Teriflunomide Aurovitas

Leaflet accompanying the packaging: information for the user

Teriflunomide Aurovitas, 14 mg, coated tablets

Teriflunomide

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so you can read it again if you need to. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What is Teriflunomide Aurovitas and what is it used for

What is Teriflunomide Aurovitas

Teriflunomide Aurovitas contains the active substance teriflunomide, which is an immunomodulatory agent that regulates the action of the immune system to limit its attack on the nervous system.

What is Teriflunomide Aurovitas used for

Teriflunomide Aurovitas is used in adults and in children and adolescents (from 10 years of age) to treat multiple sclerosis (MS) with relapsing-remitting course.

What is multiple sclerosis

Multiple sclerosis is a chronic disease that affects the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation damages the protective covering (called myelin) of the nerves in the CNS. This loss of myelin is called demyelination. It disrupts the way the nerves work. People with multiple sclerosis with a relapsing course will have recurring attacks (relapses) of physical symptoms caused by the abnormal functioning of the nerves. These symptoms vary from person to person but usually include: difficulty walking, vision problems, balance problems. The symptoms may completely disappear after the relapse has resolved, but over time, some problems may persist between relapses. This can lead to physical disability, which can make everyday activities difficult.

How does Teriflunomide Aurovitas work

Teriflunomide Aurovitas helps protect the central nervous system from the effects of the immune system by limiting the increase in the number of certain white blood cells (lymphocytes). This reduces the inflammation that leads to nerve damage in multiple sclerosis.

2. Important information before taking Teriflunomide Aurovitas

When not to take Teriflunomide Aurovitas:

• if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had a severe skin rash or peeling, blisters, or mouth sores after taking teriflunomide or leflunomide,
• if you have severe liver disease,
• if you are pregnant, think you may be pregnant, or are breastfeeding,
• if you have a severe disease that affects your immune system, such as acquired immunodeficiency syndrome (AIDS),
• if you have severe bone marrow disorders or a low white blood cell or platelet count,
• if you have a severe infection,
• if you have severe kidney disease requiring dialysis,
• if you have very low blood protein levels (hypoproteinemia).

If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Teriflunomide Aurovitas, discuss with your doctor or pharmacist if: you have liver problems and/or drink large amounts of alcohol. Your doctor will perform blood tests before and during treatment to check if your liver is working properly. If your test results show liver problems, your doctor may stop treatment with Teriflunomide Aurovitas. See section 4. you have high blood pressure, whether or not it is controlled with medication. Teriflunomide Aurovitas may increase blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. See section 4. you have an infection. Before taking Teriflunomide Aurovitas, your doctor will ensure that you have a sufficient number of white blood cells and platelets in your blood. Because Teriflunomide Aurovitas reduces the number of white blood cells in your blood, it may affect your ability to fight infection. Your doctor may perform blood tests to check your white blood cell count if you think you have an infection. During treatment with teriflunomide, herpes virus infections, including cold sores or shingles, may occur. In some cases, serious complications have occurred. You should immediately inform your doctor if you suspect you have any symptoms of a herpes virus infection. See section 4. you have severe skin reactions. you have respiratory symptoms. you have weakness, numbness, and pain in your hands and feet. you plan to receive a vaccination. you are taking leflunomide with Teriflunomide Aurovitas. you are switching from your current medicine to Teriflunomide Aurovitas or from Teriflunomide Aurovitas to another medicine. you are going to have a blood test to measure calcium levels. The results of the calcium level test may be falsely low.

Respiratory reactions

Tell your doctor if you experience unexplained cough and shortness of breath (difficulty breathing). Your doctor may perform additional tests.

Children and adolescents

Teriflunomide Aurovitas is not intended for use in children under 10 years of age, as it has not been studied in this age group with multiple sclerosis. The above warnings and precautions also apply to children. The following information is important for children, adolescents, and their caregivers: in patients taking teriflunomide, pancreatitis has been observed. Your child's doctor may perform blood tests if pancreatitis is suspected.

• in patients taking teriflunomide, pancreatitis has been observed. Your child's doctor may perform blood tests if pancreatitis is suspected.

