Teriflunomide Glenmark

Package Leaflet: Information for the Patient

Teriflunomide Glenmark, 14 mg, Film-Coated Tablets

Teriflunomide

Read the package leaflet carefully before taking the medicine, as 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What Teriflunomide Glenmark is and what it is used for
• 2. Important information before taking 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 used to treat multiple sclerosis.

What Teriflunomide Glenmark is used for

Teriflunomide Glenmark is used to treat adults and children (aged 10 years and older) with relapsing-remitting multiple sclerosis.

What multiple sclerosis is

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, the protective covering (myelin) around the nerves in the central nervous system is damaged. 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 often 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 interferes with daily activities.

How Teriflunomide Glenmark works

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

2. Important information before taking Teriflunomide Glenmark

When not to take Teriflunomide Glenmark

• if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had a severe skin reaction or liver damage after taking teriflunomide or leflunomide,
• if you have severe liver disease,
• if you are pregnant, think you may be pregnant, or are breastfeeding,
• if you have any severe immune system disorders, such as AIDS,
• if you have any severe bone marrow disorders or a low white blood cell count or low platelet count,
• if you have any severe infections,
• if you have severe kidney disease requiring dialysis,
• if you have very low protein levels in your blood (hypoproteinemia). If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Teriflunomide Glenmark, discuss with your doctor or pharmacist if:

• you have liver problems and/or drink large amounts of alcohol. Your doctor may perform blood tests to check if your liver is working properly before and during treatment. If your test results show liver problems, your doctor may stop Teriflunomide Glenmark. See section 4.
• you have high blood pressure, whether or not it is controlled with medication. Teriflunomide Glenmark may increase blood pressure. Your doctor will check your blood pressure before starting treatment and during treatment. See section 4.
• you have an infection. Before taking Teriflunomide Glenmark, your doctor will make sure you have enough white blood cells and platelets in your blood. Because Teriflunomide Glenmark reduces the number of white blood cells in your blood, it may affect your ability to fight infections. Your doctor may perform a blood test to check your white blood cell count if you think you have an infection. During treatment with teriflunomide, herpes virus infections (such as cold sores or shingles) may occur. In some cases, serious complications have occurred. You should immediately tell your doctor if you suspect you have any symptoms of a herpes virus infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, and pain in your hands and feet.
• you are planning to receive a vaccination.
• you are taking leflunomide with Teriflunomide Glenmark.
• you are switching from your current medicine to Teriflunomide Glenmark or from Teriflunomide Glenmark to another medicine.
• you need to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely low.

Respiratory reactions

Tell your doctor if you experience unexplained coughing and shortness of breath (difficulty breathing). Your 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 this age group with multiple sclerosis. 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. Your doctor may perform a blood test if pancreatitis is suspected.

Teriflunomide Glenmark 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.

• leflunomide, methotrexate, and other 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 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 (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 and breastfeeding

Do nottake Teriflunomide Glenmark if you are pregnantor think you may be pregnant. If you are pregnant or think you may be pregnant while taking Teriflunomide Glenmark, the risk of birth defects is higher for your baby. Women of childbearing age who are not using effective contraception must not take this medicine.

If a girl starts menstruating while taking Teriflunomide Glenmark, she should tell 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 Glenmark, she should tell her doctor, as it is essential to ensure that the medicine is no longer in her body before trying to become pregnant. The removal 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 removal of Teriflunomide Glenmark 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. Your doctor should confirm that the level of Teriflunomide Glenmark in your blood is low enough for you to become pregnant.

For more information on laboratory tests, consult your doctor.

If you suspect you are pregnant while taking Teriflunomide Glenmark or within 2 years after stopping treatment, stop taking Teriflunomide Glenmark and immediatelycontact your doctor to perform a pregnancy test. If the test confirms you are pregnant, your doctor may suggest taking certain medicines to quickly and sufficiently remove Teriflunomide Glenmark from your body to reduce the risk to your baby.

Contraception

While taking Teriflunomide Glenmark 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 treatment has stopped.

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

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

Driving and using machines

Teriflunomide Glenmark may cause dizziness, which may affect your ability to concentrate and react. If you experience such symptoms, do not drive or operate machinery.

