Package Insert: Information for the User

Leflunomide Medac 10 mg Film-Coated Tablets

leflunomida

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Leflunomida medac belongs to a group of medications known as anti-rheumatic medications. It contains leflunomide as the active ingredient.

Leflunomida medac is used to treat adult patients with active rheumatoid arthritis or active psoriatic arthritis.

The symptoms of rheumatoid arthritis include joint inflammation, swelling, difficulty moving, and pain. Other symptoms affecting the entire body include loss of appetite, fever, fatigue, and anemia (reduction in the number of red blood cells in the blood).

The symptoms of active psoriatic arthritis include joint inflammation, swelling, difficulty moving, pain, red plaques, and scaly skin (skin lesions).

Do not take Leflunomida medac

• if you have ever had a severe allergic reaction to leflunomida (especially a severe skin reaction, often accompanied by fever, joint pain, red skin patches, or blisters, such as Stevens-Johnson syndrome), peanuts, or soy, or any of the other components of this medication (listed in section 6), or if you are allergic to teriflunomida (used in the treatment of multiple sclerosis).
• if you have any liver problems,
• if you have moderate to severe kidney problems,
• if you have a severe decrease in the concentration of proteins in your blood (hypoproteinemia),
• if you have any condition that affects your immune system (for example, HIV/AIDS),
• if you have any bone marrow problems or if you have a reduced number of red or white blood cells in your blood or a reduced number of platelets,
• if you have a severe infection,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Leflunomida medac

• if you have ever had lung inflammation (interstitial lung disease),
• if you have ever had tuberculosis or 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 a male and wish to have children. As it cannot be ruled out that Leflunomida medac may pass into semen, reliable contraceptive methods should be used during treatment with Leflunomida medac. Men who wish to have children should contact their doctor, who may advise them to interrupt treatment with Leflunomida medac and take certain medications to quickly and sufficiently eliminate Leflunomida medac from their body. In this case, a blood test will be necessary to ensure that Leflunomida medac has been eliminated sufficiently from their body, and then they should wait at least 3 months before attempting to have children.
• if a specific blood test (calcium level) is planned. A false decrease in calcium levels may be detected,
• if you are scheduled to undergo or have recently undergone a major surgical procedure, or if you still have an open wound after a surgical procedure. Leflunomida medac may impair wound healing.

Leflunomida medac may occasionally cause some problems in the blood, liver, lungs, or nerves in the arms or legs. It may also cause some severe allergic reactions (including drug rash with eosinophilia and systemic symptoms [DRESS syndrome]), or increase the risk of a severe infection. For more information on these adverse effects, see section 4 (Possible adverse effects).

DRESS syndrome initially appears with symptoms similar to the flu and a skin rash on the face, followed by a widespread skin rash with fever, elevated liver enzymes in the blood, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

Your doctor will perform regular blood tests, before and during treatment with Leflunomida medac, to monitor your blood cells and liver. Your doctor should also regularly check your blood pressure as Leflunomida medac may cause an increase in blood pressure.

Consult your doctor if you experience chronic diarrhea of unknown origin. Additional tests may be performed to establish a differential diagnosis.

Inform your doctor if you develop a skin ulcer during treatment with Leflunomida medac (see section 4).

Children and adolescents

Leflunomida medac is not recommended for use in children and adolescents under 18 years of age.

Other medications and Leflunomida medac

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription.

This is especially important if you are taking:

• other medications for rheumatoid arthritis, such as antimalarials (e.g., chloroquine and hydroxychloroquine), gold salts administered intramuscularly or orally, D-penicillamine, azathioprine, and other immunosuppressive agents (e.g., methotrexate), as the use of these combinations is not recommended.
• warfarin (used as an anticoagulant), as a control is necessary to reduce the risk of adverse effects of this medication
• teriflunomida for multiple sclerosis
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, urinary incontinence, or renal insufficiency in diabetics
• alosetron for severe diarrhea control
• theophylline for asthma
• tizanidine, a muscle relaxant
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indomethacin, ketoprofen for pain or inflammation
• furosemide for heart disease (diuretic, diuretic pills)
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for high cholesterol (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• a medication called cholestyramine (used to reduce high cholesterol)oractivated charcoalas these medications may reduce the amount of Leflunomida medac absorbed by the body.

If you are taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting treatment with Leflunomida medac.

Vaccinations

Consult your doctor if you need to be vaccinated. Some vaccines cannot be administered while you are on treatment with Leflunomida medac or for a certain period after stopping treatment.

Taking Leflunomida medac with food, drink, and alcohol

Leflunomida medac can be taken with or without food.

Do notconsume alcohol during treatment with Leflunomida medac. Alcohol consumption during treatment with Leflunomida medac may increase the risk of liver damage.

Pregnancy and lactation

Do nottake Leflunomida medac if you are or think you may be pregnant. If you are pregnant or become pregnant while taking Leflunomida medac, there is an increased risk of having a child with severe malformations. Women of childbearing age should not take Leflunomida medac without using reliable contraceptive methods.

Inform your doctor if you plan to become pregnant after stopping treatment with Leflunomida medac, as it is necessary to ensure that there are no remaining residues of Leflunomida medac in your body before becoming pregnant. The elimination of the medication from the body may take up to 2 years. This time interval may be reduced to a few weeks by taking certain medications that accelerate the elimination of Leflunomida medac from the body. In any case, a blood test will be necessary to confirm that Leflunomida medac has been eliminated sufficiently from your body, and once this test has been performed, you should wait at least 1 month before becoming pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect that you may be pregnant during treatment with Leflunomida medac or in the 2 years after treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest that you start treatment with certain medications to quickly and sufficiently eliminate Leflunomida medac from your body, and thus reduce the risk to your child.

