, take it as soon as you remember, unless it is
almost time to take the next dose. Do not take a double dose to make up for
forgotten dose.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Leflunomide Zentiva and contact your doctor immediately:

• if you experience a feeling of weakness, lightheadedness or dizziness or if you have difficulty breathingas these signs may indicate a serious allergic reaction,
• if you develop skin rednessor mouth ulcersas these signs may indicate severe allergic reactions sometimes even fatal (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.

Contact your doctor immediatelyif you experience:

• paleness, fatigueor bruisingas these may indicate blood disorders caused by an imbalance between the different types of cells that make up the blood,
• fatigue, abdominal painor jaundice(yellowing of the eyes or skin) as these manifestations may indicate serious conditions such as liver failure which can be fatal,
• any symptom of infectionsuch as fever, sore throator coughas this medicine may increase the incidence of serious infections that can be life-threatening,
• coughor breathing difficultiesas these may indicate problems with the lungs (interstitial lung disease or pulmonary hypertension),
• tingling, weakness or unusual pain in the hands or feet as these may indicate problems with the nerves (peripheral neuropathy).

Common side effects (may affect up to 1 in 10 people)

• a mild decrease in the number of white blood cells (leukopenia),
• moderate allergic reactions,
• loss of appetite, decrease in body weight (usually not significant),
• fatigue (asthenia),
• headache, dizziness,
• abnormal skin sensations such as tingling (paresthesia),
• moderate increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• inflammation of the mouth or mouth ulcers,
• abdominal pain,
• an increase in values in some liver function tests,
• increased hair loss,
• eczema, dry skin, redness and itching,
• tendinitis (pain caused by inflammation of the sheath covering the tendons generally of feet or hands),
• an increase in some blood enzymes (creatine phosphokinase),
• problems with the nerves of the arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

• a decrease in the number of red blood cells (anemia) and a decrease in the number of platelets (thrombocytopenia),
• a decrease in potassium levels in the blood,
• anxiety,
• taste disturbances,
• urticaria (redness with itching),
• tendon rupture
• an increase in levels of fats in the blood (cholesterol and triglycerides),
• a decrease in phosphate levels in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

• an increase in the number of blood cells called eosinophils (eosinophilia); a mild decrease in the number of white blood cells (leukopenia); a reduction in the number of all blood cells (pancytopenia),
• increased blood pressure,
• inflammation of the lung (interstitial lung disease),
• an increase in some liver function values that can lead to serious conditions such as hepatitis and jaundice,
• serious infections called sepsis that can be fatal,
• an increase in some enzymes in the blood (lactate dehydrogenase)

Very rare side effects (may affect up to 1 in 10,000 people)

• a marked decrease in some white blood cells (agranulocytosis),
• serious and potentially severe allergic reactions,
• inflammation of blood vessels (vasculitis, including necrotizing cutaneous vasculitis),
• inflammation of the pancreas (pancreatitis),
• serious liver damage such as liver failure or necrosis which can be fatal,.
• severe reactions, sometimes fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects may also occur, with unknown frequency, such as kidney failure,
decreased levels of uric acid in the blood, pulmonary hypertension, male infertility (which is
reversible when treatment with this medicine is stopped), cutaneous lupus (characterized
by rash/erythema of skin areas exposed to light), psoriasis (onset or worsening),
DRESS and skin ulcer (an open, round lesion in the skin through which underlying tissues can
be seen).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Leflunomide Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging.
The expiry date refers to the last day of the month.
Blisters: store in the original packaging.
Bottle: keep the bottle tightly closed.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Leflunomide Zentiva contains

• The active ingredient is leflunomide. Each film-coated tablet contains 20 mg of leflunomide.
• The other ingredients are: corn starch, povidone (E1201), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate (E470b) and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 and yellow iron oxide (E172) in the coating.

Description of the appearance of Leflunomide Zentiva and package contents
Leflunomide Zentiva 20 mg film-coated tablets are yellowish to ochre and triangular.
Imprinted on one side: ZBO.
The tablets are packaged in blisters or bottles.
Packs of 30, 50 and 100 tablets are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
LABORMED- PHARMA S.A.
B-dul. Theodor Pallady no. 44B, sector 3
code 032266, Bucharest,
Romania
ZENTIVA S.A.
B-dul. Theodor Pallady no. 50, sector 3
code 032266, Bucharest,
Romania
For further information on this medicine, contact the local representative of the marketing authorisation holder.

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: +35924417136
[email protected]

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf.: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2034 1796
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS
Sími: +354 539 5025
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39 800081631
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

This leaflet was last updated on:
Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu/ .

Leflunomide Zentiva 100 mg film-coated tablets

leflunomide

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Leflunomide Zentiva is and what it is used for
• 2. What you need to know before you take Leflunomide Zentiva
• 3. How to take Leflunomide Zentiva
• 4. Possible side effects
• 5. How to store Leflunomide Zentiva
• 6. Contents of the pack and other information

1. What is Leflunomide Zentiva and what is it used for

Leflunomide Zentiva belongs to a group of medicines called antirheumatic drugs.
Leflunomide Zentiva is used to treat adult patients with active rheumatoid arthritis or active
psoriatic arthritis.
The symptoms of rheumatoid arthritis include inflammation of the joints, swelling, difficulty of
movement and pain. Other symptoms that can affect the whole body include loss of
appetite, fever, loss of strength and anemia (reduction in the number of red blood cells).
The symptoms of active psoriatic arthritis include inflammation of the joints, swelling, difficulty of
movement, pain and red, scaly skin patches (skin lesions).

2. What you need to know before taking Leflunomide Zentiva

Do not takeLeflunomide Zentiva:

• if you have already experienced an allergicreaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red skin patches or blisters, for example Stevens-Johnson syndrome) or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis),
• if you have any liver problems
• if you have severe or moderate kidney problems,
• if you have an extremely low number of proteins in your blood(hypoproteinemia),
• if you suffer from any condition that affects your immune system(e.g. AIDS),
• if you have any bone marrowproblems or if the number of red blood cells or white blood cells is low or if the number of platelets in your blood is reduced,
• if you suffer from a severe infection,
• if you are pregnant,planning to become pregnant or are breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Leflunomide Zentiva

• if you have ever suffered from lung inflammation(interstitial lung disease).
• if you have ever had tuberculosisor if you have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis.
• if you are maleand intend to father a child. Because it cannot be ruled out that Leflunomide Zentiva passes into semen, a reliable contraceptive method must be used during treatment with Leflunomide Zentiva. Men who intend to father a child should contact their doctor, who may advise them to stop treatment with Leflunomide Zentiva and to take certain medications to remove Leflunomide Zentiva quickly and sufficiently from their body. After that, they must have a blood test to ensure that Leflunomide Zentiva has been removed sufficiently from the body, and then they must wait at least another 3 months before attempting to conceive.
• if you are to undergo a specific blood test (calcium level). Falsely low levels of calcium may occur.
• if you are undergoing or have recently undergone major surgery or if you still have an unhealed wound following surgery. Leflunomide Zentiva may impair wound healing.

Rarely, Leflunomide Zentiva can cause problems with the blood, liver, lungs or
the nerves of the arms or legs. Leflunomide Zentiva can also cause some serious allergic reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]), or
increase the incidence of serious infections. For more information, read section 4 (Possible
side effects).
DRESS syndrome initially manifests with flu-like symptoms and a rash on the face, then widespread rash with fever, increased levels of liver enzymes and a type of white blood cells (eosinophilia)
in blood tests and enlarged lymph nodes.
Before starting to take Leflunomide Zentiva and during treatment, your doctor will prescribe you at
regular intervals blood teststo monitor blood cells and the liver. The doctor will
also check your blood pressure regularly as Leflunomide Zentiva can cause an
increase in blood pressure.
Tell your doctor if you have chronic unexplained diarrhea. The doctor may perform additional tests for
differential diagnosis.
Tell your doctor if a skin ulcer appears during treatment with Leflunomide Zentiva
(see also section 4).

Children and adolescents
The use of Leflunomide Zentiva is not recommended in children and adolescents under
18 years of age.
Other medicines and Leflunomide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines you buy without a prescription.
This information is particularly important if you are taking:

• other medicines for the treatment of rheumatoid arthritissuch as antimalarials (e.g. chloroquine and hydroxychloroquine), gold salts given by intramuscular or oral route, D-penicillamine, azathioprine and other immunosuppressant medicines (e.g. methotrexate) as these combinations are not recommended,
• warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine
• teriflunomide for multiple sclerosis
• repaglinide, pioglitazone, nateglinide or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, urinary incontinence or kidney disease in diabetics
• alosetron for the management of severe diarrhea
• theophylline for asthma
• tizanidine, to relax muscles
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart disease (diuretic, water pill)
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• a medicine called cholestyramine (which is used to lower cholesterol) or activated charcoal as these medicines can decrease the amount of Leflunomide Zentiva absorbed by the body,

If you are already taking non-steroidal anti-inflammatory drugs(NSAIDs) and/or corticosteroidsyou may
continue to take them after starting therapy with Leflunomide Zentiva.

Vaccinations
If you need to be vaccinated, ask your doctor for advice. Certain vaccinations should not be
given while you are taking Leflunomide Zentiva, and for a certain period of time after
stopping treatment.

Leflunomide Zentiva with food, drinks and alcohol
Leflunomide Zentiva can be taken with or without food.
It is recommended not to drink alcohol during treatment with Leflunomide Zentiva. Drinking alcohol while
taking Leflunomide Zentiva may increase the likelihood of liver damage.

Pregnancy and breastfeeding
Do nottake Leflunomide Zentiva if you are pregnantor think you might be. If you are pregnant or become
pregnant during treatment with Leflunomide Zentiva, the risk of having a baby with serious
birth defects is increased. Women must not take Leflunomide Zentiva without using
reliable contraceptive measures when they are of childbearing potential.
If you are planning to become pregnant after stopping treatment with Leflunomide
Zentiva, it is important to inform your doctor in advance, as they must be sure that all traces
of Leflunomide Zentiva have been eliminated from your body before attempting to become pregnant.
The elimination of Leflunomide Zentiva can take up to two years. This period can be reduced to a few
weeks by taking certain medicines that accelerate the removal of Leflunomide Zentiva from your
body. In both cases, before you become pregnant, blood tests must confirm that Leflunomide Zentiva has been eliminated from your body to a sufficient extent
and you must then wait at least another month.
For more information about laboratory tests, contact your doctor.
If you suspect you are pregnant during treatment with Leflunomide Zentiva or
within two years after stopping treatment, you must immediatelyinform your doctor
who will arrange for you to have a pregnancy test. If this confirms that you are pregnant, the
doctor will advise you to take treatment with certain medicines to remove Leflunomide Zentiva
quickly and sufficiently from your body, reducing the risk to your baby.

Do nottake Leflunomide Zentiva during breastfeedingas leflunomide passes into
breast milk.

Driving and using machines
Leflunomide Zentiva can make you feel unsteady and this sensation may impair your ability to
concentrate and react. In this case, do not drive and do not use machines.

Leflunomide Zentiva contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Leflunomide Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.
The initial dose of Leflunomide Zentiva is usually 100 mg of leflunomide once a day for the
first three days. Afterwards, most patients need:

• for rheumatoid arthritis: a daily dose of 10 or 20 mg of Leflunomide Zentiva depending on the severity of the disease.
• For psoriatic arthritis: a daily dose of 20 mg of Leflunomide Zentiva.

Takethe tablet wholeand with plenty of water.
It may take about 4 weeks or more before you start to feel an
improvement in your condition. Some patients may experience further improvements even
after 4-6 months of treatment.
Generally, Leflunomide Zentiva is taken for long periods of time.

If you use more Leflunomide Zentiva than you should
If you take more Leflunomide Zentiva than you should, contact your doctor or
seek some other form of medical advice. If possible, bring the tablets or the
package with you to show the doctor.

If you forget to take Leflunomide Zentiva
If you forget to take a dose, take it as soon as you remember, unless it is
almost time to take the next dose. Do not take a double dose to make up for
forgetting a dose.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Leflunomide Zentiva and contact your doctor immediately:

• if you experience a feeling of weakness, lightheadedness or dizziness or if you have difficulty breathingas these signs may indicate a serious allergic reaction,
• if you develop skin rednessor mouth ulcersas these signs may indicate severe allergic reactions sometimes even fatal (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.

Contact your doctor immediatelyif the following occur:

• paleness, fatigueor bruisingas these may indicate blood disorders caused by an imbalance between the different types of cells that make up the blood,
• fatigue, abdominal painor jaundice(yellowing of the eyes or skin) as these manifestations may indicate serious conditions such as liver failure which can be fatal,
• any symptom of infectionsuch as fever, sore throator coughas this medicine may increase the incidence of serious infections that can be life-threatening,
• coughor breathing difficultiesas these may indicate problems with the lungs (interstitial lung disease or pulmonary hypertension),
• tingling, weakness or unusual pain in the hands or feet as these may indicate problems with the nerves (peripheral neuropathy).

Common side effects (may affect up to 1 in 10 people)

• a mild decrease in the number of white blood cells (leukopenia),
• moderate allergic reactions,
• loss of appetite, decrease in body weight (usually not significant),
• fatigue (asthenia),
• headache, dizziness,
• abnormal skin sensations such as tingling (paresthesia),
• moderate increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• inflammation of the mouth or mouth ulcers,
• abdominal pain,
• an increase in values in some liver function tests,
• increased hair loss,
• eczema, dry skin, redness and itching,
• tendinitis (pain caused by inflammation of the sheath covering the tendons generally of feet or hands),
• an increase in some blood enzymes (creatine phosphokinase),
• problems with the nerves of the arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

• a decrease in the number of red blood cells (anemia) and a decrease in the number of platelets (thrombocytopenia),
• a decrease in potassium levels in the blood,
• anxiety,
• taste disturbances,
• urticaria (redness with itching),
• tendon rupture,
• an increase in levels of fats in the blood (cholesterol and triglycerides),
• a decrease in levels of phosphate in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

• an increase in the number of blood cells called eosinophils (eosinophilia); a mild decrease in the number of white blood cells (leukopenia); a reduction in the number of all blood cells (pancytopenia),
• increased blood pressure,
• inflammation of the lung (interstitial lung disease),
• an increase in some liver function values that can lead to serious clinical conditions such as hepatitis and jaundice,
• serious infections called sepsis that can be fatal,
• an increase in some enzymes in the blood (lactate dehydrogenase).

Very rare side effects (may affect up to 1 in 10,000 people)

• a marked decrease in some white blood cells (agranulocytosis),
• serious and potentially severe allergic reactions,
• inflammation of blood vessels (vasculitis, including necrotizing cutaneous vasculitis),
• inflammation of the pancreas (pancreatitis),
• serious liver damage such as liver failure or necrosis which can be fatal,
• serious, sometimes fatal reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Other side effects may also occur, with unknown frequency, such as renal failure,
decreased levels of uric acid in the blood, pulmonary hypertension, male infertility (which is
reversible when treatment with this medicine is stopped), cutaneous lupus (characterized by
rash/erythema of skin areas exposed to light), psoriasis (onset or worsening),
DRESS and skin ulcer (an open, round lesion in the skin through which underlying tissues can be
seen).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Leflunomide Zentiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging.
The expiry date refers to the last day of the month.
Store in the original packaging.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Leflunomide Zentiva contains

• The active ingredient is leflunomide. Each film-coated tablet contains 100 mg of leflunomide.
• The other ingredients are: corn starch, povidone (E1201), crospovidone (E1202), talc (E553b), anhydrous colloidal silica, magnesium stearate (E470b) and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171) and macrogol 8000 in the coating.

Description of the appearance of Leflunomide Zentiva and package contents
Leflunomide Zentiva 100 mg film-coated tablets are white or almost white and
round.
Imprinted on one side: ZBP.
The tablets are packaged in blisters.
A pack of 3 tablets is available.

Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: +35924417136
[email protected]

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf.: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2034 1796
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS
Sími: +354 539 5025
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39 800081631
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

This leaflet was last updated on:
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu/ .