Aramid 10 Mg 30 Tabletsingredient leflunomide

ARAMID CAUTION:

• If you have had previous interstitial lung disease,

• Have had tuberculosis or have had close contact with a person with tuberculosis. . Your doctor may conduct tests to see if you have tuberculosis.

• If you are a man and want to have a child. ARAMID can pass through the menstruation and can cause congenital defects in the baby. A reliable method of contraception should be used during ARAMID treatment. Male patients who wish to have a child should consult with their physician about the rapid and adequate excretion of ARAMID with the discontinuation of ARAMID to minimize any possible risk and the use of the prescribed drugs. A blood test should be done to ensure that ARAMID is taken out of your body sufficiently, then you should wait at least 3 months to have a child.

ARAMID rarely causes blood, liver, lungs, or nerves related to the nerves in your arms or legs. It can also lead to severe allergic reactions (including Eosinophilia and Systemic Symptomatic Drug Reaction ptomDRESS) or increase the risk of severe infection. (See 'Possible Side Effects' for more information.)

DRESS begins with flu-like symptoms and starts with percent-onset rash, elevated fever, elevated liver enzymes in blood tests, and increased blood white blood cells (eosinophilia) and growth in lymph nodes. would.

Your doctor will perform blood tests at regular intervals before and during ARAMID treatment to monitor the status of your blood cells and liver. Your doctor will also regularly check your blood pressure as ARAMID may cause an increase in blood pressure.

Tell your doctor if unexplained persistent diarrhea develops. Your doctor may perform additional tests for differential diagnosis.

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in children and adolescents

aramid children and adolescents under 18 years of age is not recommended to use.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Use of ARAMID with food and drink ARAMID may be taken before or after meals. Alcohol consumption during ARAMID treatment is not recommended. Alcohol intake during ARAMID treatment may increase the risk of liver damage.

Pregnancy Consult your doctor or pharmacist before using the medicine. Do not use ARAMID if you are pregnant or if you think you are pregnant. If you are pregnant or pregnant while using ARAMID, your risk of having a baby with serious birth defects increases. If you have a potential to give birth, do not use ARAMID without a reliable method to prevent pregnancy.

Consult with your doctor if you intend to become pregnant after discontinuation of ARAMID. Because you must make sure that ARAMID is taken out of your body before you become pregnant. This process can take 2 years. However, with the taking of certain drugs to accelerate the excretion of ARAMID, this period may be reduced to several weeks. After the excretion of ARAMID is confirmed by blood tests, you should wait at least another month to get pregnant.

Consult your doctor for more information on laboratory tests.

If you suspect that you have become pregnant during ARAMID treatment or within 2 years of discontinuation of the treatment, consult your physician immediately for a pregnancy test. If the test proves that you are pregnant, your doctor may recommend treatment with ARAMID for a rapid excretion from your body. This treatment can also reduce the risk on your baby.

If you notice that you are pregnant during your treatment, consult your doctor immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine. Leflunomide passes into breast milk. Therefore, if you are breastfeeding your baby, do not use ARAMID.

Vehicle and machine use ARAMID can reduce your concentration and mobility by stuning you. In this case, do not use any tools or machines.

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Important information on some excipients contained in ARAMID ARAMID contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Tell your doctor if you are using the following drugs:

• Malaria medications used for the treatment of rheumatoid arthritis (eg chlorokine and hydroxychloroquine), intramuscularly or orally, D-penicillamine, azathioprine and other drugs that suppress the immune system (eg methotrexate) Not recommended.

• Warfarin and other drugs used to prevent blood clotting; this drug should be monitored to reduce the risk of side effects

• Nervous system used in the treatment of multiple sclerosis disease teriflunomide

• Diabetes (diabetes mellitus) used in the treatment repaglinide, nateglinide, pioglitazone or rosiglitazone

• paclitaxel used in cancer treatment, topotecan, doxorubicin, daunorubicin, doxorubicin

• Duloxetine (used in the treatment of mental depression)

• Alosetron used in the treatment of severe diarrheaTheophylline used

•to widen the airways when asthma (asthma)

• Muscle relaxant tizanidin

• Birth control pills (including ethinylestradiol and levonorgestrel)

• Cefaclor, benzylpenicillin (penicillin G) used to treat the infection antibiotics such as ciprofloxacin

• Indomethacin and ketoprofen used for pain and inflammationFurosemide

•used as diuretic in heart diseases

• HIV-causing AIDS disease zidovudine used in

rosuvastatin, simvastatin, atorvastatin, pravastatin used to reduce high cholesterol level (hypercholesterolemia)

infection •sulfasalazine used in the treatment of inflammatory bowel disease or rheumatoid arthritis

•• cholestyramine (used to lower high cholesterol) or activated charcoal (used in the treatment of poisoning) in, can reduce the amount absorbed by the body. If you use nonsteroidal antiinflammatory drugs (NSAIDs) and / or corticositeroid which are relieving pain and inflammation, you can continue these drugs after starting ARAMID. Vaccines Consult your doctor if you need to be vaccinated. Some vaccines should not be administered for a certain period of time after ARAMID treatment or after discontinuation of treatment. Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medication or if you have recently used it.

3. How to use ARAMID? Instructions for appropriate use and dose / frequency of administration: Always use ARAMID as instructed by your doctor. Consult your doctor or pharmacist if you are unsure.

The initial dose of ARAMID is usually 100 mg per day for 3 days. Following this onset period, most patients should take the following doses:

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• For rheumatoid arthritis: 10 to 20 mg ARAMID once daily, depending on the severity of the disease.

• For psoriatic arthritis: 20 mg ARAMID once daily.

It may take 4 weeks or more to feel an improvement in your condition. In some patients this process may be extended to 4-6 months. You should use ARAMID for a long time.

If you have an impression that ARAMID's effect is too strong or weak, talk to your doctor or pharmacist.

Method and method of administration: It is taken orally. ARAMIDE tablets should be swallowed with plenty of water and as a whole.

Different age groups: Use in children: The use of ARAMID in children and adolescents under 18 years of age is not recommended.

Use in the elderly: Dose adjustment is not required for patients over 65 years of age.

Special Use Cases: Liver / Kidney Failure: You should not use ARAMID if you have liver dysfunction and / or moderate or severe kidney disorders.

If you have used ARAMID more than you should use: If you have used ARAMID more than you should, talk to a doctor or pharmacist. If possible, take your medicine or box with you to show it to your doctor.

If you forget to use ARAMID: Talk to a doctor or pharmacist if you forget to use ARAMID.

If you forgot to take the dose and the other dose has not arrived, take your medicine when you notice that you have not taken your medicine. Do not take double doses to compensate for forgotten doses.

Effects that may occur when treatment with ARAMID is terminated: There are no specific instructions for terminating treatment with ARAMID. You should use ARAMID for a long time. Your doctor will tell you how long your treatment will last. Consult your doctor or pharmacist if you have any further questions about the use of ARAMID.

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4. What are the possible side effects? As with all medications, ARAMID may have side effects in people who are sensitive to the substances present in the content,

if one of the following: Stop using ARAMID and tell your doctor immediately or consult your nearest hospital emergency department:

• Fatigue, dizziness, dizziness or breathing severe allergic reactions with symptoms such as difficulty

• Severe and sometimes life-threatening disorders with symptoms of skin rash or ulcers in the mouth (eg: Stevens-Johnson syndrome (skin, mouth, eyes and bubbles filled with fluid in the genitals, blood around the skin and eyes) , swelling and inflammation with redness), toxic epidermal necrolysis (a serious disease with fluid-filled bubbles in the skin), erythema multiforme (usually spontaneously occurring, hands, face and lace, similar rash, hypersensitivity status), Eosinophilia and Systemic Symptoms Reaction u - DRESS (starts with flu-like symptoms and starts with a percentage of the spreading rash, elevated fever, elevation of liver enzymes in blood tests and an increase in white blood cells of the blood type (eosinophilia) and growth in lymph nodes.

If you have one of these, you have a serious allergy to ARAMID. All of these very serious side effects are very rare.

If you notice any of the following, report it to your doctor immediately or contact your nearest hospital emergency department:

• Skin irritation, fatigue, bruises on the skin, different cells that make up blood may be indicative of a blood disease due to imbalance.

• Fatigue, abdominal pain or jaundice, (yellowing of the eyes or skin) may be a sign of a serious condition, such as liver failure, which can sometimes be fatal.

• Symptoms of infection, such as fever, sore throat or cough (ARAMID increases the risk of developing life-threatening severe infections)

.

• Unusual tingling, weakness or pain on your hands or feet that can indicate discomfort in the arm and leg nerves (peripheral neuropathy).

All these are serious side effects. You may need urgent medical attention or hospitalization.

Side effects are listed as shown in the following frequency categories: Very common: It can be seen in at least 1 of 10 patients. Common: Less than one in 10 patients, but more than one in 100 patients. Uncommon: Less than one in 100 patients, but more than one in 1,000 patients. Rare: Less than one in 1,000 patients, but more than one in 10,000 patients. Very rare: less than one in 10,000 patients. No known (frequency is unpredictable based on available data)

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Other side effects

Common (less than one patient in 10 patients, but more than 100 patients) side effects

• Slight reduction in the number of white cells in the blood (leukopenia)

• Slight allergic reactions

• Reduced appetite, weight loss loss (usually at insignificant level)

• Fatigue (asthenia)

• Headache, dizziness

• Sensation of abnormal sensation in the skin, such as tingling (paresthesia)

• Slight increase in blood pressure

• Large intestinal inflammation (colitis)

• Diarrhea

• Nausea, vomiting

• Infections in the mouth and mouth ulcers

• Abdominal pain

• Increase in some of the liver test resultsIncrease in

•hair loss

• Eczema, dryness in the skin, rash, itching

• Pain due to inflammation of the muscles usually in feet or hands (tendonitis)

• Increase of certain enzymes in the blood (eg creatine phosphokinase)

• Hand and foot nerves problems (peripheral neuro pati)

Side effects (less than one in 100 patients, but more than one in 100 patients).

Reduction of red blood cells (anemia) and reduction of blood platelets involved in blood clotting (thrombocytopenia).

• Decrease in potassium in the blood

• Anxiety (anxiety)

• Taste disorders

• Hives (urticaria)

• Rupture of muscles (tendon)

• Increase in blood fats (cholesterol and triglycerides)

• Reduction in phosphate levels in blood

Rare (less than one in 1,000 patients, but in 10,000 patients) side effects)

increased number of blood cells called eosinophils (eosinophilia); slight reduction in white blood cells (leukopenia); reduction in the number of all blood cells (pancytopenia).

• severe increase in blood pressure

• Lung inflammation (interstitial lung disease)

• increases in some liver enzymes, liver inflammation (hepatitis) and serious complications such as jaundice (symptoms suggestive of severe liver failure, supra.)

• and can be fatal sespis (blood germs that cause infectionSevere infections in the

•blood (lactate dehydrogenase enzyme)

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Very few (less than one visible from 10,000 patients) side effects

• Significant reduction in white blood cells (agranulocytosis)

• Light or potential Severe allergic reactions

• Inflammation of small vessels (including vasculitis, cutaneous necrotizing vasculitis)

• Pancreatic inflammation (pancreatitis) (abdominal pain, nausea, vomiting, fever, sweating, such as symptoms)

• Fatal liver failure or necrosis (tissue death) as serious liver damage

• serious disturbances serious and sometimes life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)

Unknown (undetectable frequency with available data) Side effects

• Renal failure

• reduction in uric acid levels in the blood

• Increased blood pressure in the lung veins (pulmonary hypertension)

• Infertility in men (when the treatment is stopped)

• Cutaneous lupus (a disease manifested by redness and rashes in the exposed parts of the skin)

• First-time or worsening psoriasis

• Some blood cells (eosinophils) drug reaction (DRESS) with other symptoms in the body.mentioned in

If you encounter any side effects notthis instruction, please inform your doctor or pharmacist.

Reporting side effects In the event of any side effects that occur or are not included in the instructions for use, contact your physician, pharmacist or nurse. In addition, the side effects you are experiencing www.titck.gov.t is located in the sites "Drug Side Impact Statement" by clicking on the icon directly or 0800314 00 08 number one side effect reporting line by calling Turkey Pharmacovigilance Center (TÜFAM) 'What do you notice. By informing you of any side effects, you will contribute to further information on the safety of the drug you are using.

5. Storage of ARAMID Keep ARAMID out of the reach of children and in its packaging. Keep the bottle tightly closed. Store at room temperature below 25 ° C.

Use in compliance with the expiration date. Do not use ARAMID after the expiration date in the packaging.

Do not use ARAMID if you notice a defect in the product and / or its packaging.

In order to protect the environment, do not dispose of ARAMID in city water or trash. Ask your pharmacist about this.

License holder: KOÇAK FARMA Pharmaceutical and Chemical Industry Inc.

Mahmutbey Mah. Kugu Sok. No: 18, Bağcılar / İSTANBUL

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Production site: KOÇAK FARMA Pharmaceutical and Chemical Industry Inc.

Cerkezkoy Organized Industrial Zone, Karagac Mah. 11.Sk. No: 5 Kapaklı / Tekirdağ

These instructions for use have been approved on ............................

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