TERIFLUNOMIDE LICONSA 14 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Teriflunomide Liconsa 14 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication because 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

What is Teriflunomide Liconsa

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

What is Teriflunomide Liconsa 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 (called 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 patient to patient 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 lead to physical disabilities that can interfere with daily activities.

How Teriflunomide Liconsa 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 Liconsa

Do not take Teriflunomide Liconsa:

• 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, peeling, 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, such as acquired immune deficiency syndrome (AIDS);
• if you have severe bone marrow problems or a low number of red or white blood cells or platelets in your blood;
• 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, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Teriflunomide Liconsa if:

• you have liver problems and/or if you drink large amounts of alcohol. Your doctor may perform blood tests before and during treatment to check how your liver is functioning. If the results of your tests show any liver problems, 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. The medication 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 the medication, your doctor will make sure you have enough white blood cells and platelets in your blood. As teriflunomide decreases the number of white blood cells in your blood, this may affect your ability to fight any infection you may have. Your doctor may perform blood tests to check your white blood cells if they think you have any infection. During treatment with teriflunomide, 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 a viral 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 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 a cough and shortness of breath without apparent cause. 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 Liconsa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. This includes medications purchased without a prescription.

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

• leflunomide, methotrexate, and other medications that affect the immune system (often called immunosuppressants or immunomodulators)
• rifampicin (a medication used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin for epilepsy
• St. John's Wort (a herbal remedy 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 used to thin the blood (i.e., make it more fluid) to prevent blood clots
• oral contraceptives (containing ethinylestradiol and 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 this medication if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking teriflunomide, 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 this medication, 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 teriflunomide, as you need to make sure that most of the medication has been eliminated from your body before trying to become pregnant. The elimination of the active substance naturally may take up to 2 years. This period can be reduced to a few weeks by taking certain medications that 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 two years following the end of treatment, you should stop taking teriflunomide and contact your doctor immediatelyto perform a pregnancy test. If the test confirms you are pregnant, 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 treatment. Continue using an effective contraceptive method after stopping treatment.

• 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 Liconsa during breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines

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

Teriflunomide Liconsa contains lactose

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

Teriflunomide Liconsa contains sodium

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

3. How to take Teriflunomide Liconsa

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

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.

Children and adolescents (from 10 years old)

The dose depends on body weight:

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

Teriflunomide Liconsa 14 mg film-coated tablets EFG are not suitable for pediatric patients with a body weight ≤40 kg. Other medications containing teriflunomide in a lower dose (7 mg film-coated tablets) are available.

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

Method of administration

Teriflunomide Liconsa is administered orally. It is taken once daily, at any time of day. The tablets should be swallowed whole with water.

It can be taken with or without food.

If you take more Teriflunomide Liconsa than you should

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

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Teriflunomide Liconsa

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

If you stop taking Teriflunomide Liconsa

Do not stop taking this medication or change the dose without consulting your doctor first.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

This medicine can cause the following adverse effects.

Severe Adverse Effects

Some adverse effects could be or become severe. If you experience any of these effects, inform 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 infrequent in adult patients).

Infrequent(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 ulcers in the mouth
• Severe infections or sepsis (a potentially life-threatening infection) that could include symptoms such as high fever, chills, shivering, reduced urine flow, or confusion
• Pneumonia that could include symptoms such as shortness of breath or persistent cough

Unknown 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 Adverse Effectsthat may occur with the following frequencies:

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

• Headache
• Diarrhea, feeling sick
• Increased ALT (increase in certain liver enzyme levels in blood) in 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 swallowing difficulties, cystitis, viral gastroenteritis, oral herpes, tooth infection, laryngitis, fungal infection of the feet
• 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
• Laboratory values: a decrease in the number of red blood cells (anemia), changes in liver and white blood cell test results (see section 2), as well as elevations of a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling anxious
• Pins and needles, 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 frequently than usual
• Heavy menstruation
• Pain
• Lack of energy or feeling weak (asthenia)
• Weight loss

Infrequent(may affect up to 1 in 100 people)

• Decrease in platelet count in blood (mild thrombocytopenia)
• Increased sensation or sensitivity, especially in the skin; stabbing or pulsating pain in one or more nerves, problems in the nerves of the arms or legs (peripheral neuropathy)
• Nail disorders, severe skin reactions
• Post-traumatic pain
• Psoriasis
• Mouth/lip inflammation
• Abnormal levels of fats (lipids) in blood
• Colon inflammation (colitis)

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

• Liver inflammation or damage

Unknown Frequency(cannot be estimated from available data)

• Respiratory hypertension

Children (from 10 years) and Adolescents

The above-mentioned adverse 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 Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Teriflunomida Liconsa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Teriflunomida Liconsa

The active ingredient is teriflunomide.

Teriflunomida Liconsa 14 mg film-coated tablets EFG

• Each tablet contains 14 mg of teriflunomide.
• The other ingredients are:

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

Film coating:hypromellose, titanium dioxide (E171), anhydrous colloidal silica, macrogol (E1521), carmine indigo, blue FD&C 2 (E132)

(See Section 2 "Teriflunomida Liconsa contains lactose").

Appearance of the Product and Package Contents

Teriflunomida Liconsa 14 mg film-coated tablets EFG are blue, round (8.0 mm), biconvex, and smooth on both sides.

Teriflunomida Liconsa 14 mg film-coated tablets EFG are packaged in

• Aluminum-aluminum blisters containing 28 and 84 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Liconsa, S.A.

C/ Dulcinea S/N,

28805 Alcalá de Henares,

Madrid, Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, N.º 7,

Pol. Ind. Miralcampo,

19200 Azuqueca de Henares,

Guadalajara, Spain

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

Iceland: Teriflunomida Medical Valley 14 mg film-coated tablets

Germany: Teriflunomid AXiromed 14 mg film-coated tablets

France: TERIFLUNOMIDE LICONSA 14 mg, film-coated tablet

Spain: Teriflunomida Liconsa 14 mg film-coated tablets EFG

Portugal: Teriflunomida Liconsa 14 mg film-coated tablets

Italy: Teriflunomida Xiromed

Norway: Teriflunomida Medical Valley

Poland: Teriflunomida Medical Valley

Date of the last revision of this leaflet: September 2024

Other Sources of Information

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/