Teriflunomide Medical Vallei

Leaflet accompanying the packaging: patient information

Teriflunomide Medical Valley, 14 mg, film-coated tablets

Teriflunomide

Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Teriflunomide Medical Valley and what is it used for
• 2. Important information before taking Teriflunomide Medical Valley
• 3. How to take Teriflunomide Medical Valley
• 4. Possible side effects
• 5. How to store Teriflunomide Medical Valley
• 6. Contents of the packaging and other information

1. What is Teriflunomide Medical Valley and what is it used for

What is Teriflunomide Medical Valley

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

What is Teriflunomide Medical Valley used for

Teriflunomide Medical Valley is used to treat adults and children and adolescents (aged 10 years and older) with relapsing-remitting multiple sclerosis.

What is multiple sclerosis

Multiple sclerosis is a chronic disease that affects the central nervous system. The central nervous system consists of the brain and spinal cord. In multiple sclerosis, inflammation damages the protective covering (called myelin) around the nerves in the central nervous system. This process is called demyelination. It prevents the nerves from functioning properly. In people with relapsing-remitting multiple sclerosis, there are recurring attacks (relapses) of physical symptoms caused by the abnormal functioning of the nerves. These symptoms vary from person to person but usually include:

• difficulty walking
• vision problems
• balance problems. These symptoms may completely disappear after the relapse has resolved, but over time, some problems may persist between relapses. This can lead to physical disability that interferes with daily activities.

How Teriflunomide Medical Valley works

Teriflunomide Medical Valley helps protect the central nervous system from the effects of the immune system by reducing the increase in the number of certain white blood cells (lymphocytes). This reduces the inflammation that, in people with multiple sclerosis, leads to nerve damage.

2. Important information before taking Teriflunomide Medical Valley

When not to take Teriflunomide Medical Valley:

• if the patient is allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever experienced a severe skin rash or peeling of the skin after taking teriflunomide or leflunomide,
• if the patient has severe liver disease,
• if the patient is pregnant, thinks they may be pregnant, or is breastfeeding,
• if the patient has any severe immune system disorders, such as acquired immune deficiency syndrome (AIDS),
• if the patient has any severe blood disorders or has a low white blood cell or platelet count,
• if the patient has a severe infection,
• if the patient has severe kidney disease requiring dialysis,
• if the patient has very low protein levels in the blood (hypoproteinemia),

In case of doubt, the doctor or pharmacist should be consulted before taking this medicine.

Warnings and precautions

Before starting treatment with Teriflunomide Medical Valley, the doctor or pharmacist should be consulted if:

• the patient has liver function disorders and/or the patient drinks large amounts of alcohol. The doctor may perform blood tests to check if liver function is normal before and during treatment. If the patient's test results show liver function disorders, the doctor may stop the use of Teriflunomide Medical Valley. See section 4.
• the patient has high blood pressure, whether or not it is controlled with medication. Teriflunomide Medical Valley may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly during treatment. See section 4.
• the patient has an infection. Before taking Teriflunomide Medical Valley, the doctor will ensure that the patient has a sufficient number of white blood cells and platelets in the blood. Since Teriflunomide Medical Valley reduces the number of white blood cells in the blood, it may affect the ability to fight infections. The doctor may perform a blood test to check the white blood cell count if the patient suspects they have an infection. During treatment with teriflunomide, viral infections such as herpes simplex or shingles may occur. In some cases, serious complications have occurred. The doctor should be informed immediately if any symptoms of a viral infection are suspected. See section 4.
• the patient has severe skin reactions.
• the patient has respiratory symptoms.
• the patient has weakness, numbness, and pain in the hands and feet.
• the patient is going to be vaccinated.
• the patient is taking leflunomide with Teriflunomide Medical Valley.
• the patient is switching from their current medicine to Teriflunomide Medical Valley or from Teriflunomide Medical Valley to another medicine.
• the patient is going to have a specific blood test (calcium level test). The results of the calcium level test may be falsely low.

Respiratory reactions

The doctor should be informed if the patient experiences unexplained coughing and shortness of breath (difficulty breathing). The doctor may perform additional tests.

Children and adolescents

Teriflunomide is not intended for use in children under 10 years of age, as it has not been studied in this age group with multiple sclerosis. The warnings and precautions mentioned above also apply to children. The following information is important for children, adolescents, and their caregivers:

• in patients taking teriflunomide, cases of pancreatitis have been observed. The child's doctor may perform blood tests if pancreatitis is suspected.

