FRAMASNOA 14 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Framasnoa, 14 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Framasnoa and what is it used for
   1. What is Framasnoa
   2. What is Framasnoa used for
   3. What is multiple sclerosis
   4. How Framasnoa works
4. Important information before taking Framasnoa
   1. When not to take Framasnoa:
   2. Warnings and precautions
   3. Respiratory reactions
   4. Children and adolescents
   5. Framasnoa and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Framasnoa contains lactose
   9. Framasnoa contains sodium
5. How to take Framasnoa
   1. Adults
   2. Children and adolescents (aged 10 years and older)
   3. Taking more than the recommended dose of Framasnoa
   4. Missing a dose of Framasnoa
   5. Stopping treatment with Framasnoa
6. Possible side effects
   1. Severe side effects
   2. Very common (may affect up to 1 in 10 people)
   3. Uncommon (may affect up to 1 in 100 people)
   4. Frequency not known (frequency cannot be estimated from the available data)
   5. Very common (may affect more than 1 in 10 people)
   6. Common (may affect up to 1 in 10 people)
   7. Uncommon (may affect up to 1 in 100 people)
   8. Rare (may affect up to 1 in 1000 people)
   9. Frequency not known (frequency cannot be estimated from the available data)
   10. Children (aged 10 years and older) and adolescents
   11. Common (may affect up to 1 in 10 people)
   12. Reporting side effects
7. How to store Framasnoa
8. Contents of the pack and other information
   1. What Framasnoa contains
   2. What Framasnoa looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Framasnoa, 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.
• 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 Framasnoa and what is it 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 pack and other information

1. What is Framasnoa and what is it used for

What is Framasnoa

Framasnoa 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 Framasnoa used for

Framasnoa is used to treat adults and children and adolescents (aged 10 years and older) with multiple sclerosis with a relapsing-remitting course.

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) of the nerves in the central nervous system. This process is called demyelination. It disrupts the normal functioning of the nerves. In people with multiple sclerosis with a relapsing course, 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 can completely disappear after a relapse, but over time, some problems may persist between relapses. This can lead to mobility impairment that makes it difficult to perform daily activities.

How Framasnoa works

Framasnoa 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 inflammation, which 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 had a severe skin rash or peeling or blisters or mouth ulcers after taking teriflunomide or leflunomide,
• if the patient has severe liver disease,
• if the patient is pregnant, thinks they may be pregnant, or is breastfeeding,
• if the patient has any severe diseases that affect the immune system, such as acquired immune deficiency syndrome (AIDS),
• if the patient has any severe bone marrow disorders or has a low number of red or white blood cells or platelets,
• if the patient has a severe infection,
• if the patient has severe kidney disease that requires dialysis,
• if the patient has very low protein levels in the blood (hypoproteinemia),

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

Warnings and precautions

Before starting to take Framasnoa, 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 the use of Framasnoa. Refer to section 4.
• the patient has high blood pressure, regardless of whether it is controlled with medication or not. Framasnoa may cause an increase in blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly during treatment. Refer to section 4.
• the patient has an infection. Before taking Framasnoa, the doctor will make sure the patient has a sufficient number of white blood cells and platelets in the blood. Since Framasnoa 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 thinks they have an infection. 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 Framasnoa.
• the patient is switching from their current medicine to Framasnoa or from Framasnoa 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 low.

Respiratory reactions

Tell your doctor if you experience unexplained cough and 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 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 child's doctor may perform blood tests if pancreatitis is suspected.

Framasnoa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained 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 (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 (an anticoagulant), 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, 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 Framasnoa if you are pregnantor think you may be pregnant. In pregnant women or those who become pregnant while taking Framasnoa, 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 Framasnoa, 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 Framasnoa, 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 Framasnoa from the body.
In both cases, it is necessary to confirm with a blood test that the active substance has been sufficiently removed from the body. The doctor should confirm that the level of Framasnoa in the blood is low enough for the woman to become pregnant.
More information on laboratory tests can be obtained from the doctor.
If a woman suspects she has become pregnant while taking Framasnoa or within two years after stopping treatment, she should stop taking Framasnoa and immediatelycontact her doctor to perform a pregnancy test. If the test confirms that the woman is pregnant, the doctor may suggest using certain medicines to quickly and sufficiently remove Framasnoa from the body.
Contraception
During and after taking Framasnoa, 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 stopping treatment.

