Teriflunomide Pharmascience

Leaflet accompanying the packaging: patient information

Teriflunomide Pharmascience, 14 mg, coated tablets

Teriflunomide

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 Pharmascience and what is it used for
• 2. Important information before taking Teriflunomide Pharmascience
• 3. How to take Teriflunomide Pharmascience
• 4. Possible side effects
• 5. How to store Teriflunomide Pharmascience
• 6. Contents of the packaging and other information

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

What is Teriflunomide Pharmascience

Teriflunomide Pharmascience 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 Pharmascience used for

Teriflunomide Pharmascience 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 disrupts the normal functioning of the nerves. 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 can completely disappear after a relapse, but over time, some problems may persist between relapses. This can lead to physical disability that interferes with daily activities.

How does Teriflunomide Pharmascience work

Teriflunomide Pharmascience 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 Pharmascience

When not to take Teriflunomide Pharmascience:

• 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 had a severe skin rash or peeling, blisters, or mouth sores 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 bone marrow disorders or has a low number of red or white blood cells or platelets in the blood,
• if the patient has a severe infection,
• if the patient has severe kidney disease requiring dialysis,
• if the patient has very low blood protein levels (hypoproteinemia),

In case of doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Teriflunomide Pharmascience, discuss with your doctor or pharmacist:

• if the patient has liver function disorders and/or the patient drinks large amounts of alcohol. The doctor will order a blood test 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 Pharmascience. Refer to section 4,
• if the patient has high blood pressure, regardless of whether it is controlled with medication or not. Teriflunomide Pharmascience may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and then regularly during treatment. Refer to section 4,
• if the patient has an infection. Before taking Teriflunomide Pharmascience, the doctor will ensure that the patient has a sufficient number of white blood cells and platelets in the blood. Since Teriflunomide Pharmascience reduces the number of white blood cells in the blood, it may affect the ability to fight infections. The doctor may order a blood test to check the number of white blood cells if the patient thinks 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 patient should immediately inform their doctor if they suspect any symptoms of a viral infection. Refer to section 4,
• if the patient has severe skin reactions,
• if the patient has respiratory symptoms,
• if the patient has weakness, numbness, and pain in the hands and feet,
• if the patient is going to be vaccinated,
• if the patient is taking leflunomide at the same time as Teriflunomide Pharmascience,
• if the patient is switching from their current medicine to Teriflunomide Pharmascience or from Teriflunomide Pharmascience to another medicine,
• if the patient is lactose intolerant,
• if the patient is going to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.

Respiratory reactions

Tell your doctor if you experience unexplained coughing and shortness of breath (difficulty breathing). The doctor may perform additional tests.

Children and adolescents

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

• in patients taking teriflunomide, cases of pancreatitis have been observed. The doctor treating the child may order a blood test if they suspect pancreatitis.

Teriflunomide Pharmascience and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained 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 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 ethinyl estradiol 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, breastfeeding, and fertility

Do not take Teriflunomide Pharmascience if you are pregnant or think you may be pregnant. In pregnant women or those who become pregnant while taking Teriflunomide Pharmascience, there is an increased risk of birth defects in the baby. Women of childbearing age who do not use effective contraception must not take this medicine. If a girl starts menstruating while taking Teriflunomide Pharmascience, 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 Pharmascience, she should inform her doctor, as it is essential to ensure that teriflunomide is no longer in the body before trying to conceive. 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 elimination of Teriflunomide Pharmascience 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 level of Teriflunomide Pharmascience 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 Teriflunomide Pharmascience or within two years after stopping treatment, she should stop taking Teriflunomide Pharmascience and immediately contact her doctor to perform a pregnancy test. If the test confirms pregnancy, the doctor may suggest using certain medicines to quickly and sufficiently remove Teriflunomide Pharmascience from the body to reduce the risk to the baby. Contraception During and after taking Teriflunomide Pharmascience, women should use effective contraception. Teriflunomide remains in the blood for a long time after stopping treatment. Therefore, effective contraception should still be used after stopping treatment.

• This method should be used until the level of Teriflunomide Pharmascience in the blood is low enough (the doctor will check this).
• Discuss with your doctor the best contraceptive method for you and any need to change the contraceptive method.

Do not take Teriflunomide Pharmascience while breastfeeding, as teriflunomide passes into human milk.

