Teriflunomide pharmascience

Package leaflet: information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Teriflunomide Pharmascience is and what it is used for

What Teriflunomide Pharmascience is
Teriflunomide Pharmascience contains the active substance teriflunomide, which is an immunomodulatory agent that regulates the immune system in order to reduce its attack on the nervous system.
What Teriflunomide Pharmascience is used for
Teriflunomide Pharmascience 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 destroys the protective covering (called myelin) around the nerves in the central nervous system. This process is called demyelination. It prevents nerves from functioning properly.
In people with relapsing forms of multiple sclerosis, there are recurrent attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary among individual 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 Pharmascience works
Teriflunomide Pharmascience helps protect the central nervous system from the immune system by reducing the increase in 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 taking Teriflunomide Pharmascience

When not to take Teriflunomide Pharmascience:

• 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 oral ulceration 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 protein in the blood (hypoproteinemia).

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

• if the patient has liver function disorders and/or consumes large amounts of alcohol. The doctor will order blood tests to check liver function before and during treatment. If test results indicate liver dysfunction, the doctor may discontinue Teriflunomide Pharmascience. Please refer to section 4,
• if the patient has high blood pressure (hypertension), regardless of whether it is controlled with medication or not. Teriflunomide Pharmascience may increase blood pressure. The doctor will monitor blood pressure before starting treatment and regularly thereafter. Please refer to section 4,
• if the patient has an infection. Before administering Teriflunomide Pharmascience, the doctor will ensure the patient has adequate levels of white blood cells and platelets. Since Teriflunomide Pharmascience reduces white blood cell count, it may impair the ability to fight infections. The doctor may recommend blood tests if the patient suspects an infection. During treatment with teriflunomide, herpes virus infections may occur, including cold sores or shingles. In some cases, serious complications have occurred. Immediately inform the doctor if any symptoms suggestive of herpes virus infection develop. Please refer to section 4,
• if the patient experiences severe skin reactions,
• if the patient has respiratory symptoms,
• if the patient experiences weakness, numbness, or pain in hands and feet,
• if the patient plans to receive vaccinations,
• if the patient is taking leflunomide concurrently with Teriflunomide Pharmascience,
• if the patient is switching from another medication to Teriflunomide Pharmascience or from Teriflunomide Pharmascience to another medicine,
• if the patient is lactose intolerant,
• if the patient is scheduled for a specific blood test (calcium level measurement). Calcium test results may be falsely low.

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

• pancreatitis has been observed in patients receiving teriflunomide. The treating doctor may order blood tests if pancreatitis is suspected. Teriflunomide Pharmascience and other medicines Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines. 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 immunosuppressants or immunomodulators),
• rifampicin (used to treat tuberculosis and other infections),
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy,
• St John’s wort (an herbal remedy 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 diabetic patients,
• alosetron used to treat severe diarrhoea,
• 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 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 gastric acid secretion,
• zidovudine, used to treat HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin, medicines used to treat hypercholesterolemia (elevated blood cholesterol),
• sulfasalazine, used for inflammatory bowel disease and rheumatoid arthritis,
• cholestyramine, used in cases of elevated blood cholesterol or itching in liver disease,
• activated charcoal, used to reduce absorption of medicines or other substances.

Pregnancy, breastfeeding and fertility
Do not take Teriflunomide Pharmascience if the patient is pregnant or suspects she may be pregnant. In women who are pregnant or who become pregnant during treatment with Teriflunomide Pharmascience, there is an increased risk of congenital malformations in the child. Women of childbearing potential who do not use effective contraceptive methods must not take this medicine.
If a girl starts menstruating during treatment with Teriflunomide Pharmascience, 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 Pharmascience, she should inform her doctor, as it is essential to confirm that teriflunomide 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 elimination of Teriflunomide Pharmascience 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 concentration of Teriflunomide Pharmascience is low enough to allow pregnancy.
More information about laboratory tests can be obtained from the doctor.
If a woman suspects she has become pregnant during treatment with Teriflunomide Pharmascience or within two years after stopping treatment, she must stop taking Teriflunomide Pharmascience and immediately contact her doctor for a pregnancy test. If the test confirms pregnancy, the doctor may recommend appropriate medicines to rapidly and adequately eliminate Teriflunomide Pharmascience from the body to reduce risk to the child.
Contraception
During treatment with Teriflunomide Pharmascience and after stopping it, women should use an effective method of 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 concentration of Teriflunomide Pharmascience is sufficiently low (as confirmed by the doctor).
• Discuss with the doctor the most suitable contraceptive method for the patient, and whether a change in contraceptive method is needed.

