Teriflunomide Glenmark

Patient Information Leaflet

Teriflunomide Glenmark

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Teriflunomide Glenmark is and what it is used for
  2. What you need to know 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 and modulates the immune system to limit its attacks on the nervous system.

What Teriflunomide Glenmark is used for
Teriflunomide Glenmark is used in adults, children, and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS).

What is multiple sclerosis
MS is a long-term disease affecting the central nervous system (CNS), a system made up of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (called myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. It prevents nerves from functioning properly.

People with relapsing forms of multiple sclerosis experience repeated attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient but generally include:

• difficulty walking
• vision problems
• balance problems

Symptoms may completely disappear after a relapse, but over time some problems may persist between relapses. This can lead to physical disability that may interfere with daily activities.

How Teriflunomide Glenmark works
Teriflunomide Glenmark helps protect the central nervous system from immune system attacks by limiting the increase of certain white blood cells (lymphocytes). This reduces the inflammation that leads to nerve damage characteristic of MS.

2. What you need to know before taking Teriflunomide Glenmark

Do not take Teriflunomide Glenmark

• if you are allergic to teriflunomide or to any of the other ingredients of this medicine (listed in section 6),
• if you have developed a severe skin rash or skin peeling, blistering and/or mouth ulcers after taking teriflunomide or leflunomide,
• if you have severe liver problems,
• if you are pregnant, suspect you may be pregnant, or are breastfeeding,
• if you have any serious condition affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS),
• if you have any serious bone marrow disorder or have low numbers of red blood cells or white blood cells in your blood or a reduced number of platelets,
• if you have a serious infection,
• if you have severe kidney problems requiring dialysis,
• if you have very low levels of protein in your blood (hypoproteinemia). If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Teriflunomide Glenmark if:

• you have liver problems and/or consume large amounts of alcohol. Your doctor will request blood tests before and during treatment to monitor liver function. If blood test results show a liver problem, your doctor may ask you to stop treatment with Teriflunomide Glenmark. See section 4.
• you have high blood pressure (hypertension), whether or not it is controlled with medication. Teriflunomide Glenmark may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly thereafter. See section 4.
• you have an infection. Before taking Teriflunomide Glenmark, your doctor will check that your white blood cell and platelet counts are adequate. Since Teriflunomide Glenmark reduces the number of white blood cells in the blood, this may affect your ability to fight infections. If you suspect you have an infection, your doctor may perform blood tests to monitor your white blood cells. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you experience weakness, numbness, or pain in your hands or feet.
• you are due to receive a vaccination.
• you are taking leflunomide together with Teriflunomide Glenmark.
• you are switching to or from treatment with Teriflunomide Glenmark.
• you need to undergo a specific blood test (calcium level). You may have falsely low calcium levels.

Respiratory reactions

Inform your doctor if you develop unexplained cough or shortness of breath (dyspnea). Your doctor may carry out further investigations.

Children and adolescents

Teriflunomide Glenmark is not indicated in children under 10 years of age, as it has not been studied in patients with MS in this age group. The warnings and precautions listed above also apply to children. The following information is important for children and those caring for them:

• Pancreatitis has been observed in patients taking teriflunomide. Your child’s doctor may perform blood tests if pancreatitis is suspected.

Other medicines and Teriflunomide Glenmark

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• leflunomide, methotrexate, and other medicines that affect the immune system (commonly called immunosuppressants or immunomodulators)
• rifampicin (a medicine used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin for epilepsy
• St. John’s wort (a herbal medicine for depression)
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, urinary incontinence, or kidney problems in diabetics
• alosetron for management of severe diarrhoea
• theophylline for 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 for infections
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart conditions
• cimetidine for reducing stomach acid
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolaemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• cholestyramine for high cholesterol or relief of itching in liver diseases
• activated charcoal to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding

Do not take Teriflunomide Glenmark if you are pregnant or suspect you may be pregnant. If you become pregnant while taking Teriflunomide Glenmark, the risk of birth defects in the baby increases. Women of childbearing potential must not take this medicine without using reliable contraceptive measures.

If your daughter starts menstruation while taking Teriflunomide Glenmark, inform your doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after stopping treatment with Teriflunomide Glenmark, because you must ensure that most of the medicine has been eliminated from your body before planning a pregnancy. Elimination of the active substance may take up to 2 years to occur naturally. This period can be reduced to a few weeks by taking certain medicines that accelerate the elimination of Teriflunomide Glenmark from the body.

In any case, a blood test must confirm that the active substance has been sufficiently eliminated from your body, and you must wait for your doctor’s confirmation that the level of Teriflunomide Glenmark in your blood is low enough to allow pregnancy.

For further information on laboratory tests, consult your doctor.

If you suspect you are pregnant while taking Teriflunomide Glenmark or within two years after stopping treatment, you must stop taking Teriflunomide Glenmark and contact your doctor immediately to have a pregnancy test. If the test confirms pregnancy, your doctor may recommend treatment with certain medicines to rapidly and sufficiently eliminate Teriflunomide Glenmark from your body, as this may reduce the risk to the fetus.

Contraception

You must use an effective method of contraception during and after treatment with Teriflunomide Glenmark. Teriflunomide remains in the blood for a long time after stopping treatment. Continue using effective contraception after stopping treatment.

