Teriflunomide Neuraxpharm: detailed information

PACKAGE LEAFLET

Package leaflet: information for the patient

Teriflunomide Neuraxpharm 14 mg film-coated tablets

Teriflunomide
Generic 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 they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Teriflunomide Neuraxpharm is
Teriflunomide Neuraxpharm contains the active substance teriflunomide, which is an immunomodulatory agent that modulates the immune system to reduce its attacks on the nervous system.

What Teriflunomide Neuraxpharm is used for
Teriflunomide Neuraxpharm is used in adults, children, and adolescents aged 10 years and older (with body weight above 40 kg) 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 damages the protective covering (called myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination and prevents nerves from functioning properly.

People with relapsing forms 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
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 that may interfere with daily activities.

How Teriflunomide Neuraxpharm works
Teriflunomide Neuraxpharm 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 characteristic of MS.

2. What you need to know before taking Teriflunomide Neuraxpharm

Do not take Teriflunomide Neuraxpharm

if you are allergic to the {active substance} 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 sores 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 any serious condition affecting the immune system (e.g. acquired immunodeficiency syndrome (AIDS)),
if you have any severe bone marrow disorder or if you have low levels of red blood cells 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 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 Neuraxpharm 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 blood test results indicate liver problems, your doctor may ask you to stop treatment with Teriflunomide Neuraxpharm. See section 4;
you have high blood pressure (hypertension), whether controlled or uncontrolled by medication. Teriflunomide Neuraxpharm 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 starting Teriflunomide Neuraxpharm, your doctor will check that your white blood cell and platelet counts are adequate. Since teriflunomide may reduce the number of white blood cells in your blood, this could affect your ability to fight infections. If you suspect you have an infection, your doctor may perform blood tests to monitor white blood cells. Viral infections with the herpes virus, 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 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 are due to receive a vaccination.
you are taking leflunomide together with Teriflunomide Neuraxpharm.
you are switching to or from treatment with Teriflunomide Neuraxpharm.
you need to undergo a specific blood test (calcium level). Falsely low calcium levels may be observed.

Respiratory reactions
Inform your doctor if you have unexplained cough or shortness of breath (dyspnea). Your doctor may perform further investigations.

Children and adolescents
Teriflunomide Neuraxpharm 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 above warnings and precautions also apply to children. The following information is important for children and for those caring for them:

Pancreatic inflammation has been observed in patients taking teriflunomide. Your child’s doctor may perform blood tests if pancreatic inflammation is suspected.

Other medicines and Teriflunomide Neuraxpharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 known as immunosuppressants or immunomodulators)
rifampicin (a medicine used to treat tuberculosis and other infections)
carbamazepine, phenobarbital, phenytoin for epilepsy
St. John’s wort (Hypericum perforatum), a herbal medicine used 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 the management of 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 hypercholesterolaemia (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 Teriflunomide Neuraxpharm if you are pregnant or suspect you may be pregnant.
If you become pregnant while taking Teriflunomide Neuraxpharm, the risk of birth defects in the baby increases. Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
If your daughter/adolescent daughter begins menstruation while taking teriflunomide, you must inform the 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 Neuraxpharm, because before planning a pregnancy, it is essential to ensure that most of this medicine has been eliminated from your body. Elimination of the active substance may take up to 2 years naturally. This period can be reduced to a few weeks by taking certain medicines that accelerate the elimination of Teriflunomide Neuraxpharm from the body.
In any case, a blood test must confirm that the active substance has been sufficiently eliminated from your body, and you must wait for confirmation from your doctor that the level of Teriflunomide Neuraxpharm in your blood is low enough to allow pregnancy.
For further information on laboratory tests, consult your doctor.
If you suspect pregnancy while taking Teriflunomide Neuraxpharm or within two years after stopping treatment, you must stop taking Teriflunomide Neuraxpharm and contact your doctor immediately to perform a pregnancy test. If the test confirms pregnancy, your doctor may recommend treatment with certain medicines to eliminate Teriflunomide Neuraxpharm rapidly and sufficiently from your 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 Neuraxpharm.
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 most suitable contraceptive method for you and in case of any need to change contraception.

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

Driving and using machines
Teriflunomide Neuraxpharm may cause dizziness, which could impair your ability to concentrate and react. You should not drive vehicles or operate machinery if you experience this symptom.

Teriflunomide Neuraxpharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

Teriflunomide Neuraxpharm contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Teriflunomide Neuraxpharm

Treatment with Teriflunomide Neuraxpharm 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.
Children and adolescents (aged 10 years and above)
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.

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/route of administration
Teriflunomide Neuraxpharm is for oral use. Teriflunomide Neuraxpharm is taken every day as a single daily dose at any time of day.
The tablet should be swallowed whole with some water.
Teriflunomide Neuraxpharm may be taken with or without food.
If you take more Teriflunomide Neuraxpharm than you should
If you have taken too much Teriflunomide Neuraxpharm, contact your doctor immediately. You may experience adverse effects similar to those described below in section 4.
If you forget to take Teriflunomide Neuraxpharm
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
Do not stop using Teriflunomide Neuraxpharm 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 these, 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
Serious skin reactions which may include symptoms such as rash, 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 diseases 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 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
Infections with herpes virus, 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: decreased number of red blood cells (anaemia), changes in test results related to the liver and white blood cells (see section 2), and increases in 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 your 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, particularly of the skin; stabbing or pulsating pain in one or more nerves, nerve problems in the arms or legs (peripheral neuropathy)
Nail disorders, serious 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)

Increased blood pressure in the lungs

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 who care 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 Neuraxpharm

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 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Teriflunomide Neuraxpharm contains

The active substance is teriflunomide.
The other components are monohydrate lactose, maize starch, sodium starch glycolate (type A), hydroxypropylcellulose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose 2910, titanium dioxide (E171), talc, macrogol 8000, indigo carmine – aluminium lake (E 132). (see section 2 "Teriflunomide Neuraxpharm contains lactose")

Description of the appearance of Teriflunomide Neuraxpharm and contents of the pack
Teriflunomide Neuraxpharm 14 mg film-coated tablets
Film-coated tablet, pale blue to pastel blue, round, biconvex, with a breakline on both sides, marked with "I" and "2" on either side of the breakline on one side. Diameter approximately 7.50 mm. The tablet can be divided into equal doses.
Teriflunomide Neuraxpharm 14 mg film-coated tablets are available in cardboard packs containing 28, 84 and 28x1 (unit dose) tablets in blisters.

Marketing Authorization Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 – Ascoli Piceno (AP)
Italy

Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. de Barcelona, 69
08970 Sant Joan Despí
Barcelona, Spain

This medicinal product is authorized in the European Economic Area Member States and the United Kingdom (Northern Ireland) under the following names:
Czech Republic: Teriflunomide Neuraxpharm
Hungary: Teriflunomide Neuraxpharm 14 mg Filmtabletta
Poland: Teriflunomide Neuraxpharm
Slovakia: Teriflunomide Neuraxpharm 14 mg
Norway: Teriflunomide Neuraxpharm
Iceland: Teriflunomide Neuraxpharm
Germany: Teriflunomid neuraxpharm 14 mg Filmtabletten
France: Tériflunomide Neuraxpharm 14 mg comprimés pelliculés
Spain: Teriflunomida Neuraxpharm 14 mg comprimidos recubiertos con película EFG