Do nottake Leflunomida medac while breastfeeding, as leflunomida passes into breast milk.

Driving and operating machinery

Leflunomida medac may cause dizziness, which may affect your ability to concentrate and react. If this happens, do not drive or operate machinery.

Leflunomida medac contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Leflunomida medac contains soy lecithin

Do not use the medication if you are allergic to peanuts or soy.

Leflunomida medac contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual initial dose of Leflunomida medac is 100 mg of leflunomida once a day for the first three days. After this, most people need a dose of:

• For rheumatoid arthritis: 10 mg or 20 mg of Leflunomida medac once a day, depending on the severity of the disease.
• For psoriatic arthritis: 20 mg of Leflunomida medac once a day.

Swallowthe tabletwholeand with plenty ofwater.

You may take up to 4 weeks or even longer to notice an improvement in your condition. Some patients may even notice a new improvement after 4 or 6 months of treatment. Leflunomida medac is usually taken for prolonged periods of time.

If you take more Leflunomida medac than you should

If you take more Leflunomida medac than you should, consult your doctor or any other healthcare service. If possible, bring the tablets or the box to show them to your doctor.

If you forgot to take Leflunomida medac

If you forgot to take a dose, take it as soon as you remember, unless it is almost time to take the next one. Do not take a double dose to make up for the missed dose.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately and stop taking Leflunomida medac:

• if you feelweak, dizzy or lightheaded, or havedifficulty breathing, because these may be symptoms of a severe allergic reaction,
• if you developskin rashes or mouth ulcers,because it may indicate severe reactions that in some cases can be fatal (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug eruption with eosinophilia and systemic symptoms [DRESS syndrome]), see section 2.

Inform your doctorimmediatelyif you experience:

• pallor, fatigueorbruising, because they may indicate blood problems caused by a balance disorder in the different types of cells that make up the blood,
• fatigue, abdominal painorjaundice(yellowing of the eyes or skin), because they may indicate serious problems such as liver failure, which could be fatal,
• any symptoms of infection such asfever, sore throator cough, because this medicine may increase the risk of severe infections, which could be fatal,
• coughorrespiratory problemsbecause they may indicate lung problems (interstitial lung disease or pulmonary hypertension),
• tinglingunusual,weaknessorpainin the hands or feet, because it may indicate nerve problems (peripheral neuropathy).

Frequent side effects (may affect up to one in 10 patients)

• mild decrease in the number of white blood cells in the blood (leucopenia),
• mild allergic reactions,
• loss of appetite, weight loss (usually insignificant),
• fatigue (asthenia),
• headache, dizziness,
• abnormal sensations in the skin such as tingling (paresthesia),
• mild increase in blood pressure,
• colitis,
• diarrhea,
• nausea, vomiting,
• inflammation of the mouth, mouth ulcers,
• abdominal pain,
• increase in liver test results that may lead to serious situations such as hepatitis and jaundice,
• increase in hair loss,
• eczema, dry skin, skin rash and itching (pruritus),
• tendinitis (pain caused by inflammation of the membrane surrounding the tendons of, usually, the feet or hands),
• increase in levels of certain enzymes in the blood (creatinine phosphokinase),
• nerve problems in the arms or legs (peripheral neuropathy).

Rare side effects (may affect up to one in 100 patients)

• decrease in the number of red blood cells in the blood (anemia) and platelets (thrombocytopenia),
• decrease in potassium levels in the blood,
• anxiety,
• alterations in taste,
• skin rash (urticaria),
• tendon rupture,
• increase in levels of fat in the blood (cholesterol and triglycerides),
• decrease in levels of phosphate in the blood.

Very rare side effects (may affect up to one in 1,000 patients)

• increase in the number of eosinophils in the blood (eosinophilia), mild decrease in the number of white blood cells in the blood (leucopenia), and decrease in the number of all blood cells (pancytopenia),
• severe increase in blood pressure,
• lung inflammation (interstitial lung disease),
• increase in liver test results that may lead to serious situations such as hepatitis and jaundice,
• severe infections known as sepsis, which can be fatal,
• increase in levels of certain enzymes in the blood (lactate dehydrogenase).

Extremely rare side effects (may affect up to one in 10,000 patients)

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

Other side effects such as kidney failure, decrease in uric acid levels in the blood, pulmonary hypertension, infertility in men (this effect is reversible once treatment with this medicine is completed), lupus skin (characterized by skin rash/erythema in exposed skin areas), psoriasis (new or worsening), DRESS syndrome, and skin ulcer (round, open wound in the skin through which underlying tissues can be seen), may occur with an unknown frequency.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the outer box and on the bottle after CAD. The expiration date is the last day of the month indicated.

Keep the bottle perfectly closed to protect it from moisture.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Leflunomide medac

• The active ingredient is leflunomide.

Each Leflunomide medac 10 mg film-coated tablet contains 10 mg of leflunomide.

• The other components are lactose monohydrate, low-substituted hydroxypropylcellulose, tartaric acid, sodium lauryl sulfate, and magnesium stearate (E 470b) in the core of the tablet, as well as lecithin (soybean), (alcohol) poly(vinyl), talc, titanium dioxide (E 171), and xanthan gum in the coating.

Appearance of the product and contents of the package

Leflunomide medac 10 mg film-coated tablets are white to off-white, round tablets with a diameter of approximately 6 mm.

The tablets are packaged in bottles.

Leflunomide medac 10 mg film-coated tablets: They are available in packaging sizes of 30, 60, or 100 film-coated tablets per bottle.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

medac

Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Responsible Person

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

medac

Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: 07/2024

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.