Patient Information Leaflet

TeriflunomidaKern Pharma 14 mg Film-Coated Tablets

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contentsoftheleaflet

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

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

PurposeTeriflunomidaKernPharma

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

Whatismultiplesclerosis

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

People who suffer from the relapsing form of multiple sclerosis will have repeated (recurrent) attacks of physical symptoms caused by the improper functioning of the nerves. These symptoms vary from patient to patient, but usually include:

• difficulty walking
• vision problems
• balance problems

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

HowTeriflunomidaKernPharmaworks

Teriflunomida helps to protect against attacks in 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.

Do not take Teriflunomida Kern Pharma:

• if you are allergic to teriflunomida or any of the other components of this medication (listed in section 6),
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after taking teriflunomida or leflunomida,
• if you have severe liver problems,
• if you are pregnant, think you may be pregnant, or are breastfeeding,
• if you have a severe immunological disorder, for example, acquired immunodeficiency syndrome (AIDS),
• if you have severe bone marrow problems or if you have a low number of white blood cells, red blood cells, or platelets in your blood, or a reduced number of platelets,
• if you have a severe infection,
• if you have severe kidney problems that require dialysis,
• if you have a low level of proteins in your 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 teriflunomida 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 treatment and during treatment. If the test results indicate a liver problem, your doctor may interrupt treatment with teriflunomida. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated to control it. Teriflunomida 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, your doctor will ensure that you have enough white blood cells and platelets in your blood. Since teriflunomida reduces the number of white blood cells in your blood, this may affect your ability to fight off the infection. Your doctor may perform blood tests to check your white blood cells if they suspect you have an infection. With teriflunomida treatment, you may experience viral infections, including oral herpes or shingles (herpes zoster). In some cases, serious complications have occurred. Inform your doctor immediately if you suspect you have any symptoms of a viral herpes 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 planning to be vaccinated.
• you are taking leflunomida with teriflunomida.
• you are switching from or to teriflunomida.
• you are scheduled to have a specific blood test (calcium level). A false decrease in calcium levels may be detected.

Respiratory reactions

Inform your doctor if you have cough and shortness of breath without explanation. Your doctor may perform additional tests.

Children and adolescents

Teriflunomida is not indicated for use in children under 10 years of age, as it has not been studied in patients with EM in this age group.

The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:

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

Other medications and Teriflunomida Kern Pharma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications.

Especially, inform your doctor or pharmacist if you are taking any of the following medications:

• leflunomida, methotrexate, and other medications that affect the immune system (often referred to as immunodepressants or immunomodulators)
• rifampicin (a medication used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin for epilepsy
• hypericum (a plant-based medication 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
• aloestron 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 itching in liver disease
• activated charcoal to reduce the absorption of medications or other substances

Pregnancy and breastfeeding

Do nottake teriflunomida if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking teriflunomida, you will have an increased risk of having a baby with birth defects.

Women of childbearing age should not take this medication unless they are using reliable contraceptive methods.

If your daughter starts menstruating while taking teriflunomida, she should inform her 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 teriflunomida, as you need to ensure that most of this medication has been eliminated from your body before trying to become pregnant. The elimination of the active ingredient naturally may take up to 2 years. This time period can be reduced to a few weeks by taking certain medications to accelerate the elimination of teriflunomida from your body.

In any case, you need your doctor to confirm, from a blood test, that the level of active ingredient 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 or in the two years following treatment, you should stop teriflunomida and contact your doctor immediatelyto perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest a treatment with certain medications to eliminate teriflunomida 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 teriflunomida. Follow the instructions below:

• Continue to do so until the levels of teriflunomida in your blood are low enough (your doctor will check).
• Consult your doctor about the best contraceptive method for you and, if necessary, change your method.

Do not take teriflunomida during breastfeeding as teriflunomida passes into breast milk.

Driving and operating machinery

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

Teriflunomida Kern Pharma contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

A healthcare professional with experience in treating multiple sclerosis will oversee treatment with teriflunomida.

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

Adults

The recommended dose is one 14 mg tablet per day.

Childrenandadolescents(10yearsofageandabove)

The dose depends on body weight:

• Children with a body weight greater than 40 kg: 14 mg once a day.
• Children with a body weight less than or equal to 40 kg: 7 mg once a day. (Teriflunomida Kern Pharma is only available in 14 mg film-coated tablets, therefore, the doctor will refer this category of patients to a different medication containing teriflunomida).

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

Form/via of administration

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

The tablet should be swallowed whole with water. This medication can be taken with or without food.

If you take moreTeriflunomidaKernPharma than you should

If you have taken too much teriflunomida, call 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 immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeTeriflunomidaKernPharma

Do not take a double dose to compensate for the missed doses. Take your next dose at your usual time.

If you interrupt the treatment withTeriflunomidaKernPharma

Do not interrupt treatment or change the dose of teriflunomida without consulting your doctor first. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

The following side effects may occur with this medicine.

Severe side effects

Some side effects can be severe, if you experience any of these, inform your doctor immediately.Inform your doctor immediately.

Frequent(may affect up to 1 in 10 people)

• Pancreatitis, which may include symptoms of abdominal pain, nausea, or vomiting (frequent in pediatric patients and rare in adult patients)
• Herpes virus infections, including oral herpes and shingles (zoster) 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.

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions that may include symptoms of rash, hives, swelling of 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
• Severe infections or sepsis (a type of infection that can be potentially fatal) that may include symptoms such as high fever, chills, decreased urine flow, or confusion
• Pneumonia that may include symptoms such as shortness of breath or persistent cough

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

• Severe liver disease that may include symptoms such as yellowing of the skin or eyes, darker urine, nausea, and vomiting without explanation, or abdominal pain

Other side effectsmay occur with the following frequencies:

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

• Headache
• Diarrhea, nausea
• Increased ALT (increased liver enzymes in the blood) in tests
• Thinning of hair

Frequent(may affect up to 1 in 10 people)

• Common cold, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat, and difficulty swallowing, cystitis, viral gastroenteritis, dental infection, laryngitis, fungal infection of the foot
• Laboratory values: a decrease in the number of red blood cells (anemia), changes in the liver and white blood cells in tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Anxiety
• Needle-like sensations, weakness, 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
• Nausea, vomiting, dental pain, upper abdominal pain
• Rash, acne
• Tendon, joint, or bone pain (musculoskeletal pain)
• Increased frequency of urination
• Heavy 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)
• Changes in nails, severe skin reactions
• Post-traumatic pain
• Poriasis
• Inflammation of the mouth/lips
• Abnormal lipid levels in the blood
• Colitis (inflammation of the colon)

Rare(may affect up to 1 in 1,000 patients)

• Liver inflammation or damage

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

• Pulmonary hypertension

Children (10 years of age and older) and adolescents

The previously listed side effects 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 that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of Teriflunomida Kern Pharma

• The active ingredient is teriflunomida. Each film-coated tablet contains 14 mg of teriflunomida.

•      The other components are:

Tablet core: lactose monohydrate, cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (from potato), hydroxypropylcellulose, magnesium stearate, sodium hydroxide, anhydrous colloidal silica.

Tablet coating: hypromellose, titanium dioxide (E-171), triacetin, indigo carmine (E-132), and talc.

Appearance of the product and contents of the packaging

The film-coated tablets, with a light blue or pale blue color, have a pentagonal shape, are biconvex, and are engraved with "14" on one side and are flat on the other side. Tablet dimensions: 7.4 mm.

The film-coated tablets are available in single-dose PVC/PCTFE/aluminum or aluminum/aluminum blisters in carton boxes containing 28 tablets.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona
Spain

Responsible for manufacturing:

Pharmacare Premium Ltd.

HHF003 Hal Far Industrial Estate,

Hal Far Birzebbugia, BBG3000,

Malta

or

Genepharm S.A.

18th km Marathonos Ave,

Pallini Attiki, 15351,

Greece

Last review date of this leaflet: September 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.