Teriflunomide Accord 14 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Leaflet: Information for the patient

Teriflunomide Accord 14 mg film-coated tablets

teriflunomide

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Teriflunomide Accord is

Teriflunomide Accord contains the active substance teriflunomide, which is an immunomodulatory agent that modulates the immune system to limit its attack on the central nervous system.

What Teriflunomide Accord is used for

Teriflunomide 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 affecting the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (myelin) surrounding the nerves of the CNS. This loss of myelin is called demyelination. This causes the nerves to malfunction.

People with relapsing forms of multiple sclerosis experience repeated episodes (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient but typically include:

• difficulty walking
• vision problems
• balance problems.

Symptoms may completely disappear after a relapse, but over time, some problems may persist. This can lead to physical disabilities that may interfere with daily activities.

How Teriflunomide Accord works

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

2. What you need to know before taking Teriflunomida Accord

Do not take Teriflunomida Accord:

• 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, skin peeling, blisters and/or mouth ulcers after taking teriflunomide or leflunomide,
• if you have severe liver problems,
• if you are pregnant, think you may be pregnant or are breastfeeding,
• if you have a serious disorder affecting the immune system, for example, acquired immunodeficiency syndrome (AIDS),
• if you have serious bone marrow problems or 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 requiring dialysis,
• if you have very low levels of protein in the blood (hypoproteinemia).

If in doubt, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• you have liver problems and/or drink large amounts of alcohol. Your doctor may carry out blood tests to check how your liver is working before and during treatment. If test results indicate a problem with your liver, 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 monitor 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 ensure you have sufficient white blood cells and platelets in your blood. Since Teriflunomida Accord reduces 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 cell count if they suspect you have an infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, and pain in your hands and feet.
• you are due to be vaccinated.
• you are taking leflunomide with Teriflunomida Accord.
• you are switching medication to or from Teriflunomida Accord.
• you are scheduled for a specific blood test (calcium level). A falsely low calcium level may be detected.

Respiratory reactions

Tell your doctor if you develop unexplained cough or dyspnoea (shortness of breath). Your doctor may carry out 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 (inflammation of the pancreas) has been observed in patients receiving teriflunomide. Your child’s doctor may perform blood tests if pancreatitis is suspected.

Other medicines and Teriflunomida Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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:

• 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 severe diarrhoea
• theophylline for asthma
• tizanidine, a muscle relaxant
• warfarin, an anticoagulant to thin the blood and prevent clots
• oral contraceptives (ethinylestradiol, levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine to reduce gastric acid
• zidovudine for AIDS
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolaemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• colestyramine for high cholesterol or relief of itching in liver disease
• activated charcoal to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding

Do not take Teriflunomida Accord if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking Teriflunomida Accord, there is an increased risk of having a baby with birth defects. Women of childbearing potential must not take this medicine unless they are using reliable contraceptive methods.

If your daughter starts menstruating while taking Teriflunomida Accord, you must inform the doctor, who will provide specialist advice on contraception 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 must ensure that most of the medicine has been eliminated from your body before trying to conceive. 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 teriflunomide from the body.

In any case, your doctor must confirm, through a blood test, that the level of active substance in the blood is low enough to allow pregnancy.

For further information on laboratory tests, please contact your doctor.

If you suspect you are pregnant while taking Teriflunomida Accord or within two years after stopping treatment, you must stop taking Teriflunomida Accord and contact your doctor immediately for a pregnancy test. If the test confirms pregnancy, your doctor may recommend treatment with certain medicines to rapidly and sufficiently eliminate teriflunomide from your body, as this may reduce the risk to your baby.

Contraception

You must use an effective method of contraception during and after treatment with Teriflunomida Accord. Teriflunomide remains in the blood for a long time after stopping treatment. Continue using contraception after stopping treatment.

• Continue until teriflunomide blood levels are sufficiently low (your doctor will check this).
• Consult your doctor about the best contraceptive method for you and if you need to change methods.

Do not take Teriflunomida Accord during breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines

Teriflunomida Accord may cause dizziness, which can affect concentration and reaction ability. If affected, do not drive or operate machinery.

Teriflunomida Accord contains lactose

Teriflunomida Accord contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Teriflunomida Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Teriflunomide Accord

Treatment with Teriflunomide Accord will be supervised by a doctor experienced in the management of multiple sclerosis.

Follow exactly the instructions for administration of this medicine given by your doctor. If in 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 body weight greater than 40 kg: 14 mg once daily.
• children with body weight less than or equal to 40 kg: 7 mg once daily.

This brand does not have 7 mg tablets; therefore, in such cases, another teriflunomide-containing medicine should be used.

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

Method/route of administration

Teriflunomide Accord is administered orally. Teriflunomide Accord is taken daily as a single daily dose at any time of day.

The tablet should be swallowed whole with water.

Teriflunomide Accord may be taken with or without food.

If you take more Teriflunomide Accord than you should

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

If you forget to take Teriflunomide Accord

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

If you stop taking Teriflunomide Accord

Do not interrupt treatment or change the dose of Teriflunomide Accord without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects may occur with this medicine.

Serious adverse effects

Some adverse effects may be serious or may become serious. If you experience any of these, inform your doctor immediately.

Frequent (may affect up to 1 in 10 people)

• inflammation of the pancreas which may include symptoms of abdominal pain, nausea or vomiting (frequent in pediatric patients and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 people)

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

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

• serious liver disease which may 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 adverse effects may occur with the following frequencies:

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

• Headache
• Diarrhea, feeling unwell
• Increased ALT (elevation of certain liver enzymes in blood tests)
• Thinner hair

Frequent (may affect up to 1 in 10 people)

• Flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and difficulty swallowing, cystitis, viral gastroenteritis, oral herpes, dental infection, laryngitis, fungal infection of the foot
• Laboratory findings: a decrease in red blood cell count (anemia), changes in liver function and white blood cells in blood tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling of anxiety
• Muscle soreness, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica); sensation of numbness, burning, tingling or pain in hands and fingers (carpal tunnel syndrome)
• Palpitations
• Increased blood pressure
• Feeling unwell (vomiting), toothache, upper abdominal pain
• Rash, acne
• Pain in tendons, joints, bones, muscle pain (musculoskeletal pain)
• Need to urinate more often than normal
• Heavy menstrual periods
• Pain
• Lack of energy or weakness (asthenia)
• Weight loss

Uncommon (may affect up to 1 in 100 people)

• Decrease in platelet count (mild thrombocytopenia)
• Increased sensitivity, especially in the skin; stabbing or pulsating pain in one or more nerves; nerve problems in arms and legs (peripheral neuropathy)
• Nail disorders, severe skin reactions
• Post-traumatic pain
• Psoriasis
• Inflammation of 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 adverse effects listed above also apply to children and adolescents. The following additional information is important for children, adolescents and their caregivers:

Frequent (may affect up to 1 in 10 people)

• Inflammation of the pancreas

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomide 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 "CAD" and "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Teriflunomide Accord

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

Appearance of the product and contents of the pack

Teriflunomide Accord 14 mg film-coated tablets are pentagonal, film-coated, blue tablets, marked with "T2" on one side; the other side is smooth.

Teriflunomide Accord is available in cardboard boxes containing:

• 28 and 84 tablets in aluminium/aluminium blisters;
• 28x1 and 84x1 tablets in single-dose perforated aluminium/aluminium blister packs.

Only certain pack sizes may be marketed.

Marketing Authorisation 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, The Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Date of the most recent revision of this package leaflet:

Detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.