Teriflunomide g.l. pharma

Package leaflet: Information for the patient

Teriflunomide G.L. Pharma, 14 mg, film-coated tablets
Teriflunomidum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Teriflunomide G.L. Pharma is and what it is 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 pack and other information

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

What Teriflunomide G.L. Pharma is
Teriflunomide G.L. Pharma contains the active substance teriflunomide, which is an immunomodulatory agent that regulates the immune system in order to reduce its attack on the central nervous system.

What Teriflunomide G.L. Pharma is used for
Teriflunomide G.L. Pharma is used in the treatment of adults, 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, inflammatory processes destroy the protective covering (called myelin) surrounding the nerves in the central nervous system. This process is known as demyelination. As a result, nerve signals cannot be transmitted properly.

In relapsing-remitting multiple sclerosis, patients experience repeated episodes (relapses) of physical symptoms caused by impaired nerve function. These symptoms vary between individuals but usually include:

• Difficulty walking
• Vision problems
• Balance disorders

These symptoms may completely disappear after a relapse ends, but over time, some symptoms may persist between relapses. This may lead to physical disability, making it difficult to perform daily activities.

How Teriflunomide G.L. Pharma works
Teriflunomide G.L. Pharma helps protect the central nervous system from the immune system by reducing the proliferation of certain white blood cells (lymphocytes). This reduces the inflammatory process that, in patients with multiple sclerosis, leads to nerve damage.

2. Important Information Before Using Teriflunomide G.L. Pharma

When not to use 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 severe skin rash or peeling of the skin with blisters and (or) oral mucosal ulceration after taking teriflunomide or leflunomide,
• if the patient has severe liver disease,
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding,
• if the patient has any severe diseases affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS),
• if the patient has any severe bone marrow disorders or has low numbers of red or white blood cells or a reduced platelet count,
• if the patient has severe infection,
• if the patient has severe kidney disease requiring dialysis,
• if the patient has very low levels of proteins in the blood (hypoproteinemia). If in doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions
Before starting treatment with Teriflunomide G.L. Pharma, discuss the following with your doctor or pharmacist if:

• the patient has liver function disorders and (or) drinks large amounts of alcohol. The doctor may perform blood tests to check whether liver function is normal before and during treatment. If test results indicate impaired liver function, the doctor may discontinue treatment with Teriflunomide G.L. Pharma. See section 4.
• the patient has high blood pressure (hypertension), regardless of whether it is controlled with medication or not. Teriflunomide G.L. Pharma may cause an increase in blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly thereafter. See section 4.
• the patient has an infection. The doctor will ensure that the patient has adequate levels of white blood cells and platelets in the blood before starting Teriflunomide G.L. Pharma. Since Teriflunomide G.L. Pharma reduces the number of white blood cells, this may affect the body's ability to fight infections. If the doctor suspects an infection, blood tests may be ordered to check white blood cell count. Viral infections such as herpes virus infections, including oral herpes or shingles, may occur during treatment with teriflunomide. In some cases, serious complications have occurred. Immediately inform the doctor if there are any symptoms suggestive of a herpes virus infection. See section 4.
• the patient has severe skin reactions.
• the patient has respiratory symptoms.
• the patient experiences weakness, tingling, or pain in the hands and feet.
• the patient intends to be vaccinated.
• the patient is taking leflunomide together with Teriflunomide G.L. Pharma.
• the patient is switching from another medication to Teriflunomide G.L. Pharma or from Teriflunomide G.L. Pharma to another medication.
• the patient is scheduled for a specific blood test (calcium level measurement). Results may be falsely low.

Respiratory system reactions
Inform the doctor if the patient develops unexplained cough or 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 due to lack of data in pediatric patients with multiple sclerosis. The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:

• cases of pancreatitis have been observed in patients receiving teriflunomide. The child's treating physician may perform blood tests if pancreatitis is suspected.