• Continue until the levels of Teriflunomide Glenmark in your blood are sufficiently low. Your doctor will monitor them.
• Discuss with your doctor the best contraceptive method for you and if any change in contraception is needed.

Do not take Teriflunomide Glenmark if you are breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines

Teriflunomide Glenmark may cause dizziness, which could impair your ability to concentrate and react. Do not drive or operate machinery if you experience this symptom.

Teriflunomide Glenmark contains lactose

Teriflunomide Glenmark contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Teriflunomide Glenmark contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Teriflunomide Glenmark

Treatment with Teriflunomide Glenmark must be supervised by a physician experienced in the
treatment of multiple sclerosis.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor.
Adults
The recommended dose is one 14 mg tablet daily.
Children and adolescents (aged 10 years or older)
The dose depends on body weight:

• Children with body weight above 40 kg: one 14 mg tablet daily.
• Children with body weight less than or equal to 40 kg: one 7 mg tablet daily. Teriflunomide Glenmark is not available in the 7 mg dosage strength. For this dosage, other teriflunomide-containing medicines available on the market must be used. Children and adolescents who reach a stable body weight above 40 kg will be instructed by their doctor to switch to one 14 mg tablet daily.

Route of administration
Teriflunomide Glenmark is for oral use. Teriflunomide Glenmark is taken every day as a single daily dose at any time of the day. The tablet should be swallowed whole with some water. Teriflunomide Glenmark may be taken with or without food.

If you take more Teriflunomide Glenmark than you should
If you have taken too much Teriflunomide Glenmark, contact your doctor immediately. You may
experience adverse 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 the missed tablet. Take the next dose at the scheduled time.

If you stop taking Teriflunomide Glenmark
Do not stop using Teriflunomide Glenmark or change the dose without first talking to your
doctor.
If you have any questions about how to use 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 with this medicine.
Serious side effects
Some side effects may be or may become serious. Contact your doctor immediately if you notice any of the following serious side effects.
Common (may affect 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 paediatric patients 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 breathing difficulties
• Severe skin reactions which may include symptoms such as rash, blisters, fever, or mouth ulcers
• Severe infections or sepsis (a type of infection that may be life-threatening) which may include symptoms such as high fever, shaking, chills, reduced urine output, or confusion
• Inflammation of the lungs which may include symptoms such as shortness of breath or persistent cough.

Not known (frequency cannot be estimated from the available data)

• Severe liver diseases which may include symptoms such as yellowing of the skin or whites of the eyes, dark urine, unexplained nausea and vomiting, or abdominal pain. Other side effects may occur with the following frequencies: Very common (may affect more than 1 in 10 people)
• Headache
• Diarrhoea, nausea
• Increased ALT (elevated levels of certain liver enzymes in the blood) detected by blood tests
• Hair thinning.

Common (may affect 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, oral herpes, dental infection, laryngitis, fungal foot infection
• Laboratory tests: decreased number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), and increases in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling anxious
• Tingling, weakness, numbness, tingling or pain in the lower back or legs (sciatica); numbness, tingling or pain in the hands and fingers (carpal tunnel syndrome)
• Awareness of 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 weak (asthenia)
• Weight loss.

Uncommon (may affect up to 1 in 100 people)

• Decreased number of platelets (mild thrombocytopenia)
• Increased sensitivity, particularly of the skin; stabbing or pulsating pain in one or more nerves, nerve problems in the arms or legs (peripheral neuropathy)
• Nail disorders, severe skin reactions
• Post-traumatic pain
• Psoriasis
• Inflammation of the mouth/lips
• Abnormal levels of fats (lipids) in the blood
• Inflammation of the colon (colitis).

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

• Inflammation or damage to the liver.

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 those caring for them:
Common (may affect up to 1 in 10 people)

• Inflammation of the pancreas.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 this medicine after the expiry date which is stated on the label after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Teriflunomide Glenmark contains

• The active substance is teriflunomide.
• Each tablet contains 14 mg of teriflunomide.
• The other components are monohydrate lactose, maize starch, sodium starch glycolate (Type A), hydroxypropylcellulose (E463), microcrystalline cellulose (E460), magnesium stearate (E470b), anhydrous colloidal silica, hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol (E1521), indigo carmine aluminium lake (E132) (see section 2 “Teriflunomide Glenmark contains lactose”).

Description of the appearance of Teriflunomide Glenmark and package contents
Teriflunomide Glenmark are film-coated tablets, blue to dark blue, round (diameter ≈ 7.00 mm), biconvex, with "G" engraved on one side and "42" on the other side.

Teriflunomide Glenmark 14 mg film-coated tablets are packaged in:

• Perforated, divisible unit-dose blisters in aluminium/aluminium with desiccant, in cardboard boxes containing 10x1, 14x1, 28x1, 84x1 and 98x1 film-coated tablets
• Aluminium/aluminium blisters with desiccant in cardboard boxes containing 10, 14, 28, 84 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31, 82194
Gröbenzell, Germany

Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibichovo 143 Prazske Predmesti - Vysoke Myto
56617 Czech Republic

Synoptis Industrial Sp. Z.o.o.
Ul. Rabowicka, 15
Jasin – Wielkopolskie
62-020 Poland