Teriflunomide Viatris Pharma: detailed information

Patient Information Leaflet

Teriflunomide Viatris Pharma 14 mg film-coated tablets

teriflunomide
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Teriflunomide Viatris Pharma is and what it is used for
What you need to know before taking Teriflunomide Viatris Pharma
How to take Teriflunomide Viatris Pharma
Possible side effects
How to store Teriflunomide Viatris Pharma
Contents of the pack and other information

1. What Teriflunomide Viatris Pharma is and what it is used for

What Teriflunomide Viatris Pharma is
This medicine contains the active substance teriflunomide, which is an immunomodulatory agent and
modulates the immune system to limit its attacks on the nervous system.
What Teriflunomide Viatris Pharma is used for
This medicine is used in adults, children and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS).
What multiple sclerosis is
MS is a long-term disease affecting the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation damages the protective covering (called myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. It prevents nerves from functioning properly.
People with a relapsing form of multiple sclerosis experience repeated attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient, but generally include:

difficulty walking
visual problems
balance problems.

Symptoms may disappear completely after a relapse, but over time, some problems may persist between relapses. This can lead to physical disability that may interfere with daily activities.
How Teriflunomide Viatris Pharma works
This medicine helps protect the central nervous system from attacks by the immune system by limiting the increase of certain white blood cells (lymphocytes). This reduces the inflammation that causes nerve damage in MS.

2. What you should know before taking Teriflunomide Viatris Pharma

Do not take Teriflunomide Viatris Pharma:

if you are allergic to teriflunomide or to any of the other ingredients of this medicine (listed in section 6),
if you have developed a severe skin rash or skin peeling, blistering and/or mouth ulcers after taking teriflunomide or leflunomide,
if you have severe liver problems,
if you are pregnant, suspect you may be pregnant, or are breastfeeding,
if you have a serious disorder affecting your immune system, e.g. acquired immunodeficiency syndrome (AIDS),
if you have severe bone marrow problems or low counts of red blood cells or white blood cells in your blood or low platelet count,
if you have a serious infection,
if you have severe kidney problems requiring dialysis,
if you have very low levels of proteins in your blood (hypoproteinemia).

If you have any doubts, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Teriflunomide Viatris Pharma if:

you have liver problems and/or consume large amounts of alcohol. Your doctor will request blood tests before and during treatment to monitor liver function. If test results show a liver problem, your doctor may ask you to stop treatment with Teriflunomide Viatris Pharma. See section 4.
you have high blood pressure (hypertension), whether controlled or uncontrolled by medication. This medicine may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly thereafter. See section 4.
you have an infection. Before taking this medicine, your doctor will ensure that your white blood cell and platelet counts in the blood are adequate. Since this medicine reduces the number of white blood cells in the blood, it may affect your ability to fight infections. If you suspect you have any infection, your doctor may perform blood tests to monitor white blood cells. Viral infections caused by herpes viruses, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications may arise. You must inform your doctor immediately if you suspect any symptoms of a herpes virus infection. See section 4.
you have severe skin reactions.
you have respiratory symptoms.
you experience weakness, numbness, or pain in your hands or feet.
you need to receive a vaccination.
you are taking leflunomide together with Teriflunomide Viatris Pharma.
you are switching to or from treatment with Teriflunomide Viatris Pharma.
you need to undergo a specific blood test (calcium level). Falsely low calcium levels may be observed.

Respiratory reactions
Inform your doctor if you develop unexplained cough or shortness of breath (dyspnea). Your doctor may perform further investigations.
Children and adolescents
Teriflunomide is not indicated in children under 10 years of age, as it has not been studied in paediatric patients with MS in this age group.
The warnings and precautions listed above also apply to children. The following information is important for children and those caring for them:

inflammation of the pancreas has been observed in patients taking teriflunomide. Your child’s doctor may perform blood tests if pancreatitis is suspected.

