Teriflunomide Pharmathen

Package Leaflet: Information for the Patient

Teriflunomide Pharmathen, 14 mg, Film-Coated Tablets

Teriflunomide

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, 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 only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

What is Teriflunomide Pharmathen

Teriflunomide Pharmathen 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 Teriflunomide Pharmathen used for

Teriflunomide Pharmathen is used to treat adults and 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) of the nerves in the central nervous system. This process is called demyelination. It disrupts the normal functioning of the nerves. In people with relapsing-remitting multiple sclerosis, there are recurring attacks (relapses) of physical symptoms caused by the abnormal functioning of the nerves. These symptoms vary among patients 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 physical disability that interferes with daily activities.

How Teriflunomide Pharmathen Works

Teriflunomide Pharmathen 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 Teriflunomide Pharmathen

When Not to Take Teriflunomide Pharmathen:

• such as acquired immune deficiency syndrome (AIDS);

Warnings and Precautions

Before starting treatment with Teriflunomide Pharmathen, discuss with your doctor or pharmacist:

Respiratory Reactions

Tell your doctor if you experience unexplained cough and shortness of breath (difficulty breathing). Your 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 this age group with multiple sclerosis.
The warnings and precautions mentioned above also apply to children.
The following information is important for children and their caregivers:

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

Teriflunomide Pharmathen 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 (a blood thinner) used to thin the blood (i.e., to 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 conditions;
• cimetidine, used to reduce stomach acid production;
• zidovudine, used to treat HIV infections;
• rosuvastatin, simvastatin, atorvastatin, pravastatin, medicines 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 diseases;
• activated charcoal, used to reduce the absorption of medicines or other substances.

Pregnancy and Breastfeeding

Do not take Teriflunomide Pharmathen if you are pregnant or think you may be pregnant. In pregnant women or those who become pregnant while taking Teriflunomide Pharmathen, there is an increased risk of birth defects in the baby.
Women of childbearing age should not take this medicine unless they use effective contraception.
If a girl starts menstruating while taking Teriflunomide Pharmathen, 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 Teriflunomide Pharmathen, she should inform her doctor, as it is essential to ensure that the medicine is no longer in the body before trying to conceive. 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 Teriflunomide Pharmathen from the body.
In both cases, it should be confirmed by a blood test that the active substance has been sufficiently removed from the body. The doctor should confirm that the level of Teriflunomide Pharmathen 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 that she has become pregnant while taking Teriflunomide Pharmathen or within two years after stopping treatment, she should stop taking Teriflunomide Pharmathen and immediately contact her doctor to perform a pregnancy test. If the test confirms pregnancy, the doctor may suggest using appropriate medicines to quickly and sufficiently remove Teriflunomide Pharmathen from the body.
Contraception
During and after treatment with Teriflunomide Pharmathen, 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 Teriflunomide Pharmathen in the blood is low enough (checked by the doctor).
• Discuss with your doctor the best contraceptive method for you and any need to change the contraceptive method.

Do not take Teriflunomide Pharmathen while breastfeeding, as teriflunomide passes into human milk.

Driving and Using Machines

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

Teriflunomide Pharmathen Contains Lactose

Teriflunomide Pharmathen contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Teriflunomide Pharmathen 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 Teriflunomide Pharmathen

Treatment with Teriflunomide Pharmathen will be supervised by a doctor experienced in treating multiple sclerosis.
Always take Teriflunomide Pharmathen exactly as your doctor has told you. If you are unsure, 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 above 40 kg: one 14 mg tablet per day.
• Children with a body weight of 40 kg or less: for children and adolescents aged 10 years and older and with a body weight of 40 kg or less, other teriflunomide-containing medicines with a different strength are appropriate; consult your doctor or pharmacist about the availability of teriflunomide-containing tablets with a different strength.

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.
Teriflunomide Pharmathen 14 mg film-coated tablets are not suitable for children and adolescents with a body weight of 40 kg or less.
Method of Administration
Teriflunomide Pharmathen is taken orally. Teriflunomide Pharmathen should be taken once daily at any time of day as a single daily dose.
Swallow the tablets whole with water.
Teriflunomide Pharmathen can be taken with or without food.

Taking More Than the Recommended Dose of Teriflunomide Pharmathen

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

Missing a Dose of Teriflunomide Pharmathen

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

Stopping Treatment with Teriflunomide Pharmathen

Do not stop taking Teriflunomide Pharmathen or change the dose without first consulting your doctor.
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 can be severe or may become severe if you experience any of these symptoms, inform your doctor immediately.
Common(may affect up to 1 in 10 people)

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

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 difficulty breathing;
• severe skin reactions, which may cause symptoms including skin rash, blisters on the skin, fever, or ulcers in the mouth;
• severe infections or sepsis (a life-threatening infection), which may cause symptoms including high fever, chills, shivering, reduced urine output, or disorientation;
• pneumonia, 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 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 laboratory tests;
• hair thinning.

Common(may affect up to 1 in 10 people)

• flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, herpes simplex, tooth infection, laryngitis, pharyngitis;
• laboratory test results: decreased red blood cell count (anemia), changes in liver function and white blood cell count (see section 2), also observed were increased muscle enzyme activity (creatine kinase);
• mild allergic reactions;
• feeling anxious;
• feeling of tingling, feeling of weakness, numbness, tingling, or pain in the lower back or leg (sciatica), feeling of numbness, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome);
• feeling of "heart pounding";
• increased blood pressure;
• vomiting, toothache, abdominal pain;
• rash, acne;
• tendon, joint, bone, 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 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 the nails, severe skin reactions;
• traumatic pain;
• psoriasis;
• mouth ulcers;
• abnormal blood fat (lipid) levels;
• inflammation of the large intestine.

Rare(may affect up to 1 in 1,000 people)

• inflammation or damage to the liver.

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, adolescents, and their caregivers:
Common(may affect up to 1 in 10 people)

• pancreatitis.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform 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 181C
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 Teriflunomide Pharmathen

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.
Do not store above 30°C.
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 Teriflunomide Pharmathen Contains

The active substance is teriflunomide.

• Each tablet contains 14 mg of teriflunomide.
• The other ingredients are: lactose monohydrate (150M), cornstarch, microcrystalline cellulose type 102, sodium carboxymethylcellulose (type A), hydroxypropylcellulose (type L), magnesium stearate, silicon dioxide; coating Opadry 03F220186 Yellow: hypromellose type 2910, titanium dioxide (E171), talc, macrogol 6000, yellow iron oxide (E172) (see section 2 "Teriflunomide Pharmathen contains lactose").

What Teriflunomide Pharmathen Looks Like and Contents of the Pack

Pentagonal film-coated tablet with a diameter of 7.3 ± 0.2 mm and a thickness of 3.8 ± 0.5 mm, light yellow to pale yellow, with printing on one side "14".
This medicine is packed in blisters of OPA/Aluminum/PVC/Aluminum foil, in a cardboard box.
Pack size: 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pharmathen S.A.
Dervenakion 6
153 51 Pallini
Greece
+302106604300
info@pharmathen.com

Manufacturer

Pharmathen International S.A.,
Industrial Park Sapes
Rodopi Prefecture, Block No 5
693 00 Rodopi
Greece
Pharmathen S.A.
Dervenakion 6
153 51 Pallini
Greece

This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Leaflet: