Leflunomide Orion

Leaflet attached to the packaging: patient information

Leflunomide Orion, 20 mg, coated tablets

leflunomide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Leflunomide Orion belongs to a group of medicines called antirheumatic drugs. It contains the active substance leflunomide.
Leflunomide Orion is used in adults to treat active rheumatoid arthritis or active psoriatic arthritis.
The symptoms of rheumatoid arthritis include joint inflammation, swelling, difficulty moving, and pain. Other symptoms that affect the whole body are loss of appetite, fever, lack of energy, and anemia (low red blood cell count).
The symptoms of psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, and redness and scaling of the skin (skin lesions).

2. Important information before taking Leflunomide Orion

When not to take Leflunomide Orion

• if the patient has ever had an allergic reactionto leflunomide (especially severe skin reactions, often with accompanying fever, joint pain, red spots, or blisters on the skin [e.g., Stevens-Johnson syndrome]) or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to teriflunomide (used to treat multiple sclerosis)
• if the patient has liver dysfunction
• if the patient has moderate to severe kidney dysfunction
• if the patient has significantly reduced blood protein levels (hypoproteinemia)
• if the patient has any disease that reduces immunity(e.g., AIDS)
• if the patient has bone marrow disorders or a significantly reduced number of red, white, or platelet blood cells
• if the patient has a severe infection
• if the patient is pregnant, thinks they may be pregnant, or is breastfeeding.

Warnings and precautions

Before starting to take Leflunomide Orion, the patient should discuss it with their doctor or pharmacist if:

• -the patient has ever had pneumonia(interstitial lung disease).
• the patient has ever had tuberculosisor has been in close contact with someone who has or has had tuberculosis. The doctor may order tests to determine if the patient has tuberculosis.
• the patient is a manand plans to father a child. It cannot be excluded that Leflunomide Orion passes into semen, so effective contraception should be used during treatment. Men planning to father a child should consult their doctor, who may advise stopping Leflunomide Orion and prescribing other medicines to quickly and effectively remove Leflunomide Orion from the body. Effective removal of the medicine must be confirmed by blood tests. The decision to father a child can be made no earlier than 3 months after this time.
• the patient is to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.
• if the patient is to undergo or has undergone major surgery, or if they still have an unhealed postoperative wound. Leflunomide Orion may interfere with wound healing.

Leflunomide Orion may rarely cause blood disorders, liver or lung problems, or nerve damage in the hands or feet. It may also cause severe allergic reactions (including drug rash with eosinophilia and systemic symptoms [DRESS]) or increase the risk of serious infections. More information on this can be found in section 4 "Possible side effects".
DRESS syndrome typically starts with flu-like symptoms and a rash on the face, followed by the spread of the rash, high fever, increased liver enzyme activity, and an increased number of a certain type of white blood cell (eosinophilia) visible in blood tests, as well as swollen lymph nodes.
Before starting to take Leflunomide Orion, and regularly during treatment, the doctor will order blood teststo monitor the blood count and liver function. The doctor will also recommend regular blood pressure checks, as Leflunomide Orion may cause an increase in blood pressure.
If the patient experiences chronic diarrhea of unknown cause, they should consult their doctor. The doctor may order additional tests to determine the diagnosis.
The patient should inform their doctor if they experience skin ulcers (see also section 4).

Children and adolescents

Leflunomide Orion should not be used in children and adolescents under 18 years of age.

Leflunomide Orion and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
This is especially important if the patient is taking:

• other medicines used to treat rheumatoid arthritis, such as antimalarial drugs (e.g., chloroquine and hydroxychloroquine), gold products administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive medicines (e.g., methotrexate), as these combinations are not recommended

if the patient is taking non-steroidal anti-inflammatory drugs(NSAIDs) and (or) corticosteroids, they may continue treatment with these medicines after starting Leflunomide Orion.

Vaccinations

If the patient plans to be vaccinated, they should consult their doctor. Some vaccines should not be used during or for some time after treatment with Leflunomide Orion.

Leflunomide Orion with food, drink, and alcohol

Leflunomide Orion can be taken with or without food.
Alcohol
It is not recommended to consume alcoholic beverages during treatment with Leflunomide Orion. Drinking alcohol during treatment with Leflunomide Orion may increase the risk of liver damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Do not takeLeflunomide Orion if the patient is pregnantor thinks they may be pregnant. If a woman is pregnant or becomes pregnant while taking Leflunomide Orion, the risk of serious birth defects in the child increases. Women of childbearing age should not take Leflunomide Orion unless they use effective contraception.
Women planning to become pregnant after stopping Leflunomide Orion should tell their doctor, as it is necessary to ensure that Leflunomide Orion has been completely removed from the body beforehand. This may take up to 2 years. However, this time can be shortened to a few weeks by taking medicines that accelerate the removal of Leflunomide Orion from the body.
In any case, the patient should undergo the appropriate blood tests to ensure that Leflunomide Orion has been effectively removed from the body. After obtaining a normal test result, the patient should wait at least one month before trying to become pregnant.
To obtain more information about the laboratory test, the patient should consult their doctor.
If the patient thinks they have become pregnant while taking Leflunomide Orion or within 2 years of stopping it, they should immediatelyconsult their doctor to have a pregnancy test. If the test result confirms pregnancy, the doctor may prescribe specific medicines that quickly and effectively remove Leflunomide Orion from the body, which may reduce the risk to the child.
Do not takeLeflunomide Orion while breastfeeding, as leflunomide passes into breast milk.

Driving and using machines

Leflunomide Orion may cause dizziness, which can affect concentration and reaction speed. If this occurs, the patient should not drive or operate machinery.

