Teriflunomid Adamed

Leaflet accompanying the packaging: patient information

Teriflunomid Adamed, 14 mg, film-coated tablets

Teriflunomidum

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 to a specific person. 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Teriflunomid Adamed and what is it used for

What is Teriflunomid Adamed

Teriflunomid Adamed contains the active substance teriflunomide, which is an immunomodulatory agent that regulates the immune system to limit its attack on the nervous system.

What is Teriflunomid Adamed used for

Teriflunomid Adamed is used to treat multiple sclerosis (MS) with a relapsing-remitting course in adults and children and adolescents (aged 10 years and older).

What is multiple sclerosis

Multiple sclerosis is a chronic disease that affects the central nervous system. The central nervous system consists of the brain and spinal cord. In multiple sclerosis, inflammation damages the protective covering (called myelin) around the nerves in the central nervous system. This process is called demyelination. It disrupts the normal functioning of the nerves. In people with multiple sclerosis with a relapsing-remitting course, there are 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.

These symptoms may completely disappear after a relapse, but over time, some problems may persist between relapses. This can lead to physical disability that interferes with daily activities.

How Teriflunomid Adamed works

Teriflunomid Adamed 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 Teriflunomid Adamed

When not to take Teriflunomid Adamed:

• if the patient is allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever experienced a severe skin rash or peeling, blisters, or mouth sores after taking teriflunomide or leflunomide;
• if the patient has severe liver problems;
• if the patient is pregnant, thinks they may be pregnant, or is breastfeeding;
• if the patient has a severe immune system disorder, such as acquired immune deficiency syndrome (AIDS);
• if the patient has any severe blood disorders or a low white blood cell or platelet count;
• if the patient has a severe infection;
• if the patient has severe kidney problems that require dialysis;
• if the patient has very low protein levels in the blood (hypoproteinemia). If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Teriflunomid Adamed, discuss with your doctor or pharmacist if:

• the patient has liver problems and/or drinks large amounts of alcohol; the doctor will order a blood test before and during treatment to check if the liver is working properly. If the patient's test results show liver problems, the doctor may stop the treatment with Teriflunomid Adamed. Refer to section 4.
• the patient has high blood pressure, whether or not it is controlled with medication. Teriflunomid Adamed may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and will regularly monitor it. Refer to section 4.
• the patient has an infection. Before taking Teriflunomid Adamed, the doctor will ensure that the patient has a sufficient white blood cell and platelet count in their blood. Since Teriflunomid Adamed reduces the white blood cell count in the blood, it may affect the ability to fight infections. The doctor may perform a blood test to check the white blood cell count if they suspect that the patient has an infection. During treatment with teriflunomide, herpes virus infections, including cold sores or shingles, may occur. In some cases, serious complications have occurred. If you suspect any symptoms of a herpes virus infection, inform your doctor immediately. Refer to section 4;
• the patient has severe skin reactions;
• the patient has respiratory symptoms;
• the patient has weakness, numbness, and pain in the hands and feet;
• the patient is about to receive a vaccination;
• the patient is taking leflunomide in combination with Teriflunomid Adamed;
• the patient is switching from their current medicine to Teriflunomid Adamed or from Teriflunomid Adamed to another medicine;
• the patient is to undergo a special blood test (calcium level test). The results of the calcium level test may be falsely low.

Respiratory reactions

Tell your doctor if you experience unexplained coughing or shortness of breath. The doctor may order additional tests.

Children and adolescents

Teriflunomid Adamed 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 and their caregivers:

• -In patients taking teriflunomide, cases of pancreatitis have been observed. The doctor may perform blood tests if they suspect pancreatitis.

Teriflunomid Adamed 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. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• leflunomide, methotrexate, and other 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, an anticoagulant used to thin the blood (i.e., increase its fluidity) to prevent blood clots;
• oral contraceptives (containing ethinylestradiol and levonorgestrel);
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin, used to treat infections;
• indomethacin, ketoprofen, used to treat inflammation or pain;
• furosemide, used to treat heart disease;
• cimetidine, used to reduce stomach acid production;
• zidovudine, used to treat HIV infection;
• rosuvastatin, simvastatin, atorvastatin, pravastatin, used to treat high cholesterol;
• sulfasalazine, used to treat inflammatory bowel disease and rheumatoid arthritis;
• cholestyramine, used to treat high cholesterol or relieve itching in liver disease;
• activated charcoal, used to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding

Do nottake Teriflunomid Adamed if you are pregnantor think you may be pregnant. In pregnant women or those who become pregnant while taking Teriflunomid Adamed, there is an increased risk of birth defects in the baby. Women of childbearing age should not take this medicine without using effective contraception. If a girl starts menstruating while taking Teriflunomid Adamed, she should inform her doctor, who will provide specialized advice on contraception and potential pregnancy risks. If a patient plans to become pregnant after stopping Teriflunomid Adamed, she should inform her doctor, as it is necessary to ensure that the medicine is no longer present in the body before trying to conceive. The elimination of the active substance may take up to 2 years. This period can be shortened to a few weeks by taking certain medicines that accelerate the elimination of Teriflunomid Adamed from the body. In both cases, it should be confirmed by a blood test that the active substance has been sufficiently removed from the body. The doctor should confirm that the level of Teriflunomid Adamed in the blood is low enough to allow conception. For more information on laboratory tests, consult your doctor. If a patient becomes pregnant while taking Teriflunomid Adamed or within 2 years after stopping treatment, they should stop taking Teriflunomid Adamed and immediatelycontact their doctor for a pregnancy test. If the test confirms pregnancy, the doctor may suggest taking certain medicines to quickly and sufficiently remove Teriflunomid Adamed from the body to reduce the risk to the baby. Contraception During and after treatment with Teriflunomid Adamed, effective contraception should be used. Teriflunomide remains in the blood for a long time after stopping treatment. Effective contraception should continue to be used after stopping treatment.

• This should be done until the level of Teriflunomid Adamed in the blood is low enough - which should be checked by the doctor.
• The choice of the most suitable contraceptive method or the need to change it should be discussed with the doctor.

Do not take Teriflunomid Adamed while breastfeeding, as teriflunomide passes into human milk.

Driving and using machines

Teriflunomid Adamed may cause dizziness, which can affect concentration and reaction time. In such cases, do not drive or operate machinery.

Teriflunomid Adamed contains lactose

Teriflunomid Adamed contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

Teriflunomid Adamed contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Teriflunomid Adamed

Taking Teriflunomid Adamed should be supervised by a doctor experienced in treating multiple sclerosis. This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (aged 10 years and older)

The dose depends on body weight:

• Children with a body weight over 40 kg: one 14 mg tablet per day.
• Children with a body weight of 40 kg or less: one 7 mg tablet per day. For these patients, other medicines containing teriflunomide in a lower dose are available (7 mg 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 Teriflunomid Adamed is intended for oral use. Teriflunomid Adamed should be taken once daily at any time of day. The tablet should be swallowed whole, with water. Teriflunomid Adamed can be taken with or without food.

Taking a higher dose of Teriflunomid Adamed than recommended

If a higher dose of Teriflunomid Adamed than recommended is taken, contact your doctor immediately. Side effects similar to those described in section 4 below may occur.

Missing a dose of Teriflunomid Adamed

Do not take a double dose to make up for a missed dose. The next dose should be taken as scheduled.

Stopping treatment with Teriflunomid Adamed

Do not stop taking Teriflunomid Adamed or change the dose without consulting your doctor first. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Teriflunomid Adamed can cause side effects, although not everybody gets them. After taking this medicine, the following side effects may occur.

Severe side effects

Some side effects may be severe or become severe. If you experience any of these symptoms, inform your doctor immediately.

Common (may affect up to 1 in 10 people):

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

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, blisters, fever, or mouth sores;
• severe infections or sepsis (a life-threatening infection), which may cause symptoms such as high fever, chills, shivering, reduced urine output, or disorientation;
• pneumonia, which may cause 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 cause yellowing of the skin or eyes, darker than usual urine, unexplained nausea, 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 activity of certain liver enzymes in the blood);
• 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 foot infection;
• 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;
• laboratory test results: reduced red blood cell count (anemia), changes in liver test results and white blood cell count (see section 2), as well as increased muscle enzyme activity (creatine phosphokinase);
• mild allergic reactions;
• feeling anxious;
• feeling of pins and needles, weakness, numbness, or pain in the lower back or leg (sciatica); feeling of numbness, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome);
• palpitations;
• increased blood pressure;
• nausea (vomiting), toothache, abdominal pain;
• rash, acne;
• tendon, joint, bone, or muscle pain (musculoskeletal pain);
• need to urinate more frequently than usual;
• heavy menstrual bleeding;
• pain;
• lack of energy or feeling weak (asthenia);
• weight loss.

Uncommon(may affect up to 1 in 100 people):

• reduced platelet count (mild thrombocytopenia);
• increased sensitivity or hypersensitivity, especially of the skin; tingling or pulsating pain along one or more nerves, nerve disorders of the hands or feet (peripheral neuropathy);
• nail disorders, severe skin reactions;
• traumatic pain;
• psoriasis;
• mouth or lip inflammation;
• abnormal blood fat (lipid) levels;
• inflammation of the large intestine (colitis).

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 (aged 10 years and older) and adolescents

The above side effects also apply to children and adolescents. The following additional information is important for children, adolescents, and their caregivers:

Common(may affect up to 1 in 10 people)

• pancreatitis.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your 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 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 Teriflunomid Adamed

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Teriflunomid Adamed contains

• The active substance is teriflunomide. Each film-coated tablet contains 14 mg of teriflunomide.
• The other ingredients are: Tablet core: lactose monohydrate, corn starch, hydroxypropyl cellulose, sodium hydroxide, microcrystalline cellulose, sodium carboxymethyl cellulose, colloidal silicon dioxide, magnesium stearate. Coating: hypromellose 2910, titanium dioxide (E 171), triacetin, talc, indigo carmine, aluminum lake (E 132).

What Teriflunomid Adamed looks like and contents of the pack

Teriflunomid Adamed film-coated tablets are pale blue, biconvex, pentagonal, approximately 7.4 mm in length, with "14" engraved on one side and smooth on the other. Teriflunomid Adamed is available in PVC/PCTFE/Aluminum or Aluminum/PVC/OPA/Aluminum blisters in a cardboard box, containing 14, 28, 84, or 98 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Pharmacare Premium Ltd., HHF003 Hal Far Industrial Estate, Birzebbugia, BBG 3000, Malta, Genepharm S.A., 18th km Marathonos Ave, 153 51 Pallini Attiki, Greece. Date of last revision of the leaflet:12.2024