Teriflunomide pharmathen

Package leaflet: Information for the user

Teriflunomide Pharmathen, 14 mg, coated tablets
Teriflunomidum
Please read all of 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 ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

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

What Teriflunomide Pharmathen is used for
Teriflunomide Pharmathen is used to treat 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 attacks the central nervous system. The central nervous system consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective covering (called myelin) around the nerves in the central nervous system. This process is known as demyelination. This impairs the ability of nerves to function properly.

In people with relapsing-remitting multiple sclerosis, there are repeated attacks (relapses) of physical symptoms caused by improper nerve function. Symptoms vary between individuals but usually include:

• difficulty walking,
• vision problems,
• problems with balance.

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

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

2. Important information before taking Teriflunomide Pharmathen

When not to take Teriflunomide Pharmathen:

• 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 developed severe skin rash, skin peeling, blisters and/or mouth ulcers 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 reduced platelet count;
• if the patient has a 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 Pharmathen, discuss with the 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 liver function before and during treatment. If test results indicate liver dysfunction, the doctor may discontinue treatment with Teriflunomide Pharmathen. Please refer to section 4.
• if the patient has high blood pressure (hypertension), regardless of whether it is controlled with medication or not. Teriflunomide Pharmathen may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly during treatment. Please refer to section 4.
• if the patient has an infection. Before the patient takes Teriflunomide Pharmathen, the doctor will ensure that the patient has adequate levels of white blood cells and platelets in the blood. Because Teriflunomide Pharmathen reduces the number of white blood cells, it may affect the ability to fight infections. The doctor may perform a blood test to check white blood cell count if the patient suspects an infection. Please refer to section 4.
• if the patient has severe skin reactions;
• if the patient has symptoms affecting the respiratory system;
• if the patient experiences weakness, numbness, or pain in the hands and feet;
• if the patient intends to receive vaccination;
• if the patient is taking leflunomide together with Teriflunomide Pharmathen;
• if the patient is switching from another treatment to Teriflunomide Pharmathen or from Teriflunomide Pharmathen to another medicine;
• if the patient is scheduled for a specific blood test (calcium level measurement). The test results may show falsely low calcium levels.

Respiratory system reactions
Inform the doctor if the patient develops unexplained cough or 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 patients with multiple sclerosis in this age group.
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 doctor may perform blood tests if pancreatitis is suspected.

Teriflunomide Pharmathen and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines.
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 (used to treat tuberculosis and other infections);
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy;
• St. John’s wort (herbal remedy 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 kidney disease in patients with diabetes;
• alosetron, used to treat severe diarrhoea;
• 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 to treat inflammation or pain;
• furosemide, used to treat heart conditions;
• cimetidine, used to reduce stomach acid secretion;
• zidovudine, used to treat HIV infection;
• rosuvastatin, simvastatin, atorvastatin, pravastatin, medicines used to treat hypercholesterolemia (elevated blood cholesterol levels);
• sulfasalazine, used for inflammatory bowel disease and rheumatoid arthritis;
• cholestyramine, used in case of elevated blood cholesterol or itching in liver diseases;
• activated charcoal, used to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take Teriflunomide Pharmathen if the patient is pregnant or suspects she may be pregnant. In women who are pregnant or who become pregnant while taking Teriflunomide Pharmathen, there is an increased risk of congenital malformations in the child.
Women of childbearing potential who do not use effective contraception must not take this medicine.
If a girl starts menstruating while taking Teriflunomide Pharmathen, inform the doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
If a woman plans to become pregnant after stopping Teriflunomide Pharmathen, she should inform her doctor, because it is essential to ensure that the medicine is no longer present in the body before attempting pregnancy. 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 Pharmathen from the body.
In both cases, blood testing must confirm that the active substance has been sufficiently eliminated from the body. The doctor should confirm that the blood concentration of Teriflunomide Pharmathen is low enough to allow pregnancy.
More information about laboratory tests can be obtained from the doctor.
If a woman suspects she has become pregnant while taking Teriflunomide Pharmathen or within two years after stopping treatment, she must stop taking Teriflunomide Pharmathen immediately and 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 Pharmathen from the body to reduce the risk to the unborn child.

Contraception
Women must use an effective method of contraception during treatment with Teriflunomide Pharmathen and after stopping treatment. Teriflunomide remains in the blood for a long time after stopping treatment. For this reason, effective contraception must continue after treatment ends.

• This method should be used until the blood concentration of Teriflunomide Pharmathen is sufficiently low (as confirmed by the doctor).
• Discuss with the doctor the most suitable method of contraception for the patient and any potential need to change the contraceptive method.

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

Driving and operating machinery
Teriflunomide Pharmathen may cause dizziness, which may impair the ability to concentrate and react. Patients experiencing such symptoms should not drive or operate machinery.

Teriflunomide Pharmathen contains lactose
Teriflunomide Pharmathen 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.