Teriflunomide G.L. Pharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• leflunomide, methotrexate, and other medicines affecting the immune system (often called immunosuppressive or immunomodulatory drugs)
• rifampicin (a medicine used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin, used in the treatment of epilepsy
• St. John's wort (a herbal medicine used to treat depression)
• repaglinide, pioglitazone, nateglinide, or rosiglitazone, used in the treatment of diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan, used in cancer treatment
• duloxetine, used to treat depression, urinary incontinence, or kidney disease in diabetic patients
• 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
• indometacin, ketoprofen, used for pain relief or anti-inflammatory treatment
• furosemide, used to treat heart conditions
• cimetidine, used to reduce gastric acid secretion
• zidovudine, used to treat HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin – medicines used to treat hypercholesterolemia (elevated blood cholesterol levels)
• sulfasalazine, a medicine used to treat inflammatory bowel disease and rheumatoid arthritis
• cholestyramine, used to treat elevated blood cholesterol levels or pruritus in liver diseases
• activated charcoal, used to reduce absorption of medicines or other substances

Pregnancy and breastfeeding
Do not take Teriflunomide G.L. Pharma if the patient is pregnant or suspects she may be pregnant. In women who are pregnant or who become pregnant while taking Teriflunomide G.L. Pharma, there is an increased risk of congenital malformations in the child. Women of childbearing potential must not take this medicine unless they are using effective contraception.
If a girl experiences her first menstrual period while taking Teriflunomide G.L. Pharma, she should inform her doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
Inform the doctor if planning pregnancy after stopping Teriflunomide G.L. Pharma, because before attempting conception it is essential to ensure that the drug has been eliminated from the body. Elimination of the active substance may take up to 2 years. This period can be shortened to several weeks by taking specific medicines that accelerate the removal of Teriflunomide G.L. Pharma from the body.
In both cases, adequate elimination of the active substance from the body must be confirmed by a blood test. The doctor should confirm that the concentration of Teriflunomide G.L. Pharma in the blood is sufficiently low to allow pregnancy.
Contact your doctor for further information about laboratory tests.
If a woman suspects she became pregnant while taking Teriflunomide G.L. Pharma or within two years after stopping treatment, she must stop taking Teriflunomide G.L. Pharma and immediately contact her doctor to perform a pregnancy test. If the test confirms pregnancy, the doctor may recommend appropriate treatment to rapidly and adequately eliminate Teriflunomide G.L. Pharma from the body to reduce the risk to the fetus.

Contraception
Women must use effective contraception during treatment with Teriflunomide G.L. Pharma and after stopping the medicine. Teriflunomide remains in the blood for a long time after discontinuation. Therefore, effective contraception must be continued after stopping treatment.

• This method should be used until the teriflunomide blood concentration is sufficiently low – this will be verified by the doctor.
• Discuss with the doctor the most suitable contraceptive method for the patient, and also in case a change of contraceptive method is needed.

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

Driving and operating machinery
Teriflunomide G.L. Pharma may cause dizziness, which may impair the ability to concentrate and react. Patients experiencing 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 previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Teriflunomide G.L. Pharma

Treatment with Teriflunomide G.L. Pharma will be supervised by a physician experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. In case of any doubts, consult your doctor.

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 body weight above 40 kg: one 14 mg tablet once daily.

• Children with body weight equal to or less than 40 kg: 7 mg of teriflunomide once daily.

• The 14 mg coated tablet formulation of Teriflunomide G.L. Pharma is not suitable for children and adolescents with body weight ≤ 40 kg.

• Other medicines containing teriflunomide are available at a lower strength (7 mg coated tablets).

Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor to switch the dose to one 14 mg tablet per day.

Route/Method of administration
Teriflunomide G.L. Pharma is administered orally. Teriflunomide G.L. Pharma should be taken daily at any time of day as a single daily dose.
The tablet should be swallowed whole with water.
Teriflunomide G.L. Pharma may be taken with or without food.

Taking more Teriflunomide G.L. Pharma than prescribed
If more Teriflunomide G.L. Pharma has been taken than prescribed, contact your doctor immediately.
Adverse effects may occur similar to those described in section 4 below.

Missing a dose of Teriflunomide G.L. Pharma
Do not take a double dose to make up for a missed tablet. Take the next dose according to the prescribed dosing schedule.

Stopping treatment with Teriflunomide G.L. Pharma
Do not stop taking Teriflunomide G.L. Pharma or change the dose without first consulting your doctor.

If you have any further questions 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 everyone gets them.
The following side effects may occur after using this medicine.

Serious side effects
Some side effects may be serious or may become serious. If any of the following symptoms occur, you must contact your doctor immediately.

Frequent (may affect more than 1 in 10 people)

• Pancreatitis, which may cause symptoms such as abdominal pain, nausea or vomiting (frequency of occurrence is frequent in children and adolescents and uncommon in adult patients).

Uncommon (may affect less than 1 in 100 people)

• Allergic reactions, which may cause symptoms such as rash, hives, swelling of the lips, tongue or face, or sudden breathing difficulties;
• Severe skin reactions, which may cause symptoms such as skin rash, blisters on the skin, fever or mouth ulcers;
• Severe infections or sepsis (a type of infection that may be life-threatening), which may cause symptoms such as high fever, seizures, chills, reduced urine output or confusion;
• Lung inflammation, which may cause symptoms such as shortness of breath or persistent cough.

Frequency unknown (frequency cannot be estimated from available data):

• Severe liver disease, which may cause symptoms such as 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 common (may affect more than 1 in 10 people)

• Headache;
• Diarrhoea, nausea;
• Increased AlAT activity (increased activity of certain liver enzymes in blood) shown in laboratory tests;
• Hair thinning.

Common (may affect less than 1 in 10 people)

• Influenza, upper respiratory tract infections, urinary tract infections, bronchitis, sinusitis, sore throat and discomfort during swallowing, bladder inflammation, viral gastroenteritis, dental infections, laryngitis, fungal foot infections;
• Herpes virus infections, including oral herpes and shingles, with symptoms such as blisters, burning, itching, tingling or pain in the skin, usually on one side of the upper body or face, and other symptoms such as fever and fatigue;
• Laboratory findings: decreased number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), increased activity of muscle enzymes (creatine kinase) has also been observed;
• Mild allergic reactions;
• Feeling of anxiety;
• Tingling sensation, feeling of weakness, tingling, numbness or pain in the lower back or leg (sciatica); tingling, burning, numbness or pain in hands and fingers (carpal tunnel syndrome);
• Palpitations;
• Increased blood pressure;
• Vomiting, toothache, upper abdominal pain;
• Rash, acne;
• Pain in tendons, joints, bones, muscle pain (musculoskeletal pain);
• Need to urinate more frequently than usual;
• Heavy menstrual periods;
• Pain;
• Lack of energy or feeling of weakness (asthenia);
• Decreased body weight.

Uncommon (may affect less than 1 in 100 people)

• Decreased number of platelets (mild thrombocytopenia);
• Increased sensation or sensitivity, especially of the skin; stabbing or pulsating pain along one or more nerves, nerve disorders of arms or legs (peripheral neuropathy);
• Changes in the area of nails, severe skin reactions;
• Traumatic pain;
• Psoriasis;
• Inflammation of the mucous membrane of the mouth and/or lips;
• Abnormal levels of fats (lipids) in the blood;
• Inflammation of the large intestine (colitis).

Rare (may affect less than 1 in 1000 people)

• Inflammation or damage to the liver.

Frequency unknown (frequency cannot be estimated from available data)

• Pulmonary hypertension.

Children (aged 10 years and older) and adolescents
The side effects listed above also apply to children and adolescents. The following additional information is important for children, adolescents and their caregivers:

Common (may affect less than 1 in 10 people)

• Pancreatitis.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 directly to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teriflunomide G.L. Pharma

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

6. Contents of the pack and other information

What Teriflunomide G.L. Pharma contains

• The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.
• The other components are:
  Tablet core: Lactose monohydrate, maize starch, hydroxypropylcellulose, microcrystalline cellulose (PH 112), sodium carboxymethylstarch (type A), colloidal anhydrous silica, magnesium stearate.
  Tablet coating: Hypromellose 2910, titanium dioxide (E 171), talc, macrogol 6000, indigo carmine, aluminium lake (E 132).

What Teriflunomide G.L. Pharma looks like and contents of the pack
Blue, pentagonal film-coated tablet measuring approximately 7.30 x 7.20 mm, embossed with the mark "T2" on one side and plain on the other.
Teriflunomide G.L. Pharma is available in blisters made of OPA/Aluminium/PVC/Aluminium foil containing 10, 14, 28, 30 or 84 film-coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]