Teriflunomide medical valley

Package leaflet: Information for the patient

Teriflunomide Medical Valley, 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 as you may need to read it again.
• If you have any further questions, please ask 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, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Teriflunomide Medical Valley is and what it is used for

What Teriflunomide Medical Valley is
Teriflunomide Medical Valley 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 Medical Valley is used for
Teriflunomide Medical Valley 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 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) 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 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, making it difficult to perform daily activities.

How Teriflunomide Medical Valley works
Teriflunomide Medical Valley helps protect the central nervous system from immune system activity by reducing the increase in 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 Medical Valley

When not to take Teriflunomide Medical Valley:

• 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 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 Medical Valley, 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 Teriflunomide Medical Valley. Refer to section 4.
• the patient has high blood pressure (hypertension), regardless of whether it is controlled with medication or not. Teriflunomide Medical Valley may increase blood pressure. The doctor will check the patient’s blood pressure before starting treatment and regularly thereafter. Refer to section 4.
• the patient has an infection. Before the patient takes Teriflunomide Medical Valley, the doctor will ensure the patient has adequate levels of white blood cells and platelets in the blood. Because Teriflunomide Medical Valley reduces the number of white blood cells, it may affect the ability to fight infections. The doctor may perform a blood test to check white blood cell count if the patient suspects any infection. Viral infections such as herpes virus, including cold sores or shingles, may occur during treatment. In some cases, serious complications have occurred. Immediately inform the doctor if any symptoms suggestive of herpes virus infection occur. Refer to section 4.
• the patient has severe skin reactions.
• the patient has respiratory symptoms.
• the patient experiences weakness, numbness, or pain in hands and feet.
• the patient intends to be vaccinated.
• the patient is taking leflunomide together with Teriflunomide Medical Valley.
• the patient is switching from another medication to Teriflunomide Medical Valley or from Teriflunomide Medical Valley to another medicine.
• 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 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. Teriflunomide Medical Valley and other medicines Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including medicines obtained 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 immunosuppressants or immunomodulators)
• 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 diarrhoea
• theophylline, used to treat asthma
• tizanidine (a muscle relaxant)
• warfarin (an anticoagulant), used to thin the blood (i.e. make it less likely to clot) to prevent thrombosis
• 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)
• sulfasalazine, used for inflammatory bowel disease and rheumatoid arthritis
• cholestyramine, used in cases 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 this medicine if the patient is pregnant or suspects she may be pregnant. In women who are pregnant or who become pregnant while taking this medicine, 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 this medicine, 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 Medical Valley, she should inform her doctor, as it is essential to confirm 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 certain medicines that accelerate removal of this drug 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 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 this medicine or within two years after stopping treatment, she should discontinue the medicine and immediately contact her doctor to perform a pregnancy test. If the test confirms pregnancy, the doctor may recommend certain medicines to rapidly and adequately eliminate this medicine from the body to reduce the risk to the unborn child.
Contraception
While taking this medicine 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 Medical Valley is sufficiently low – this will be confirmed 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 Teriflunomide Medical Valley while breastfeeding, as teriflunomide passes into human milk.
Driving and operating machinery
This medicine may cause dizziness, which may impair the ability to concentrate and react.
Patients experiencing such symptoms should not drive or operate machinery.
Teriflunomide Medical Valley contains lactose
This medicine contains lactose (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
Teriflunomide Medical Valley 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 Teriflunomide Medical Valley

The use of Teriflunomide Medical Valley will be supervised by a physician 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 per day.

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 per day.
• Children with body weight less than or equal to 40 kg: one 7 mg tablet per day.
  Teriflunomide Medical Valley 14 mg film-coated tablets are not suitable for children and adolescents with body weight ≤ 40 kg. Other medicines containing teriflunomide at a lower strength are available (in the form of 7 mg film-coated 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.

