Teriflunomide glenmark

Package leaflet: Information for the user

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Teriflunomide Glenmark is
Teriflunomide Glenmark contains the active substance teriflunomide, which is an immunomodulatory agent that helps reduce the immune system's attack on the nervous system.

What Teriflunomide Glenmark is used for
Teriflunomide Glenmark 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 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 known as demyelination. As a result, nerves are unable to function properly. In relapsing-remitting multiple sclerosis, patients experience repeated attacks (relapses) of physical symptoms caused by impaired 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 symptoms may persist between relapses. This may lead to physical disability, making it difficult to carry out daily activities.

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

2. Important information before using Teriflunomide Glenmark

When NOT to use Teriflunomide Glenmark

• 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, skin peeling, blisters, and/or oral 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 protein in the blood (hypoproteinemia).
  If in doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions
Before starting treatment with Teriflunomide Glenmark, discuss with your 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 whether liver function is normal before and during treatment. If test results indicate liver dysfunction, the doctor may discontinue Teriflunomide Glenmark. Refer to section 4.
• the patient has high blood pressure (hypertension), regardless of whether it is controlled with medication or not. Teriflunomide Glenmark may increase blood pressure. The doctor will monitor the patient's blood pressure before starting treatment and during treatment. Refer to section 4.
• the patient has an infection. Before administering Teriflunomide Glenmark, the doctor will ensure the patient has adequate levels of white blood cells and platelets. Since Teriflunomide Glenmark reduces the number of white blood cells, it may impair the ability to fight infections. The doctor may perform blood tests to check white blood cell counts if the patient suspects an infection. Viral infections such as herpes virus (including cold sores or shingles) may occur during treatment. In some cases, serious complications may develop. Immediately inform the doctor if any symptoms suggestive of herpes virus infection occur. Refer to section 4.
• the patient has experienced severe skin reactions.
• the patient has respiratory symptoms.
• the patient experiences weakness, numbness, or pain in hands and feet.
• the patient plans to receive vaccination.
• the patient is taking leflunomide together with Teriflunomide Glenmark.
• the patient is switching from another medication to Teriflunomide Glenmark or from Teriflunomide Glenmark to another medicine.
• the patient is scheduled for a specific blood test (calcium level measurement). Calcium test 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 perform additional tests.

Children and adolescents
Teriflunomide Glenmark is not intended for use in children under 10 years of age, as it has not been studied in pediatric patients with multiple sclerosis.
The above warnings and precautions 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 order blood tests if pancreatitis is suspected.

Teriflunomide Glenmark 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, as well as any medicines the patient plans to take.
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 immunosuppressants or immunomodulators),
• rifampicin (a medicine used to treat tuberculosis and other infections),
• carbamazepine, phenobarbital, phenytoin used to treat epilepsy,
• St. John’s wort (a 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 diabetic patients,
• alosetron used to treat severe diarrhea,
• theophylline used to treat asthma,
• tizanidine, a muscle relaxant,
• warfarin, an anticoagulant medicine used to thin the blood (i.e. to 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 pain or inflammation,
• 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 (high blood cholesterol levels),
• sulfasalazine used for inflammatory bowel disease and rheumatoid arthritis,
• cholestyramine used for high blood cholesterol or itching in liver disease,
• activated charcoal used to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do NOT take Teriflunomide Glenmark if the patient is pregnant or suspects she may be pregnant.
The risk of congenital malformations is higher in children born to women who are pregnant or who become pregnant while taking Teriflunomide Glenmark. Women of childbearing potential who do not use effective contraception must not take this medicine.
If a girl starts menstruating while taking Teriflunomide Glenmark, 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 Glenmark, she should inform her doctor, as it is essential to ensure the medicine is no longer 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 certain medicines that accelerate elimination of Teriflunomide Glenmark from the body.
In both cases, blood testing must confirm that the active substance has been sufficiently eliminated from the body. The doctor must confirm that the blood concentration of Teriflunomide Glenmark 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 Glenmark or within two years after stopping treatment, she must stop taking Teriflunomide Glenmark and immediately contact her doctor for a pregnancy test. If pregnancy is confirmed, the doctor may recommend certain medicines to rapidly and adequately eliminate Teriflunomide Glenmark from the body to reduce the risk to the unborn child.

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

• Contraception should be continued until blood levels of Teriflunomide Glenmark are sufficiently low – this will be verified by the doctor.
• Discuss with the doctor the most suitable method of contraception for the patient and whether a change in contraceptive method may be necessary.

