TERIFLUNOMIDE KRKA 14 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Teriflunomide Krka 14 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Teriflunomide Krka contains the active substance teriflunomide, which is an immunomodulatory agent that adjusts 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 that affects the central nervous system (CNS). The CNS consists 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 causes the nerves to stop functioning 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 may disappear completely after a relapse, but over time, some problems may persist. This can cause physical disabilities that can interfere with daily activities.

How Teriflunomide Krka works

Teriflunomide helps protect against attacks on the central nervous system by the immune system, limiting the growth of certain white blood cells (lymphocytes). This limits 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 medication (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 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 problem that affects your immune system, for example, acquired immune deficiency syndrome (AIDS),
• if you have serious bone marrow problems or 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 medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take teriflunomide 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 interrupt 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 check 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 medication decreases the number of white blood cells in the blood, it may affect your ability to fight infection. Your doctor may perform blood tests to check your white blood cells if they suspect you have an infection. With teriflunomide treatment, viral infections, including oral herpes or shingles (herpes zoster), may occur. In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect you have any symptoms of a viral 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 leflunomide with teriflunomide.
• you are being switched from or to teriflunomide.
• 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 cough and shortness of breath without explanation. Your doctor may perform 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 has been observed in patients receiving teriflunomide. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other medications and Teriflunomide Krka

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

This includes medications without a prescription.

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

• leflunomide, methotrexate, and other medications that affect the immune system (often referred to as immunosuppressants or immunomodulators)
• rifampicin (a medication 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
• 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 medications or other substances

Pregnancy and breastfeeding

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

If your daughter has her first menstrual period while taking teriflunomide, she should inform her doctor, who will provide specialized advice on contraceptive methods and potential risks in case of pregnancy.

Tell your doctor if you plan to become pregnant after stopping treatment with this medication, as you will need to make sure that most of the medication 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 medications 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 the 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 teriflunomide or in the 2 years following treatment, you should stop taking teriflunomide and contact your doctor immediatelyto perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest treatment with certain medications to eliminate teriflunomide from your body quickly, as this may reduce the risk to your baby.

Contraception

You should use an effective contraceptive method during and after treatment with this medication. Teriflunomide remains in the blood for a long time after stopping it. Continue to take contraceptive measures after stopping treatment.

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

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

Driving and using machines

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

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 medication.

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

3. How to take Teriflunomide Krka

A doctor with experience in treating multiple sclerosis will supervise treatment with teriflunomide.

Always follow the instructions for administration of this medication 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 (10 years of age and older)

The dose depends on body weight:

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

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

Teriflunomide Krka is not available in a 7 mg dose. For this dose, you will need to take other medications that contain teriflunomide and are available on the market. Consult your doctor or pharmacist.

Form/Route of Administration

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

Teriflunomide can be taken with or without food.

If you take more Teriflunomide Krka than you should

If you have taken too much teriflunomide, call your doctor immediately. You may experience side 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Teriflunomide Krka

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

If you stop taking Teriflunomide Krka

Do not stop treatment or change the dose of Teriflunomide Krka without consulting your doctor first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects may occur with this medication.

Serious side effects

Some side effects may be serious, and if you experience any of them, tell your doctor immediately.

Frequent(may affect up to 1 in 10 people)

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

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

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

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

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

Frequent(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, dental infection, laryngitis, fungal infection of the foot
• viral infections, including oral herpes and shingles (herpes zoster), 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 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
• increased 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 the arms and legs (peripheral neuropathy)
• changes in the 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 available data)

• pulmonary hypertension

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 their caregivers:

Frequent(may affect up to 1 in 10 people)

• pancreatitis

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Teriflunomida Krka

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, and the blister pack after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in a pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicine through the pharmacy's SIGRE point. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Teriflunomida Krka

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

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

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

See section 2 "Teriflunomida Krka contains lactose and sodium".

Appearance and Package Contents of the Product

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

Tablet diameter: approximately 7 mm

Teriflunomida Krka 14 mg film-coated tablets are available in boxes 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 calendarized unit-dose 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:November 2024

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