Teriflunomide Teva Italia: detailed information

Patient Information Leaflet

Teriflunomide Teva Italia 14 mg Film-coated Tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Teriflunomide Teva Italia and what is it used for

What is Teriflunomide Teva Italia
Teriflunomide Teva Italia contains the active substance teriflunomide, an immunomodulatory agent that
modulates the immune system to limit its attacks on the nervous system.

What Teriflunomide Teva Italia is used for
Teriflunomide Teva Italia 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
MS is a long-term disease affecting the central nervous system (CNS), which consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective covering (called myelin) that surrounds the nerves of the CNS. This loss of myelin is known as demyelination and prevents nerves from functioning properly.

People with relapsing forms of multiple sclerosis experience repeated episodes (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient, but generally include:

difficulty walking;
vision problems;
balance problems.

Symptoms may completely disappear after a relapse, but over time some problems may persist between relapses, leading to physical disabilities that can interfere with daily activities.

How Teriflunomide Teva Italia works
Teriflunomide Teva Italia helps protect the central nervous system from attacks by the immune system by limiting the increase of certain white blood cells (lymphocytes) and, consequently, the inflammation that causes nerve damage characteristic of MS.

2. What you need to know before taking Teriflunomide Teva Italia

Do not take Teriflunomide Teva Italia

if you are allergic to teriflunomide or to any of the other ingredients of this medicine (listed in section 6);
if you have ever 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 or suspect you may be pregnant, or if you are breastfeeding;
if you have a serious disorder affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS);
if you have a serious bone marrow disorder or have low levels of red or white blood cells in your blood or a reduced number of platelets;
if you have a serious infection;
if you have severe kidney problems requiring dialysis;
if you have very low levels of protein in your blood (hypoproteinemia). If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Teriflunomide Teva Italia:

if you have liver problems and/or consume large amounts of alcohol. Your doctor will perform blood tests before and during treatment to monitor liver function. If test results indicate a liver problem, your doctor may ask you to stop treatment with Teriflunomide Teva Italia. See section 4;
if you have high blood pressure (hypertension), whether controlled by medication or not. Teriflunomide may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly thereafter. See section 4;
if you have an infection. Before taking Teriflunomide Teva Italia, your doctor will ensure that your white blood cell and platelet counts are adequate. Teriflunomide reduces the number of white blood cells in the blood and may therefore affect your ability to fight infections. During treatment with teriflunomide, herpes virus infections may occur, including oral herpes or herpes zoster (shingles). In some cases, serious complications may arise. Inform your doctor immediately if you suspect any symptoms of herpes virus infection. See section 4;
if you develop severe skin reactions;
if you have respiratory symptoms;
if you experience weakness, numbness, or pain in your hands and feet;
if you are due to receive a vaccination;
if you are taking leflunomide together with teriflunomide;
if you are switching to or from treatment with teriflunomide;
if you are undergoing a specific blood test (in which calcium levels are measured). Falsely low calcium levels may be detected.

Children and adolescents
Teriflunomide Teva Italia is not indicated in children under 10 years of age, as it has not been studied in 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:

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

Other medicines and Teriflunomide Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those 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 (often 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 disease 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 to reduce gastric acidity;
zidovudine for HIV infection;
rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolaemia (high cholesterol);
sulfasalazine for inflammatory bowel disease or rheumatoid arthritis;
colestyramine for high cholesterol or relief of itching in liver disease;
activated charcoal to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take Teriflunomide Teva Italia if you are pregnant or suspect you may be pregnant. If pregnancy occurs or begins during treatment with Teriflunomide Teva Italia, the risk of birth defects in the baby increases. Women of childbearing potential must not take this medicine without using reliable contraceptive methods.
If your daughter reaches menarche during treatment with Teriflunomide Teva Italia, 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 Teva Italia. Before planning a pregnancy, you must ensure that most of this medicine has been eliminated from your body. Natural elimination of the active substance may take up to 2 years. This period can be reduced to a few weeks by taking certain medicines that accelerate the elimination of teriflunomide from the body.
In any case, it is necessary to confirm by a blood test that the active substance has been sufficiently eliminated from the body, and you must wait for your doctor’s confirmation that the level of teriflunomide in the blood is low enough to allow pregnancy.
For further information on laboratory tests, consult your doctor.
If you suspect pregnancy during treatment with Teriflunomide Teva Italia or within two years after stopping treatment, you must stop therapy with Teriflunomide Teva Italia and contact your doctor immediately for a pregnancy test.
If the test confirms pregnancy, your doctor may recommend treatment with certain medicines to rapidly and sufficiently eliminate teriflunomide from the body, as this may reduce the risk to the foetus.

