Package Insert: Information for the Patient

Teriflunomida Dr. Reddys 7 mg Film-Coated Tablets

Teriflunomida Dr. Reddys 14 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

What is Teriflunomida Dr. Reddys

This medication contains the active ingredient teriflunomida, which is an immunomodulator agent that adjusts the immune system to limit its attack on the nervous system.

For what is Teriflunomida Dr. Reddys used

Teriflunomida 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 that affects the central nervous system (CNS). The CNS is formed by the brain and spinal cord. In MS, inflammation destroys the protective covering (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This makes the nerves stop functioning correctly.

People who suffer from the relapsing form of MS will have repeated attacks (recurrences) of the physical symptoms caused by the inadequate functioning of the nerves. These symptoms vary from patient to patient, but usually include:

•difficulty walking

•vision problems

•balance problems.

The symptoms may disappear completely after the recurrence but, over time, some problems may remain. This can cause physical disabilities that can interfere with daily activities.

How Teriflunomida Dr. Reddys works

Teriflunomida helps to protect against attacks in the central nervous system by the immune system, limiting the growth of some white blood cells (lymphocytes). This limits the inflammation that causes nerve damage in MS.

Do not take Teriflunomida Dr. Reddys:

In case of doubt, ask your doctor or pharmacist before taking this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Teriflunomida Dr. Reddys if:

Respiratory Reactions

Inform your doctor if you have cough and shortness of breath without explanation. Your doctor may perform additional tests.

Children and Adolescents

Teriflunomida is not indicated for use in children under 10 years of age, as it has not been studied in patients with EM in this age group.

The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:

- inflammation of the pancreas has been observed in patients receiving teriflunomida. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other Medicines and Teriflunomida Dr. Reddys

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

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

Pregnancy and Breastfeeding

Do not take teriflunomida if you are pregnant or think you may be pregnant.

Women of childbearing age should not take this medicine unless they are using reliable contraceptive methods.

If your daughter has her first menstruation while taking teriflunomida, she must inform her doctor, who will give her specialized advice on contraceptive methods and the possible risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after interrupting treatment with teriflunomida, as you need to ensure that most of this medicine has been eliminated from your body before attempting to become pregnant. The natural elimination of the active ingredient may take up to 2 years. This time period can be reduced to a few weeks by taking certain medicines to accelerate the elimination of teriflunomida from the body.

In any case, your doctor needs to confirm, from a blood test, that the level of active ingredient in the blood is low enough for you to become pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect that you are pregnant while taking teriflunomida or in the two years following the end of treatment, you must interrupt teriflunomida and contact your doctor immediately to perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest a treatment with certain medicines to eliminate teriflunomida from the body quickly and effectively, as this may reduce the risk to your baby.

Contraception

You must use an effective contraceptive method during and after treatment with teriflunomida. Teriflunomida remains in the blood for a long time after stopping treatment. Continue to take contraceptive measures after interrupting treatment.

Do not take teriflunomida during breastfeeding as teriflunomida passes into breast milk.

Driving and Operating Machines

Teriflunomida may cause dizziness, which may affect your ability to concentrate and react. If you are affected, do not drive or operate machines.

Teriflunomida Dr. Reddys contains lactose

Teriflunomida contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Teriflunomida Dr. Reddys contains sodium

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

A healthcare professional experienced in treating multiple sclerosis will supervise the treatment with teriflunomida.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (10 years of age and above)

The dose depends on body weight:

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

Your doctor will instruct children and adolescents who reach a stable body weight above 40 kg to change to one 14 mg tablet per day.

Form/administration route

Teriflunomida is administered orally.

Teriflunomida is taken once a day in a single daily dose at any time of the day.

The tablet should be swallowed whole with water.

Teriflunomida can be taken with or without food.

If you take more teriflunomida than you should

If you have taken too much teriflunomida, call 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take teriflunomida

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 teriflunomida

Do not interrupt treatment or change the dose of teriflunomida without consulting your doctor first. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

This medicine may cause the following side effects.

Severe side effects

Some side effects may be severe, if you experience any of these, inform your doctor immediately.Inform your doctor immediately.

Common(may affect up to 1 in 10 people)

-Pancreatitis that may include symptoms of abdominal pain, nausea, or vomiting (common in pediatric patients and rare in adult patients).

Uncommon(may affect up to 1 in 100 people)

• allergic reactions that may include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing
• severe skin reactions that may include symptoms of skin rash, blisters, fever, or ulcers in your mouth
• severe infections or sepsis (a type of infection that can be potentially fatal) that may include symptoms such as high fever, chills, decreased urine flow, or confusion
• lung inflammation that may include symptoms such as shortness of breath or persistent cough

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

-Severe liver disease that may include symptoms such as yellowing of the skin or eyes, darker urine than normal, nausea, and vomiting without explanation, 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 ALT (increase in certain liver enzymes in the blood) in tests
• Thinner hair

Common(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 infection of the foot
• Laboratory values: a decrease in the number of red blood cells (anemia), changes in the liver and white blood cells in tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Anxiety
• Needles, feeling weak, numbness, tingling, or pain in the lower back or leg (sciatica); feeling numb, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome)
• Palpitations
• Increased blood pressure
• Nausea, vomiting, dental pain, upper abdominal pain
• Rash, acne
• Tendon, joint, or bone pain (musculoskeletal pain)
• Increased frequency of urination
• Heavy 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 changes, severe skin reactions
• Post-traumatic pain
• Psoriasis
• Mouth or lip inflammation
• Abnormal lipid levels in blood
• Colitis (inflammation of the colon)

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

• Liver inflammation or damage

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

• Pulmonary hypertension

Children (10 years of age and older) and adolescents

The previously listed 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 type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box, and the case after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Teriflunomida Dr. Reddys

The active ingredient is teriflunomida.

Teriflunomida Dr. Reddys 7 mg film-coated tablets

Each tablet contains 7 mg of teriflunomida.

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

Teriflunomida Dr. Reddys 14 mg film-coated tablets

Each tablet contains 14 mg of teriflunomida.

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

Appearance of the product and contents of the pack

Teriflunomida 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 face.

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

Teriflunomida 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 face.

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

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacture

Holder of the Marketing Authorization

Reddy Pharma Iberia, S.A.

Avenida Josep Tarradellas nº 38

08029 Barcelona (Spain)

Telephone: 93.355.49.16

Fax: 93.355.49.61

Responsible for Manufacture

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Iceland

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last revision date of this leaflet:April 2023

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