Driving and using machines

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

Teriflunomide Pharmascience contains lactose

Teriflunomide Pharmascience contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

Teriflunomide Pharmascience contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Teriflunomide Pharmascience

Treatment with Teriflunomide Pharmascience should be supervised by a doctor experienced in treating multiple sclerosis. This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor. AdultsThe recommended dose is one 14 mg coated tablet per day.

Use in 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 coated tablet per day.
• Children with a body weight of 40 kg or less: one 7 mg coated tablet per day. Teriflunomide Pharmascience 7 mg is not available, so other teriflunomide 7 mg medicines should be used.

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

Taking more than the recommended dose of Teriflunomide Pharmascience

If you take more than the recommended dose of Teriflunomide Pharmascience, contact your doctor immediately. Side effects may occur, similar to those described in section 4 below.

Missing a dose of Teriflunomide Pharmascience

Do not take a double dose to make up for a missed tablet. Take the next dose as scheduled.

Stopping treatment with Teriflunomide Pharmascience

Do not stop taking Teriflunomide Pharmascience or change the dose without first consulting your doctor. If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

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 potentially severe; if you experience any of these symptoms, contact your doctor immediately. Frequent(may occur in up to 1 in 10 patients)

• pancreatitis, which can cause symptoms such as abdominal pain, nausea, or vomiting (frequency: frequent in children and adolescents and less frequent in adult patients). Less frequent(may occur in up to 1 in 100 patients)
• allergic reactions, which can include symptoms such as rash, hives, swelling of the lips, tongue, or face, or sudden difficulty breathing,
• severe skin reactions, which can cause symptoms such as skin rash, blisters, fever, or mouth sores,
• severe infections or sepsis (a potentially life-threatening infection), which can cause symptoms such as high fever, chills, shivering, reduced urine output, or disorientation,
• pneumonia, which can cause symptoms such as shortness of breath or persistent cough.

Unknown 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 effects may occur with the following frequency: Very frequent(may occur in more than 1 in 10 patients)

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

Frequent(may occur in up to 1 in 10 patients)

• 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 cold sores 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, and other symptoms such as fever and weakness;
• laboratory 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 tingling, weakness, numbness, tingling, or pain in the lower back or leg (sciatica), feeling numbness, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome),
• feeling "heart pounding",
• increased blood pressure,
• vomiting, toothache, abdominal pain in the upper abdomen,
• rash, acne,
• tendon, joint, bone, muscle pain (musculoskeletal pain),
• need to urinate more often than usual,
• heavy menstrual periods,
• pain,
• lack of energy or feeling weak (asthenia),
• weight loss.

Less frequent(may occur in up to 1 in 100 patients)

• 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 pain,
• psoriasis,
• mouth ulcers,
• abnormal blood lipid levels,
• colitis.

Rare(may occur in up to 1 in 1000 patients)

• liver inflammation or damage.

Unknown 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: Frequent(may occur in up to 1 in 10 patients)

• pancreatitis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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 or PDG Cetus Pharma Sp. z o.o., ul. Sokratesa 11B, 01-909 Warsaw, tel.: +48 606 383 970, e-mail: pv@cetuspharma.pl, which is a partner of the marketing authorization holder Pharmascience International Limited in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teriflunomide Pharmascience

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month stated. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Teriflunomide Pharmascience contains

• The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.
• The other ingredients are: hydroxypropyl cellulose, lactose monohydrate, cornstarch, microcrystalline cellulose (type 102), sodium carboxymethyl cellulose (type A), magnesium stearate, hypromellose 2910, titanium dioxide (E 171), macrogol 8000, colloidal anhydrous silica, indigo carmine, aluminum lake (E 132).

What Teriflunomide Pharmascience looks like and contents of the pack

Teriflunomide Pharmascience is a pentagonal, coated tablet, 7.3 mm in size, light blue to pale blue in color, with the imprint "14" on one side and smooth on the other side (thickness: 3.5 mm - 4.1 mm). Teriflunomide Pharmascience is available in cartons containing 14 or 28 coated tablets in blisters. Not all pack sizes may be marketed.

Marketing authorization holder

Pharmascience International Limited. Lampousas 1 1095 Nicosia Cyprus

Manufacturer/Importer

Pharmascience International Limited 1st floor Iacovides Tower 81-83 Griva Digeni Avenue 1090 Nicosia Cyprus GE Pharmaceuticals Limited Industrial Zone Chekanitza South area 2140, Botevgrad Bulgaria

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

Date of last revision of the leaflet: 09/2024