Do not take Teriflunomide Pharmascience during breastfeeding, as
teriflunomide passes into human milk.
Driving and operating machinery
Teriflunomide Pharmascience may cause dizziness, which may impair concentration and reaction ability. Patients experiencing such symptoms should not drive or operate machinery.
Teriflunomide Pharmascience contains lactose
Teriflunomide Pharmascience 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 Pharmascience 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 take Teriflunomide Pharmascience

Treatment with Teriflunomide Pharmascience should be supervised by a physician experienced in the management of multiple sclerosis.
This medicine should always be taken exactly as prescribed by the doctor. In case of any doubts, consult your doctor.
Adults
The recommended dose is one 14 mg coated tablet per day.
Use in 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 coated tablet per day.
• Children with body weight less than or equal to 40 kg: one 7 mg coated tablet per day. Teriflunomide Pharmascience 7 mg tablets are not available; therefore, alternative medicines containing 7 mg of teriflunomide should be used.

Children and adolescents who reach a stable body weight above 40 kg will be informed by the doctor to change the dose to one 14 mg coated tablet per day.
Route and method of administration
Teriflunomide Pharmascience is administered orally. Teriflunomide Pharmascience is taken daily at any time as a single daily dose.
Tablets should be swallowed whole with water.
Teriflunomide Pharmascience may be taken with or without food.
Taking more Teriflunomide Pharmascience than prescribed
If a patient takes more Teriflunomide Pharmascience than prescribed, they should contact their doctor immediately. Adverse effects may occur similar to those described in section 4 below.
Missing a dose of Teriflunomide Pharmascience
Do not take a double dose to make up for a missed tablet. Take the next dose according to the prescribed dosing schedule.
Stopping treatment with Teriflunomide Pharmascience
Do not stop taking Teriflunomide Pharmascience 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 everybody will get them.
The following adverse reactions may occur after taking this medicine.
Serious adverse reactions
Some adverse reactions may be or may become serious; if any of these symptoms occur, seek immediate medical advice.
Common (may occur in up to 1 in 10 patients)

• pancreatitis, which may cause symptoms such as abdominal pain, nausea or vomiting (frequency: common in children and adolescents and uncommon in adult patients). Uncommon (may occur in up to 1 in 100 patients)
• allergic reactions, which may include symptoms such as rash, hives, swelling of the lips, tongue or face, or sudden breathing difficulties,
• severe skin reactions, which may cause symptoms such as skin rash, blisters on the skin, fever or mouth ulcers,
• severe infections or sepsis (a type of infection potentially life-threatening to the patient), which may cause symptoms such as high fever, seizures, chills, reduced urine output or confusion,
• lung inflammation, which may cause symptoms such as shortness of breath or persistent cough.

Frequency not known (cannot be estimated from 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 patients)

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

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

• influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort during swallowing, bladder inflammation, viral gastroenteritis, dental 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 fatigue;
• laboratory findings: decreased number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), increased activity of muscle enzymes (creatine kinase) has also been observed,
• mild allergic reactions,
• feeling of restlessness,
• tingling sensation, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica), sensation of numbness, burning, tingling or pain in hands and fingers (carpal tunnel syndrome),
• sensation of "heart beating",
• increased blood pressure,
• vomiting, toothache, upper abdominal pain,
• rash, acne,
• tendon, joint or bone pain, muscle pain (musculoskeletal pain),
• need to pass urine more often than usual,
• heavy menstrual periods,
• pain,
• lack of energy or feeling of weakness (asthenia),
• weight loss.

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

• 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 mouth/lips,
• abnormal levels of fats (lipids) in the blood,
• inflammation of the large intestine.

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

• inflammation or damage to the liver.

Frequency not known (cannot be estimated from 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)

• pancreatitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 .
Adverse reactions can also be reported to the Marketing Authorisation Holder or to PDG Cetus Pharma Sp. z o.o., Sokratesa 11B, 01-909 Warsaw, tel.: +48 606 383 970, e-mail: [email protected], which is the partner of the Marketing Authorisation Holder Pharmascience International Limited in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Teriflunomide Pharmascience

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following:
"EXP". The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Teriflunomide Pharmascience contains

• The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.
• The other ingredients are: hydroxypropylcellulose, monohydrate lactose, corn starch, microcrystalline cellulose (type 102), sodium carboxymethyl starch (type A), magnesium stearate, hypromellose 2910, titanium dioxide (E 171), polyethylene glycol 8000, colloidal anhydrous silica, indigo carmine, aluminium lake (E 132).

What Teriflunomide Pharmascience looks like and contents of the pack
Teriflunomide Pharmascience is a 7.3 mm pentagonal film-coated tablet, light blue to pastel blue in colour, with the imprint “14” on one side and smooth on the other side (thickness: 3.5 mm – 4.1 mm).
Teriflunomide Pharmascience is available in cardboard boxes containing 14 or 28 film-coated tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pharmascience International Limited.
Lampousas 1
1095 Nicosia
Cyprus
Manufacturer/Importer
Pharmascience International Limited
1st floor Iacovides Tower
81-83 Griva Digeni Avenue
1090 Nicosia
Cyprus
GE Pharmaceuticals Limited
Industrial Zone
Chekanitza South area
2140, Botevgrad
Bulgaria
This medicinal product is authorised in the European Economic Area countries under the following names: