Teriflunomide Dr. Reddy's 14 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Teriflunomide Dr. Reddy's 7 mg Film-coated Tablets EFG

Teriflunomide Dr. Reddy's 14 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Teriflunomide Dr. Reddys is and what it is used for

What Teriflunomide Dr. Reddys is

This medicine contains the active substance teriflunomide, which is an immunomodulatory agent that modulates the immune system to limit its attack on the nervous system.

What Teriflunomide Dr. Reddys is used for

Teriflunomide is used in adults and in children and adolescents (10 years of age and older) to treat relapsing-remitting multiple sclerosis (MS).

What is multiple sclerosis

MS is a long-term disease affecting the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This causes the nerves to malfunction.

People with the relapsing form of multiple sclerosis will experience repeated attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from person to person but typically include:

• difficulty walking
• vision problems
• balance problems.

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

How Teriflunomide Dr. Reddys works

Teriflunomide helps protect against immune system attacks on the central nervous system by inhibiting the growth of certain white blood cells (lymphocytes). This reduces the inflammation that causes nerve damage in MS.

2. What you need to know before starting Teriflunomide Dr. Reddys

Do not take Teriflunomide Dr. Reddys:

• if you are allergic to teriflunomide or to any of the other ingredients of this medicine (listed in section 6),
• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth ulcers after taking teriflunomide or leflunomide,
• if you have severe liver problems,
• if you are pregnant, think you may be pregnant, or are breastfeeding,
• if you have a serious disorder affecting the immune system, for example, acquired immunodeficiency syndrome (AIDS),
• if you have serious bone marrow problems or have a low number of white blood cells or red blood cells in the 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 the blood (hypoproteinemia),

If in doubt, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Teriflunomide Dr. Reddy's if:

• you have liver problems and/or drink large amounts of alcohol. Your doctor may carry out blood tests to check your liver function before and during treatment. If test results indicate a problem with your liver, your doctor may discontinue treatment with teriflunomide. See section 4.
• you have high blood pressure (hypertension), whether or not you are receiving treatment for it. Teriflunomide may cause an increase in blood pressure. Your doctor will monitor your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before you start taking teriflunomide, your doctor will ensure that you have adequate levels of white blood cells and platelets in your blood. Since teriflunomide reduces the number of white blood cells, this may affect your ability to fight infections. Your doctor may perform blood tests to monitor your white blood cell count if an infection is suspected. Treatment with teriflunomide may lead to infections caused by the herpes virus, including oral herpes or herpes zoster (shingles). In some cases, serious complications have occurred. Inform your doctor immediately if you suspect any symptoms of herpes virus infection. See section 4.
• you experience severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, or pain in your hands and feet.
• you are due to be vaccinated.
• you are taking leflunomide together with teriflunomide.
• you are switching medication to or from teriflunomide.
• you are scheduled for a specific blood test (calcium level). A false decrease in calcium levels may be detected.

Respiratory reactions

Inform your doctor if you have unexplained cough or dyspnea (shortness of breath). Your doctor may carry out additional tests.

Children and adolescents

Teriflunomide is not indicated for use 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 their caregivers:

• Pancreatic inflammation has been observed in patients receiving teriflunomide. Your child's doctor may perform blood tests if pancreatic inflammation is suspected.

Other medicines and Teriflunomide Dr. Reddys

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes over-the-counter medicines.

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 (often 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 disease in diabetics
• alosetron for severe diarrhea
• theophylline for asthma
• tizanidine, a muscle relaxant
• warfarin, an anticoagulant to thin the blood (make it less thick) and prevent clots
• oral contraceptives (ethinylestradiol, levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine to reduce gastric acid
• zidovudine for AIDS
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• colestyramine for high cholesterol or relief of itching in liver disease
• activated charcoal to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding

Do not take teriflunomide if you are pregnant or think you might be pregnant. If you are pregnant or become pregnant while taking teriflunomide, there is an increased risk of having a baby with birth defects.

Women of childbearing potential must not take this medicine unless they are using reliable contraceptive methods.

If your daughter starts menstruation while taking teriflunomide, you must inform the doctor, who will provide specialized advice regarding contraception and the potential risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after stopping treatment with teriflunomide, as you must ensure that most of the medicine has been eliminated from your body before attempting to conceive. Natural elimination of the active substance may take up to 2 years. This time period can be reduced to a few weeks by taking certain medications to accelerate the elimination of teriflunomide from the body.

In any case, your doctor must confirm, through a blood test, that the level of active substance in the blood is low enough to allow pregnancy.

For further information about laboratory testing, please contact your doctor.

If you suspect you are pregnant while taking teriflunomide or within two years after stopping treatment, you must stop taking teriflunomide and contact your doctor immediately to perform a pregnancy test. If pregnancy is confirmed, your doctor may recommend treatment with certain medications to rapidly and sufficiently eliminate teriflunomide from the body, as this may reduce the risk to your baby.