• This method should be used until the level of Framasnoa in the blood is low enough - the 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 Framasnoa while breastfeeding, as teriflunomide passes into human milk.

Driving and using machines

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

Framasnoa contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

Framasnoa contains sodium

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

3. How to take Framasnoa

The use of Framasnoa will be supervised by a doctor experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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. Framasnoa is only available in 14 mg coated tablets, so the doctor will prescribe another teriflunomide-containing medicine for these patients.

Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor to change the dose to one 14 mg tablet per day.
Route and method of administration
Framasnoa is taken orally. Framasnoa should be taken once daily at any time of day as a single dose. The tablets should be swallowed whole with water.
The medicine can be taken with or without food.

Taking more than the recommended dose of Framasnoa

If you take more than the recommended dose of Framasnoa, contact your doctor immediately. Side effects similar to those described in section 4 below may occur.

Missing a dose of Framasnoa

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

Stopping treatment with Framasnoa

Do not stop taking Framasnoa 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, 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, contact your doctor immediately.

Very common (may affect up to 1 in 10 people)

• Pancreatitis, which may cause symptoms such as abdominal pain, nausea, or vomiting (very common in children and adolescents and uncommon in adults)

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions, which may cause 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, fever, or mouth ulcers
• Severe infections or sepsis (a life-threatening infection), which may cause symptoms such as high fever, chills, shivering, reduced urine output, or disorientation
• Pneumonia, which may cause symptoms such as shortness of breath or persistent cough

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

• Severe liver disease, which may cause symptoms such as 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 ALT activity (increased activity of certain liver enzymes in the blood) shown in tests
• Hair loss

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, herpes simplex, tooth infection, laryngitis, fungal foot infection
• Laboratory test results: reduced 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 numb, weak, tingling, or pain in the lower back or leg (sciatica), feeling numb, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome)
• Feeling "heart pounding"
• Increased blood pressure
• Vomiting, toothache, abdominal pain
• Rash, acne
• Tendon, joint, bone, or 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)

• 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 nails, severe skin reactions
• Post-traumatic pain
• Psoriasis
• Oral mucositis
• Abnormal blood lipid levels
• Colitis

Rare (may affect up to 1 in 1000 people)

• Hepatitis 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 above side effects also apply to children and adolescents. The following additional information is important for children and 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 181 C
02-222 Warsaw
Phone: +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 Framasnoa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions 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. This 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: lactose monohydrate, microcrystalline cellulose type 101, corn starch, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, silicon dioxide, anhydrous, sodium stearyl fumarate, hypromellose type 2910 - 6mPas, titanium dioxide (E 171), talc, macrogol 8000, and indigo carmine, aluminum lake (E 132).

What Framasnoa looks like and contents of the pack

Framasnoa is available in the form of blue, round, coated tablets with a diameter of about 6.6 mm and a thickness of about 4.1 mm, with the imprint "TV" on one side and "Y12" on the other.
Framasnoa is available in:

• Blisters of OPA/Aluminum/PVC/Aluminum foil containing 7, 10, 14, 28, 30, and 84 coated tablets in a cardboard box.
• Perforated single-dose blisters of OPA/Aluminum/PVC/Aluminum foil containing 10x1, 28x1, 30x1, and 84x1 coated tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Sigillata Limited
Inniscarra,
Main Street,
Rathcoole,
Co. Dublin D24 E029 Ireland
Phone: +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 medicine is authorized in the Member States of the European Economic Area under the following names:

Austria:
Framasnoa 14 mg Filmtabletten
Poland:
Framasnoa

Date of last revision of the leaflet: