Terebio

Package Leaflet: Information for the Patient

TEREBYO, 14 mg, 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, please inform your doctor or pharmacist. See section 4.

Table of Contents

• 1. What is Terebyo and what is it used for
• 2. Important information before taking Terebyo
• 3. How to take Terebyo
• 4. Possible side effects
• 5. How to store Terebyo
• 6. Contents of the pack and other information

1. What is Terebyo and what is it used for

What is Terebyo

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

What is Terebyo used for

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

What is multiple sclerosis

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, inflammation damages the protective covering (called myelin) of the nerves in the central nervous system. 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 among individuals but usually include:

• difficulty walking,
• vision problems,
• balance problems. These symptoms can completely disappear after a relapse, but over time, some problems may persist between relapses. This can lead to physical disability that makes it difficult to perform daily activities.

How Terebyo works

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

2. Important information before taking Terebyo

When not to take Terebyo:

Warnings and precautions

Before starting treatment with Terebyo, 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 Terebyo. See section 4.
• you have high blood pressure, whether or not it is controlled with medication. Terebyo may increase your blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before taking Terebyo, your doctor will make sure you have a sufficient number of white blood cells and platelets in your blood. Since Terebyo 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, viral infections such as herpes simplex or shingles may occur. In some cases, serious complications have occurred. You should immediately inform your doctor if you suspect any symptoms of a viral 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 plan to be vaccinated.
• you are taking leflunomide with Terebyo.
• you are switching from your current medicine to Terebyo or from Terebyo 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 cough and shortness of breath (difficulty breathing). Your doctor may perform additional tests.

Children and adolescents

Terebyo 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:
­cases of pancreatitis have been observed in patients taking teriflunomide. Your child's doctor may perform blood tests if pancreatitis is suspected.

Terebyo 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.
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 called 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 thin the blood (i.e., make it more fluid) to prevent blood clots;
• oral contraceptives (containing ethinyl estradiol and levonorgestrel);
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin, used to treat infections;
• indomethacin, ketoprofen, used to treat inflammation or pain;
• 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 Terebyo if you are pregnantor think you may be pregnant. In pregnant women or those who become pregnant while taking Terebyo, there is an increased risk of birth defects in the baby. Women of childbearing age who do not use effective contraception should not take this medicine.
If a girl starts menstruating while taking Terebyo, she should inform 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 Terebyo, she should inform her doctor, as it is essential to ensure that the medicine is no longer in her body before trying to become pregnant. The elimination of the active substance may take up to two years. This period can be shortened to a few weeks by taking specific medicines that accelerate the removal of Terebyo 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. The doctor should confirm that the level of Terebyo in the blood is low enough for the woman to become pregnant.
More information on laboratory tests can be obtained from the doctor.
In case of suspected pregnancy during treatment with Terebyo or within two years after stopping treatment, Terebyo should be discontinued, and the doctor should be immediatelycontacted to perform a pregnancy test. If the test confirms pregnancy, the doctor may suggest using specific medicines to quickly and sufficiently remove Terebyo from the body.
Contraception
During treatment with Terebyo 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 stopping treatment.

• This method should be used until the teriflunomide level in the blood is low enough (checked by the doctor).
• Discuss with your doctor the best contraceptive method for you and any need to change the contraceptive method.

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

Driving and using machines

Terebyo may cause dizziness, which can affect your ability to concentrate and react. Patients who experience such symptoms should not drive or operate machinery.

Terebyo contains lactose

Terebyo contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Terebyo contains Allura Red AC (E 129)

Allura Red AC (E 129) may cause allergic reactions.

Terebyo contains sodium

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

3. How to take Terebyo

Treatment with Terebyo will be supervised by a doctor experienced in treating 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 coated tablet per day.

Children and adolescents (aged 10 years and older)

The dose depends on body weight:

• Children with a body weight > 40 kg: one 14 mg tablet per day.
• Children with a body weight ≤ 40 kg: one 7 mg tablet per day. Since Terebyo is only available in 14 mg coated tablets, the doctor will prescribe another available medicine for this group of patients. Children and adolescents who reach a stable body weight above 40 kg will be informed by the doctor to switch to one 14 mg tablet per day.

