TERIFLUNOMIDE 14 mg Фильм-Coated Таблетки

Содержание инструкции

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

Teriflunomide Teva Italia 14 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 Teriflunomide Teva Italia is and what it is used for
• 2. What you need to know before you take Teriflunomide Teva Italia
• 3. How to take Teriflunomide Teva Italia
• 4. Possible side effects
• 5. How to store Teriflunomide Teva Italia
• 6. Contents of the pack and other information

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

What is Teriflunomide Teva Italia
Teriflunomide Teva Italia contains the active ingredient teriflunomide, an immunomodulatory agent that
regulates the immune system to limit its attacks on the nervous system.
What is Teriflunomide Teva Italia used for
Teriflunomide Teva Italia 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), 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 nerve malfunction. These symptoms vary from patient to patient,
but generally involve:

• difficulty walking;
• vision problems;
• balance problems.

It is possible that the symptoms disappear completely at the end of the relapse, but over time
some problems may persist between relapses, causing physical disabilities that can
interfere with daily activities.

How Teriflunomide Teva Italia works
Teriflunomide Teva Italia helps to 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 leads to 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 peeling of the skin, blistering and/or sores in the mouth after taking teriflunomide or leflunomide;
• if you have serious liver problems;
• if you are pregnant or suspect you may be pregnant, or if you are breastfeeding;
• if you suffer from a serious problem affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS);
• if you have a serious problem 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 serious kidney problems, requiring dialysis;
• if you have very low levels of proteins in your blood (hypoproteinemia). 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 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 check your liver function. If the test results show a liver problem, your doctor may ask you to stop taking Teriflunomide Teva Italia. See section 4;
• if you have high blood pressure (hypertension), whether controlled or not with medication. Teriflunomide can cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and subsequently at regular intervals. See section 4;
• if you have an infection. Before taking Teriflunomide Teva Italia, your doctor will make sure that your number of white blood cells and platelets in your blood is sufficient. Teriflunomide reduces the number of white blood cells in the blood and can therefore affect your ability to fight infections. If you suspect you have an infection, your doctor may perform blood tests to check your white blood cells. Infections from herpes viruses, including oral herpes or shingles (herpes zoster) may occur during treatment with teriflunomide. In some cases, serious complications have occurred. Tell your doctor immediately if you suspect you have any symptoms of herpes virus infection. See section 4;
• if you develop severe skin reactions;
• if you experience respiratory symptoms;
• if you feel weakness, numbness and pain in your hands and feet;
• if you are going to have a vaccination;
• if you are taking leflunomide with teriflunomide;
• if you are starting or stopping treatment with teriflunomide;
• if you are going to have a specific blood test (in which the level of calcium is measured). Falsely low calcium levels may be found.

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 who care for them:

• 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 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 (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 the management of severe diarrhea;
• 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 to reduce stomach acid;
• zidovudine for HIV infection;
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol);
• 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
Do nottake Teriflunomide Teva Italia if you are pregnant or suspect you may be pregnant. If you are pregnant or become
pregnant during treatment with Teriflunomide Teva Italia, the risk of your baby having
birth defects increases. Women of childbearing potential must not take this medicine without
using reliable contraceptive methods.
If your daughter has her first menstrual period during treatment with Teriflunomide Teva Italia, inform your doctor, who
will provide specialist advice on contraception and potential risks in case of
pregnancy.
Tell your doctor if you are planning to become pregnant after stopping treatment with
Teriflunomide Teva Italia. You must first make sure that most of this medicine has been eliminated from your body.
Natural elimination of the active ingredient can take up to 2 years. This period can be reduced to a few weeks by taking
some medicines that accelerate the elimination of teriflunomide from the body.
In any case, it is necessary to confirm with a blood test that the active ingredient has been eliminated
from the body in a sufficient amount and you must await confirmation from your doctor that the level of
teriflunomide 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 during treatment with Teriflunomide Teva Italia or within two years
after stopping treatment, you should stop therapy with Teriflunomide Teva Italia and
contact your doctor immediatelyto undergo a pregnancy test.
If the test confirms the pregnancy, your doctor may suggest treatment with some medicines to
quickly and sufficiently eliminate teriflunomide from the body, as this can reduce the
risk to the fetus.
Contraception
It is necessary to 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 to
use effective contraceptive methods after stopping treatment.

• Continue to do so until the levels of teriflunomide in the blood are sufficiently low. These will be checked by your doctor.
• Ask your doctor about the most suitable method of contraception for you and if necessary, a change of 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 can cause a feeling of dizziness that can impair your ability to
concentrate and react. If you experience this symptom, do not drive vehicles and do not use machines.

Teriflunomide Teva Italia contains lactose
Teriflunomide Teva Italia contains lactose (a type of sugar). If your doctor has diagnosed
a lactose intolerance, 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 doctor experienced in the treatment
of multiple sclerosis.
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor.

Adults
The recommended dose is one 14 mg tablet once a day.

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

• Children with a body weight over 40 kg: one 14 mg tablet per day.
• Children with a body weight equal to or less than 40 kg: one 7 mg tablet per day. For these patients, other medicines containing teriflunomide are available at a lower dosage (such as 7 mg tablets). Children and adolescents who reach a stable body weight over 40 kg will be instructed by the doctor to switch to one 14 mg tablet per day.

Route of administration/method of administration
Teriflunomide Teva Italia is for oral use. Teriflunomide Teva Italia is taken every day in a
single daily dose at any time of the day. You must swallow the tablet whole with
a little water.
Teriflunomide Teva Italia can 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, call your doctor immediately. You may experience
undesirable 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 a 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 further questions on 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 serious or become serious. If you experience any of these effects,

tell 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, blistering, fever or ulcers in the mouth
• Serious infections or sepsis (a type of infection with potentially 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 (the frequency cannot be estimated from the available data):

• Severe liver disease which may include symptoms of yellowing of the skin or the white 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 (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 difficulty 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 values: decreases in the number of 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 anxious
• Tingling, feeling of weakness, numbness, pins and needles or pain in the lower back or leg (sciatica); feeling of numbness, burning, pins and needles or pain in the hands and fingers (carpal tunnel syndrome)
• Awareness of heartbeat
• Increased blood pressure
• Vomiting, toothache, upper abdominal pain
• Skin rash, acne
• Pain in tendons, joints, bones, muscle pain (musculoskeletal pain)
• Need 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 at the skin level; throbbing or shooting pain along
• one or more nerves, problems with the nerves of 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)

• Inflammation or damage to the liver

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

• Pulmonary hypertension

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

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 which is stated on the package and on the pouch after
the wording “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 waste water 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 Teriflunomide Teva Italia contains
The active ingredient is teriflunomide.
Each film-coated tablet contains 14 mg of teriflunomide.
The other ingredients are:
tablet core: lactose monohydrate, corn starch, microcrystalline cellulose,
hydroxypropylcellulose, sodium starch glycolate (type A), anhydrous colloidal silica, magnesium stearate
tablet coating:
Hypromellose, titanium dioxide (E171), Indigotine 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 contents of the pack
Film-coated tablets of blue colour, round, biconvex, with imprinted “14” on one side.
Teriflunomide Teva Italia is available in packs containing
OPA/Al/PVC//Al blisters inserted in wallets (of 14 or 28 film-coated tablets) and packaged
in a carton containing 14 (1 wallet of 14), 28 (1 wallet of 28), 84 (3 wallets of 28) and
98 (7 wallets of 14) film-coated tablets.
OPA/Al/PVC//Al blisters packaged in a carton containing 14, 28, 84 and 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 Milan, Italy

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