AUBAGIO 14 мг Фильм-coated таблетки

Содержание инструкции

1. AUBAGIO 7 mg film-coated tablets, 14 mg film-coated tablets
   1. What is AUBAGIO and what is it used for
   2. What you need to know before taking AUBAGIO
   3. How to take AUBAGIO
   4. Possible side effects
   5. How to store AUBAGIO
   6. Contents of the pack and other information

AUBAGIO 7 mg film-coated tablets, 14 mg film-coated tablets

teriflunomide

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 their symptoms are the same as yours, as it could 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 AUBAGIO is and what it is used for
• 2. What you need to know before you take AUBAGIO
• 3. How to take AUBAGIO
• 4. Possible side effects
• 5. How to store AUBAGIO
• 6. Contents of the pack and other information

1. What is AUBAGIO and what is it used for

What is AUBAGIO
AUBAGIO contains the active substance teriflunomide, which is an immunomodulatory agent and modulates the
immune system to limit its attacks on the nervous system.

What is AUBAGIO used for
AUBAGIO is used in adults, children and adolescents (aged 10 years and over) 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), a system consisting 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. It
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 does AUBAGIO work
AUBAGIO 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 AUBAGIO

Do not take AUBAGIO:

• if you are allergic to teriflunomide 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 may be pregnant or are planning a pregnancy, 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 low numbers of red blood cells or white blood cells in your blood or a reduced number of platelets,
• if you have a severe 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 AUBAGIO 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 AUBAGIO. Read section 4.
• you have high blood pressure (hypertension), whether it is controlled or not by medication. AUBAGIO 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 AUBAGIO, your doctor will check that your number of white blood cells and platelets in your blood is sufficient. Because AUBAGIO lowers the number of white blood cells in your blood, this can affect your ability to fight an infection. If you think you have any infection, your doctor may perform blood tests to check your white blood cells. Infections from herpes viruses, 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 breathing problems.
• you have weakness, numbness and pain in your hands or feet.
• you are to have a vaccination.
• you are taking leflunomide with AUBAGIO.
• you are switching to or from treatment with AUBAGIO. you should undergo a specific blood test (calcium level). Falsely low calcium levels may occur.

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

Children and adolescents
AUBAGIO 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 AUBAGIO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including those available without a prescription.
In particular, tell 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 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 AUBAGIO if you are pregnant or suspect you are pregnant. If you are pregnant or become
pregnant while taking AUBAGIO, the risk that your baby will have birth defects increases. Women of childbearing
potential must not take this medicine without using reliable contraceptive measures.
If your daughter has her first menstrual period while taking AUBAGIO, you must 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 AUBAGIO,
because before planning a pregnancy, you must be sure that most of this medicine has been eliminated from your
body. Elimination of the active ingredient 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 AUBAGIO from the body.
In each case, it must be confirmed with a blood test that the active ingredient has been eliminated
from the body to a sufficient extent and you must await confirmation from the doctor that the level of AUBAGIO
in the blood is sufficiently low to allow the start of a pregnancy.
For further information about laboratory tests, consult your doctor.
If you suspect you are pregnant while taking AUBAGIO or within two years after stopping
treatment, you must stop AUBAGIO and see your doctor immediatelyfor a pregnancy test. If the test
confirms the pregnancy, your doctor may suggest treatment with certain medicines to eliminate AUBAGIO 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 AUBAGIO. The
teriflunomide remains in the blood for a long time after stopping treatment. Continue to use effective
contraception after stopping treatment.

• Continue until the levels of AUBAGIO 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 AUBAGIO if you are breastfeeding as teriflunomide passes into breast milk.

Driving and using machines
AUBAGIO can cause dizziness which may affect your ability to concentrate and react. Do not drive or use
machines if you experience this symptom.

AUBAGIO contains lactose
AUBAGIO contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

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

3. How to take AUBAGIO

Treatment with AUBAGIO must be supervised by a doctor experienced in the treatment of multiple sclerosis.
Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor.

Adults
The recommended dose is one 14 mg tablet daily.

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 daily.
• Children with a body weight of 40 kg or less: one 7 mg tablet daily.

Children and adolescents who reach a stable body weight greater than 40 kg will be instructed by
their doctor to switch to a 14 mg tablet daily.

Route/method of administration
AUBAGIO is for oral use. AUBAGIO is taken every day in a single daily dose at any
time of day.
The tablet must be swallowed whole with a little water.
AUBAGIO can be taken with or without food.

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

If you forget to take AUBAGIO
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 AUBAGIO
Do not stop using AUBAGIO or change the dose without first talking to your doctor.
If you have any further 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 may be or can become serious. Tell your doctor immediately if you
notice any of the following serious side effects.

Common (may affect up to 1 in 10 people)

• inflammation of the pancreas which may include symptoms of abdominal pain, 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 mouth sores
• severe infections or sepsis (a type of infection with life-threatening potential) which may include symptoms of high fever, shivering, chills, decreased 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)

• serious liver diseases which may include symptoms of yellowing of the skin or whites of the eyes, darker than usual 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
• Diarrhea, 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 the number of red blood cells (anemia), 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, 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
• Tenderness, joint pain, bone pain, 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):

• Decreased 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 1,000):
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 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)

• Pancreatitis (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 listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AUBAGIO

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 the container (wallet)
after “Exp”. 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 wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AUBAGIO contains
The active ingredient is teriflunomide.
AUBAGIO 7 mg film-coated tablets

• Each tablet contains 7 mg of teriflunomide. The other components are lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine - aluminium lake (E132) and yellow iron oxide (E172) (see section 2 “Aubagio contains lactose”).

AUBAGIO 14 mg film-coated tablets

• Each tablet contains 14 mg of teriflunomide.
• The other components are lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine - aluminium lake (E132) (see section 2 “Aubagio contains lactose”).

Description of the appearance of AUBAGIO and contents of the pack
AUBAGIO 7 mg film-coated tablets (tablets)
The film-coated tablets are hexagonal in shape, ranging in colour from very light greyish-green-blue
to light blue-greenish, with the inscription (“7”) embossed on one side and the company logo engraved on the other.
AUBAGIO 7 mg film-coated tablets are available in cardboard boxes containing 28 tablets in
wallet packs with integrated blisters.
AUBAGIO 14 mg film-coated tablets (tablets)
The film-coated tablets are pentagonal in shape, ranging in colour from light blue to pastel blue,
with the inscription “14” embossed on one side and the company logo engraved on the other.
AUBAGIO 14 mg film-coated tablets are available in cardboard boxes containing:

• 14, 28, 84 and 98 tablets in wallet packs with integrated blisters;
• 10x1 tablet in perforated blister strips with unit doses.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200
Compiègne
France
Sanofi Winthrop Industrie
30-36, avenue Gustave Eiffel
37100 Tours
France
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Sanofi Belgium
Tel/Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 04 36 996
Tel. aus dem Ausland: +49 69 305 70 13

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0) 8 634 5000

Latvia
Swixx Biopharma SIA
Tel: +371 6 616 47 50

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
information on safety at the QR code indicated below.
QR code to be included + www.qr-aubagio-sanofi.eu