Route and method of administration
Terebyo is taken orally. Terebyo is taken once daily at any time of day as a single dose.
Swallow the tablets whole with water.
Terebyo can be taken with or without food.

If you take more Terebyo than you should

If you take more Terebyo than you should, contact your doctor immediately. Side effects similar to those described in section 4 below may occur.

If you forget to take Terebyo

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 Terebyo

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

4. Possible side effects

Like all medicines, Terebyo 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 can be severe or may become severe if you experience any of these symptoms, contact your doctor immediately.

Very common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• allergic reactions, which may cause symptoms including rash, hives, swelling of the lips, tongue, or face, or sudden difficulty breathing;
• severe skin reactions, which may cause symptoms including skin rash, blisters, fever, or mouth sores;
• severe infections or sepsis (a life-threatening infection), which may cause symptoms including high fever, chills, shivering, reduced urine output, or disorientation;
• pneumonia, which may cause symptoms including shortness of breath or persistent cough.

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

• severe liver disease, which may cause symptoms including yellowing of the skin or whites of the eyes, darker than usual urine, unexplained nausea and vomiting, or abdominal pain.

Other side effectsmay occur with the following frequency:
Very common(may affect more than 1 in 10 people)

• headache;
• diarrhea, nausea;
• increased activity of liver enzymes (increased activity of certain liver enzymes in the blood) shown in blood 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, cystitis, viral gastroenteritis, tooth infection, laryngitis, fungal foot infection;
• herpes virus infections, including herpes simplex and shingles, with symptoms such as blisters, burning, itching, numbness, or pain of the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness;
• laboratory test results: decreased red blood cell count (anemia), changes in liver function and white blood cell count (see section 2), also increased muscle enzyme activity (creatine kinase);
• mild allergic reactions;
• feeling anxious;
• feeling of tingling, feeling of 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)

• decreased 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 the nails, severe skin reactions;
• traumatic pain;
• psoriasis;
• mouth ulcers;
• 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 Terebyo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Terebyo contains

The active substance is teriflunomide. Each coated tablet contains 14 mg of teriflunomide.
The other ingredients are:
Tablet core: lactose monohydrate, maize starch, microcrystalline cellulose, type 101D+, hydroxypropylcellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.
Tablet coating: hypromellose 2910 (6 mPas), titanium dioxide (E 171), indigo carmine, aluminum lake (E 132), glycerol, talc, brilliant blue FCF, aluminum lake (E 133), and Allura Red AC, aluminum lake (E 129).

What Terebyo looks like and contents of the pack

Blue coated tablet, biconvex, round (about 7 mm in diameter) with "14" engraved on one side.
The tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters in cartons.
Blisters containing 28 coated tablets are placed in foldable cartons (1 foldable carton of 28 tablets).

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer/Importer

Combino Pharm (Malta) Limited
HF60, Hal Far Industrial Estate
BBG3000 Birzebbuga, Malta
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben, Germany
HBM Pharma s.r.o.
Sklabinská 30
SK-036 80 Martin, Slovakia

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

Austria
Terebyo 14 mg Filmtabletten
Belgium
Terebyo 14 mg filmomhulde tabletten
Bulgaria
TEREBYO 14 mg film-coated tablet
Czech Republic
TEREBYO
Estonia
Terebyo
Germany
TEREBYO
Greece
TEREBYO ΕΠΙΚΑΛΥΜΜΕΝΟ ΜΕ ΛΕΠΤΟ ΥΜΕΝΙΟ ΔΙΣΚΙΟ 14 MG/TAB
France
TEREBYO 14 mg, comprimé pelliculé
Italy
Terebyo
Latvia
Terebyo 14 mg apvalkotās tabletes
Lithuania
Terebyo 14 mg plėvele dengtos tabletės
Poland
TEREBYO
Romania
TEREBYO 14 mg Comprimate filmate
Slovakia
TEREBYO 14 mg filmom obalené tablety
Slovenia
TEREBYO 14 mg filmsko obložene tablete
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50C
02-672 Warsaw
tel. +48 22 209 70 00
Date of last revision of the leaflet:08/2024

Other sources of information

Detailed and up-to-date information on this medicine is available by scanning the QR code on the patient leaflet with a smartphone or other device. The same information is also available at the following URL: www.sandoz-teriflunomide.com
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