10 mg film-coated tablets
leflunomide
What Leflunomide medac is and what it is used for
Leflunomide medac belongs to a group of medicines called anti-rheumatic medicines. Leflunomide medac contains the active substance leflunomide.
Leflunomide medac is used to treating adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Symptoms of rheumatoid arthritis include inflammation of the joints, swelling, difficulty moving, and pain. Other symptoms that can affect the whole body include decreased appetite, fever, decreased energy, and anemia (lack of red blood cells ).
Symptoms of active psoriatic arthritis include inflammation of the joints, swelling, difficulty moving and pain, and red and scaly patches on the skin (skin damage).
What you need to know before using Leflunomide medac
Do not use Leflunomide medac
- if you have ever had an allergic reaction to leflunomide (especially a severe skin reaction, often accompanied by fever, joint pain, red spots on the skin or blisters, such as Stevens-Johnson syndrome), peanuts, soy or any of the other ingredients in it medicines (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis ).
- if you have liver problems ,
- if you have moderate to severe renal impairment ,
- if you have a sharp drop in your blood protein (egg white) concentration (hypoproteinemia),
- if you suffer from a disease that weakens your immune system (ex AIDS ),
- if you have impaired bone marrow function or if the number of red or white blood cells or platelet counts is low,
- if you suffer from a serious infection ,
- if you are pregnant , think you may be pregnant or breast-feeding.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Leflunomide medac
- if you have ever had inflammation of the lungs (interstitial lung disease).
- if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis. Your doctor may take samples to see if you have tuberculosis .
- if you are a man and want to have children. As it can not be ruled out that Leflunomide medac passes into the semen, reliable contraception should be used during treatment with Leflunomide medac. Men wishing to have children should contact their doctor who may advise them to discontinue treatment with Leflunomide medac and take certain medications to quickly remove Leflunomide medac from the body. A blood test will confirm that Leflunomide medac has been adequately excreted. After that, you should wait at least another 3 months before trying to have children.
- if you are going to take a specific blood test (calcium level). Measurements can show falsely low calcium levels.
Leflunomide medac can affect your blood, liver, lungs, or nerves in your arms or legs. Leflunomide medac may also cause severe allergic reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]), or increase the risk of developing serious infections. For further information, see section 4 (Possible side effects ).
DRESS initially appears with flu-like symptoms and rashes on the face, followed by widespread rashes and high fever, increased liver enzyme levels seen in blood tests, and an increase in a type of white blood cell ( eosinophilia ) and enlarged lymph nodes.
Your doctor will regularly take blood samples, before and during treatment with Leflunomide medac to check your blood and your liver. Your doctor will also regularly check your blood pressure as Leflunomide medac may cause high blood pressure.
Tell your doctor if you have diarrhea that lasts for a long time for no particular reason. Your doctor may need to perform additional tests to find out what this is causing.
Children and young people
Leflunomide medac is not recommended for use in children and adolescents below 18 years.
Other medicines and Leflunomide medac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines.
This is especially important if you are using:
- other drugs for rheumatoid arthritis such as antimalarial drugs (eg chloroquine and hydroxychloroquine); intramuscular or oral gold, D penicillamine, azathioprine and other immunosuppressive drugs (eg methotrexate) as these combinations are not recommended.
- warfarin and other oral blood thinners, as controls are necessary to reduce the risk of side effects from this medicine
- teriflunomide in multiple sclerosis
- repaglinide, pioglitazone, nateglinide or rosiglitazone in diabetes
- daunorubicin, doxorubicin, paclitaxel or topotecan in cancer
- duloxetine for depression, urinary incontinence or kidney disease in diabetics
- alosetron in the treatment of severe diarrhea
- theophylline in asthma
- tizanidine, a muscle relaxant
- oral contraceptives (containing ethinyl estradiol and levonorgestrel)
- cefaclor, benzylpenicillin ( penicillin G), ciprofloxacin in case of infection are
- indomethacin, ketoprofen for pain or inflammation
- furosemide for heart disease (diuretic, diuretic)
- zidovudine in HIV infection
- rosuvastatin, simvastatin , atorvastatin, pravastatin for hypercholesterolemia (high cholesterol )
- sulfasalazine in inflammatory bowel disease or rheumatoid arthritis
- a drug called cholestyramine (used to treat increased blood fat levels) and activated charcoal as these drugs can reduce the body’s uptake of Leflunomide medac.
If you are already taking non-steroidal anti-inflammatory drugs ( NSAIDs ) and/or corticosteroids, you can continue to take them after starting treatment with Leflunomide medac.
Vaccinations
If you need to be vaccinated, ask your doctor for advice. Some vaccines should not be given during treatment with Leflunomide medac, and for a period after stopping treatment.
Leflunomide medac with food, drink and alcohol
Leflunomide medac can be taken independently of food intake. Alcohol intake should be avoided during treatment with Leflunomide medac. Consumption of alcohol during treatment may increase the risk of liver damage.
Pregnancy and breastfeeding
Do not use Leflunomide medac if you are or think you may be pregnant. If you are pregnant or become pregnant while taking Leflunomide medac, the risk of having a baby with severe birth defects increases. Women of childbearing potential should not use Leflunomide medac without using a reliable contraceptive.
Tell your doctor if you are planning to become pregnant after stopping treatment with Leflunomide medac as you need to make sure that Leflunomide medac is completely excreted from your body before attempting to conceive. This can take up to 2 years, but this period can be shortened to a few weeks if you take special medicines that accelerate the excretion of Leflunomide medac from your body.
In both cases, a blood test should confirm that Leflunomide medac has been adequately excreted from your body. After that, you have to wait at least another month before you get pregnant.
For further information on laboratory tests, please contact your doctor.
If you suspect that you are pregnant during treatment with Leflunomide medac or for the next two years after stopping treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest treatment with specific drugs to quickly remove Leflunomide medac from your body as this may reduce the risk to your baby.
Do not use Leflunomide medac if you are breastfeeding as Leflunomide medac may be excreted in human milk.
Driving and using machines
Leflunomide medac may cause dizziness which may impair your ability to concentrate and react. If you feel affected, do not drive or operate machinery.
Leflunomide medac 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.
Leflunomide medac contains soy lecithin
If you are allergic to peanuts or soy, do not use this medicine.
Leflunomide medac contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free.
How to use Leflunomide medac
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual starting dose is 100 mg Leflunomide medac once daily for the first three days. Then, most people need:
- In rheumatoid arthritis: 10 to 20 mg Leflunomide medac once a day, depending on the severity of the disease.
- In psoriatic arthritis: 20 mg Leflunomide medac once daily.
Swallow the tablet whole with plenty of water.
It may take about 4 weeks or longer before you feel an improvement in your condition. Some patients may even feel further improvement after 4 to 6 months of treatment.
Treatment with Leflunomide medac usually takes longer periods.
If you take more Leflunomide medac than you should
If you take more Leflunomide medac than you should, contact your doctor or seek other medical advice. If possible, take your tablets or pack them to the doctor.
If you forget to take Leflunomide medac
If you forget to take a dose, take it as soon as you remember unless it is time for the next dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately and stop using Leflunomide medac:
- if you feel weak , dizzy or have difficulty breathing , as this may be a symptom of a severe allergic reaction .
- if you get a skin rash or mucous membrane damage in the mouth , as these may be symptoms of severe, sometimes life-threatening, reactions (eg Stevens-Johnson syndrome , toxic epidermal necrolysis , erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]), see section 2.
Contact your doctor immediately if you experience:
- pallor, fatigue or increased tendency to bruise , as this may indicate blood disease caused by an imbalance between different types of blood cells in the blood.
- fatigue, abdominal pain or jaundice (yellowing of the eyes and skin), as this may indicate serious conditions such as liver problems which can be life threatening.
- Symptoms of infection such as fever, sore throat or cough , as this medicine may increase the risk of serious infection which can be life threatening.
- cough or difficulty breathing as this may indicate lung problems (interstitial lung disease or pulmonary hypertension ).
- unusual tingling , weakness or pain in your hands or feet as these may indicate problems with your nerves ( peripheral neuropathy ).
Common side effects (may affect up to 1 in 10 people)
- a marginal decrease in the number of white blood cells ( leukopenia ),
- mild allergic reactions,
- loss of appetite, weight loss (usually insignificant),
- fatigue ( asthenia ),
- headache, dizziness,
- abnormal skin sensations such as tingling ( paresthesia ),
- slightly increased blood pressure ,
- colitis (intestinal inflammation),
- diarrhea,
- nausea, vomiting,
- inflammation of the mouth or affected oral mucosa,
- abdominal pain,
- increase in certain liver values,
- hair loss,
- eczema , dry skin, rash and itching ,
- tendonitis (pain caused by inflammation of the membrane surrounding the tendon, usually in the feet or hands),
- an increase in certain blood enzymes (creatine kinase),
- peripheral nerve effects in arms and 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 changes,
- hives,
- tendon rupture,
- an increase in blood fat levels ( cholesterol and triglycerides ),
- a decrease in the level of phosphate in the blood.
Rare side effects (may affect up to 1 in 1,000 people)
- increase in the number of eosinophilic blood cells ( eosinophilia ); a slight decrease in the number of white blood cells ( leukopenia ); and a decrease in the number of blood cells (pancytopenia),
- sharply increased blood pressure ,
- inflammation of the lungs (interstitial lung disease),
- an increase in certain liver values that can develop into serious conditions such as hepatitis and jaundice,
- severe infection you so-called sepsis , which can be life-threatening,
- an increase in certain enzymes in the blood ( lactate dehydrogenase ).
