Teriflunomide +pharma

Package leaflet: Information for the patient

Teriflunomide +pharma, 14 mg, film-coated tablets
Teriflunomide
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

What Teriflunomide +pharma is
Teriflunomide +pharma contains the active substance teriflunomide, which is an immunomodulatory agent that regulates the immune system to reduce its attack on the nervous system.
What Teriflunomide +pharma is used for
Teriflunomide +pharma is used to treat adults, children, and adolescents (aged 10 years and older) with relapsing-remitting multiple sclerosis.
What is multiple sclerosis
Multiple sclerosis is a chronic disease that attacks 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 known as demyelination. This damage prevents nerves from functioning properly.
In people with relapsing forms of multiple sclerosis, there are repeated attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary between patients but usually include:

• difficulty walking
• vision problems
• problems with balance

These symptoms may completely disappear after a relapse ends, but over time, some problems may persist between relapses. This may lead to physical disability that makes it difficult to perform daily activities.
How Teriflunomide +pharma works
Teriflunomide +pharma helps protect the central nervous system from the immune system by reducing the increase in the number of certain white blood cells (lymphocytes). This reduces the inflammation that, in patients with multiple sclerosis, leads to nerve damage.

2. Important information before using Teriflunomide +pharma

When not to use Teriflunomide +pharma

• if the patient is allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever experienced severe skin rash, skin peeling, blisters and/or mouth ulcers after taking teriflunomide or leflunomide
• if the patient has severe liver disease
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding
• if the patient has any severe diseases affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS)
• if the patient has any severe bone marrow disorders or has low numbers of red or white blood cells or reduced platelet count
• if the patient has a severe infection
• if the patient has severe kidney disease requiring dialysis
• if the patient has very low levels of proteins in the blood (hypoproteinemia)

If in doubt, consult a doctor or pharmacist before taking this medicine.
Warnings and precautions
Before starting treatment with Teriflunomide +pharma, discuss with your doctor or
pharmacist if:

• the patient has liver function disorders and/or drinks large amounts of alcohol; the doctor may perform blood tests to check liver function before and during treatment. If test results indicate impaired liver function, the doctor may discontinue Teriflunomide +pharma. Please refer to section 4.
• the patient has high blood pressure (hypertension), 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 regularly thereafter. Please refer to section 4.
• the patient has an infection. Before administering Teriflunomide +pharma, the doctor will ensure the patient has adequate levels of white blood cells and platelets in the blood. Since Teriflunomide +pharma reduces the number of white blood cells, it may impair the ability to fight infections. The doctor may perform blood tests to check white blood cell count if the patient suspects an infection. Herpes virus infections, including cold sores or shingles, may occur during treatment with teriflunomide. In some cases, serious complications have occurred. Inform the doctor immediately if any symptoms suggestive of herpes virus infection are suspected. Please refer to section 4.
• the patient experiences severe skin reactions
• the patient has respiratory symptoms
• the patient experiences weakness, numbness, or pain in the hands and feet
• the patient intends to receive vaccination
• the patient is taking leflunomide together with teriflunomide
• the patient is switching from another medication to teriflunomide or from teriflunomide to another medication
• the patient is scheduled for a specific blood test (calcium level measurement). Test results may show falsely low calcium levels.

Respiratory system reactions
Inform the doctor if the patient develops unexplained cough or 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 listed above also apply to children. The following
information is important for children and their caregivers:

• cases of pancreatitis have been observed in patients receiving teriflunomide. The child's doctor may perform blood tests if pancreatitis is suspected.

Teriflunomide +pharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription. In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• leflunomide, methotrexate, and other medicines affecting 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 kidney disease in patients with diabetes
• alosetron used to treat severe diarrhoea
• 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 clots
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin used to treat infections
• indometacin, ketoprofen used to treat inflammation or pain
• furosemide used to treat heart conditions
• cimetidine used to reduce stomach acid secretion
• zidovudine used to treat HIV infections
• rosuvastatin, simvastatin, atorvastatin, pravastatin, medicines used to treat hypercholesterolemia (high blood cholesterol levels)
• sulfasalazine used for inflammatory bowel disease and rheumatoid arthritis
• cholestyramine used for high blood cholesterol levels or itching in liver diseases
• activated charcoal used to reduce absorption of medicines or other substances

Pregnancy and breastfeeding
Do not take Teriflunomide +pharma if the patient is pregnant or suspects she may be pregnant.
Women who are pregnant or become pregnant while taking Teriflunomide +pharma have an increased risk of congenital malformations in the child.
Women of childbearing potential who do not use effective contraception must not take this medicine.
If a girl starts menstruating while taking Teriflunomide +pharma, inform the doctor, who will provide specialist advice regarding 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 the medicine is no longer present in the body before attempting pregnancy. Elimination of the active substance may take up to 2 years. This period can be shortened to several weeks by taking specific medicines that accelerate the removal of teriflunomide from the body.
In both cases, blood testing must confirm that the active substance has been sufficiently eliminated from the body. The doctor should confirm that the blood level of teriflunomide is low enough to allow pregnancy.
More information about laboratory tests can be obtained from the doctor.
If pregnancy is suspected during treatment with Teriflunomide +pharma or within two years after stopping treatment, discontinue Teriflunomide +pharma and immediately contact the doctor to perform a pregnancy test.
If the test confirms pregnancy, the doctor may recommend appropriate treatment to rapidly and adequately eliminate teriflunomide from the body to reduce risk to the child.
Contraception
During treatment with Teriflunomide +pharma and after stopping it, women should use effective contraception. Teriflunomide remains in the blood for a long time after stopping treatment. For this reason, effective contraception should continue after treatment ends.

• This method should be used until the blood level of teriflunomide is sufficiently low (confirmed by the doctor).
• Discuss with the doctor the most suitable contraceptive method for the patient and any potential need to change contraceptive methods.

Do not take Teriflunomide +pharma while breastfeeding, as teriflunomide passes into human milk.
Driving and operating machinery
Teriflunomide +pharma may cause dizziness, which may impair the ability to concentrate and react. Patients experiencing such symptoms should not drive or operate machinery.
Teriflunomide +pharma contains lactose
Teriflunomide +pharma contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a 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, meaning the medicine is considered "sodium-free".

3. How to use Teriflunomide +pharma

Treatment with Teriflunomide +pharma will be supervised by a physician experienced in the treatment of multiple sclerosis.
This medicine should always be used exactly as prescribed by your doctor. In case of doubt, consult your doctor.
Adults
The recommended dose is one tablet (14 mg) once daily.
Children and adolescents (aged 10 years and older)
The dose depends on body weight:

• children with body weight greater than 40 kg: one 14 mg tablet once daily
• children with body weight less than or equal to 40 kg: one 7 mg tablet once daily. For these patients, other medicines containing lower amounts 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 the doctor about changing the dose to one tablet (14 mg) once daily.
Route and method of administration
Teriflunomide +pharma is administered orally. Teriflunomide +pharma should be taken daily at any time, as a single daily dose.
Tablets should be swallowed whole with water. Teriflunomide +pharma may be taken with food or independently of meals.
Use of a higher than recommended dose of Teriflunomide +pharma
If a higher than recommended dose of Teriflunomide +pharma is taken, contact your doctor immediately. Adverse effects similar to those described in section 4 below may occur.
Missed dose of Teriflunomide +pharma
Do not take a double dose to make up for a missed tablet. Take the next dose according to the prescribed dosing schedule.
Discontinuation of Teriflunomide +pharma
Do not stop taking Teriflunomide +pharma or change the dose without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur after taking this medicine.
Serious adverse reactions
Some adverse reactions may be serious or may become serious. If any of the following symptoms occur, you must immediately contact your doctor.
Common (may occur in up to 1 in 10 people)

• inflammation of the pancreas (pancreatitis), which may cause symptoms such as: abdominal pain, nausea or vomiting (frequency is common in children and adolescents and uncommon in adult patients)

Uncommon (may occur in up to 1 in 100 people)

• allergic reactions, which may cause symptoms including: rash, hives, swelling of the lips, tongue or face, or sudden breathing difficulties
• severe skin reactions, which may cause symptoms including: skin rash, blisters on the skin, fever or mouth ulcers
• severe infections or sepsis (a type of infection potentially life-threatening), which may cause symptoms including: high fever, seizures, chills, reduced urine output or confusion
• inflammation of the lungs (pneumonitis), 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 adverse reactions may occur with the following frequency:
Very common (may occur in more than 1 in 10 people)

• headache
• diarrhoea, nausea
• increased AlAT activity (elevated levels of certain liver enzymes in blood tests)
• hair thinning

Common (may occur in up to 1 in 10 people)

• flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, bladder inflammation, viral gastroenteritis, tooth infection, laryngitis, fungal foot infection
• herpes virus infection, including cold sores and shingles, with symptoms such as: blisters, burning, itching, tingling or pain in the skin, usually on one side of the upper body or face, and other symptoms such as fever and fatigue
• laboratory test results: decreased number of red blood cells (anaemia), changes in liver function and white blood cell counts (see section 2), increased activity of muscle enzymes (creatine kinase) has also been observed
• mild allergic reactions
• feeling anxious
• tingling sensation, feeling weak, numbness, tingling or pain in the lower back or leg (sciatica), tingling, burning, numbness or pain in the hands and fingers (carpal tunnel syndrome)
• sensation of heart pounding
• increased blood pressure
• vomiting, toothache, upper abdominal pain
• rash, acne
• tendon, joint, bone pain, muscle pain (musculoskeletal pain)
• need to pass urine more often than usual
• heavy menstrual periods
• pain
• lack of energy or feeling weak (asthenia)
• weight loss

Uncommon (may occur in up to 1 in 100 people)

• decreased number of platelets (mild thrombocytopenia)
• increased sensitivity (especially of the skin), stabbing or pulsating pain along one or more nerves, nerve disorders of arms or legs (peripheral neuropathy)
• nail changes, severe skin reactions
• traumatic pain
• psoriasis
• inflammation of the mucous membrane of the mouth/lips
• abnormal levels of fats (lipids) in the blood
• inflammation of the large intestine (colitis)

Rare (may occur in up to 1 in 1000 people)

• liver inflammation or liver damage

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

• pulmonary hypertension

Children (aged 10 years and older) and adolescents
The adverse reactions listed above also apply to children and adolescents. The following additional information is important for children, adolescents and their caregivers:
Common (may occur in up to 1 in 10 people)

• inflammation of the pancreas (pancreatitis)

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Teriflunomide +pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the blister pack following "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Teriflunomide +pharma contains

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

What Teriflunomide +pharma looks like and contents of the pack
Blue, round, biconvex film-coated tablets, embossed with the mark "14" on one side.
Pack sizes
Blister packs made of OPA/Aluminium/PVC/Aluminium, placed in folding cartons containing
14 (1 pack of 14), 28 (1 pack of 28) or 84 (3 packs of 28) film-coated tablets, in a cardboard box.
Blister packs made of OPA/Aluminium/PVC/Aluminium containing 14, 28, 84 or 98 film-coated tablets
in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Poland Teriflunomide +pharma
Czech Republic Teriflunomid +pharma
Austria Teriflunomid Genericon 14 mg Filmtabletten
Germany Teriflunomid Tiefenbacher 14 mg Filmtabletten