Teriflunomide Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription. This includes herbal medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: leflunomide, methotrexate, and other medicines that affect the immune system (often called immunosuppressive or immunomodulatory medicines) rifampicin (used to treat tuberculosis and other infections) carbamazepine, phenobarbital, phenytoin used to treat epilepsy St. John's Wort (a herbal medicine for depression) repaglinide, pioglitazone, nateglinide, or rosiglitazone used to treat diabetes daunorubicin, doxorubicin, paclitaxel, or topotecan used to treat cancer duloxetine used to treat depression, urinary incontinence, or diabetic neuropathy alosetron used to treat severe diarrhea theophylline used to treat asthma tizanidine, a muscle relaxant warfarin, a blood thinner used to prevent blood clots (i.e., to thin the blood) oral contraceptives (containing ethinyl estradiol and levonorgestrel) cefaclor, benzylpenicillin (penicillin G), ciprofloxacin used to treat infections indomethacin, ketoprofen used to treat pain or inflammation furosemide used to treat heart disease cimetidine used to reduce stomach acid secretion zidovudine used to treat HIV infection rosuvastatin, simvastatin, atorvastatin, pravastatin used to treat high cholesterol sulfasalazine used to treat inflammatory bowel disease or rheumatoid arthritis cholestyramine used to treat high cholesterol or to relieve itching in liver disease activated charcoal used to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding

Do not take Teriflunomide Aurovitas if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking Teriflunomide Aurovitas, there is an increased risk of birth defects in your baby. Women of childbearing potential must not take this medicine without using effective contraception. If a girl starts menstruating while taking Teriflunomide Aurovitas, she should inform her doctor, who will provide specialized advice on contraception and potential risks in case of pregnancy. Tell your doctor if you plan to become pregnant after stopping treatment with Teriflunomide Aurovitas, as you will need to ensure that most of the medicine has been removed from your body before trying to become pregnant. It may take up to 2 years for the active substance to be naturally eliminated from your body. This time can be shortened to a few weeks by taking certain medicines that speed up the removal of Teriflunomide Aurovitas from your body. In both cases, you will need to confirm with a blood test that the active substance has been sufficiently removed from your body. Your doctor should confirm that the level of Teriflunomide Aurovitas in your blood is low enough for you to become pregnant. For more information on laboratory tests, contact your doctor. If you suspect you are pregnant while taking Teriflunomide Aurovitas or within 2 years after stopping treatment, stop taking Teriflunomide Aurovitas and immediately contact your doctor for a pregnancy test. If the test confirms you are pregnant, your doctor may recommend taking certain medicines to quickly and sufficiently remove teriflunomide from your body, as this may reduce the risk to your baby. Contraception You must use effective contraception during and after treatment with Teriflunomide Aurovitas. Teriflunomide remains in the blood for a long time after stopping treatment. You must continue to use effective contraception after stopping treatment. You should do this until your doctor has checked that the level of Teriflunomide Aurovitas in your blood is low enough. You should discuss with your doctor the best method of contraception for you and any need to change your method of contraception.

• You should do this until your doctor has checked that the level of Teriflunomide Aurovitas in your blood is low enough.
• You should discuss with your doctor the best method of contraception for you and any need to change your method of contraception.

Do not take Teriflunomide Aurovitas while breastfeeding, as teriflunomide passes into human milk.

Driving and using machines

Teriflunomide Aurovitas may cause dizziness, which may affect your ability to concentrate and react. If you experience such symptoms, do not drive or operate machinery.

Teriflunomide Aurovitas contains lactose

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

Teriflunomide Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Teriflunomide Aurovitas

Treatment with Teriflunomide Aurovitas will be supervised by a doctor experienced in treating multiple sclerosis. Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (from 10 years of age)

The dose depends on body weight: Children with a body weight above 40 kg: one 14 mg tablet per day. Children with a body weight of 40 kg or less: one 7 mg tablet per day. Teriflunomide Aurovitas, 14 mg, coated tablets are not suitable for children and adolescents with a body weight of 40 kg or less. Teriflunomide Aurovitas 7 mg is not available. Other medicines containing teriflunomide are available in lower strengths (as 7 mg coated tablets). Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor about changing the dose to one 14 mg tablet per day. Route and method of administration Teriflunomide Aurovitas is taken orally. Teriflunomide Aurovitas is taken once daily as a single dose at any time of day. Swallow the tablet whole with water. Teriflunomide Aurovitas can be taken with or without food.

Taking more than the recommended dose of Teriflunomide Aurovitas

If you take more than the recommended dose of Teriflunomide Aurovitas, contact your doctor immediately. Side effects similar to those described in section 4 below may occur.

Missing a dose of Teriflunomide Aurovitas

Do not take a double dose to make up for a forgotten tablet. Take the next dose at the scheduled time.

Stopping treatment with Teriflunomide Aurovitas

Do not stop taking Teriflunomide Aurovitas or change the dose without first consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur after taking this medicine.

Severe side effects

Some side effects can be serious or life-threatening. If you experience any of these symptoms, contact your doctor immediately.

