Framasnoa

Package leaflet: Information for the patient

Framasnoa, 14 mg, coated tablets
Teriflunomide
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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 not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Framasnoa is and what it is used for

What is Framasnoa
Framasnoa 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 Framasnoa is used for
Framasnoa is used in the treatment of 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 affects 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) surrounding 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. Symptoms vary among individual patients but usually include:

• difficulty walking
• vision disturbances
• problems with balance.

These symptoms may completely disappear after a relapse ends, but over time, some symptoms may persist between relapses. This may lead to physical disability, making it difficult to perform daily activities.

How Framasnoa works
Framasnoa 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 inflammatory process that, in patients with multiple sclerosis, leads to nerve damage.

2. Important information before taking Framasnoa

When not to take Framasnoa:

• 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 proteins in the blood (hypoproteinemia).

If in doubt, consult a doctor or pharmacist before taking this medicine.
Warnings and precautions
Before starting treatment with Framasnoa, 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 whether liver function is normal before and during treatment. If test results indicate impaired liver function, the doctor may discontinue treatment with Framasnoa. Please refer to section 4.
• the patient has high blood pressure (hypertension), regardless of whether it is controlled with medication or not. Framasnoa may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly during treatment. Please refer to section 4.
• the patient has an infection. Before taking Framasnoa, the doctor will ensure the patient has adequate levels of white blood cells and platelets in the blood. Since Framasnoa reduces the number of white blood cells, it may impair the body's ability to fight infections. The doctor may perform a blood test to check white blood cell count if the patient suspects an infection. Please refer to section 4.
• the patient experiences severe skin reactions.
• the patient experiences respiratory symptoms.
• the patient experiences weakness, numbness, or pain in hands and feet.
• the patient plans to receive a vaccination.
• the patient is taking leflunomide together with Framasnoa.
• the patient is switching from another medication to Framasnoa or from Framasnoa to another medication.
• the patient is scheduled for a specific blood test (calcium level measurement). Calcium test results may be falsely low. Respiratory 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
Framasnoa 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. 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.
  Framasnoa 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 immunosuppressive or immunomodulatory drugs),
• rifampicin (used to treat tuberculosis and other infections),
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy,
• St. John’s wort (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 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 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 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 levels),
• sulfasalazine, used for inflammatory bowel disease and rheumatoid arthritis,
• cholestyramine, used in case of elevated blood cholesterol or itching in liver diseases,
• activated charcoal, used to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take Framasnoa if the patient is pregnant or suspects she may be pregnant. In women who are pregnant or who become pregnant while taking Framasnoa, 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 while taking Framasnoa, 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 Framasnoa, she should inform her doctor, as it is essential to ensure that 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 reduced to several weeks by taking specific medicines that accelerate the removal of Framasnoa 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 Framasnoa is low enough to allow pregnancy.
More information about laboratory tests can be obtained from the doctor.
If a woman suspects she became pregnant while taking Framasnoa or within two years after stopping treatment, she must stop taking Framasnoa and immediately contact her doctor to perform a pregnancy test. If the test confirms pregnancy, the doctor may recommend appropriate treatment to rapidly and adequately eliminate Framasnoa from the body to reduce the risk to the unborn child.

Contraception
During treatment with Framasnoa and after stopping it, the woman should use an effective method of contraception. Teriflunomide remains in the blood for a long time after stopping treatment. For this reason, effective contraception must continue after stopping treatment.

• This method should be used until the blood concentration of Framasnoa is sufficiently low — this will be verified by the doctor.
• Discuss with the doctor the most suitable contraceptive method for the patient, and also in case a change of contraceptive method is needed.

Do not take Framasnoa while breastfeeding, as teriflunomide passes into human milk.
Driving and operating machinery
Framasnoa may cause dizziness, which may impair concentration and reaction ability. Patients experiencing such symptoms should not drive or operate machinery.
Framasnoa contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
Framasnoa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Framasnoa

Treatment with Framasnoa will be supervised by a doctor experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.

Adults
The recommended dose is one 14 mg tablet 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. Framasnoa is only available as 14 mg coated tablets; therefore, for these patients the doctor will recommend using another medicine containing teriflunomide.

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 tablet once daily.

Route and method of administration
Framasnoa is administered orally. Framasnoa should be taken daily at any time of the day as a single daily dose. Tablets should be swallowed whole with water.
The medicine may be taken with food or independently of meals.

Overdose of Framasnoa
If more Framasnoa has been taken than prescribed, contact your doctor immediately. Adverse reactions may occur similar to those described in section 4 below.

Missed dose of Framasnoa
Do not take a double dose to make up for a missed tablet. Take the next dose according to the prescribed dosing schedule.

Stopping Framasnoa
Do not stop taking Framasnoa 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur after using this medicine.
Serious adverse effects
Some adverse effects may be or may become serious. If any of the following symptoms occur, contact your doctor immediately.
Common (may affect 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 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 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 potentially life-threatening infection), which may cause symptoms including high fever, seizures, chills, reduced urine output or confusion
• Lung inflammation, which may cause symptoms including shortness of breath or persistent cough

Frequency unknown (frequency 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 effects may occur with the following frequencies:
Very common (may affect more than 1 in 10 people)

• Headache
• Diarrhea, nausea
• Increased AlAT activity (elevated activity of certain liver enzymes in blood tests)
• Hair thinning

Common (may affect up to 1 in 10 people)

• Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, cold sores, dental infection, laryngitis, fungal foot infection
• Laboratory findings: decreased number of red blood cells (anemia), 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), tingling, burning, numbness or pain in the hands and fingers (carpal tunnel syndrome)
• Palpitations
• Increased blood pressure
• Vomiting, toothache, epigastric pain
• Rash, acne
• Tendon, joint or bone pain, 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 number of platelets (mild thrombocytopenia)
• Increased sensitivity (especially of the skin), stabbing or pulsating pain along one or more nerves, nerve disorders affecting arms or legs (peripheral neuropathy)
• Changes in nails, severe skin reactions
• Pain due to injury
• 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 affect up to 1 in 1000 people)

• Inflammation or damage to the liver

Frequency unknown (frequency cannot be estimated from available data)

• Pulmonary hypertension

Children (aged 10 years and older) and adolescents
The adverse effects listed above 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)

• Inflammation of the pancreas (pancreatitis)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Framasnoa

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 blister after
"Expiry date (EXP)". The expiry date refers to the last day of the stated 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 Framasnoa contains

• The active substance is teriflunomide. Each coated tablet contains 14 mg of teriflunomide.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose type 101, corn starch, sodium carboxymethyl starch (type A), hydroxypropylcellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose type 2910 - 6 mPas, titanium dioxide (E 171), talc, macrogol 8000, and indigo carmine, aluminium lake (E 132).

What Framasnoa looks like and contents of the pack
Framasnoa is available as blue, round, film-coated tablets with a diameter of approximately 6.6 mm and a thickness of approximately 4.1 mm, printed with the code "TV" on one side and "Y12" on the other side.

Framasnoa is available in:

• OPA/Aluminium/PVC/Aluminium foil blisters containing 7, 10, 14, 28, 30 and 84 film-coated tablets in cardboard packaging.
• Perforated single-dose blisters made of OPA/Aluminium/PVC/Aluminium foil containing 10x1, 28x1, 30x1 and 84x1 film-coated tablets in cardboard packaging.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sigillata Limited
Inniscarra,
Main Street,
Rathcoole,
Co. Dublin D24 E029 Ireland
Tel.: +44 1624 672777
e-mail: [email protected]

Importer
Teva Operations Poland Sp. z o.o
ul. Mogilska 80
31-546 Kraków
Poland
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorised in the European Economic Area under the following names:
Austria: Framasnoa 14 mg Filmtabletten
Poland: Framasnoa