Leflunomide Orion contains lactose

This medicine contains 36 mg of lactose (in the form of lactose monohydrate). If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Leflunomide Orion

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Usually, the initial dose is 100 mg of leflunomide (five Leflunomide Orion tablets) once a day, taken for the first three days. After this time, for most patients:

• In the treatment of rheumatoid arthritis: 10 or 20 mg of Leflunomide Orion once a day, depending on the severity of the disease. In the case of a 10 mg dose, the doctor may prescribe another medicine containing leflunomide to achieve the appropriate dose for the patient.
• In the treatment of active psoriatic arthritis: 20 mg of Leflunomide Orion once a day.

The tablet should be swallowed whole, with a large amount of water.
The dividing line on the tablet is only to facilitate breaking it, to make it easier to swallow.
A noticeable improvement in health may occur after 4 weeks or longer from the start of treatment. Some patients may experience further improvement after 4 to 6 months of treatment. Leflunomide Orion is usually taken for a long time.

Taking a higher dose of Leflunomide Orion than recommended

If the patient takes a higher dose of Leflunomide Orion than recommended, they should consult their doctor or seek other medical advice. If possible, they should take the tablets or packaging with them to show the doctor.

Missing a dose of Leflunomide Orion

If the patient misses a dose of the medicine, they should take it as soon as they remember, unless it is almost time for the next dose. They should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Leflunomide Orion can cause side effects, although not everybody gets them.
The patient should immediatelyinform their doctor and stop taking Leflunomide Orion if:

• they experience weakness, mild dizziness, and dizziness or breathing difficulties, as these may be symptoms of a severe allergic reaction
• they experience skin rashor mouth ulcers, as these may indicate serious, potentially life-threatening reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms [DRESS]). See section 2 "Warnings and precautions".

The patient should immediatelyinform their doctor if they experience:

• pale skin, feeling tiredor bruising, as these may be symptoms of blood disorders caused by an imbalance between different types of blood cells
• feeling tired, abdominal painor jaundice(yellowing of the eyes or skin), as these may indicate severe disorders, such as liver failure, which can be life-threatening
• symptoms of infection, such as fever, sore throat, or cough, as Leflunomide Orion may increase the risk of serious, potentially life-threatening infections
• coughor breathing difficulties, as these may indicate lung disease (interstitial lung disease or pulmonary hypertension)
• unusual tingling, weakness, or pain in the hands or feet, as these may indicate nerve damage (peripheral neuropathy).

Frequently ( affecting up to 1 in 10 people):

• mild decrease in white blood cell count (leukopenia)
• mild allergic reactions
• loss of appetite, weight loss (usually slight)
• weakness (asthenia)
• pain and dizziness
• unusual sensations, such as tingling (paresthesia)
• mild increase in blood pressure
• colitis
• diarrhea
• nausea, vomiting
• inflammation or ulcers in the mouth
• abdominal pain
• increased values of some liver function tests
• increased hair loss
• rash, dry skin, and itching
• tendinitis (pain caused by inflammation of the tendon sheath, usually in the hands and feet)
• increased activity of some enzymes in the blood (creatine kinase)
• nerve damage in the hands or feet (peripheral neuropathy).

Less frequently ( affecting up to 1 in 100 people):

• decrease in red blood cell count (anemia) and decrease in platelet count (thrombocytopenia)
• decrease in blood potassium levels
• anxiety
• taste disorders
• hives (urticaria)
• tendon rupture
• increased blood lipid levels (cholesterol and triglycerides)
• decrease in blood phosphate levels.

Rarely ( affecting up to 1 in 1,000 people):

• increase in eosinophil count in the blood, mild decrease in white blood cell count (leukopenia), decrease in all blood cell counts (pancytopenia)
• significant increase in blood pressure
• pneumonia (interstitial lung disease)
• increased liver function test values, which may indicate severe disorders, such as hepatitis and jaundice
• severe infections called sepsis, which can be life-threatening
• increased activity of some enzymes in the blood (lactate dehydrogenase).

Very rarely ( affecting up to 1 in 10,000 people):

• significant decrease in certain white blood cell counts (agranulocytosis)
• severe and potentially severe allergic reactions
• vasculitis (including vasculitis with skin necrosis)
• pancreatitis
• severe liver damage, such as liver failure or necrosis, which can be life-threatening
• severe, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

Frequency not known ( frequency cannot be estimated from the available data):

• kidney failure
• decrease in blood uric acid levels
• pulmonary hypertension
• male infertility (reversible after stopping treatment with this medicine)
• skin form of lupus (characterized by rash and/or redness on sun-exposed skin areas), psoriasis (occurring for the first time or worsening of existing disease), DRESS syndrome, and skin ulcers (round, open sore in the skin, through which underlying tissues are visible).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181 C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301,
Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Leflunomide Orion

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Leflunomide Orion contains

• The active substance is leflunomide. Each tablet contains 20 mg of leflunomide.
• The other ingredients of the medicine are: Tablet core: Microcrystalline cellulose, lactose monohydrate (type 102), maize starch, crospovidone, povidone (K 30), colloidal silicon dioxide, anhydrous, and magnesium stearate. Tablet coating Opadry Yellow OY-SR-6497: Hypromellose 2910 (15 cP), titanium dioxide (E 171), macrogol 6000, talc, and yellow iron oxide (E 172).

What Leflunomide Orion looks like and contents of the pack

Yellow, round, biconvex, coated tablets with a dividing line on one side, approximately 8 mm in diameter.
The coated tablets are packaged in blisters in a carton.
Pack sizes: 30 tablets.

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
Pharmathen S.A.
Dervenakion 6
15351 Pallini
Attiki
Greece
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture, Block No 5
69300 Rodopi
Greece
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl
Date of last revision of the leaflet:09.09.2024