Tifai

Leaflet accompanying the packaging: patient information

TIFAY, 14 mg, coated tablets

teriflunomide

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tifay and what is it used for

What is Tifay

Tifay contains the active substance teriflunomide, which is an immunomodulating medicine regulating the immune system to limit its attack on the nervous system.

What is Tifay used for

This medicine is used to treat adults and children and adolescents (aged 10 years and older) with multiple sclerosis (MS) with a relapsing-remitting course.

What is multiple sclerosis (MS)

MS is a chronic disease that attacks the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective covering (called myelin) around the nerves in the CNS. This process is called demyelination. It prevents the nerves from functioning properly.

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

These symptoms may completely disappear after the relapse has resolved, but over time, some problems may persist between relapses. This can lead to physical disability that makes it difficult to perform daily activities.

How Tifay works

This medicine 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 MS patients leads to nerve damage.

2. Important information before taking Tifay

When not to take Tifay:

Warnings and precautions

Before starting Tifay, the doctor or pharmacist should be consulted if the patient:

• has liver function disorders and/or drinks large amounts of alcohol; the doctor may perform blood tests to check if liver function is normal before and during treatment. If the patient's test results show liver function disorders, the doctor may stop Tifay. See section 4.
• has high blood pressure, regardless of whether it is controlled with medication or not. This medicine may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly during treatment. See section 4.
• has an infection. Before taking Tifay, the doctor will ensure that the patient has a sufficient number of white blood cells and platelets in their blood. Since this medicine reduces the number of white blood cells in the blood, it may affect the ability to fight infections. The doctor may perform a blood test to check the white blood cell count if the patient suspects they have an infection. During treatment with teriflunomide, viral infections such as herpes simplex or shingles may occur. In some cases, serious complications have occurred. The doctor should be informed immediately if the patient suspects they have any symptoms of a viral infection. See section 4.
• has severe skin reactions.
• has respiratory symptoms.
• has weakness, numbness, and pain in the hands and feet.
• plans to be vaccinated.
• takes leflunomide with this medicine.
• switches from their current medicine to Tifay or from Tifay to another medicine.
• needs to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.

Respiratory reactions

The doctor should be informed if the patient experiences unexplained cough and shortness of breath. The doctor may perform additional tests.

Children and adolescents

Teriflunomide is not intended for use in children under 10 years of age, as it has not been studied in this age group with MS.

• pancreatitis has been observed in patients taking teriflunomide. The doctor may perform blood tests if they suspect pancreatitis.

Tifay and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, including those obtained without a prescription.

• leflunomide, methotrexate, and other medicines that affect the immune system (often called immunosuppressants or immunomodulators);
• 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 (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, 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 this medicine if the patient is pregnantor thinks they may be pregnant. In pregnant women or those who become pregnant while taking Tifay, 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.

• The method should be used until the level of Tifay in the blood is low enough (checked by the doctor).
• The patient should discuss the best method of contraception with their doctor, as well as any need to change the method of contraception.

Do nottake Tifay while breastfeeding, as teriflunomide passes into human milk.

Driving and using machines

This medicine may cause dizziness, which can affect concentration and reaction time. Patients who experience these symptoms should not drive or operate machinery.

Tifay contains lactose and sodium

This medicine contains lactose (a type of sugar). If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Tifay

Treatment with Tifay will be supervised by a doctor experienced in treating multiple sclerosis.

Use in adults

The recommended dose is one 14 mg tablet per day.

Use in children and adolescents (aged 10 years and older)

The dose depends on body weight:

• Children with a body weight over 40 kg: one 14 mg tablet per day.
• Children with a body weight of 40 kg or less: one 7 mg tablet per day.

Tifay is only available in a 14 mg dose. If the doctor has prescribed teriflunomide in a 7 mg dose per day, the Tifay tablet should be divided into two equal halves along the score line and half of the tablet taken, which corresponds to 7 mg. In case of doubt, the doctor should be consulted.

4. Possible side effects

Like all medicines, Tifay can cause side effects, although not everybody gets them.

Severe side effects

Some side effects may be severe or become severe if any of the following symptoms occur, the doctor should be informed immediately.

• pancreatitis, which may cause symptoms such as stomach pain, nausea, or vomiting.

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 stomach pain.

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

• headache;
• diarrhea, nausea;
• increased ALT activity (increased activity of certain liver enzymes in the blood) shown in 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: reduced 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 numb, weak, tingling, or pain in the lower back or leg (sciatica), feeling numb, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome);
• feeling a "racing heart";
• increased blood pressure;
• vomiting, toothache, stomach pain;
• 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)

• reduced platelet count (mild thrombocytopenia);
• increased sensitivity (especially of the skin), stabbing or pulsating pain along one or more nerves, nerve damage in the arms or legs (peripheral neuropathy);
• changes in the nails, severe skin reactions;
• trauma-related 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:

• pancreatitis.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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.

5. How to store Tifay

The medicine should be stored out of sight and reach of children.

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

There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tifay contains

• The active substance of Tifay is teriflunomide. One Tifay tablet contains 14 mg of teriflunomide.
• The other ingredients are:
  • Core of the tablet: lactose monohydrate (see section 2 "Tifay contains lactose and sodium"), cornstarch, microcrystalline cellulose type 101, hydroxypropylcellulose, sodium carboxymethylcellulose (type A), talc, calcium stearate.
  • Coating of the tablet: hypromellose 2910 (6 mPa.s), titanium dioxide (E 171), macrogol 8000, indigo carmine, aluminum lake (E 132).

What Tifay looks like and contents of the pack

Tifay 14 mg coated tablets are round, light blue, with a score line, approximately 7 mm in diameter.

The tablet can be divided into equal doses.

The carton contains aluminum/PVC/Aluminum/OPA blisters, each containing 14 tablets.

The pack contains 28 or 84 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Importer

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany, Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola PLA 3000, Malta, Adalvo Limited, Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann SGN 3000, Malta, KeVaRo GROUP Ltd, 9 Tzaritza Elenora Str., office 23, Sofia 1618 Bulgaria

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

Czech Republic: TIFAY, Estonia: TIFAY, Iceland: TIFAY 14 mg film-coated tablets, Lithuania: TIFAY 14 mg coated tablets, Latvia: TIFAY 14 mg coated tablets, Poland: TIFAY, Hungary: TIFAY 14 mg coated tablets

Date of last revision of the leaflet:11/2024