Contraception

You must use an effective method of contraception during and after treatment with teriflunomide. Teriflunomide remains in the blood for a long period after you stop taking it. Continue using contraceptive measures after stopping treatment.

• Continue doing so until teriflunomide blood levels are sufficiently low (your doctor will verify this).
• Consult your doctor about the most suitable contraceptive method for you and if you need to change methods.

Do not take teriflunomide during breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines

Teriflunomide may cause dizziness, which can affect the ability to concentrate and react. If affected, do not drive or operate machinery.

Teriflunomide Dr. Reddy's contains lactose

Teriflunomide contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Teriflunomide Dr. Reddy's contains sodium

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

3. How to take Teriflunomide Dr. Reddys

A doctor experienced in the treatment of multiple sclerosis will supervise treatment with teriflunomide.

Always follow exactly the instructions for use given by your doctor. If you are not sure, check with your doctor again.

Adults

The recommended dose is one 14 mg tablet daily.

Children and adolescents (10 years of age and above)

The dose depends on body weight:

• children with body weight greater than 40 kg: 14 mg once daily.
• children with body weight less than or equal to 40 kg: 7 mg once daily.

Your doctor will instruct children and adolescents who reach a stable body weight above 40 kg to switch to a 14 mg tablet once daily.

Form/route of administration

Teriflunomide is administered orally.

Teriflunomide is taken every day as a single daily dose at any time of the day.

The tablet should be swallowed whole with water.

Teriflunomide may be taken with or without food.

If you take more teriflunomide than you should

If you have taken too much teriflunomide, contact your doctor immediately. You may experience adverse effects similar to those described in section 4 below.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take teriflunomide

Do not take a double dose to make up for missed doses. Take your next dose at the scheduled time.

If you interrupt treatment with teriflunomide

Do not stop treatment or change the dose of teriflunomide without first consulting your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The following adverse effects may occur with this medicine.

Serious adverse effects

Some adverse effects may be or may become serious. If you experience any of these, contact your doctor immediately.

Frequent (may affect up to 1 in 10 people)

• Inflammation of the pancreas, which may include symptoms of abdominal pain, nausea, or vomiting (frequent in pediatric patients and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 people)

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

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

• Severe liver disease, which may include symptoms such as yellowing of the skin or whites of the eyes, abnormally dark urine, unexplained nausea and vomiting, or abdominal pain.

Other adverse effects may occur with the following frequencies:

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

• Headache
• Diarrhea, feeling unwell
• Increased ALT (elevation of certain liver enzymes in blood tests)
• Thinner hair

Frequent (may affect up to 1 in 10 people)

• Flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and difficulty swallowing, cystitis, viral gastroenteritis, oral herpes, dental infection, laryngitis, fungal foot infection
• Laboratory findings: decreased red blood cell count (anemia), changes in liver function and white blood cells in blood tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling of anxiety
• Muscle soreness, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica); sensation of numbness, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome)
• Palpitations
• Increased blood pressure
• Feeling unwell (vomiting), toothache, upper abdominal pain
• Rash, acne
• Tendon, joint, or bone pain, muscle pain (musculoskeletal pain)
• Need to urinate more often than normal
• Heavy menstrual periods
• Pain
• Lack of energy or weakness (asthenia)
• Weight loss

Uncommon (may affect up to 1 in 100 people)

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

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

• Liver inflammation or liver damage

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

• Pulmonary hypertension

Children (aged 10 years and older) and adolescents

The adverse effects listed above 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)

• Inflammation of the pancreas

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomide Dr. Reddy's

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and the blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of any containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Teriflunomide Dr. Reddys

The active substance is teriflunomide.

Teriflunomide Dr. Reddys 7 mg film-coated tablets

Each tablet contains 7 mg of teriflunomide.

The other components are monohydrate lactose, microcrystalline cellulose, corn starch, sodium carboxymethyl potato starch (Type A), hydroxypropylcellulose, magnesium stearate, hypromellose, calcium carbonate, triacetin.

Teriflunomide Dr. Reddys 14 mg film-coated tablets

Each tablet contains 14 mg of teriflunomide.

The other components are monohydrate lactose, microcrystalline cellulose, corn starch, sodium carboxymethyl potato starch (Type A), hydroxypropylcellulose, magnesium stearate, hypromellose, calcium carbonate, triacetin, indigo carmine aluminium lake (E132).

Nature of the product and contents of the container

Teriflunomide Dr. Reddys 7 mg film-coated tablets

The 7 mg film-coated tablets are round, white, 6 mm in diameter and marked with an "O" on one side.

Pack sizes: 28, 28x1 or 84 film-coated tablets

Teriflunomide Dr. Reddys 14 mg film-coated tablets

The 14 mg film-coated tablets are round, blue, 7 mm in diameter and marked with "C14" on one side.

Pack sizes: 28, 28x1, 56, 84 or 98 film-coated tablets

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Telephone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Iceland

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

Date of the last review of this leaflet: April 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es.