Teriflunomide msn

Patient Information Leaflet

Teriflunomide MSN, 14 mg, film-coated tablets
Teriflunomidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Leaflet Contents:

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

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

What Teriflunomide MSN is
Teriflunomide MSN contains the active substance teriflunomide, which is an immunomodulatory agent that regulates the immune system's activity to reduce its attack on the nervous system.

What Teriflunomide MSN is used for
Teriflunomide MSN is used in adults, children, and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS).

What is multiple sclerosis
Multiple sclerosis is a chronic disease that attacks the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation damages the protective covering (called myelin) around the nerves in the CNS. This loss of myelin is known as demyelination. This causes the nerves to malfunction.

People with relapsing-remitting multiple sclerosis experience repeated attacks (relapses) of physical symptoms caused by abnormal nerve function. Symptoms vary between individuals but usually include:

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

Symptoms may completely disappear after a relapse ends, but over time, some problems may persist between relapses. This may lead to physical disability, which can make daily activities more difficult.

How Teriflunomide MSN works
Teriflunomide MSN helps protect the central nervous system from the immune system by reducing the proliferation of certain white blood cells (lymphocytes). This reduces the inflammation that leads to nerve damage in multiple sclerosis.

2. Important information before using Teriflunomide MSN

When not to use Teriflunomide MSN:

• 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 severe skin rash, skin peeling, blisters and/or oral mucosal ulcers after taking teriflunomide or leflunomide,
• if the patient has severe liver disease,
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding,
• if the patient has a severe disease affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS),
• if the patient has severe bone marrow dysfunction or has low numbers of red or white blood cells or reduced platelet count,
• if the patient has a severe infection,
• if the patient has severe kidney disease requiring dialysis,
• if the patient has very low levels of proteins in the blood (hypoproteinemia). If in doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions
Before starting treatment with Teriflunomide MSN, discuss with your 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 whether liver function is normal. If test results indicate impaired liver function, the doctor may discontinue treatment with Teriflunomide MSN. Please refer to section 4.
• the patient has high blood pressure (hypertension), 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. Please refer to section 4.
• the patient has an infection. Before taking Teriflunomide MSN, the doctor will ensure that the patient has adequate levels of white blood cells and platelets. Since Teriflunomide MSN reduces the number of white blood cells, it may impair the ability to fight infections. The doctor may perform blood tests to check white blood cell count if the patient suspects any infection. Viral infections such as herpes virus, including cold sores or shingles, may occur during treatment with teriflunomide. In some cases, serious complications have occurred. Inform the doctor immediately if any symptoms suggestive of herpes virus infection are suspected. Please refer to section 4.
• the patient has experienced severe skin reactions.
• the patient has respiratory symptoms.
• the patient experiences weakness, numbness, or pain in the hands and feet.
• the patient plans to receive a vaccination.
• the patient is taking leflunomide together with Teriflunomide MSN.
• the patient is switching from another medication to Teriflunomide MSN or from Teriflunomide MSN to another medicine.
• the patient is scheduled for a specific blood test (calcium level measurement). Calcium test results may be falsely low.

Respiratory reactions
Inform the doctor if the patient develops an 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 and their caregivers:

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

Teriflunomide MSN and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines obtained without a prescription.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• leflunomide, methotrexate, and other medicines affecting the immune system (often called immunosuppressive or immunomodulatory drugs),
• rifampicin (a medicine used to treat tuberculosis and other infections),
• carbamazepine, phenobarbital, phenytoin used to treat epilepsy,
• St. John’s wort (a herbal medicine used 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 kidney disease in patients with diabetes,
• alosetron used to treat severe diarrhoea,
• theophylline used to treat asthma,
• tizanidine, a muscle relaxant,
• warfarin, an anticoagulant medicine used to thin the blood (i.e. increase blood fluidity) to prevent blood clots,
• oral contraceptives (containing ethinylestradiol and levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin used to treat infections,
• indometacin, ketoprofen used to treat pain or inflammation,
• furosemide used to treat heart conditions,
• cimetidine used to reduce gastric acid secretion,
• zidovudine used to treat HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin used to treat hypercholesterolemia (elevated cholesterol levels),
• sulfasalazine used for inflammatory bowel disease or rheumatoid arthritis,
• cholestyramine used for elevated cholesterol levels or to relieve itching in liver disease,
• activated charcoal used to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take Teriflunomide MSN if the patient is pregnant or suspects she may be pregnant. If the patient is pregnant or becomes pregnant while taking Teriflunomide MSN, there is an increased risk of congenital malformations in the child. Women of childbearing potential must not take this medicine without using effective contraceptive methods. If a girl starts menstruating while taking Teriflunomide MSN, inform the doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
Inform your doctor if the patient plans to become pregnant after stopping Teriflunomide MSN, because before attempting pregnancy, it is essential to ensure that most of the medicine has been eliminated from the body. Natural elimination of the active substance may take up to 2 years. This time can be reduced to several weeks by taking appropriate medicines that accelerate the removal of teriflunomide from the body. In both cases, blood testing must confirm that the active substance has been sufficiently eliminated from the body. The doctor should confirm that the blood concentration of teriflunomide is low enough for the woman to become pregnant.
For additional information regarding laboratory testing, contact your doctor.
If the patient suspects she is pregnant while taking Teriflunomide MSN or within two years after stopping treatment, stop taking Teriflunomide MSN immediately and contact the doctor without delay to perform a pregnancy test. If the test confirms pregnancy, the doctor may recommend appropriate treatment to rapidly and adequately eliminate teriflunomide from the body, as this may reduce the risk to the unborn child.
Contraception
Effective contraception must be used during and after stopping treatment with Teriflunomide MSN. Teriflunomide remains in the blood for a long time after stopping administration. Effective contraception should be continued after stopping treatment.

• This should be continued until the blood concentration of teriflunomide is sufficiently low – your doctor will confirm this.
• Discuss with your doctor the most suitable contraceptive method for the patient and whether a change in contraceptive method may be necessary.

Do not take Teriflunomide MSN while breastfeeding, as teriflunomide passes into human milk.
Driving and operating machinery
Teriflunomide MSN may cause dizziness, which may impair the ability to concentrate and react. 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 certain sugars, consult a doctor before taking this medicine.
Teriflunomide MSN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Teriflunomide MSN

Treatment with Teriflunomide MSN will be supervised by a physician experienced in the treatment of multiple sclerosis.
This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor.

Adults
The recommended dose is one 14 mg tablet once daily.

Children and adolescents (aged 10 years and older)
The dose depends on body weight:

• Children with body weight greater than 40 kg: one 14 mg tablet once daily.
• Children with body weight less than or equal to 40 kg: one 7 mg tablet once daily.

Teriflunomide 14 mg is not suitable for children and adolescents with body weight ≤ 40 kg; alternative formulations are available at a lower strength (as 7 mg coated tablets).
Children and adolescents who reach a stable body weight above 40 kg will be advised by their doctor to switch to a dose of one 14 mg tablet once daily.

Route and method of administration
Teriflunomide MSN is administered orally. Teriflunomide MSN is taken daily as a single dose at any time of day. The tablet should be swallowed whole with water.
Teriflunomide MSN may be taken with food or independently of meals.

Taking more Teriflunomide MSN than recommended
If more Teriflunomide MSN has been taken than recommended, contact your doctor immediately. Adverse 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 Teriflunomide MSN
Do not stop taking Teriflunomide MSN or change the dose without first consulting your doctor.

If you have any further questions about the use of this medicine, consult 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.
Serious side effects
Some side effects may be serious or may become serious. If any of the following symptoms occur, you should contact your doctor immediately.

Common (may affect up to 1 in 10 people)

• pancreatitis, which may include symptoms such as abdominal pain, nausea or vomiting (frequency is 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 breathing difficulties
• severe skin reactions, which may include symptoms such as skin rash, blistering, fever or mouth ulcers
• severe infections or sepsis (a type of potentially life-threatening infection), which may include symptoms such as high fever, shivering, chills, reduced urine output or confusion
• lung inflammation, 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 normal urine, unexplained nausea and vomiting, or abdominal pain.

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

• headache
• diarrhoea, nausea
• increased AlAT activity (increased activity of certain liver enzymes in blood) observed in laboratory tests
• hair thinning.

Common (may affect up to 1 in 10 people)

• influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort during 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, tingling or pain in the skin, usually on one side of the upper body or face, and other symptoms such as fever and fatigue
• laboratory test results: decreased number of red blood cells (anaemia), changes in liver function tests and white blood cells (see section 2), and increased activity of muscle enzyme (creatine phosphokinase)
• mild allergic reactions
• feeling of restlessness
• tingling or pricking sensation, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica), feeling of numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
• sensation of "pounding heartbeat"
• increased blood pressure
• vomiting, toothache, upper abdominal pain
• rash, acne
• tendon, joint, bone pain, muscle pain (musculoskeletal pain)
• need to urinate more often than usual
• heavy menstrual periods
• pain
• lack of energy or feeling of weakness (asthenia)
• weight loss.

Uncommon (may affect up to 1 in 100 people)

• decreased number of platelets (mild thrombocytopenia)
• increased sensation or sensitivity, especially of the skin; stabbing or pulsating pain along one or more nerves, nerve disorders of arms or legs (peripheral neuropathy)
• changes in nails, severe skin reactions
• traumatic pain
• psoriasis
• inflammation of the mucous membrane of the mouth/lips
• abnormal levels of fats (lipids) in the blood
• inflammation of the large intestine.

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 side effects listed above 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 of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting side effects helps 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 pack after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack 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"), corn starch, sodium carboxymethyl starch (type A), hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, anhydrous.
  Coating: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 6000, and indigo carmine, aluminium lake (E 132).

What Teriflunomide MSN looks like and contents of the pack
Teriflunomide MSN 14 mg film-coated tablets are blue, pentagonal, biconvex, film-coated tablets, with the imprint "14" 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 blister packs;
• 10 x 1 tablet in unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
tel.: (+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 medicinal product is authorised in the European Economic Area countries 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