Teriflunomide Medical Valley and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription. In particular, the doctor or pharmacist should be informed if the patient is taking any of the following medicines:

• leflunomide, methotrexate, and other medicines that affect the immune system (often called immunosuppressive or immunomodulatory medicines)
• rifampicin (used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy
• St. John's Wort (a herbal medicine for depression)
• repaglinide, pioglitazone, nateglinide, or rosiglitazone, used to treat diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan, used to treat cancer
• duloxetine, used to treat depression, urinary incontinence, or diabetic neuropathy
• alosetron, used to treat severe diarrhea
• theophylline, used to treat asthma
• tizanidine (a muscle relaxant)
• warfarin (a blood thinner), 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, used to treat infections
• indomethacin, ketoprofen, used to treat inflammation or pain
• furosemide, used to treat heart disease
• cimetidine, used to reduce stomach acid production
• zidovudine, used to treat HIV infections
• rosuvastatin, simvastatin, atorvastatin, pravastatin, used to treat high cholesterol
• sulfasalazine, used to treat inflammatory bowel disease and rheumatoid arthritis
• cholestyramine, used to treat high cholesterol or itching in liver disease
• activated charcoal, used to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding

Do nottake this medicine if the patient is pregnantor thinks they may be pregnant. In pregnant women or those who become pregnant while taking this medicine, there is an increased risk of birth defects in the baby. Women of childbearing age who do not use effective contraception should not take this medicine. If a girl starts menstruating while taking this medicine, she should inform her doctor, who will provide specialized advice on contraception and potential risks in case of pregnancy. If a woman plans to become pregnant after stopping Teriflunomide Medical Valley, she should inform her doctor, as it is essential to ensure that the medicine is no longer in the body before trying to become pregnant. The elimination of the active substance may take up to 2 years. This period can be shortened to a few weeks by taking certain medicines that accelerate the removal of this medicine from the body. In both cases, it should be confirmed by a blood test that the active substance has been sufficiently removed from the body. The doctor should confirm that the teriflunomide level in the blood is low enough for the woman to become pregnant. More information on laboratory tests can be obtained from the doctor. If a woman suspects she has become pregnant while taking this medicine or within 2 years after stopping treatment, she should stop taking it and immediatelycontact her doctor to have a pregnancy test. If the test confirms that the woman is pregnant, the doctor may suggest using certain medicines to quickly and sufficiently remove this medicine from the body. Contraception During and after taking this medicine, women should use effective contraception. Teriflunomide remains in the blood for a long time after stopping treatment. For this reason, effective contraception should continue to be used after treatment has stopped.

• This method should be used until the level of Teriflunomide Medical Valley in the blood is low enough - the doctor will check this.
• The doctor should be consulted about the best method of contraception for the patient and in case of a need to change the method of contraception.

Do nottake Teriflunomide Medical Valley while breastfeeding, as teriflunomide passes into human milk.

Driving and using machines

This medicine may cause dizziness, which can affect concentration and reaction time. Patients who experience these symptoms should not drive or operate machinery.

Teriflunomide Medical Valley contains lactose

This medicine contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

Teriflunomide Medical Valley contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Teriflunomide Medical Valley

Treatment with Teriflunomide Medical Valley will be supervised by a doctor experienced in treating multiple sclerosis. This medicine should always be taken as directed by the doctor. In case of doubt, the doctor should be consulted.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (aged 10 years and older)

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 Medical Valley 14 mg film-coated tablets are not suitable for children and adolescents with a body weight of ≤ 40 kg. Other medicines containing teriflunomide with lower strengths (in the form of 7 mg film-coated tablets) are available.

Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor about changing the dose to one 14 mg tablet per day. Route and method of administration Teriflunomide Medical Valley is taken orally. The medicine should be taken once daily at any time of day as a single dose. The tablets should be swallowed whole with water. The medicine can be taken with or without food.

Taking more than the recommended dose of Teriflunomide Medical Valley

In case of taking more than the recommended dose of Teriflunomide Medical Valley, the doctor should be contacted immediately. Side effects similar to those described in section 4 below may occur.

Missing a dose of Teriflunomide Medical Valley

A double dose should not be taken to make up for a missed tablet. The next dose should be taken as scheduled.

Stopping treatment with Teriflunomide Medical Valley

Treatment with this medicine should not be stopped or the dose changed without first consulting the doctor. In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. After taking this medicine, the following side effects may occur.

