THEDITRAX 14 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Theditrax 14 mg film-coated tablets EFG

teriflunomide

Read 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Theditrax and what is it used for

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

What Theditrax 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 that affects the central nervous system (CNS). The CNS is made up of the brain and spinal cord. In multiple sclerosis, 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 working properly.

People with the relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by the poor functioning of the nerves. These symptoms vary from person to person but usually include:

• difficulty walking,
• vision problems,
• balance problems.

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

How Theditrax works

This medicine helps protect against attacks on 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.

2. What you need to know before you take Theditrax

Do not take Theditrax:

• if you are allergic to teriflunomide or 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 ulcers in the mouth after taking teriflunomide or leflunomide,
• if you have severe liver problems,
• if you are pregnant, think you may be pregnant, or are breast-feeding,
• if you have a serious immune system problem, for example, acquired immune deficiency syndrome (AIDS),
• if you have serious bone marrow problems or if you 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 severe infection,
• if you have severe kidney problems that require dialysis,
• if you have a low level of proteins in the blood (hypoproteinemia),

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 this medicine:

• if you have liver problems and/or if you drink large amounts of alcohol. Your doctor may perform blood tests to check your liver function before and during treatment. If the test results indicate a liver problem, your doctor may stop treatment with this medicine. See section 4.
• if you have high blood pressure (hypertension), whether or not you are being treated for it. This medicine may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. See section 4.
• if you have an infection. Before you start taking this medicine, your doctor will make sure you have enough white blood cells and platelets in your blood. Since this medicine decreases the number of white blood cells in the blood, it may affect your ability to fight infection. Your doctor may perform blood tests to check your white blood cells if they think you have an infection. With treatment with teriflunomide, viral herpes infections, including oral herpes or shingles (herpes zoster), may occur. In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect you have any symptoms of viral herpes infection. See section 4.
• if you have severe skin reactions.
• if you have respiratory symptoms.
• if you have weakness, numbness, and pain in hands and feet.
• if you are going to be vaccinated.
• if you are taking leflunomide with this medicine.
• if you are being switched from or to this medicine.
• if you are scheduled to have a specific blood test (calcium level). A false decrease in calcium levels may be detected.

Respiratory reactions

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

Children and adolescents

This medicine 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:

• pancreatitis has been observed in patients receiving teriflunomide. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other medicines and Theditrax

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

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

• leflunomide, methotrexate, and other medicines that affect the immune system (often referred to as immunodepressants 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 more fluid) and prevent clots
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indomethacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine to reduce stomach acid
• zidovudine for AIDS
• rosuvastatin, simvastatin, atorvastatin, pravastatin for high cholesterol
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• cholestyramine for high cholesterol or relief of itching in liver disease
• activated charcoal to reduce the absorption of medicines or other substances.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking this medicine, there is an increased risk of having a baby with birth defects. Women of childbearing age must not take this medicine if they are not using reliable contraceptive methods.

If your daughter has her first menstrual period while taking this medicine, she must inform her doctor, who will provide specialized advice on contraceptive methods and potential risks in case of pregnancy.

Tell your doctor if you plan to become pregnant after stopping treatment with this medicine, as you need to make sure that most of this medicine has been eliminated from your body before trying to become pregnant. The natural elimination of the active substance may take up to 2 years. This period can be reduced to a few weeks by taking certain medicines to accelerate the elimination of this medicine from the body.

In any case, you need your doctor to confirm, based on a blood test, that the level of the active substance in your blood is low enough for you to become pregnant.

For more information on laboratory tests, contact your doctor.

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

Contraception

You must use an effective contraceptive method during and after treatment with this medicine. Teriflunomide remains in the blood for a long time after stopping it. Continue to take contraceptive measures after stopping treatment.

• Do so until the levels of this medicine in your blood are low enough (your doctor will check this).
• Ask your doctor about the best contraceptive method for you and in case you need to change methods.

Do not take this medicine during breast-feeding, as teriflunomide passes into breast milk.

Driving and using machines

This medicine may cause dizziness, which can affect your ability to concentrate and react. If you are affected, do not drive or use machines.

Theditrax contains lactose

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

Theditrax contains sodium

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

3. How to take Theditrax

A doctor with experience in the treatment of multiple sclerosis will supervise treatment with this medicine.

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, consult your doctor again.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (10 years of age and older)

The dose depends on body weight:

• children with a body weight over 40 kg: one 14 mg tablet once a day.
• children with a body weight of 40 kg or less: other medicines containing teriflunomide at different concentrations are suitable for children and adolescents from 10 years of age with a body weight of 40 kg or less; ask your doctor or pharmacist about the availability of this medicine in other concentrations.

Your doctor will instruct children and adolescents who reach a stable body weight of over 40 kg to switch to a 14 mg tablet per day.

Teriflunomide 14 mg film-coated tablets are not suitable for pediatric patients with a body weight of 40 kg or less.

Method of administration

This medicine is taken orally. This medicine is taken once a day in a single daily dose at any time of day.

The tablet should be swallowed whole with water.

This medicine can be taken with or without food.

If you take more Theditrax than you should

If you have taken too much of this medicine, call your doctor immediately. You may experience side effects similar to those described in section 4 (below).

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

If you forget to take Theditrax

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

If you stop taking Theditrax

Do not stop treatment or change the dose of this medicine 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 with this medicine.

Serious side effects

Some side effects may be serious, if you experience any of these, tell 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 uncommon in adult patients).

Uncommon(may affect up to 1 in 100 people)

• allergic reactions that could include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing,
• severe skin reactions that could include symptoms of skin rash, blisters, fever, or ulcers in the mouth,
• severe or life-threatening infections that could include symptoms such as high fever, chills, shaking, decreased urine flow, or confusion,
• inflammation of the lungs that could include symptoms such as shortness of breath or persistent cough.

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

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

Other side effectsmay occur with the following frequencies:

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

• headache,
• diarrhea, feeling unwell,
• increased ALT (increase in certain liver enzymes in the blood) in blood tests,
• thinning of 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, dental infection, laryngitis, fungal infection of the foot,
• herpes virus infections, including oral herpes and shingles (herpes zoster), with symptoms such as blisters, burning, itching, numbness, or pain in the skin, usually on one side of the upper body or face, and other symptoms, such as fever and weakness
• laboratory values: a decrease in the number of red blood cells (anemia), changes in liver and white blood cells in tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase),
• mild allergic reactions,
• feeling anxious,
• tingling, 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,
• feeling sick (vomiting), toothache, pain in the upper abdominal region,
• rash, acne,
• pain in tendons, joints, bones, muscle pain (musculoskeletal pain),
• need to urinate more often than usual,
• heavy periods,
• pain,
• lack of energy or weakness (asthenia),
• weight loss.

Uncommon(may affect up to 1 in 100 people)

• decrease in the number of platelets (mild thrombocytopenia),
• increased sensitivity, especially in the skin; stabbing or pulsating pain in one or more nerves; problems in the nerves of the arms and legs (peripheral neuropathy),
• changes in the nails, 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 patients)

• liver inflammation or damage.

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

• pulmonary hypertension.

Children (10 years of age 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 affect up to 1 in 10 people)

• pancreatitis.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Theditrax

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 carton and blister after "EXP". The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Theditrax

The active substance is teriflunomide.

• Each tablet contains 14 mg of teriflunomide.
• The other ingredients (excipients) are lactose monohydrate, corn starch, microcrystalline cellulose 102, sodium carboxymethyl starch (type A) (potato), hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, coating material Opadry 03F220186 yellow [Composed of: HPMC 2910/hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol/PEG (E1521), yellow iron oxide (E172)] (see section 2 "Theditrax contains lactose").

Appearance of the product and package contents

The film-coated tablets are light yellow or pastel yellow in color, pentagonal in shape, 7.3 ± 0.2 mm in diameter, and 3.8 ± 0.5 mm in thickness, engraved with "14" on one side.

The medicine is packaged in a cardboard box containing OPA/AL/PVC-AL blisters.

Package size of 28, 84 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmathen S.A.

Dervenakion 6 Str.

15351 Pallini, Attiki

Greece

Manufacturer

Pharmathen S.A.

Dervenakion 6 Str.

15351 Pallini, Attiki

Greece

Or

Pharmathen International S.A.,

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

69300 Rodopi,

Greece

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

Date of last revision of this leaflet: March 2024

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