Teriflunomide Msn

Leaflet accompanying the packaging: patient information

Teriflunomide MSN, 14 mg, coated tablets

Teriflunomide

Read the contents of 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 a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 Teriflunomide MSN and what is it used for
• 2. Important information before taking Teriflunomide MSN
• 3. How to take Teriflunomide MSN
• 4. Possible side effects
• 5. How to store Teriflunomide MSN
• 6. Contents of the packaging and other information

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

What is Teriflunomide MSN

Teriflunomide MSN contains the active substance teriflunomide, which is an immunomodulating agent and regulates the activity of the immune system to limit its attack on the nervous system.

What is Teriflunomide MSN used for

Teriflunomide MSN is used in adults and children and adolescents (aged 10 years and older) for the treatment of 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 destroys the protective covering (called myelin) around the nerves in the CNS. This loss of myelin is called demyelination. It disrupts the way nerves work. People with relapsing-remitting multiple sclerosis will have recurring attacks (relapses) of physical symptoms caused by the abnormal functioning of nerves. These symptoms vary among patients but usually include:

• difficulty walking,
• vision problems,
• balance problems.

Symptoms may completely disappear after a relapse, but over time, some problems may persist between relapses. This can lead to physical disability, making everyday activities difficult.

How Teriflunomide MSN works

Teriflunomide MSN 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 inflammation, which leads to nerve damage in multiple sclerosis.

2. Important information before taking Teriflunomide MSN

When not to take Teriflunomide MSN:

Warnings and precautions

Before starting treatment with Teriflunomide MSN, discuss with a doctor or pharmacist if:

• the patient has liver function disorders and/or drinks large amounts of alcohol. The doctor will perform blood tests before and during treatment to check if liver function is normal. If the patient's test results show liver function disorders, the doctor may stop the use of Teriflunomide MSN. Refer to section 4.
• the patient has high blood pressure, regardless of whether it is controlled with medication or not. Teriflunomide MSN may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly during treatment. Refer to section 4.
• the patient has an infection. Before taking Teriflunomide MSN, the doctor will ensure that the patient has a sufficient number of white blood cells and platelets in the blood. Since Teriflunomide MSN reduces the number of white blood cells in the blood, it may affect the ability to fight infection. The doctor may perform blood tests to check the number of white blood cells if the patient suspects they have an infection. During treatment with teriflunomide, herpes virus infections, including cold sores or shingles, may occur. In some cases, serious complications have occurred. If symptoms of a herpes virus infection are suspected, the doctor should be informed 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 plans to be vaccinated.
• the patient is taking leflunomide with Teriflunomide MSN.
• the patient is switching from their current medicine to Teriflunomide MSN or from Teriflunomide MSN to another medicine.
• the patient is to undergo a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.

Respiratory reactions

Tell a doctor if the patient experiences unexplained cough and shortness of breath (difficulty breathing). The doctor may perform additional tests.

Children and adolescents

Teriflunomide MSN is not intended for use in children under 10 years of age, as it has not been studied in patients with multiple sclerosis in this age group. The above warnings and precautions also apply to children. The following information is important for children, adolescents, and their caregivers:

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

Teriflunomide MSN and other medicines

Tell a doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription. In particular, inform a doctor or pharmacist if the patient is taking any of the following medicines:

• leflunomide, methotrexate, and other medicines that affect the immune system (often called immunosuppressive or immunomodulating medicines)
• rifampicin (a medicine 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 pain or inflammation
• furosemide used to treat heart disease
• cimetidine used to reduce stomach acid production
• zidovudine used to treat HIV infections
• 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 relieve itching in liver disease
• activated charcoal used to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding

Do nottake Teriflunomide MSN if the patient is pregnant or thinks they may be pregnant. If the patient becomes pregnant while taking Teriflunomide MSN, the risk of birth defects in the baby increases. Women of childbearing age must not take this medicine without using effective contraception. If a girl starts menstruating while taking Teriflunomide MSN, she should inform her doctor, who will provide specialized advice on contraception and potential risks in case of pregnancy. Tell a doctor if the patient plans to become pregnant after stopping Teriflunomide MSN, as it is necessary to ensure that most of the medicine has been removed from the body before trying to become pregnant. The natural elimination of the active substance may take up to 2 years. This time can be shortened to a few weeks by taking certain medicines that accelerate the removal of teriflunomide 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 teriflunomide level in the blood is low enough for the woman to become pregnant. For more information on laboratory tests, contact a doctor. If the patient suspects they are pregnant while taking Teriflunomide MSN or within 2 years after stopping treatment, they should stop taking Teriflunomide MSN and immediately contact a doctor for a pregnancy test. If the test confirms pregnancy, the doctor may recommend taking certain medicines to quickly and sufficiently remove teriflunomide from the body, as this may reduce the risk to the baby. Contraception should be used during and after treatment with Teriflunomide MSN. Teriflunomide remains in the blood for a long time after stopping treatment. Contraception should be continued until the teriflunomide level in the blood is low enough - the doctor will check this.

• Discuss with a doctor the best method of contraception for the patient and any need to change the method of contraception.

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

Driving and using machines

Teriflunomide MSN may cause dizziness, which can affect concentration and reaction time. If such symptoms occur, do not drive or operate machinery.

Teriflunomide MSN contains lactose

Teriflunomide MSN contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to some sugars, they should contact a doctor before taking this medicine.

Teriflunomide MSN contains sodium

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

3. How to take Teriflunomide MSN

Treatment with Teriflunomide MSN will be supervised by a doctor experienced in treating multiple sclerosis. This medicine should always be taken exactly as prescribed by a doctor. If in doubt, consult a 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.

Teriflunomide 14 mg is not suitable for children and adolescents with a body weight of 40 kg or less; other medicines are available in lower strengths (as 7 mg coated tablets). Children and adolescents who reach a stable body weight over 40 kg will be informed by their doctor to switch to one 14 mg tablet per day. Route and method of administration Teriflunomide MSN is taken orally. Teriflunomide MSN is taken once daily at any time of day. The tablet should be swallowed whole with water. Teriflunomide MSN can be taken with or without food.

Taking more than the recommended dose of Teriflunomide MSN

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

Missing a dose of Teriflunomide MSN

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

Stopping treatment with Teriflunomide MSN

Do not stop taking Teriflunomide MSN or change the dose without first consulting a 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 severe or become severe if any of these symptoms occur, inform a doctor immediately. Common(may affect up to 1 in 10 people)

• pancreatitis, which may include symptoms such as stomach 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 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 stomach pain.

Other side effectsmay occur with the following frequency: Very common(may affect more than 1 in 10 people)

• headache
• diarrhea, nausea
• increased ALT activity (increased activity of certain liver enzymes in the blood) shown in laboratory 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 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: 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 activity (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, stomach pain in the upper abdomen
• rash, acne
• tendon, joint, bone, or muscle pain (musculoskeletal pain)
• need to urinate more frequently 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 sensitivity, 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
• trauma-related pain
• psoriasis
• mouth ulcers
• abnormal blood fat (lipid) levels
• colitis.

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

• liver inflammation or damage.

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 side effects occur, including any side effects not listed in this leaflet, tell a 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, phone: +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 MSN

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. There are no special precautions for storing this medicine. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Teriflunomide MSN contains

• The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.
• The other ingredients are: Tablet core: lactose monohydrate (see section "Teriflunomide MSN contains lactose"), cornstarch, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, magnesium stearate, colloidal silicon dioxide, anhydrous.

Coating: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 6000, and indigo carmine, aluminum lake (E 132).

What Teriflunomide MSN looks like and contents of the pack

Blue, pentagonal, biconvex, film-coated tablets with "14" engraved on one side and "T" on the other. Teriflunomide MSN, 14 mg, film-coated tablets are available in cardboard boxes containing:

• 14, 28, 84, and 98 tablets in calendar blisters;
• 10 x 1 tablet in single-dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

MSN Labs Europe Limited KW20A, Corradino Park Paola, PLA 3000 Malta phone: (+48) 699 711 147

Manufacturer/Importer:

Pharmadox Healthcare Limited KW20A, Kordin Industrial Park Paola, PLA 3000 Malta MSN Labs Europe Limited KW20A, Corradino Park Paola, PLA 3000 Malta

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

Germany: Teriflunomid Vivanta Generics 14 mg Filmtabletten Czech Republic: Teriflunomide MSN Hungary: Teriflunomide MSN 14 mg filmtabletta Poland: Teriflunomide MSN Romania: Teriflunomidă MSN 14 mg comprimate filmate Slovakia: Teriflunomide MSN Bulgaria: терифлуномид MSN 14 mg филмирани таблетки

Date of last revision of the leaflet: 08/2024