Teriflunomide +pharma

Leaflet accompanying the packaging: patient information

Teriflunomide +pharma, 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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 Teriflunomide +pharma and what is it used for
• 2. Important information before taking Teriflunomide +pharma
• 3. How to take Teriflunomide +pharma
• 4. Possible side effects
• 5. How to store Teriflunomide +pharma
• 6. Contents of the packaging and other information

1. What is Teriflunomide +pharma and what is it used for

What is Teriflunomide +pharma

Teriflunomide +pharma 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 Teriflunomide +pharma used for

Teriflunomide +pharma 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, there are recurring attacks (relapses) of physical symptoms caused by 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 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 does Teriflunomide +pharma work

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

2. Important information before taking Teriflunomide +pharma

When not to take Teriflunomide +pharma

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

Warnings and precautions

Before starting to take Teriflunomide +pharma, discuss it 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 the use of Teriflunomide +pharma. Refer to section 4.
• the patient has high blood pressure, regardless of whether it is controlled with medication or not. Teriflunomide +pharma may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and then regularly during treatment. Refer to section 4.
• the patient has an infection. Before taking Teriflunomide +pharma, the doctor will ensure that the patient has a sufficient number of white blood cells and platelets in the blood. Since Teriflunomide +pharma 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 number of white blood cells if the patient suspects they have an infection. During treatment with teriflunomide, herpes virus infections, including cold sores or shingles, may occur. In some cases, serious complications have occurred. If you suspect you have any symptoms of a herpes virus infection, inform your doctor immediately. Refer to section 4.
• the patient has severe skin reactions
• the patient has respiratory symptoms
• the patient has weakness, numbness, and pain in the hands and feet
• the patient is going to be vaccinated
• the patient is taking leflunomide with teriflunomide
• the patient is switching from their current medicine to teriflunomide or from teriflunomide to another medicine
• the patient is going to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.

Respiratory reactions

Inform your doctor if you experience unexplained coughing and shortness of breath (difficulty breathing). The doctor may perform additional tests.

Children and adolescents

Teriflunomide +pharma is not intended for use in children under 10 years of age, as teriflunomide has not been studied in patients with multiple sclerosis in this age group.
The warnings and precautions mentioned above also apply to children. The following information is important for children and their caregivers:

• in patients taking teriflunomide, cases of pancreatitis have been observed. The doctor may perform blood tests if they suspect pancreatitis.

Teriflunomide +pharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription. 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 immunomodulatory 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 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 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, medicines 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 Teriflunomide +pharma if you are pregnantor think you may be pregnant. In pregnant women or those who become pregnant while taking Teriflunomide +pharma, there is an increased risk of birth defects in the baby.
Women of childbearing age who do not use effective contraception must not take this medicine.
If a girl starts menstruating while taking Teriflunomide +pharma, 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 Teriflunomide +pharma, she should inform her doctor, as it is essential to ensure that the medicine is no longer in the body before trying to become pregnant. The 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 teriflunomide 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 teriflunomide level in the blood is low enough for the woman to become pregnant.
More information about laboratory tests can be obtained from your doctor.
In case of suspected pregnancy while taking Teriflunomide +pharma or within two years after stopping treatment, stop taking Teriflunomide +pharma and immediatelycontact your doctor to perform a pregnancy test.
If the test confirms that you are pregnant, your doctor may suggest using certain medicines to quickly and sufficiently remove teriflunomide from the body to reduce the risk to the baby.
Contraception
While taking Teriflunomide +pharma 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 treatment is stopped.

• 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 potential need to change the contraceptive method.

Do nottake Teriflunomide +pharma while breastfeeding, as teriflunomide passes into human milk.

Driving and using machines

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

Teriflunomide +pharma contains lactose

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

Teriflunomide +pharma contains Allura Red AC (E 129)

Allura Red may cause allergic reactions.

Teriflunomide +pharma contains sodium

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

3. How to take Teriflunomide +pharma

Treatment with Teriflunomide +pharma will be supervised by a doctor experienced in treating multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor.

Adults

The recommended dose is one tablet (14 mg) 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. For these patients, other medicines containing a lower amount of teriflunomide are available (such as 7 mg tablets)

Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor about changing the dose to one 14 mg tablet per day.

Method and route of administration

Teriflunomide +pharma is taken orally. Teriflunomide +pharma should be taken once daily, at any time, as a single daily dose.
Tablets should be swallowed whole, with water. Teriflunomide +pharma can be taken with or without food.

Taking a higher dose of Teriflunomide +pharma than recommended

If a higher dose of Teriflunomide +pharma than recommended is taken, contact your doctor immediately. Side effects similar to those described in section 4 below may occur.

Missing a dose of Teriflunomide +pharma

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

Stopping treatment with Teriflunomide +pharma

Do not stop taking Teriflunomide +pharma or change the dose without consulting your doctor first.
If you have any further doubts about taking this medicine, consult 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 after taking this medicine.

Severe side effects

Some side effects may be severe or become severe. If you experience any of these symptoms, inform your doctor immediately.
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 adult patients)

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 ulcers in the mouth
• severe infections or sepsis (a type of 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 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 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 observed 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
• vomiting, toothache, abdominal pain
• rash, acne
• tendon, joint, bone, or muscle pain (musculoskeletal pain)
• need to urinate more frequently 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 disorders of the arms or legs (peripheral neuropathy)
• changes in nail condition, severe skin reactions
• post-traumatic pain
• psoriasis
• mouth ulcers
• abnormal blood lipid levels
• colitis

Rare(may affect up to 1 in 1000 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 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, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Teriflunomide +pharma

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister packaging after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist 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 Teriflunomide +pharma contains

• The active substance of the medicine is teriflunomide. Each coated tablet contains 14 mg of teriflunomide.
• The other ingredients are: tablet core: lactose monohydrate, cornstarch, microcrystalline cellulose type 101D+, hydroxypropyl cellulose, sodium carboxymethyl cellulose (type A), colloidal silicon dioxide, 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), Allura Red AC, aluminum lake (E 129)

What Teriflunomide +pharma looks like and contents of the pack

Blue, round, biconvex coated tablets with the inscription "14" on one side.
Pack sizes
Blisters of OPA/Aluminum/PVC/Aluminum foil in cardboard boxes containing 14 (1 pack of 14), 28 (1 pack of 28), and 84 (3 packs of 28) coated tablets,
Blisters of OPA/Aluminum/PVC/Aluminum foil containing 14, 28, 84, or 98 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer/Importer

HBM Pharma s.r.o.
Sklabinská 30
SK-036 80 Martin
Slovakia
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36
e-mail: [email protected]

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

Poland
Teriflunomide +pharma
Czech Republic
Teriflunomide +pharma
Austria
Teriflunomide Genericon 14 mg film-coated tablets
Germany
Teriflunomide Tiefenbacher 14 mg film-coated tablets
Date of last revision of the leaflet:August 2024