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

Driving and operating machinery
Teriflunomide Glenmark may cause dizziness, which may impair the ability to concentrate and react. If such symptoms occur, the patient should not drive or operate machinery.

Teriflunomide Glenmark contains lactose
Teriflunomide Glenmark contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Teriflunomide Glenmark 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 use Teriflunomide Glenmark

Treatment with Teriflunomide Glenmark will be supervised by a physician experienced
in the treatment of multiple sclerosis.
This medicine should always be used exactly as prescribed by your doctor. If you have any doubts, consult
your doctor.
Adults
The recommended dose is one 14 mg tablet once daily.
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 once daily.
• Children with body weight less than or equal to 40 kg: one 7 mg tablet once daily.
  The 7 mg strength of Teriflunomide Glenmark is not available. If this dose is required, another teriflunomide-containing medicine with a 7 mg strength available on the market should be used.

Children and adolescents who reach a stable body weight above 40 kg will be informed by their
doctor to change the dose to one 14 mg tablet once daily.
Route and method of administration
Teriflunomide Glenmark is for oral use. Teriflunomide Glenmark should be taken every day at any time as a single daily dose.
Tablets should be swallowed whole with water.
Teriflunomide Glenmark may be taken with food or independently of meals.
Taking more Teriflunomide Glenmark than prescribed
If you take more Teriflunomide Glenmark than prescribed, contact your doctor immediately.
Adverse effects may occur similar to those described in section 4 below.
Missing a dose of Teriflunomide Glenmark
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 Glenmark
Do not stop taking Teriflunomide Glenmark 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 everybody will get 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 should contact your doctor immediately.
Common (may occur in up to 1 in 10 people)

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

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

• severe liver disease, which may include symptoms such as yellowing of the skin or whites of the eyes, darker than normal urine, unexplained nausea and vomiting, or abdominal pain.

Other side effects may occur with the following frequencies:
Very common (may occur in more than 1 in 10 people)

• headache,
• diarrhoea, nausea,
• increased AlAT activity (increased activity of certain liver enzymes in blood tests) in liver function 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 when swallowing, cystitis, viral gastroenteritis, dental 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 findings: decreased number of red blood cells (anaemia), changes in the 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 anxious,
• tingling sensation, feeling weak, numbness, tingling or pain in the lower back or leg (sciatica), numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome),
• sensation of "pounding heartbeat",
• increased blood pressure,
• vomiting, toothache, epigastric pain,
• rash, acne,
• tendon, joint or bone pain, muscle pain (musculoskeletal pain),
• need to urinate more often than usual,
• heavy menstrual periods,
• pain,
• lack of energy or feeling weak (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 the nails, severe skin reactions,
• traumatic pain,
• psoriasis,
• inflammation of the mucous membrane of the mouth or lips,
• abnormal levels of fats (lipids) in the blood,
• inflammation of the large intestine.

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

• inflammation or damage to the liver.

Frequency unknown (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 any side effects occur, including any unmentioned side effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Side effects can 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 this medicine.

5. How to store Teriflunomide Glenmark

• Keep this medicine out of sight and reach of children.
• Do not use Teriflunomide Glenmark after the expiry date stated on the outer carton and blister pack following the abbreviation EXP. The expiry date refers to the last day of the stated month.
• The packaging contains Aluminium/Aluminium blisters with a desiccant moisture-absorbing agent.
• 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 help protect the environment.

6. Contents of the pack and other information

What Teriflunomide Glenmark contains:

• The active substance is teriflunomide.
• Each tablet contains 14 mg of teriflunomide.
• The other ingredients are: monohydrate lactose, maize starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), hydroxypropyl cellulose, magnesium stearate, colloidal anhydrous silica, hypromellose 2910, titanium dioxide (E 171), talc, polyethylene glycol 8000 (see section 2 "Teriflunomide Glenmark contains lactose").

What Teriflunomide Glenmark looks like and contents of the pack
Film-coated tablets, white to almost white, round (diameter ≈ 7 mm),
biconvex, with an embossed marking “G” on one side and the number “42” on the other side.
Pack sizes available:

• Single-dose perforated aluminium/aluminium blisters with a desiccant in a cardboard box containing 10x1, 14x1, 28x1, 84x1 and 98x1 film-coated tablet.
• Aluminium/aluminium blisters with a desiccant in a cardboard box containing 10, 14, 28, 84 and 98 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
Manufacturer/Importer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
This medicinal product is authorised in the European Economic Area countries under the following names:

For more detailed information about the medicinal product, please contact the local representative of the marketing authorization holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3
00-728 Warsaw
Email: [email protected]