Very common (may affect up to 1 in 10 people)

• pancreatitis, which may include symptoms such as abdominal pain, nausea, or vomiting (common in children and adolescents and uncommon in adults).

Uncommon (may affect up to 1 in 100 people)

allergic reactions, which may include symptoms such as rash, hives, swelling of the lips, tongue, or face, or sudden difficulty breathing severe skin reactions, which may include symptoms such as skin rash, blistering, fever, or mouth sores severe infections or sepsis (a life-threatening infection), which may include symptoms such as high fever, chills, shivering, reduced urine output, or disorientation pneumonia, which may include symptoms such as shortness of breath or persistent cough.

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

• severe liver disease, which may include symptoms such as yellowing of the skin or whites of the eyes, darker than usual urine, unexplained nausea and vomiting, or abdominal pain.

Other side effectsmay occur with the following frequency:

Very common (may affect more than 1 in 10 people)

• headache
• diarrhea, nausea
• increased liver enzyme levels (increased levels of certain liver enzymes in the blood) shown in blood tests
• hair thinning.

Common (may affect up to 1 in 10 people)

• flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, tooth infection, laryngitis, fungal infection of the foot
• herpes virus infections, including cold sores and shingles, with symptoms such as blisters, burning, itching, numbness, or pain of the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness
• blood test results: decreased red blood cell count (anemia), changes in liver test results and white blood cell count (see section 2), as well as increased muscle enzyme levels (creatine phosphokinase)
• mild allergic reactions
• feeling anxious
• tingling or prickling sensation, feeling weak, numbness, tingling, or pain in the lower back or leg (sciatica), feeling numbness, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome)
• feeling of "heart pounding"
• increased blood pressure
• vomiting, toothache, abdominal pain above the navel
• rash, acne
• tendon, joint, bone, or muscle pain (musculoskeletal pain)
• need to urinate more often than usual
• heavy menstrual periods
• pain
• lack of energy or feeling weak (asthenia)
• weight loss.

Uncommon (may affect up to 1 in 100 people)

• decreased platelet count (mild thrombocytopenia)
• increased sensitivity or sensation, especially of the skin; stabbing or pulsating pain along one or more nerves, nerve disorders of the arms or legs (peripheral neuropathy)
• changes in the nails, severe skin reactions
• traumatic pain
• psoriasis
• mouth ulcers
• abnormal blood fat (lipid) levels
• inflammation of the large intestine.

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

• inflammation or damage to the liver.

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

pulmonary hypertension.

Children (from 10 years of age) and adolescents

The above side effects also apply to children and adolescents. The following information is important for children, adolescents, and their caregivers: in patients taking teriflunomide, pancreatitis has been observed.

Common (may affect up to 1 in 10 people)

• pancreatitis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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, you can help provide more information on the safety of this medicine.

5. How to store Teriflunomide Aurovitas

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. Cold-forming triply laminated blister (OPA/Aluminum/PVC/Aluminum):There are no special precautions for storage. White non-transparent blister (PVC/PVDC/Aluminum):Store in a temperature below 25°C. 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 protect the environment.

6. Contents of the pack and other information

What Teriflunomide Aurovitas contains

• The active substance is teriflunomide. Each coated tablet contains 14 mg of teriflunomide.

Other ingredients are: Tablet core:lactose monohydrate, cornstarch, sodium carboxymethylcellulose (type A), hydroxypropylcellulose (low viscosity), microcrystalline cellulose (type 102), silicon dioxide, magnesium stearate. Tablet coating:hypromellose 2910 (E 464), titanium dioxide (E 171), talc (E 553b), macrogol 6000 (E 1521), indigo carmine, aluminum lake (E 132).

What Teriflunomide Aurovitas looks like and contents of the pack

Coated tablet Light blue to blue, round, coated tablet, approximately 7.2 mm in diameter, with "N" embossed on one side and "14" on the other. Pack sizes:14, 28, 30, 56, 60, 70, 84, 90, 98, 100, 120, and 200 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus 19, Venda Nova 2700-487 Amadora Portugal Arrow Génériques 26 Avenue Tony Garnier 69007 Lyon France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Teriflunomide AB 14 mg film-coated tablets / coated tablets / film tablets France: Teriflunomide Arrow 14 mg coated tablet Germany: Teriflunomid PUREN 14 mg film-coated tablets Netherlands: Teriflunomide Aurobindo 14 mg, film-coated tablets Poland: Teriflunomide Aurovitas Portugal: Teriflunomida Generis Spain: Teriflunomida Aurovitas 14 mg film-coated tablets EFG

Date of last revision of the leaflet: