Teriflunomide Krka 14 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Teriflunomide Krka 14 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult 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, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

What Teriflunomide Krka is used for

Teriflunomide is used in adults and in children and adolescents (10 years of age and older) 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 the relapsing form 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 Krka works

Teriflunomide 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 Teriflunomide Krka

Do not take Teriflunomide Krka:

• if you are allergic to teriflunomide 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 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 condition affecting the immune system, for example, acquired immunodeficiency syndrome (HIV infection),
• if you have serious bone marrow problems or have low levels of white blood cells or red blood cells in your 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 your 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 teriflunomide if:

• you have liver problems and/or drink large amounts of alcohol. Your doctor may carry out blood tests to check how well your liver is working before and during treatment. If test results indicate a problem with your liver, your doctor may stop treatment with teriflunomide. See section 4.

• you have high blood pressure (hypertension), whether or not you are being treated for it. Teriflunomide 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 teriflunomide, your doctor will make sure you have enough white blood cells and platelets in your blood. Since this medicine 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. Infections caused by herpes viruses, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications have occurred. You must inform your doctor immediately if you suspect you have any symptoms of a herpes virus 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 teriflunomide.

• you are switching medication to or from teriflunomide.

• 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 have unexplained cough or dyspnea (shortness of breath). Your doctor may carry out additional tests.

Children and adolescents

Teriflunomide 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 Teriflunomide Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This includes medicines you buy 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 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
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine to reduce gastric acid
• zidovudine for AIDS
• 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 absorption of medicines or other substances

Pregnancy and breastfeeding

Do not take teriflunomide if you are pregnant or think you might be pregnant. If you are pregnant or become pregnant while taking this medicine, 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 menstruation while taking teriflunomide, you must inform the doctor, who will provide specialized advice on contraceptive methods and the potential risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after stopping treatment with this medicine, as you must first ensure that most of this medicine has been eliminated from your body before attempting to become pregnant. 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, you need your doctor to confirm, based on a blood test, that the level of active substance in the blood is low enough to allow pregnancy.

For more information about laboratory tests, contact your doctor.

If you suspect you are pregnant while taking teriflunomide or within two years after stopping treatment, you must stop teriflunomide 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 this medicine. Teriflunomide remains in the blood for a long period after you stop taking it. Continue using contraceptive measures after stopping treatment.

• Continue until teriflunomide levels in the blood 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 teriflunomide during breastfeeding, as teriflunomide passes into breast milk.

Driving and use of machines

Teriflunomide may cause dizziness, which may affect your ability to concentrate and react. If affected, do not drive or operate machinery.

Teriflunomide Krka contains lactose and sodium

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

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

3. How to take Teriflunomida Krka

Treatment with teriflunomide will be supervised by a physician experienced in the management of multiple sclerosis.

Always follow exactly the instructions for use of this medicine as provided by your doctor. If in doubt, consult your doctor again.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (10 years of age and above)

The dose depends on body weight:

• children with body weight greater than 40 kg: one 14 mg tablet once daily.
• children with body weight less than or equal to 40 kg: one 7 mg tablet once daily.

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.

Teriflunomida Krka is not available in 7 mg strength. For this dose, you will need to take other medicinal products containing teriflunomide that are available on the market. Please consult your doctor or pharmacist.

Method/route of administration

Teriflunomide is administered orally. This medicine is taken every day as a single daily dose at any time of day. The tablet should be swallowed whole with water.

Teriflunomide may be taken with or without food.

If you take more Teriflunomida Krka than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Teriflunomida Krka

Do not take a double dose to make up for missed doses. Take your next dose at the scheduled time.

If you stop taking Teriflunomida Krka

Do not interrupt treatment or change the dose of Teriflunomida Krka 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, contact your doctor immediately.

Frequent (may affect up to 1 in 10 people)

• Inflammation of the pancreas, which may include symptoms such as 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 that could include symptoms such as rash, hives, swelling of the lips, tongue, or face, or sudden difficulty breathing
• Severe skin reactions that could include symptoms such as skin rash, blisters, fever, or mouth ulcers
• Serious infections or sepsis (a type of infection that may be potentially life-threatening), which could include symptoms such as high fever, trembling, chills, reduced urine output, 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 available data)

• Severe liver disease, which may include symptoms such as yellowing of the skin or whites of the eyes, unusually dark 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 (elevated levels 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, 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 on the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness
• Laboratory findings: decreased red blood cell count (anemia), changes in liver function and white blood cells in blood tests (see section 2), and elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling anxious
• Muscle pain, feeling weak, numbness, tingling, or pain in the lower back or leg (sciatica); 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
• Tendon, joint, or bone pain, 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)

• Decreased 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 available data)

• Pulmonary hypertension

Children (aged 10 years and older) 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, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomide Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and the pack after "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. Dispose of unused medicines and their containers at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need at the SIGRE point in your pharmacy. This will help protect the environment.

6. Contents of the pack and other information

Composition of Teriflunomide Krka

• The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.
• The other components (excipients) are:

Core: lactose monohydrate, corn starch, hydroxypropylcellulose (E463), microcrystalline cellulose (E460), sodium carboxymethylstarch (potato type A), magnesium stearate (E470b) and colloidal anhydrous silica.

Film coating: hypromellose, titanium dioxide (E171), macrogol and indigo carmine aluminium lake (E132) in the coating.

See section 2 “Teriflunomide Krka contains lactose and sodium”.

Appearance of the product and contents of the pack

The film-coated tablets (tablets) are blue, round, biconvex, film-coated tablets engraved with "14" on one side.

Tablet diameter: approximately 7 mm.

Teriflunomide Krka 14 mg film-coated tablets are available in packs containing:

• 14, 28, 30, 84, 90 and 98 film-coated tablets in blisters.
• 14, 28, 84 and 98 film-coated tablets in calendarized blisters.
• 14 x 1 and 28 x 1 film-coated tablets in perforated unit dose blisters.
• 14 x 1 and 28 x 1 film-coated tablets in perforated unit dose calendarized blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto

Slovenia

or

KRKA-FARMA d.o.o.

Holjevca 20/E,

10450 Jastrebarsko,

Croatia

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura, 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last revision of this leaflet: November 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)