TERIFLUNOMIDE 14 mg Film-Coated Tablets

Зміст інструкції

1. Teriflunomide Neuraxpharm 14 mg film-coated tablets
   1. What Teriflunomide Neuraxpharm is and what it is used for
   2. What you need to know before taking Teriflunomide Neuraxpharm
   3. How to take Teriflunomide Neuraxpharm
   4. Possible side effects
   5. How to store Teriflunomide Neuraxpharm
   6. Package contents and other information

Teriflunomide Neuraxpharm 14 mg film-coated tablets

Teriflunomide

Generic medicine
Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Teriflunomide Neuraxpharm is and what it is used for
• 2. What you need to know before you take Teriflunomide Neuraxpharm
• 3. How to take Teriflunomide Neuraxpharm
• 4. Possible side effects
• 5. How to store Teriflunomide Neuraxpharm
• 6. 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 ingredient teriflunomide, which is an immunomodulating agent and modulates the immune system to limit 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 over (body weight over 40 kg) for the treatment of relapsing-remitting multiple sclerosis (MS).

What is multiple sclerosis
MS is a long-term illness that affects the central nervous system (CNS), which consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (called myelin) that covers the nerves of the CNS. This loss of myelin is called demyelination and prevents nerves from functioning properly.
People who suffer from a relapsing form of multiple sclerosis have 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 at the end of the relapse, but over time some problems may persist even between relapses. This can cause physical disability that can interfere with daily activities.

How Teriflunomide Neuraxpharm works
Teriflunomide Neuraxpharm helps to protect the central nervous system from attacks by the immune system, by limiting the increase of certain cells belonging to white blood cells (lymphocytes). This limits the inflammation that leads to 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 any of the other ingredients of this medicine (listed in section 6),
• if you have developed a severe skin rash or peeling of the skin, blistering and/or sores in the mouth after taking teriflunomide or leflunomide,
• if you have severe liver problems,
• if you are pregnant, suspect you are pregnant or if you are breastfeeding,
• if you have any serious condition that affects your immune system (e.g. acquired immunodeficiency syndrome (AIDS)),
• if you have any serious problems with your bone marrow or if you have a low number 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 (hypoproteinaemia). If you are unsure, ask 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 require blood tests before and during treatment to check your liver function. If the blood test results show a liver problem, your doctor may ask you to stop taking Teriflunomide Neuraxpharm. Read section 4;
• you have high blood pressure (hypertension), whether it is controlled or not with medication. Teriflunomide Neuraxpharm can cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly afterwards. Read section 4.
• you have an infection. Before taking Teriflunomide Neuraxpharm, your doctor will check that the number of white blood cells and platelets in your blood is sufficient. Because Teriflunomide Neuraxpharm decreases the number of white blood cells in your blood, this can affect your ability to fight an infection. If you think you have an infection, your doctor may perform blood tests to check your white blood cells. Infections from the herpes virus, including oral herpes or shingles (herpes zoster) can occur with teriflunomide treatment. In some cases, serious complications have occurred. You must tell your doctor immediately if you suspect you have any symptoms of a herpes virus infection. Read section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness and pain in your hands or feet.
• you are to undergo vaccination.
• you are taking leflunomide 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 levels may be found.

Respiratory reactions
Tell your doctor if you have unexplained cough and shortness of breath. Your doctor may perform further
checks.

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 warnings and precautions listed above also apply to children. The following information
is important for children and those who care 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 Neuraxpharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• leflunomide, methotrexate and other medicines that alter 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 disease
• cimetidine for reducing stomach acid
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for high cholesterol (hypercholesterolaemia)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• cholestyramine for high cholesterol or relief of itching in liver disease
• -activated charcoal to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding
Donot take Teriflunomide Neuraxpharm if you are pregnant or suspect you are pregnant.
If you are pregnant or become pregnant while taking Teriflunomide
Neuraxpharm, the risk that your baby will have birth defects increases. Women of childbearing potential should
not take this medicine without using reliable contraceptive measures.
If your daughter/teenage daughter has her first menstrual period (menarche) while taking teriflunomide, you
should inform the doctor, who will provide specialist advice regarding contraception and potential
risks in case of pregnancy.
Tell your doctor if you are planning to become pregnant after stopping treatment with
Teriflunomide Neuraxpharm, because you must be sure that most of this medicine has been eliminated from
your body before planning a pregnancy. Elimination of the active substance can 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 Teriflunomide Neuraxpharm from the body.
In any case, it must be confirmed by a blood test that the active substance has been
eliminated from the body to a sufficient extent and you must await confirmation from your doctor that the
level of Teriflunomide Neuraxpharm in the blood is sufficiently low to allow the start of
a pregnancy.
For further information on laboratory tests, consult your doctor.
If you suspect you are pregnant while taking Teriflunomide Neuraxpharm or within two years
after stopping treatment, you must stop Teriflunomide Neuraxpharm and see

immediatelyyour doctor to perform a pregnancy test. If the test confirms the pregnancy, the
doctor may suggest treatment with certain medicines to eliminate Teriflunomide
Neuraxpharm quickly and sufficiently from the body, as this can 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 treatment is stopped. Continue to use an
effective contraception after stopping treatment.

• Continue until the levels of teriflunomide in the blood are sufficiently low. Your doctor will check these.
• Consult your doctor about the best method of contraception for you and if you need any changes to your contraception.

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

Driving and using machines
Teriflunomide Neuraxpharm can cause a feeling of dizziness which may impair your
ability to concentrate and react. Do not drive or use machines if you experience this
symptom.

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

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

3. How to take Teriflunomide Neuraxpharm

Treatment with Teriflunomide Neuraxpharm must be supervised by a doctor experienced in the
treatment of multiple sclerosis.
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor.

Adults
The recommended dose is one 14 mg tablet per day.

Children and adolescents (10 years of age or older)
The dose depends on body weight:

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

Children and adolescents who reach a stable body weight greater than 40 kg will be
instructed by their doctor to switch to one 14 mg tablet per day.
Route of administration
Teriflunomide Neuraxpharm is for oral use. Teriflunomide Neuraxpharm is taken every day in a
single daily dose at any time of the day.
The tablet must be swallowed whole with a little water.
Teriflunomide Neuraxpharm can be taken with or without food.

If you take more Teriflunomide Neuraxpharm than you should
If you have taken too much Teriflunomide Neuraxpharm, call your doctor immediately. You may develop
undesirable effects similar to those described below in paragraph 4.

If you forget to takeTeriflunomide Neuraxpharm
Do not take a double dose to make up for a 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 talking to
your doctor.
If you have any questions about 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 with this medicine.

Serious side effects
Some side effects can be or can become serious. If you experience any of these, inform your doctor immediately:
Common(may affect up to 1 in 10 people)

• Inflammation of the pancreas which may include symptoms of pain in the abdomen, nausea or vomiting (the frequency is common in pediatric patients and uncommon in adult patients).

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions which may include symptoms of skin rash, hives, swelling of the lips, tongue or face or sudden difficulty breathing
• Severe skin reactions which may include symptoms of skin rash, blisters, fever, or ulcers in the mouth
• Severe infections or sepsis (a type of infection with potential life-threatening danger) which may include symptoms of high fever, shivering, chills, reduced urine flow, or confusion
• Inflammation of the lungs which may include symptoms of shortness of breath or persistent cough

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

• Severe liver diseases which may include symptoms of yellowing of the skin or whites of the eyes, urine darker than usual, unexplained nausea and vomiting, or abdominal pain.

Other side effectsmay occur with the following frequencies:

Very common(may affect more than 1 in 10 people):

• Headache
• Diarrhoea, nausea
• Increased ALT (increased levels of certain liver enzymes in the blood) found with 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 in 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 cells (anaemia), changes in test results relating to the liver and white blood cells (see section 2), and also increases in a muscle enzyme (creatine phosphokinase) have been observed
• Mild allergic reactions
• Feeling of anxiety
• Tingling, feeling of weakness, numbness, tingling or pain in the lower back or legs (sciatica); feeling of numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
• Feeling your heartbeat
• Increased blood pressure
• Vomiting, toothache, upper abdominal pain
• Skin rash, acne
• Pain in tendons, joints, bones, muscle pain (musculoskeletal pain)
• Needing to urinate more often than usual
• Heavy menstrual bleeding
• Pain
• Lack of energy or feeling weak (asthenia)
• Weight loss.

Uncommon(may affect up to 1 in 100 people)

• Decrease in the number of platelets (mild thrombocytopenia)
• Increased sensitivity, especially of the skin; shooting or pulsating pain in one or more nerves, problems with nerves 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 1000 people)

• Inflammation or damage to the liver

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

• Increased blood pressure at the level of the lungs

Children (10 years of age and over) and adolescents
The side effects listed above apply to children and adolescents as well. 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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 which is stated on the package and on the blister after
SCAD. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions
Do not dispose of any medicine in waste water 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 Neuraxpharm contains

• The active ingredient is teriflunomide
• The other ingredients are lactose monohydrate, corn starch, sodium starch glycolate (type A), hydroxypropylcellulose, microcrystalline cellulose, anhydrous colloidal silica, 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 package contents
Teriflunomide Neuraxpharm 14 mg film-coated tablets
Film-coated tablet, from pale blue to pastel blue, round, biconvex, with a fracture line on
both sides, with imprinted “I” and “2” on both sides of the fracture line 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 authorisation 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 authorised in the Member States of the European Economic Area
United Kingdom (Northern Ireland) with the following denominations:
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