TERIFLUNOMIDE KERN PHARMA 14 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Terpharma 14 mg film-coated tabletsEFG

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.

Contentsofthepackageleaflet

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

1. What is Teriflunomida Kern Pharma and what is it used for

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

PeriflunomidaKharma

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

WhatisMultipleSclerosis

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 improper functioning 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.

CeriflunomidaKharma

Teriflunomida 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 Teriflunomida Kern Pharma

Do not take Teriflunomida Kern Pharma:

• if you are allergic to teriflunomida or any of the other ingredients 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 serious problem that affects your immune system, for example, acquired immune deficiency syndrome (AIDS),
• if you have serious bone marrow problems or have a low number 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 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 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 for 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 make sure you have enough white blood cells and platelets in your blood. Since teriflunomida decreases the number of white blood cells in your blood, this 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 teriflunomida treatment, viral infections, including oral or genital herpes, may occur. In some cases, serious complications have occurred. You should immediately inform your doctor if you suspect you have any symptoms of 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 leflunomida with teriflunomida.
• you are being switched 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

Tell your doctor if you have unexplained cough and shortness of breath. 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 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 medications and Teriflunomida Kern Pharma

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:

• 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
• 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 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 increase the risk of having a baby with birth defects.

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 teriflunomida, 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 teriflunomida, as you need to make sure that most of this 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 teriflunomida 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 teriflunomida or in the 2 years following the end of treatment, you should stop taking teriflunomida and contact your doctor immediatelyto have a pregnancy test. If the test confirms pregnancy, your doctor may suggest 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. 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).
• Consult your doctor about the best contraceptive method for you and in case you need to change methods.

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

Driving and using machines

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

Teriflunomida Kern Pharma contains lactose and sodium

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 Teriflunomida Kern Pharma

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

Follow the instructions for administration of this medication 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.

Childrenandadolescents(10yearsofageandolder)

The dose depends on body weight:

• children with a body weight over 40 kg: 14 mg once daily.
• children with a body weight of 40 kg or less: 7 mg once daily. (Teriflunomida Kern Pharma is only available in 14 mg film-coated tablets, so the doctor will switch these patients to a different medication that contains teriflunomida).

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

Form/Route of administration

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

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

WhattodoifyoutakemoreTeriflunomidaKernPharmathanyoushould

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

WhattodoifyouforgettotakeTeriflunomidaKernPharma

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

WhattodoifyouwanttostoptakingTeriflunomidaKernPharma

Do not stop 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.

4. Possible side effects

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

The following side effects may occur with this medication.

Serious side effects

Some side effects can be serious, and if you experience any of them, 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)
• herpes virus 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.

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 mouth ulcers
• serious or life-threatening infections that could include symptoms such as high fever, chills, 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
• increased ALT (increase in certain liver enzymes in the blood) in blood tests
• thinning 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, 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, 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)

• liver inflammation or damage

Frequency not known(frequency cannot be estimated from the 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:

Common(may affect up to 1 in 10 people)

• pancreatitis

Adverse Reaction Reporting

If you experience adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

5. Storage of Teriflunomida Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the box and blister pack after "EXP". The expiration date is the last day of the indicated month.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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, corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A) (potato), hydroxypropyl cellulose, magnesium stearate, sodium hydroxide, anhydrous colloidal silica.

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

Appearance of the Product and Package Contents

The film-coated tablets are light blue or pastel blue in color, pentagonal in shape, biconvex, engraved with "14" on one side and 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 cardboard boxes containing 28 tablets.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona, Spain

Manufacturer:

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

Date of the Last Revision of this Leaflet: September 2024

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