Teriflunomide Pharmathen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Teriflunomide Pharmathen

Treatment with Teriflunomide Pharmathen will be supervised by a physician experienced in the management of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, 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 greater than 40 kg: one 14 mg tablet per day.
• Children with body weight less than or equal to 40 kg: for children and adolescents aged at least 10 years and with body weight ≤ 40 kg, alternative teriflunomide-containing medicines with different strengths are appropriate; consult your doctor or pharmacist regarding the availability of teriflunomide tablets with different strengths.

Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor to switch to a dose of one 14 mg tablet per day.
Teriflunomide Pharmathen 14 mg film-coated tablets are not suitable for children and adolescents with body weight ≤ 40 kg.

Method of administration
Teriflunomide Pharmathen is administered orally. Teriflunomide Pharmathen should be taken daily at any time, as a single daily dose.
Tablets should be swallowed whole with water.
Teriflunomide Pharmathen may be taken with food or independently of meals.

Overdose of Teriflunomide Pharmathen
In case of taking more than the recommended dose of Teriflunomide Pharmathen, contact your doctor immediately. Adverse effects similar to those described in section 4 below may occur.

Missed dose of Teriflunomide Pharmathen
Do not take a double dose to make up for a missed tablet. Take the next dose according to the prescribed dosing schedule.

Stopping Teriflunomide Pharmathen
Do not stop taking Teriflunomide Pharmathen or change the dose without prior consultation with 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 everybody 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,
contact your doctor immediately.
Common (may occur in up to 1 in 10 people)

• inflammation of the pancreas, which may cause symptoms such as abdominal pain, nausea or vomiting (frequency is common in children and adolescents and uncommon in adult patients).

Uncommon (may occur in up to 1 in 100 people)

• allergic reactions, which may cause symptoms including rash, hives, swelling of the lips, tongue or face, or sudden breathing difficulties;
• severe skin reactions, which may cause symptoms including skin rash, blisters on the skin, fever or mouth ulcers;
• severe infections or sepsis (a type of infection potentially life-threatening to the patient), which may cause symptoms including high fever, seizures, chills, reduced urine output or confusion;
• inflammation of the lungs, which may cause symptoms including shortness of breath or persistent cough.

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

• severe liver disease, which may 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 common (may occur in more than 1 in 10 people)

• headache;
• diarrhoea, nausea;
• increased AlAT activity (elevation of certain liver enzymes in blood) detected in laboratory tests;
• hair thinning.

Common (may occur in up to 1 in 10 people)

• influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort during swallowing, cystitis, viral gastroenteritis, cold sores, dental infection, laryngitis, fungal foot infection;
• laboratory findings: decreased number of red blood cells (anaemia), changes in liver function 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, numbness, tingling or pain in the lower back or leg (sciatica), numbness, burning, tingling or pain in hands and fingers (carpal tunnel syndrome);
• sensation of "pounding heartbeat";
• increased blood pressure;
• vomiting, toothache, upper abdominal pain;
• rash, acne;
• tendon, joint, bone pain, muscle pain (musculoskeletal pain);
• need to urinate more often than usual;
• heavy menstrual periods;
• pain;
• lack of energy or feeling of weakness (asthenia);
• weight loss.

Uncommon (may occur in up to 1 in 100 people)

• decreased number of platelets (mild thrombocytopenia);
• increased sensitivity (especially of the skin), stabbing or pulsating pain along one or more nerves, nerve disorders of arms or legs (peripheral neuropathy);
• changes in nails, severe skin reactions;
• traumatic pain;
• psoriasis;
• inflammation of the mucous membrane of the mouth/lips;
• abnormal levels of fats (lipids) in the blood;
• inflammation of the large intestine.

Rare (may occur in 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 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 occur in up to 1 in 10 people)

• inflammation of the pancreas.

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

5. How to store Teriflunomide Pharmathen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: Expiry (EXP). The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Teriflunomide Pharmathen contains
The active substance is teriflunomide.

• Each tablet contains 14 mg of teriflunomide.
• The other ingredients are: lactose monohydrate (150M), corn starch, microcrystalline cellulose type 102, sodium carboxymethyl starch (type A), hydroxypropyl cellulose (type L), magnesium stearate, anhydrous colloidal silicon dioxide; coating Opadry 03F220186 Yellow: hypromellose type 2910, titanium dioxide (E171), talc, macrogol 6000, iron oxide yellow (E172) (see section 2 "Teriflunomide Pharmathen contains lactose").

What Teriflunomide Pharmathen looks like and contents of the pack
A pentagonal film-coated tablet with a diameter of 7.3 ± 0.2 mm and thickness of 3.8 ± 0.5 mm, light yellow to pastel yellow in colour, printed "14" on one side.
This medicine is packed in blisters made of OPA/Aluminium/PVC/Aluminium, contained in a cardboard box.
Pack size: 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmathen S.A.
Dervenakion 6
153 51 Pallini
Greece
+302106604300
[email protected]

Manufacturer
Pharmathen International S.A.,
Industrial Park Sapes
Rodopi Prefecture, Block No 5
693 00 Rodopi
Greece
Pharmathen S.A.
Dervenakion 6
153 51 Pallini
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names: