Teriflunomide Kern Pharma 14 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Teriflunomide Kern pharma 14 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 package leaflet

1. What Teriflunomida Kern Pharma is and what it is used for
2. What you need to know before starting to take 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 other information

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

Teriflunomida Kern Pharma 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 KernPharma 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 malfunction.

People with the relapsing form of multiple sclerosis will experience repeated attacks (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 Teriflunomida KernPharma works

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

2. What you need to know before starting to take Teriflunomida Kern Pharma

Do not take Teriflunomide Kern Pharma:

• 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 disorders or if you have low levels 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

Consult your doctor or pharmacist before starting to take teriflunomide if:

• you have liver problems and/or drink large amounts of alcohol. Your doctor may perform blood tests to check your liver function before and during treatment. If test results indicate a liver problem, your doctor may discontinue treatment with teriflunomide. See section 4.
• you have high blood pressure (hypertension), whether or not you are receiving treatment to control 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 starting teriflunomide, your doctor will ensure you have adequate levels of white blood cells and platelets in your blood. Since teriflunomide reduces the number of white blood cells, this may affect your ability to fight infections. Your doctor may perform blood tests to monitor your white blood cell count if an infection is suspected. Viral herpes infections, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications have occurred. Inform your doctor immediately if you suspect symptoms of a herpes virus infection. See section 4.
• you experience severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, or pain in your hands and feet.
• you are planning to receive a vaccination.
• you are taking leflunomide together with teriflunomide.
• you are switching from or to teriflunomide treatment.
• 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 unexplained cough and dyspnea (shortness of breath). 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:

• 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 Kern Pharma

Inform 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, inform 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 less thick) 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 the 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 teriflunomide, 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 teriflunomide, you must inform the doctor, who will provide specialized advice regarding contraception and the potential risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after stopping treatment with teriflunomide, as you must ensure that most of the medicine has been eliminated from your body before attempting pregnancy. Naturally eliminating the active substance 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 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 about laboratory testing, please contact your doctor.

If you suspect you are pregnant while taking teriflunomide or within two years after stopping treatment, you must immediately stop taking teriflunomide and contact your doctor immediately to perform a pregnancy test. If pregnancy is confirmed, your doctor may recommend treatment with certain medications to sufficiently and rapidly 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 teriflunomide. Teriflunomide remains in the blood for a long period after you stop taking it. Continue using contraceptive measures after stopping treatment.

• Continue doing so until teriflunomide blood levels are low enough (your doctor will verify this).
• Consult your doctor about the most suitable contraceptive method for you and if you need to change your method.

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

Driving and operating machinery

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

Teriflunomide Kern Pharma contains lactose and sodium

If your doctor has advised you that you have an intolerance to certain sugars, consult with him 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 Kern Pharma

A doctor experienced in the treatment of multiple sclerosis will supervise treatment with teriflunomide.

Follow exactly the instructions for use 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 (10 years of age and above)

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. (Teriflunomide Kern Pharma is only available in 14 mg film-coated tablets; therefore, the physician will switch patients in this category to a different medicinal product containing teriflunomide).

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.

Form/route of administration

This medicine is administered orally. Teriflunomide is taken every day as a single daily dose at any time of the day.

The tablet should be swallowed whole with water. This medicine may be taken with or without food.

If you take more Teriflunomide KernPharma 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Teriflunomide KernPharma

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

If you interrupt treatment with Teriflunomide KernPharma

Do not stop treatment or change the dose of teriflunomide 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 may 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 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 of abdominal pain, nausea or vomiting (frequent in pediatric patients and uncommon in adult patients)
• 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.

Uncommon (may affect up to 1 in 100 people)

• allergic reactions which may include symptoms such as rash, hives, swelling of lips, tongue or face, or sudden difficulty breathing
• severe skin reactions which may 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 may include symptoms such as high fever, shaking, chills, reduced urine output, or confusion
• inflammation of the lungs which may 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 frequent (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, 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 anxious
• Muscle soreness, feeling weak, 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
• Tendon, joint, 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)

• Decrease in platelet count (mild thrombocytopenia)
• Increased sensitivity, especially in the skin; stabbing or throbbing 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)

• Liver 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 reactions

If you experience adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomide Kern Pharma

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 blister after "EXP". The expiry date refers to 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. Unused medicines and their containers should be handed over to the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Teriflunomide Kern Pharma

• The active substance is teriflunomide. Each film-coated tablet contains 14 mg of teriflunomide.

• The other components are:

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

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

Appearance of the product and contents of the pack

The film-coated tablets are light blue or pastel blue in colour, pentagonal in shape, biconvex, marked with "14" on one side and flat on the other side. Tablet dimensions: 7.4 mm.

Film-coated tablets are available in unit dose blisters of PVC/PCTFE/aluminium or aluminium/aluminium, packed in cardboard boxes containing 28 tablets.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona, Spain

Manufacturer responsible:

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 most recent review of this leaflet: September 2024

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