TERIFLUNOMIDE ACCORD 14 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Teriflunomida Accord 14 mg Film-Coated Tablets

teriflunomida

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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 pack

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

1. What is Teriflunomida Accord and what is it used for

What is Teriflunomida Accord

Teriflunomida Accord contains the active substance teriflunomida, which is an immunomodulatory agent that adjusts the immune system to limit its attack on the nervous system.

What is Teriflunomida Accord used for

Teriflunomida Accord is used in adults and in children and adolescents (from 10 years of age) to treat relapsing-remitting multiple sclerosis (MS).

What is multiple sclerosis

MS is a long-term disease that affects the central nervous system (CNS). The CNS is made up of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This makes the nerves stop working properly.

People with the relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by the malfunctioning of the nerves. These symptoms vary from person to person but usually include:

• difficulty walking
• vision problems
• balance problems.

The symptoms can disappear completely after a relapse, but over time, some problems may remain. This can cause physical disabilities that can interfere with daily activities.

How Teriflunomida Accord works

Teriflunomida Accord helps protect against attacks on the central nervous system by the immune system, limiting the growth of some white blood cells (lymphocytes). This limits the inflammation that causes nerve damage in MS.

2. What you need to know before you take Teriflunomida Accord

Do not take Teriflunomida Accord:

• if you are allergic to teriflunomida or 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, blisters and/or ulcers in the mouth after taking teriflunomida or leflunomida,
• if you have severe liver problems,
• if you are pregnant, think you may be pregnant or are breast-feeding,
• if you have a serious immune system problem, for example, acquired immune deficiency syndrome (AIDS),
• if you have serious bone marrow problems or if you have a low number of white blood cells or red blood cells in the blood or a reduced number of platelets,
• if you have a serious infection,
• if you have severe kidney problems that require dialysis,
• if you have a low level of proteins in the blood (hypoproteinemia),

In case of doubt, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Teriflunomida Accord if:

• you have liver problems and/or if you drink large amounts of alcohol. Your doctor may perform blood tests to check your liver function before and during treatment. If the test results indicate a liver problem, your doctor may stop treatment with Teriflunomida Accord. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated for it.
• Teriflunomida Accord may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before you start taking Teriflunomida Accord, your doctor will make sure you have enough white blood cells and platelets in your blood. Since Teriflunomida Accord decreases the number of white blood cells in the blood, this may affect your ability to fight infection. Your doctor may perform blood tests to check your white blood cells if they think you have an infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, and pain in hands and feet.
• you are going to be vaccinated.
• you are taking leflunomida with Teriflunomida Accord.
• you are being switched from or to Teriflunomida Accord.
• a specific blood test (calcium level) is scheduled. A false decrease in calcium levels may be detected.

Respiratory reactions

Tell your doctor if you have unexplained cough and shortness of breath. Your doctor may perform additional tests.

Children and adolescents

Teriflunomida Accord is not indicated for use 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 their caregivers:

• pancreatitis has been observed in patients receiving teriflunomida. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other medicines and Teriflunomida Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• leflunomida, methotrexate, and other medicines that affect the immune system (often referred to as 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 diabetic nephropathy
• alosetron for severe diarrhea
• theophylline for asthma
• tizanidine, a muscle relaxant
• warfarin, an anticoagulant to thin the blood (make it more fluid) and prevent clots
• oral contraceptives (ethinylestradiol, levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indomethacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine to reduce stomach acid
• zidovudine for AIDS
• rosuvastatin, simvastatin, atorvastatin, pravastatin for 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 breast-feeding

Do nottake Teriflunomida Accord if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking Teriflunomida Accord, you will increase the risk of having a baby with birth defects. Women of childbearing age must not take this medicine if they are not using reliable contraceptive methods.

If your daughter has her first period while taking Teriflunomida Accord, she must tell her doctor, who will give her specialized advice on contraceptive methods and the potential risks in case of pregnancy.

Tell your doctor if you plan to become pregnant after stopping treatment with Teriflunomida Accord, as you need to make sure that most of this medicine has been eliminated from your body before trying to become pregnant. The natural elimination of the active substance may take up to 2 years. This period can be reduced to a few weeks by taking certain medicines to accelerate the elimination of teriflunomida from the body.

In any case, you need your doctor to confirm, based on a blood test, that the level of active substance in your blood is low enough for you to become pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect you are pregnant while taking Teriflunomida Accord or in the 2 years following the end of treatment, you must stop taking Teriflunomida Accord and contact your doctor immediatelyto have a pregnancy test. If the test confirms pregnancy, your doctor may suggest treatment with certain medicines to eliminate teriflunomida from your body quickly enough, as this may reduce the risk to your baby.

Contraception

You must use an effective contraceptive method during and after treatment with Teriflunomida Accord. Teriflunomida remains in the blood for a long time after stopping it. Continue to take contraceptive measures after stopping treatment.

• Do so until the levels of teriflunomida in your blood are low enough (your doctor will check this).
• Ask your doctor about the best contraceptive method for you and in case you need to change methods.

Do not take Teriflunomida Accord during breast-feeding, as teriflunomida passes into breast milk.

Driving and using machines

Teriflunomida Accord may cause dizziness, which may affect your ability to concentrate and react. If you are affected, do not drive or use machines.

Teriflunomida Accord contains lactose

Teriflunomida Accord contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Teriflunomida Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Teriflunomida Accord

A doctor with experience in the treatment of multiple sclerosis will supervise treatment with Teriflunomida Accord.

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor again.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (from 10 years of age)

The dose depends on body weight:

• children with a body weight over 40 kg: 14 mg once a day.
• children with a body weight of 40 kg or less: 7 mg once a day.

This brand does not have 7 mg tablets, so in this case, another teriflunomida medicine should be used.

Your doctor will tell children and adolescents who reach a stable body weight over 40 kg to switch to a 14 mg tablet per day.

Form/Route of Administration

Teriflunomida Accord is administered orally. Teriflunomida Accord is taken once a day in a single daily dose at any time of day.

The tablet should be swallowed whole with water.

Teriflunomida Accord can be taken with or without food.

If you take more Teriflunomida Accord than you should

If you have taken too much Teriflunomida Accord, call your doctor immediately. You may experience side effects similar to those described in section 4 (below).

If you forget to take Teriflunomida Accord

Do not take a double dose to make up for forgotten doses.

If you stop taking Teriflunomida Accord

Do not stop treatment or change the dose of Teriflunomida Accord without consulting your doctor first.

If you have any other 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 can occur with this medicine.

Serious side effects

Some side effects can be serious, if you experience any of these, tell your doctor immediately.

Common(may affect up to 1 in 10 people)

• pancreatitis that can include symptoms of abdominal pain, nausea, or vomiting (common in pediatric patients and uncommon in adult patients).

Uncommon(may affect up to 1 in 100 people)

• allergic reactions that could include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing
• severe skin reactions that could include symptoms of skin rash, blisters, fever, or ulcers in the mouth
• severe infections or sepsis (a type of infection that can be life-threatening) that could include symptoms such as high fever, chills, shaking, decreased urine flow, or confusion
• inflammation of the lungs that could include symptoms such as shortness of breath or persistent cough

Frequency not known(frequency cannot be estimated from the available data)

• severe liver disease that can 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 effectsmay occur with the following frequencies:

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

• headache
• diarrhea, feeling sick
• increase in ALT (increase in certain liver enzymes in the blood) in blood tests
• thinning of hair

Common(may affect up to 1 in 10 people)

• flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, oral herpes, dental infection, laryngitis, fungal infection of the foot
• laboratory values: a decrease in the number of red blood cells (anemia), changes in liver and white blood cells in blood tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• mild allergic reactions
• feeling anxious
• tingling, feeling weak, numbness, tingling, or pain in the lower back or leg (sciatica); feeling numb, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome)
• palpitations
• increase in blood pressure
• feeling sick (vomiting), toothache, pain in the upper abdominal region
• rash, acne
• pain in tendons, joints, bones, muscle pain (musculoskeletal pain)
• need to urinate more often than usual
• heavy periods
• pain
• lack of energy or weakness (asthenia)
• weight loss

Uncommon(may affect up to 1 in 100 people)

• decrease in the number of platelets (mild thrombocytopenia)
• increased sensitivity, especially in the skin; stabbing or pulsating pain in one or more nerves; problems in the nerves of arms and legs (peripheral neuropathy)
• changes in nails, 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 patients)

• inflammation or liver damage

Frequency not known(frequency cannot be estimated from the available data)

• pulmonary hypertension

Children (from 10 years of age) and adolescents

The side effects 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 side effects

If you experience side effects, talk to your doctor or pharmacist. This includes any possible 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. Storage of Teriflunomida Accord

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 carton after "EXP". The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Teriflunomida Accord

• The active ingredient is teriflunomide. Each tablet contains 14 mg of teriflunomida.
• The other components are lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol (E1521), and aluminum lake carmine indigo (E132).

Product Appearance and Packaging Contents

Teriflunomida Accord 14 mg film-coated tablets are pentagonal film-coated tablets, blue in color, engraved with "T2" on one side; the other side is smooth.

Teriflunomida Accord is available in cardboard boxes containing:

• 28 and 84 tablets in aluminum/aluminum blisters;
• 28x1 and 84x1 tablets in perforated unit-dose aluminum/aluminum blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

Accord Healthcare S.L.U.

World Trade Center,

Moll De Barcelona s/n,

Edifici Est, 6a Planta,

Barcelona, 08039

Spain

Manufacturer:

Accord Healthcare Polska Sp. z.o.o.

ul.Lutomierska 50,

95-200, Pabianice, Poland

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht, Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.