Contraception
You must use an effective method of contraception during and after treatment with Teriflunomide Teva Italia. Teriflunomide remains in the blood for a long time after stopping treatment. Continue using effective contraceptive methods after stopping treatment.

Continue in this way until teriflunomide blood levels are sufficiently low. These will be monitored by your doctor.
Consult your doctor to determine the most suitable contraceptive method for you and if you need to change your contraceptive method.

Do not take Teriflunomide Teva Italia if you are breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines
Teriflunomide Teva Italia may cause dizziness, which could impair your ability to concentrate and react. If you experience this symptom, do not drive or operate machinery.

Teriflunomide Teva Italia contains lactose
Teriflunomide Teva Italia contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Teriflunomide Teva Italia contains Allura Red AC (E129)
Allura Red AC (E129) may cause allergic reactions.

Teriflunomide Teva Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Teriflunomide Teva Italia

Treatment with Teriflunomide Teva Italia will be supervised by a physician experienced in the treatment of multiple sclerosis.
Take this medicine exactly as your doctor has told you. If you have any doubts, 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 above 40 kg: one 14 mg tablet daily.
Children with body weight of 40 kg or less: one 7 mg tablet daily. For these patients, other teriflunomide-containing medicines with a lower dosage (such as 7 mg tablets) are available. Children and adolescents who reach a stable body weight above 40 kg will be instructed by their doctor to switch to one 14 mg tablet daily.

Route and method of administration
Teriflunomide Teva Italia is for oral use. Teriflunomide Teva Italia is taken every day as a single daily dose at any time of day. Swallow the tablet whole with some water.
Teriflunomide Teva Italia may be taken with or without food.

If you take more Teriflunomide Teva Italia than you should
If you have taken too much Teriflunomide Teva Italia, contact your doctor immediately. You may experience adverse effects similar to those described below in section 4.

If you forget to take Teriflunomide Teva Italia
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 Teva Italia
Do not stop treatment with Teriflunomide Teva Italia or change the dose without first talking to 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 become serious. If you experience any of these effects,
contact your doctor immediately.

Common (may affect up to 1 in 10 people)

Inflammation of the pancreas, which may include symptoms such as 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, blistering, fever or mouth ulcers
Serious infections or sepsis (a type of infection that may be life-threatening), which may include symptoms such as high fever, trembling, 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 (elevation in levels of certain liver enzymes in the blood) detected by blood tests
Thinning of the hair

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 infection, 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 findings: decreased number of red blood cells (anaemia), changes in liver function tests and white blood cell counts (see section 2), and increases in a muscle enzyme (creatine phosphokinase)
Mild allergic reactions
Feeling of anxiety
Tingling, weakness, numbness, tingling or pain in the lower back or leg (sciatica); numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
Awareness of 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 weak (asthenia)
Weight loss

Uncommon (may affect up to 1 in 100 people)

Decreased number of platelets (mild thrombocytopenia)
Increased sensitivity, especially of the skin; pulsating or stabbing pain along 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

Children (aged 10 years and older) and adolescents
The side effects listed above also apply to children and adolescents. The following 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

5. How to store Teriflunomide Teva Italia

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 the wording “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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Teriflunomide Teva Italia contains
The active substance is teriflunomide.
Each film-coated tablet contains 14 mg of teriflunomide.
The other components are:
Tablet core: monohydrate lactose, maize starch, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate.
Tablet coating:
Hypromellose, titanium dioxide (E171), indigo carmine aluminium lake (E132), glycerol, talc, brilliant blue FCF aluminium lake (E133), allura red AC aluminium lake (E129).

Description of the appearance of Teriflunomide Teva Italia and package contents
Blue, round, biconvex, film-coated tablets, marked “14” on one side.
Teriflunomide Teva Italia is available in packages containing:
OPA/Al/PVC//Al blisters placed in wallets (containing 14 or 28 film-coated tablets), packed in a box containing 14 (1 wallet of 14), 28 (1 wallet of 28), 84 (3 wallets of 28), or 98 (7 wallets of 14) film-coated tablets.
OPA/Al/PVC//Al blisters packed in a box containing 14, 28, 84, or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano, Italy

Manufacturer
HBM Pharma s.r.o.
Sklabinská 30
SK-036 80 Martin, Slovakia