Very rare side effects (may affect up to 1 in 10,000 people)
- a marked decrease in certain white blood cells ( agranulocytosis ),
- severe and possibly severe allergic reactions,
- inflammation of the small blood vessels ( vasculitis , including cutaneous necrotizing vasculitis ),
- inflammation of the pancreas ( pancreatitis ),
- severe liver damage such as liver failure or necrosis , which can be fatal,
- severe, sometimes life-threatening, reactions ( Stevens-Johnson syndrome , toxic epidermal necrolysis , erythema multiforme).
Other side effects such as kidney failure, a decrease in uric acid in the blood, pulmonary hypertension, male infertility (this side effect returns when treatment with this drug is stopped), cutaneous lupus (characterized by rash/redness on exposed skin areas), psoriasis (new or aggravated) and DRESS may also occur with unknown frequency.
How to store Leflunomide medac
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 carton and jar after EXP. The expiration date is the last day of the specified month.
Close the jar tightly. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is leflunomide. One tablet of Leflunomide medac 10 mg film-coated tablets contains 10 mg leflunomide.
- The other ingredients are: lactose monohydrate , low-substituted hydroxypropylcellulose, tartaric acid, sodium lauryl sulphate and magnesium stearate in the tablet core, as well as lecithin (soybeans), poly (vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum.
What the medicine looks like and contents of the pack
Leflunomide medac 10 mg film-coated tablets are white to almost white and round with a diameter of about 6 mm.
The tablets are packaged in jars.
Leflunomide medac 10 mg film-coated tablets: Packs of 30, 60, or 100 tablets per can are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
medac
Society for Clinical Specialties mbH
Theater. 6
22880 Wedel
Germany
Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
medac
Society for Clinical Specialties mbH
Theater. 6
22880 Wedel
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienLamepro BVTel: +31 162 51 49 04Leflunomide@medac.eu | .ΠροςGidamed Medical Supplies Ltd.:Ηλ: + 357-257 510 30Leflunomide@medac.eu |
| Bulgariamedac GmbHTel: + 49 4103 8006 0Leflunomide@medac.eu | Luxembourg / Luxemburgmedac GmbHTel: +49 4103 8006 0Leflunomide@medac.eu |
| Česká republika / Slovenská republikamedac GmbH organizani slozkaTel: +420 543 233 857Leflunomid@medac.eu | Hungarymedac GmbHTel: + 49 4103 8006 0Leflunomide@medac.eu |
| Denmark / Norway / SwedenmedacTel: +46 340 64 54 70Leflunomid@medac.eu | Maltamedac GmbHTel: + 49 4103 8006 0Leflunomide@medac.eu |
| Germanymedac GmbHTel: +49 4103 8006 0Leflunomid@medac.eu | The Netherlandsmedac GmbHTel: + 49 4103 8006 0Leflunomide@medac.eu |
| Eesti / Latvija / LietuvaViaSanaTel: +370 5 2788 414Leflunomide@medac.eu | AustriaEVER Valinject GmbHTel: +43 7665 20555Leflunomide@medac.eu |
| Greecemedac GmbH.:Ηλ: + 49 4103 8006-0Leflunomide@medac.eu | Polandmedac GmbH Sp. ZooTel: + 48 22 430 00 30Leflunomid@medac.eu |
| SpainGebro Pharma Laboratories, SATel: +34 93 205 86 86Leflunomida@medac.eu | Portugalmedac GmbH – Sucursal in PortugalTel: + 351 21 410 75 83Leflunomida@medac.eu |
| Francemedac sasTel: + 33 437 66 14 70Leflunomide@medac.eu | Romaniamedac GmbH.Tel: +49 4103 8006-0Leflunomide@medac.eu |
| CroatiaMedis Adria dooTel: + 385 (0) 1 230 34 46Leflunomid@medac.eu | Sloveniamedac GmbHTel: + 49 4103 8006 0Leflunomid@medac.eu |
| Irelandmedac GmbHTel: + 49 4103 8006 0Leflunomide@medac.eu | Finland / Finlandmedac GmbH sivuliike suomessaPuh / Tel: +358 10 420 4000Leflunomide@medac.eu |
| IcelandWilliams & Halls ehf.Phone: + 354 499 01 68Leflunomide@medac.eu | United Kingdommedac Pharma LLPTel: +44 (0) 1786458086Leflunomide@medac.eu |
| Italymedac Pharma SrlTel: + 39 06 515912 1Leflunomide@medac.eu |