Teriflunomide Glenmark contains lactose

Teriflunomide Glenmark contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Teriflunomide Glenmark contains sodium

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

3. How to take Teriflunomide Glenmark

The use of Teriflunomide Glenmark will be supervised by a doctor experienced in the treatment of multiple sclerosis.

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 a body weight above 40 kg: one 14 mg tablet per day. Children with a body weight of 40 kg or less: one 7 mg tablet per day. Teriflunomide Glenmark 7 mg is not available. If this dose is necessary, another teriflunomide-containing medicine with this 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 about changing the dose to one 14 mg tablet per day.

Route and method of administration

Teriflunomide Glenmark is taken orally. Teriflunomide Glenmark should be taken once daily at any time as a single daily dose.

Tablets should be swallowed whole with water.

Teriflunomide Glenmark can be taken with or without food.

If you take more Teriflunomide Glenmark than you should

If you take more Teriflunomide Glenmark than you should, contact your doctor immediately. You may experience side effects similar to those described in section 4 below.

If you forget to take Teriflunomide Glenmark

Do not take a double dose to make up for a forgotten tablet. Take the next dose at the scheduled time.

If you stop taking Teriflunomide Glenmark

Do not stop taking Teriflunomide Glenmark or change the dose without consulting your doctor first.

If you have any further questions on the use of this medicine, ask 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 taking this medicine:

Severe side effects

Some side effects may be severe or may become severe if you experience any of these symptoms, contact your doctor immediately.

Common(may affect up to 1 in 10 people)

• pancreatitis, which may include symptoms such as abdominal pain, nausea, or vomiting (common in children and adolescents and uncommon in adult patients).

Uncommon(may affect 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 difficulty breathing,
• severe skin reactions, which may include symptoms such as skin rash, blisters, fever, or ulcers in the mouth,
• severe infections or sepsis (a life-threatening infection), which may include symptoms such as high fever, chills, shivering, reduced urine output, or confusion,
• pneumonia, which may include symptoms such as shortness of breath or persistent cough.

Frequency not known(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 usual urine, nausea, and vomiting of unknown origin, or abdominal pain.

Other side effectsmay occur with the following frequencies:

Very common(may affect more than 1 in 10 people)

• headache,
• diarrhea, nausea,
• increased liver enzyme levels in liver function tests,
• hair thinning.

Common(may affect up to 1 in 10 people)

• flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat, and discomfort when swallowing,
• herpes virus infections, including cold sores and shingles, with symptoms such as blisters, burning, itching, numbness, or pain on 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 are increased muscle enzyme levels (creatine kinase),
• mild allergic reactions,
• feeling anxious,
• feeling of tingling, weakness, numbness, tingling, or pain in the lower back or leg (sciatica), feeling of numbness, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome),
• feeling of "heart pounding",
• increased blood pressure,
• vomiting, toothache, abdominal pain,
• skin rash, acne,
• tendon, joint, bone, or 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)

• 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 nail condition, severe skin reactions,
• post-traumatic pain,
• psoriasis,
• mouth ulcers or mouth sores,
• abnormal blood lipid levels,
• colitis.

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

• liver inflammation or damage.

Frequency not known(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:

Common(may affect up to 1 in 10 people)

• pancreatitis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

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:

Jerozolimskie Avenue 181C, 02-222 Warsaw

Phone: +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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teriflunomide Glenmark

• Keep this medicine out of the sight and reach of children.
• Do not use Teriflunomide Glenmark after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
• The pack contains aluminum/aluminum blisters with a desiccant
• do not store above 30°C.
• Medicines should 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 Glenmark contains:

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

What Teriflunomide Glenmark looks like and contents of the pack

White to almost white, round (diameter = approximately 7 mm), biconvex, film-coated tablets with "G" engraved on one side and "42" on the other side.

Available pack sizes:

• Perforated unit dose aluminum/aluminum blisters with a desiccant in a cardboard box containing 10x1, 14x1, 28x1, 84x1, and 98x1 film-coated tablets.
• Aluminum/aluminum 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 authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

For further information on this medicine, contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.

Dziekońskiego 3

00-728 Warsaw

Email: poland.receptionist@glenmarkpharma.com

Date of last revision of the leaflet:September 2024