Other medicines and Teriflunomide Viatris Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

leflunomide, methotrexate, and other medicines that affect the immune system (commonly called immunosuppressants or immunomodulators)
rifampicin (a medicine used to treat tuberculosis and other infections)
carbamazepine, phenobarbital, phenytoin for epilepsy
St. John’s wort (a herbal medicine for depression)
repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
duloxetine for depression, urinary incontinence, or kidney problems in diabetics
alosetron for managing severe diarrhoea
theophylline for asthma
tizanidine, a muscle relaxant
warfarin, an anticoagulant used to thin the blood (i.e., make it more fluid) to prevent blood clots
oral contraceptives (containing ethinylestradiol and levonorgestrel)
cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
indometacin, ketoprofen for pain or inflammation
furosemide for heart conditions
cimetidine for reducing gastric acid
zidovudine for HIV infection
rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
colestyramine for high cholesterol or relief of itching in liver diseases
activated charcoal to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or suspect you are pregnant. If you are pregnant or become pregnant while taking Teriflunomide Viatris Pharma, the risk of your baby having birth defects increases. Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
If your daughter begins menstruation while taking this medicine, inform your doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
Inform your doctor if you plan to become pregnant after stopping treatment with Teriflunomide Viatris Pharma, as you must ensure that most of this medicine has been eliminated from your body before planning a pregnancy. Elimination of the active substance may take up to 2 years to occur naturally. This period can be reduced to a few weeks by taking certain medicines that accelerate the elimination of this medicine from the body. In any case, blood testing must confirm that the active substance has been sufficiently eliminated from your body, and you must wait for your doctor’s confirmation that teriflunomide blood levels are low enough to allow pregnancy.
For further information on laboratory tests, contact your doctor.
If you suspect pregnancy while taking this medicine or within two years after stopping treatment, you must stop taking Teriflunomide Viatris Pharma and contact your doctor immediately to perform a pregnancy test. If the test confirms pregnancy, your doctor may recommend treatment with certain medicines to rapidly and sufficiently eliminate this medicine from your body, as this may reduce the risk to your baby.
Contraception
You must use an effective method of contraception during and after treatment with this medicine.
Teriflunomide remains in the blood for a long time after stopping treatment. Continue using effective contraception after stopping treatment.

Continue until teriflunomide blood levels are sufficiently low. Your doctor will monitor them.
Consult your doctor about the best contraceptive method for you and any potential need to change contraception.

Do not take Teriflunomide Viatris Pharma if you are breastfeeding, as teriflunomide passes into breast milk.
Driving and use of machinery
This medicine may cause dizziness, which could impair your ability to concentrate and react. You must not drive or operate machinery if you experience this symptom.
Teriflunomide Viatris Pharma contains lactose
This medicine contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Teriflunomide Viatris Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Teriflunomide Viatris Pharma

Treatment with Teriflunomide Viatris Pharma must be supervised by a physician experienced in the
treatment of multiple sclerosis.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor.
Adults
The recommended dose is one 14 mg tablet daily.
Use in children (10 years of age or older) and adolescents
The dose depends on body weight:

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

Teriflunomide 14 mg film-coated tablets are not suitable for pediatric patients with body weight ≤ 40 kg. Other medicinal products containing teriflunomide are available at lower strengths (such as 7 mg film-coated tablets).
Children and adolescents who reach a stable body weight above 40 kg will be instructed by their physician to switch to one 14 mg tablet daily.
Route/method of administration
Teriflunomide Viatris Pharma is for oral use. It should be taken every day as a single daily dose at any time of the day. The tablet must be swallowed whole with some water.
This medicine may be taken with or without food.
If you take more Teriflunomide Viatris Pharma than you should
If you have taken too much Teriflunomide Viatris Pharma, contact your doctor immediately. You may experience adverse effects similar to those described below in section 4.
If you forget to take Teriflunomide Viatris Pharma
Do not take a double dose to make up for the missed tablet. Take the next dose at the scheduled time.
If you stop taking Teriflunomide Viatris Pharma
Do not stop using this medicine or change the dose without first discussing it with your doctor.
If you have any 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 with this medicine.
Serious side effects
Some side effects may be or may become serious. If you experience any of the following, contact your doctor immediately.
Common (may affect up to 1 in 10 people)

inflammation of the pancreas, which may include symptoms of abdominal pain, nausea or vomiting (frequency is common in paediatric patients 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 rash, rash with blisters, fever, or mouth ulcers
severe infections or sepsis (a type of infection that may be life-threatening), which may include symptoms such as high fever, shaking, chills, reduced urine output, or confusion
inflammation of the lungs, which may include symptoms such as shortness of breath or persistent cough.