Route and method of administration
Teriflunomide Medical Valley is administered orally. The medicine should be taken daily as a single daily dose. Tablets should be swallowed whole with water.
Teriflunomide Medical Valley may be taken with food or independently of meals.

Taking more Teriflunomide Medical Valley than recommended
If more Teriflunomide Medical Valley is taken than recommended, contact your doctor immediately. Adverse effects similar to those described in section 4 below may occur.

Missing a dose of Teriflunomide Medical Valley
Do not take a double dose to make up for a missed tablet. Take the next dose according to the prescribed dosing schedule.

Stopping Teriflunomide Medical Valley
Do not stop taking this medicine 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 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.
Serious side effects
Some side effects may be serious 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, fever or mouth ulcers
• Severe infections or sepsis (a type of infection that may be life-threatening),
  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 not known (frequency cannot be estimated from available data):

• Severe liver disease, which may cause symptoms including yellowing of the skin or whites of the eyes, dark-coloured urine, unexplained nausea and vomiting, or abdominal pain

Other side effects may occur with the following frequencies:
Very common (may affect more than 1 in 10 people)

• Headache
• Diarrhoea, nausea
• Increased AlAT activity (increased activity of certain liver enzymes in blood) observed in laboratory 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, tooth infection, laryngitis, fungal foot infection
• Herpes virus infections, including cold sores and shingles, with symptoms such as blisters, burning, itching, tingling 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 anxiety
• Tingling sensation, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica), sensation of numbness, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
• Palpitations
• Increased blood pressure
• Vomiting, toothache, upper abdominal pain
• Rash, acne
• Tendon, joint, bone pain, muscle pain (musculoskeletal pain)
• Need to urinate more often than usual
• Heavy menstrual bleeding
• Pain
• Lack of energy or feeling weak (asthenia)
• Decreased body weight

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, disorders of nerves in arms or legs (peripheral neuropathy)
• Changes in the nails, 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 affect up to 1 in 1,000 people)

• Inflammation or damage to the liver

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

• Pulmonary hypertension

Children (aged 10 years and older) and adolescents
The side 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 side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects 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 181 C
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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Teriflunomide Medical Valley

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Teriflunomide Medical Valley contains
The active substance is teriflunomide.
Teriflunomide Medical Valley

• Each tablet contains 14 mg of teriflunomide.
• Other ingredients are:
  Tablet core: monohydrate lactose, corn starch, hydroxypropylcellulose, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

Tablet coating: hypromellose – 6 mPa·s, titanium dioxide (E 171), colloidal anhydrous silica, macrogol 8000, and indigo carmine, aluminium lake (E 132).
(see section 2 “Teriflunomide Medical Valley contains lactose”).

What Teriflunomide Medical Valley looks like and contents of the pack
Blue, round (8.0 mm), biconvex film-coated tablets, smooth on both sides.
Teriflunomide Medical Valley is packed in:

• Aluminium/Aluminium foil blisters containing 28 and 84 film-coated tablets in a cardboard box
• Unit dose blister (Unit Dose Blister) made of Aluminium-Aluminium foil containing 28 film-coated tablets in a cardboard box
• Calendar blister made of Aluminium/Aluminium foil containing 98 film-coated tablets in a cardboard box

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer/Importer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº7
Pol. Ind. Miralcampo,
19200 Azuqueca de Henares, Guadalajara
Spain

Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park,
Paola, PLA 3000,
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
France: TERIFLUNOMIDE VIATRIS SANTÉ 14 mg, comprimé pelliculé
Spain: Teriflunomide Viatris Pharmaceuticals 14 mg comprimidos recubiertos con película EFG
Iceland: Teriflunomide Medical Valley 14 mg filmuhúðaðar töflur
Germany: TerifluViatris 14 mg Filmtabletten
Norway: Teriflunomide Medical Valley
Poland: Teriflunomide Medical Valley
Portugal: Teriflunomida Viatris Pharma 14 mg comprimidos revestidos por película
Italy: Teriflunomida Viatris Pharma