Teriflunomide G.l. Pharma

Leaflet included in the packaging: patient information

Teriflunomide G.L. Pharma, 14 mg, coated tablets
Teriflunomide
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific condition. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Teriflunomide G.L. Pharma and what is it used for

What is Teriflunomide G.L. Pharma

Teriflunomide G.L. Pharma contains the active substance teriflunomide, which is an immunomodulatory medicine that regulates the immune system to limit its attack on the nervous system.

What is Teriflunomide G.L. Pharma used for

Teriflunomide G.L. Pharma 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, recurring attacks (relapses) of physical symptoms occur due to 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 a relapse, but over time, some problems may persist between relapses. This can lead to physical disability that makes it difficult to perform daily activities.

How does Teriflunomide G.L. Pharma work

Teriflunomide G.L. Pharma helps protect the central nervous system from the effects of the immune system by limiting the increase in the number of certain white blood cells (lymphocytes). This reduces inflammation, which in people with multiple sclerosis leads to nerve damage.

2. Important information before taking Teriflunomide G.L. Pharma

When not to take Teriflunomide G.L. Pharma:

• 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 diseases that affect the immune system, 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,
• if the patient has a severe infection,
• if the patient has severe kidney disease that requires dialysis,
• if the patient has very low protein levels in the blood (hypoproteinemia). In case of doubt, the patient should consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Teriflunomide G.L. Pharma, the patient should discuss the following with their doctor or pharmacist:

• if the patient has liver function disorders and/or consumes 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 treatment with Teriflunomide G.L. Pharma. See section 4.
• if the patient has high blood pressure, regardless of whether it is controlled with medication or not. Teriflunomide G.L. Pharma may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly thereafter. See section 4.
• if the patient has an infection. The doctor will ensure that the patient has a sufficient number of white blood cells and platelets in their blood before taking Teriflunomide G.L. Pharma. Since Teriflunomide G.L. Pharma reduces the number of white blood cells, it may affect the body's ability to fight infections. If the doctor suspects that the patient has an infection, they may order a blood test to check the number of white blood cells. During treatment with teriflunomide, viral infections such as herpes simplex (including oral herpes) 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. See section 4.
• if the patient experiences severe skin reactions.
• if the patient experiences respiratory symptoms.
• if the patient experiences weakness, fatigue, and pain in the arms and legs.
• if the patient is going to be vaccinated.
• if the patient is taking leflunomide with Teriflunomide G.L. Pharma.
• if the patient is switching from their current medicine to Teriflunomide G.L. Pharma or from Teriflunomide G.L. Pharma to another medicine.
• if the patient is going to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely decreased.

Respiratory reactions

The patient should inform their doctor if they experience unexplained cough and shortness of breath (difficulty breathing). The doctor may order additional tests.

Children and adolescents

Teriflunomide G.L. Pharma is not indicated 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. The following information is important for children, adolescents, and their caregivers:

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

Teriflunomide G.L. Pharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that can be obtained without a prescription.

• leflunomide, methotrexate, and other medicines that affect the immune system (often called immunosuppressive or immunomodulatory medicines)
• rifampicin (a medicine used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy
• St. John's Wort (a herbal medicine used to treat 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, 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, used to treat infections
• indomethacin, ketoprofen, used to treat pain or inflammation
• furosemide, used to treat heart disease
• cimetidine, used to reduce stomach acid production
• zidovudine, used to treat HIV infections
• rosuvastatin, simvastatin, atorvastatin, pravastatin - medicines used to treat high cholesterol
• sulfasalazine, a medicine used to treat inflammatory bowel disease and rheumatoid arthritis
• cholestyramine, used to treat high cholesterol or liver disease
• activated charcoal, used to reduce the absorption of medicines or other substances

Pregnancy and breastfeeding

Do not takeTeriflunomide G.L. Pharma if you are pregnant or think you may be pregnant. In pregnant women taking Teriflunomide G.L. Pharma, there is an increased risk of birth defects in the baby. Women of childbearing age must not take this medicine unless they use effective contraception. If a girl starts her first period while taking Teriflunomide G.L. Pharma, she should inform her doctor, who will provide specialized advice on contraception and potential risks in case of pregnancy. The patient should inform their doctor if they plan to become pregnant after stopping Teriflunomide G.L. Pharma, as they need to make sure that the medicine has been eliminated from their body before trying to become pregnant. 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 G.L. Pharma from the body. In both cases, the patient should confirm through a blood test that the active substance has been sufficiently eliminated from their body. The doctor should confirm that the level of Teriflunomide G.L. Pharma in the blood is low enough for the patient to become pregnant. The patient should contact their doctor for more information about laboratory tests. If a woman suspects that she has become pregnant while taking Teriflunomide G.L. Pharma or within 2 years after stopping treatment, she should stop taking Teriflunomide G.L. Pharma and immediatelycontact her doctor to perform a pregnancy test. If the test confirms that the woman is pregnant, the doctor may suggest taking certain medicines to quickly and sufficiently eliminate Teriflunomide G.L. Pharma from the body to reduce the risk to the baby. Contraception: During treatment with Teriflunomide G.L. Pharma and after stopping it, 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 in the blood is low enough - the doctor will check this.
• The patient should discuss with their doctor the best method of contraception for them and any potential need to change the method of contraception.

Do not takeTeriflunomide G.L. Pharma while breastfeeding, as teriflunomide passes into human milk.

Driving and using machines

Teriflunomide G.L. Pharma may cause dizziness, which can affect concentration and reaction time. Patients who experience such symptoms should not drive or operate machinery.

Teriflunomide G.L. Pharma contains lactose

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

3. How to take Teriflunomide G.L. Pharma

Treatment with Teriflunomide G.L. Pharma will be supervised by a doctor specializing in the treatment of multiple sclerosis. This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (aged 10 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: 7 mg of teriflunomide per day. Teriflunomide G.L. Pharma 14 mg coated tablets are not suitable for children and adolescents with a body weight of 40 kg or less.

Other medicines containing teriflunomide are available in lower strengths (7 mg coated tablets). 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 tablet per day. Route of administration: Teriflunomide G.L. Pharma is taken orally. Teriflunomide G.L. Pharma should be taken once daily at any time, as a single daily dose. The tablet should be swallowed whole, with a glass of water. Teriflunomide G.L. Pharma can be taken with or without food.

Taking more than the recommended dose of Teriflunomide G.L. Pharma

If the patient takes more than the recommended dose of Teriflunomide G.L. Pharma, they should immediately contact their doctor. Side effects may occur, similar to those described in section 4 below.

Missing a dose of Teriflunomide G.L. Pharma

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

Stopping treatment with Teriflunomide G.L. Pharma

The patient should not stop taking Teriflunomide G.L. Pharma or change the dose without first consulting their doctor. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Teriflunomide G.L. Pharma can cause side effects, although not everybody gets them. The following side effects may occur after taking this medicine:

Severe side effects

Some side effects can be severe or become severe if the patient experiences any of the following symptoms, they should immediately inform their doctor.

Very 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 less common in adults).

Common(may affect up to 1 in 10 people)

• influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, tooth infection, pharyngitis, and tonsillitis
• herpes virus infections, including oral herpes and shingles, with symptoms such as blisters, burning, itching, discomfort, or pain on the skin, usually on one side of the upper body or face, as well as other symptoms such as fever and weakness
• laboratory test results: decreased red blood cell count (anemia), changes in liver function and white blood cell count (see section 2), as well as increased muscle enzyme activity (creatine kinase)
• mild allergic reactions
• feeling anxious
• tingling, feeling weak, discomfort, or pain in the lower back or leg (sciatica); feeling discomfort, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome)
• feeling a "racing heart"
• increased blood pressure
• vomiting, toothache, abdominal pain
• rash, itching
• muscle and joint pain, bone pain, muscle pain (musculoskeletal pain)
• need to urinate more often than usual
• heavy menstrual bleeding
• pain
• lack of energy or feeling weak (asthenia)
• weight loss

Uncommon(may affect up to 1 in 100 people)

• decreased platelet count (mild thrombocytopenia)
• increased sensitivity or hypersensitivity, especially of the skin; stabbing or pulsating pain along one or more nerves, nerve disorders in the arms or legs (peripheral neuropathy)
• changes in nail condition, severe skin reactions
• traumatic pain
• psoriasis
• inflammation of the mucous membrane of the mouth and/or lips
• abnormal blood lipid levels
• inflammation of the large intestine (colitis)

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

• inflammation or damage to the liver

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

• pulmonary hypertension

Children (aged 10 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:

• pancreatitis

Reporting side effects

If side effects occur, including any side effects not mentioned in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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. Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Teriflunomide G.L. Pharma

The medicine should be stored out of 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 stated. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist 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 does Teriflunomide G.L. Pharma contain

• The active substance of the medicine is teriflunomide. Each tablet contains 14 mg of teriflunomide.
• The other ingredients of the medicine are: tablet core: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose (PH 112), sodium carboxymethyl cellulose (type A), colloidal anhydrous silica, magnesium stearate. Tablet coating: hypromellose 2910, titanium dioxide (E 171), talc, macrogol 6000, indigo carmine, aluminum lake (E 132).

What does Teriflunomide G.L. Pharma look like and what does the pack contain

Blue, pentagonal, coated tablet with dimensions of approximately 7.30 x 7.20 mm, with the inscription "T2" on one side and smooth on the other. Teriflunomide G.L. Pharma is available in blisters of OPA/Aluminum/PVC/Aluminum foil containing 10, 14, 28, 30, or 84 coated tablets, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Importer

Laboratori Fundació Dau, C/ C, 12-14 Pol. Industrial Zona Franca, 08040, Barcelona, Spain