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, dark urine, unexplained nausea and vomiting, or abdominal pain.

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

Headache
Diarrhoea, nausea
Increased ALT (increase in levels of certain liver enzymes in the blood) detected by blood 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 when swallowing, cystitis, viral gastroenteritis, dental infection, laryngitis, fungal foot infection
Herpes virus infections, including oral herpes and herpes zoster (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 tests: decreases in red blood cell count (anaemia), changes in liver function and white blood cell test results (see section 2), as well as increases in levels of a muscle enzyme (creatine phosphokinase)
Mild allergic reactions
Feeling anxious
Tingling, weakness, numbness, tingling or pain in the lower back or legs (sciatica); numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
Awareness of heartbeat
Increased blood pressure
Malaise (nausea), 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 weak (asthenia)
Weight loss

Uncommon (may affect up to 1 in 100 people)

Decrease in platelet count (mild thrombocytopenia)
Increased sensitivity, particularly of the skin; stabbing or pulsating pain in one or more nerves, nerve problems in the arms or legs (peripheral neuropathy)
Nail disorders, severe skin reactions
Post-traumatic pain
Psoriasis
Inflammation of the mouth/lips
Abnormal levels of fats (lipids) in the blood
Inflammation of the colon (colitis)

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

Inflammation or damage to the liver

Not known (frequency cannot be estimated from the available data)

Pulmonary hypertension.

Additional side effects in 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 those caring for them:
Common (may affect up to 1 in 10 people)

Inflammation of the pancreas.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teriflunomide Viatris Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Teriflunomide Viatris Pharma contains
The active substance is teriflunomide.
Teriflunomide Viatris Pharma

Each tablet contains 14 mg of teriflunomide.
The other components are: Tablet core: monohydrate lactose, corn starch, hydroxypropylcellulose, microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E171), anhydrous colloidal silica, Macrogol (E1521), indigo carmine–aluminium lake (E132).

(see section 2 “Teriflunomide Viatris Pharma contains lactose”).
Description of the appearance of Teriflunomide Viatris Pharma and package contents
Teriflunomide Viatris Pharma are film-coated, biconvex, blue, round tablets (8.0 mm), smooth on both sides.
Teriflunomide Viatris Pharma is packaged in:

aluminium-aluminium blisters containing 28 and 84 film-coated tablets
divisible single-dose aluminium-aluminium blisters containing 28 film-coated tablets
calendar aluminium-aluminium blisters containing 98 film-coated tablets

Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20,
20124 Milano
Italy
Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº7,
Pol. Ind. Miralcampo,
19200 Azuqueca de Henares,
Guadalajara, Spain
Pharmadox Healthcare Ltd (Paola - MT)
KW20A Kordin Industrial Park, Paola,
PLA3000, Malta (MT)
This medicinal product is authorised in the European Economic Area countries under the following names:
Iceland: Teriflunomide Medical Valley 14 mg filmuhúðaðar töflur
Germany: TerifluViatris14 mg Filmtabletten
France: TERIFLUNOMIDE VIATRIS SANTE’ 14 mg, comprimé pelliculé
Spain: Teriflunomide Viatris Pharmaceuticals 14 mg comprimidos recubiertos con película EFG
Portugal: Teriflunomide Viatris Pharma
Italy: Teriflunomide Viatris Pharma
Norway: Teriflunomide Medical Valley
Poland: Teriflunomide Medical Valley