Severe side effects

Some side effects can be severe or become severe if any of these symptoms occur, the doctor should be informed immediately. Common(may affect up to 1 in 10 people)

• pancreatitis, which can cause symptoms such as abdominal pain, nausea, or vomiting (common in children and adolescents and uncommon in adult patients)

Uncommon(may affect up to 1 in 100 people)

• allergic reactions, which can cause symptoms, including rash, hives, swelling of the lips, tongue, or face, or sudden difficulty breathing
• severe skin reactions, which can cause symptoms, including skin rash, blisters, fever, or mouth ulcers
• severe infections or sepsis (a life-threatening infection),

which can cause symptoms, including high fever, chills, reduced urine output, or disorientation

• pneumonia, which can cause symptoms, including shortness of breath or persistent cough

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

• severe liver disease, which can cause symptoms, including yellowing of the skin or whites of the eyes, darker than usual urine, unexplained nausea and vomiting, or abdominal pain

Other side effectsmay occur with the following frequency:
Very common(may affect more than 1 in 10 people)

• headache
• diarrhea, nausea
• increased ALT activity (increased activity of certain liver enzymes in the blood) shown in tests
• hair loss

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, tooth infection, laryngitis, fungal foot infection
• herpes virus infections, including herpes simplex and shingles, with symptoms such as blisters, burning, itching, numbness, or pain of the skin, usually on one side of the upper body or face, as well as other symptoms such as fever and weakness
• blood test results: reduced red blood cell count (anemia), changes in liver function and white blood cell count (see section 2), also observed increased muscle enzyme activity (creatine kinase)
• mild allergic reactions
• feeling anxious
• feeling of tingling, weakness, numbness, tingling, or pain in the lower back or leg (sciatica), feeling of numbness, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome)
• feeling of "heart pounding"
• increased blood pressure
• vomiting, toothache, abdominal pain
• rash, acne
• tendon, joint, bone, or muscle pain (musculoskeletal pain)
• need to urinate more frequently than usual
• heavy menstrual bleeding
• pain
• lack of energy or feeling weak (asthenia)
• weight loss

Uncommon(may affect up to 1 in 100 people)

• reduced platelet count (mild thrombocytopenia)
• increased sensitivity (especially of the skin), stabbing or pulsating pain along one or more nerves, nerve disorders of the arms or legs (peripheral neuropathy)
• changes in the nails, severe skin reactions
• trauma-related pain
• psoriasis
• mouth ulcers
• abnormal blood fat (lipid) levels
• colitis

Rare(may affect up to 1 in 1000 people)

• inflammation or damage to the liver

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

• pulmonary hypertension

Children (aged 10 years and older) and adolescents

The above side effects 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

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Teriflunomide Medical Valley

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Teriflunomide Medical Valley contains

The active substance is teriflunomide. Teriflunomide Medical Valley

• Each tablet contains 14 mg of teriflunomide.
• The other ingredients are: Tablet core: lactose monohydrate, maize starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethyl cellulose (type A), colloidal anhydrous silica, magnesium stearate.

Tablet coating: hypromellose – 6mPas, titanium dioxide (E 171), colloidal anhydrous silica, macrogol 8000, and indigo carmine, aluminum lake (E 132). (see section 2 "Teriflunomide Medical Valley contains lactose").

What Teriflunomide Medical Valley looks like and contents of the pack

Blue, round (8.0 mm), biconvex film-coated tablets, smooth on both sides. Teriflunomide Medical Valley is packaged in:

• Aluminum/Aluminum foil blisters containing 28 and 84 film-coated tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB Brädgårdsvägen 28 236 32 Höllviken Sweden email: safety@medicalvalley.se

Manufacturer/Importer

Laboratorios Liconsa, S.A. Avda. Miralcampo, Nº7 Pol. Ind. Miralcampo, 19200 Azuqueca de Henares, Guadalajara Spain

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

France: TERIFLUNOMIDE LICONSA 14 mg, comprimé pelliculé Spain: Teriflunomide Liconsa 14 mg comprimidos recubiertos con película Iceland: Teriflunomide Medical Valley 14 mg filmuhúðaðar töflur Germany: Teriflunomid AXiromed 14 mg Filmtabletten Norway: Teriflunomide Medical Valley Poland: Teriflunomide Medical Valley Portugal: Teriflunomide Liconsa 14 mg comprimidos revestidos por película Italy: Teriflunomide Xiromed

Date of last revision of the leaflet: 09/2024