Aregalu

Leaflet attached to the packaging: patient information

Aregalu, 14 mg, coated tablets

Teriflunomide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Aregalu and what is it used for

What is Aregalu

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

What is Aregalu used for

Aregalu 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) around 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, recurring attacks (relapses) of physical symptoms occur due to the abnormal functioning of the nerves. These symptoms vary from person to person but usually include:

• difficulty walking
• vision problems
• balance problems.

These symptoms may completely disappear after a relapse, but over time, some problems may persist between relapses. This can lead to physical disability that interferes with daily activities.

How Aregalu works

Aregalu helps protect the central nervous system from the immune system's effects 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 Aregalu

When not to take Aregalu

Warnings and precautions

Before starting Aregalu, discuss with your doctor or pharmacist if:

• the patient has liver function disorders and (or) the patient 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 Aregalu treatment. See section 4.
• the patient has high blood pressure, regardless of whether it is controlled with medication or not. Aregalu may cause an increase in blood pressure. The doctor will check the patient's blood pressure before starting treatment and then regularly during treatment. See section 4.
• the patient has an infection. The doctor will ensure that the patient has a sufficient number of white blood cells and platelets in the blood before taking Aregalu. Aregalu may affect the body's ability to fight infections, as it reduces the number of white blood cells in the blood. The doctor may perform a blood test to check the number of white blood cells if the patient suspects they have an infection. During teriflunomide treatment, viral infections such as herpes simplex or shingles may occur. In some cases, serious complications have occurred. If symptoms of a viral infection are suspected, the doctor should be notified immediately. See section 4.
• the patient has severe skin reactions.
• the patient has respiratory symptoms.
• the patient experiences weakness, numbness, and pain in the hands and feet.
• the patient is about to be vaccinated.
• the patient is taking leflunomide with Aregalu.
• the patient is switching from their current medicine to Aregalu or from Aregalu to another medicine.
• the patient is to undergo a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.

Respiratory reactions

Tell your doctor if you experience unexplained coughing and shortness of breath (shallow breathing). The doctor may order additional tests.

Children and adolescents

Aregalu is not indicated 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 and their caregivers:

• -cases of pancreatitis have been observed in patients taking teriflunomide. The doctor may perform blood tests if pancreatitis is suspected.

Aregalu and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
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 immunosuppressive or immunomodulating medicines)
• rifampicin (a medicine used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy
• St. John's Wort (a herbal medicine used to treat 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 medicine 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 pain or inflammation
• furosemide, used to treat heart disease
• cimetidine, used to reduce stomach acid production
• zidovudine, used to treat HIV infections
• rosuvastatin, simvastatin, atorvastatin, pravastatin - medicines used to treat high cholesterol
• sulfasalazine, a medicine 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 Aregalu if you are pregnant or think you may be pregnant. In pregnant women or those who become pregnant while taking Aregalu, there is an increased risk of birth defects in the baby. Women of childbearing age must not take this medicine unless they use effective contraception. If a girl starts menstruating while taking Aregalu, she should tell her doctor, who will provide specialized advice on contraception and potential risks in case of pregnancy.
Tell your doctor if you plan to become pregnant after stopping Aregalu, as you need to make sure the medicine has been eliminated from your body before trying to become pregnant. Elimination of the active substance may take up to 2 years. This period can be shortened to a few weeks by taking certain medicines that accelerate the removal of Aregalu from the body. In both cases, you should confirm with a blood test that the active substance has been sufficiently eliminated from your body. Your doctor should confirm that the level of Aregalu in your blood is low enough for you to become pregnant.
Contact your doctor for more information about laboratory tests.
If you suspect you have become pregnant while taking Aregalu or within 2 years after stopping treatment, stop taking Aregalu and immediatelycontact your doctor to perform a pregnancy test. If the test confirms you are pregnant, your doctor may suggest taking certain medicines to quickly and sufficiently eliminate Aregalu from your body.
Contraception
During and after taking Aregalu, women should use effective contraception. Teriflunomide remains in the blood for a long time after stopping treatment. For this reason, effective contraception should still be used after stopping treatment.

• This method should be used until the level of Aregalu in the blood is low enough - your doctor will check this.
• Discuss with your doctor the best method of contraception for you and any need to change the method of contraception.

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

Driving and using machines

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

Aregalu contains lactose and sodium

Aregalu contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Aregalu

Treatment with Aregalu will be supervised by a doctor experienced in treating multiple sclerosis.
Always take Aregalu exactly as your doctor has told you. If you are unsure, consult your doctor.

Adults

The recommended dose is one 14 mg tablet per day.

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.

Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor to switch to one 14 mg tablet per day.
A 7 mg strength of Aregalu is not available. To take this dose, you should use other available medicines that contain teriflunomide. Contact your doctor or pharmacist for more information about available alternatives.
Route of administration
Aregalu is taken orally. Aregalu is taken once daily at any time of day as a single dose.
Aregalu can be taken with or without food.

Taking more Aregalu than prescribed

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

Missing a dose of Aregalu

Do not take a double dose to make up for a missed tablet. Take the next dose as scheduled.

Stopping Aregalu treatment

Do not stop taking Aregalu or change the dose 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, Aregalu 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 may be serious or become serious 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 stomach 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 rash, blisters on the skin, fever, or mouth sores;
• severe infections or sepsis (a life-threatening infection), which may cause symptoms including high fever, chills, shivering, reduced urine flow, or disorientation;
• pneumonia, which may cause symptoms such as shortness of breath or persistent cough.

Unknown(frequency cannot be estimated from the available data)

• serious 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.

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

• headache
• diarrhea, nausea
• increased liver enzyme activity (increased activity of certain liver enzymes in the blood) shown in blood tests
• hair loss

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 cold sores and shingles, with symptoms such as blisters, burning, itching, numbness, or pain on 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, 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
• being sick (vomiting), toothache, abdominal pain
• rash, acne
• tendon, joint, bone, 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 sensations or sensitivity, especially of the skin; stabbing or pulsating pain along one or more nerves, nerve disorders of the arms or legs (peripheral neuropathy)
• nail disorders, severe skin reactions
• post-traumatic pain
• psoriasis
• mouth and (or) lip inflammation
• abnormal blood fat (lipid) levels
• colitis (inflammation of the colon)

Rare(may affect up to 1 in 1000 people)

• liver inflammation or damage

Unknown(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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 Aregalu

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 packaging after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicinal product.
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 packaging and other information

What Aregalu contains

• The active substance is teriflunomide. Each coated tablet contains 14 mg of teriflunomide.
• The other ingredients (excipients) are lactose monohydrate, cornstarch, hydroxypropylcellulose (LF), microcrystalline cellulose (200), sodium carboxymethylcellulose (A), magnesium stearate (E 470b), silicon dioxide, and the coating contains hypromellose (2910, 5 mPa·s), titanium dioxide (E 171), macrogol 8000, and indigo carmine, aluminum lake (E 132). See section 2 "Aregalu contains lactose and sodium".

What Aregalu looks like and contents of the pack

Blue, round, biconvex coated tablets with "14" engraved on one side. Tablet diameter: approximately 7 mm.
Aregalu 14 mg coated tablets are available in packs containing:

• 28 coated tablets in blisters in a cardboard box.
• 28 coated tablets in blisters in a calendar pack in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
To obtain more detailed information on the names of medicinal products in other European Economic Area countries, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500
Date of last revision of the leaflet: 06.11.2024