Teriflunomide aurovitas

Package leaflet: Information for the user

Teriflunomide Aurovitas, 14 mg, film-coated tablets
Teriflunomidum
Read all of 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people. It may harm them, even
if their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
Contents of the leaflet:

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

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

What Teriflunomide Aurovitas is
Teriflunomide Aurovitas 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 Aurovitas is used for
Teriflunomide Aurovitas is used in adults and in 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, inflammatory processes destroy the protective covering (called myelin) around the nerves in the CNS. This loss of myelin is known as demyelination. This causes nerves to malfunction.
People with relapsing-remitting MS experience repeated attacks (relapses) of physical symptoms caused by improper nerve function. Symptoms vary between patients 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 that can make daily activities difficult.
How Teriflunomide Aurovitas works
Teriflunomide Aurovitas helps protect the central nervous system from immune system attack 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 Aurovitas

When not to use Teriflunomide Aurovitas:

• 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 mouth 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 disorders or has low numbers of red or white blood cells or a 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 Aurovitas, discuss with a doctor or
pharmacist if:
the patient has impaired liver function 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 show liver function abnormalities, the doctor may discontinue
treatment with Teriflunomide Aurovitas. Refer to section 4.
the patient has high blood pressure (hypertension), regardless of whether it is
controlled with medication or not. Teriflunomide Aurovitas may increase blood pressure. The doctor will monitor the patient’s blood pressure
before starting treatment and regularly during treatment. Refer to section 4.
the patient has an infection. Before taking Teriflunomide Aurovitas, the doctor will ensure
that the patient has sufficient numbers of white blood cells and platelets in the blood. Since Teriflunomide Aurovitas reduces the number of white blood cells, this may impair
the ability to fight infections. The doctor may perform blood tests to check white blood cell count if the patient suspects an infection. Viral infections such as herpes virus, including cold sores or shingles, may occur during treatment. In some cases, serious complications may arise. Immediately inform the doctor if any symptoms of herpes virus infection are suspected. Refer to section 4.
the patient has 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 Aurovitas.
the patient is switching from another medicine to Teriflunomide Aurovitas or from Teriflunomide Aurovitas 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 a cough of unknown origin and shortness of breath (difficulty breathing). The doctor may perform additional tests.

Children and adolescents
Teriflunomide Aurovitas 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 Aurovitas and other medicines
Inform the 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 the 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 agents),
• rifampicin (a medicine used to treat tuberculosis and other infections),
• carbamazepine, phenobarbital, phenytoin used to treat epilepsy,
• St. John’s wort (an herbal remedy 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 hypercholesterolaemia (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 Aurovitas if the patient is pregnant or suspects she may be pregnant. If the patient is pregnant or becomes pregnant while taking Teriflunomide Aurovitas, the risk of congenital malformations in the unborn child increases. Women of childbearing potential must not take this medicine without using effective contraception.
If a girl starts menstruating while taking Teriflunomide Aurovitas, inform the doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
Inform the doctor if the patient plans to become pregnant after stopping Teriflunomide Aurovitas, as it is essential to ensure that most of the medicine has been eliminated from the body before attempting pregnancy. Natural elimination of the active substance may take up to 2 years. This time can be reduced to several weeks by taking specific medicines that accelerate the removal of Teriflunomide Aurovitas from the body.
In both cases, blood testing must confirm that the active substance has been sufficiently eliminated from the body. The doctor must confirm that the blood concentration of Teriflunomide Aurovitas is low enough to allow pregnancy.
For additional information regarding laboratory tests, contact the doctor.
If the patient suspects she is pregnant while taking Teriflunomide Aurovitas or within two years after stopping treatment, discontinue Teriflunomide Aurovitas immediately and contact the doctor promptly to perform a pregnancy test. If pregnancy is confirmed, 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 treatment with Teriflunomide Aurovitas. Teriflunomide remains in the blood for a long time after stopping treatment. Effective contraception must be continued after stopping treatment.

• This should be continued until blood levels of Teriflunomide Aurovitas are sufficiently low – this will be confirmed by the doctor.
• Discuss with the doctor the most suitable contraceptive method for the patient and any potential need to change contraceptive methods.

Do not take Teriflunomide Aurovitas while breastfeeding, as teriflunomide passes into human milk.

Driving and operating machinery
Teriflunomide Aurovitas may cause dizziness, which may impair the ability to concentrate and react. If such symptoms occur, do not drive or operate machinery.

Teriflunomide Aurovitas contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Teriflunomide Aurovitas 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 Aurovitas

Treatment with Teriflunomide Aurovitas 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 per day.

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

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

Teriflunomide Aurovitas 14 mg, coated tablets is not suitable for children and adolescents with body weight ≤ 40 kg.
Teriflunomide Aurovitas 7 mg is not available. Other medicines containing teriflunomide 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 informed by their doctor to change the dose to one 14 mg tablet per day.

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

Taking more Teriflunomide Aurovitas than prescribed
If more than the prescribed dose of Teriflunomide Aurovitas has been taken, contact your doctor immediately. Adverse effects may occur similar to those described in section 4 below.

Missing a dose of Teriflunomide Aurovitas
Do not take a double dose to make up for a missed tablet. Take the next dose at the scheduled time.

Stopping Teriflunomide Aurovitas
Do not stop taking Teriflunomide Aurovitas 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur after taking this medicine.
Serious adverse reactions
Some adverse reactions may be serious or may become serious. If any of the following symptoms occur, 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 available data)

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

Other adverse reactions 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, bladder inflammation, 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 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 and white blood cell test results (see section 2), and increased activity of muscle enzyme (creatine phosphokinase)
• mild allergic reactions
• feeling anxious
• tingling or prickling sensation, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica), sensation of numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
• sensation of "heart beating"
• increased blood pressure
• vomiting, toothache, epigastric 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 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 oral mucosa/lips
• abnormal levels of fats (lipids) in 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 available data)
pulmonary hypertension.
Children (aged 10 years and older) and adolescents
The adverse reactions 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 adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Teriflunomide Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister marked with: EXP.
The expiry date refers to the last day of the stated month.
Cold-form triple-layered blister (OPA/Aluminium/PVC/Aluminium):
No special storage instructions apply.
White opaque blister made of PVC/PVDC/Aluminium foil:
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Teriflunomide Aurovitas contains

• The active substance is teriflunomide. Each film-coated tablet contains 14 mg of teriflunomide.

The other ingredients are:
Tablet core: Lactose monohydrate, corn starch, sodium carboxymethyl starch (type A),
hydroxypropylcellulose (low viscosity), microcrystalline cellulose (type 102), colloidal anhydrous silica, magnesium stearate.
Tablet coating: Hypromellose 2910 (E 464), titanium dioxide (E 171), talc (E 553b), macrogol 6000 (E 1521), indigo carmine, aluminium lake (E 132).

What Teriflunomide Aurovitas looks like and contents of the pack
Film-coated tablet
Light blue to blue, round film-coated tablet, approximately 7.2 mm in diameter, embossed with the mark "N" on one side and "14" on the other side.

Pack sizes: 14, 28, 30, 56, 60, 70, 84, 90, 98, 100, 120 and 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
email: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Teriflunomide AB 14 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten
France: Teriflunomide Arrow 14 mg comprimé pelliculé
Germany: Teriflunomid PUREN 14 mg Filmtabletten
Netherlands: Teriflunomide Aurobindo 14 mg, filmomhulde tabletten
Poland: Teriflunomide Aurovitas
Portugal: Teriflunomida Generis
Spain: Teriflunomida Aurovitas 14 mg comprimidos recubiertos con película EFG