Teriflunomide ranbaxy

Package leaflet: Information for the user

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

• 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 a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

What Teriflunomide Ranbaxy is
Teriflunomide Ranbaxy 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 Ranbaxy is used for
Teriflunomide Ranbaxy is used in the treatment of adults, children and adolescents (aged 10 years and above) 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 damages the protective covering (called myelin) around the nerves in the central nervous system. This process is known as demyelination. This impairs the nerves' ability to function properly.

In people with relapsing-remitting multiple sclerosis, there are recurrent attacks (relapses) of physical symptoms caused by improper nerve function. Symptoms vary between patients but usually include:

• difficulty walking,
• vision problems,
• balance problems.

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 Ranbaxy works
Teriflunomide Ranbaxy helps protect the central nervous system from the immune system by limiting 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 Ranbaxy

When not to take Teriflunomide Ranbaxy:

• 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 developed severe skin rash, skin peeling, blisters and/or mouth ulcers 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 severe diseases affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS);
• if the patient has 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 Teriflunomide Ranbaxy, discuss with a doctor or pharmacist if:

• the patient has liver function disorders and/or drinks large amounts of alcohol. The doctor will perform blood tests to check whether liver function is normal before and during treatment. If test results show liver function abnormalities, the doctor may discontinue Teriflunomide Ranbaxy. Please refer to section 4.
• the patient has high blood pressure (hypertension), regardless of whether it is controlled with medication or not. Teriflunomide Ranbaxy may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly thereafter. Please refer to section 4.
• the patient has an infection. Before the patient takes Teriflunomide Ranbaxy, the doctor will ensure that the patient has sufficient white blood cells and platelets in the blood. Since Teriflunomide Ranbaxy 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. Herpes virus infections, including cold sores or shingles, may occur during treatment with teriflunomide. In some cases, severe complications have occurred. Inform the doctor immediately if any symptoms suggestive of herpes virus infection are suspected. Please 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 Ranbaxy.
• the patient is switching from another medication to Teriflunomide Ranbaxy or from Teriflunomide Ranbaxy to another medicine.
• 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 Ranbaxy is not intended for use in children under 10 years of age, as it has not been studied in pediatric patients with multiple sclerosis. 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 Ranbaxy and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

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 (a medicine used to treat tuberculosis and other infections);
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy;
• St. John’s wort (a 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 blood clots;
• oral contraceptives (containing ethinylestradiol and levonorgestrel);
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin, used to treat infections;
• indometacin, ketoprofen, used for pain relief or to treat inflammatory conditions;
• furosemide, used to treat heart conditions;
• cimetidine, used to reduce gastric acid secretion;
• zidovudine, used to treat HIV infections;
• rosuvastatin, simvastatin, atorvastatin, pravastatin, medicines used to treat hypercholesterolemia (elevated blood cholesterol levels);
• sulfasalazine, used for inflammatory bowel disease or rheumatoid arthritis;
• cholestyramine, used for elevated blood cholesterol levels or itching in liver disease;
• activated charcoal, used to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take Teriflunomide Ranbaxy if the patient is pregnant or suspects she may be pregnant. Women who are pregnant or become pregnant while taking Teriflunomide Ranbaxy have an increased risk of giving birth to a child with congenital malformations. Women of childbearing potential who are not using effective contraception must not take this medicine. If a girl starts menstruating while taking Teriflunomide Ranbaxy, inform the doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.

If the patient plans to become pregnant after stopping Teriflunomide Ranbaxy, she should inform her doctor, because 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 shortened to several weeks by taking specific medicines that accelerate the removal of Teriflunomide Ranbaxy 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 Ranbaxy is low enough to allow pregnancy. More information on laboratory tests can be obtained from the doctor.

If pregnancy is suspected during treatment with Teriflunomide Ranbaxy or within two years after stopping treatment, discontinue Teriflunomide Ranbaxy immediately and contact the doctor immediately to perform a pregnancy test. If the test confirms pregnancy, the doctor may recommend appropriate treatment to rapidly and adequately eliminate Teriflunomide Ranbaxy from the body, as this may reduce the risk to the unborn child.

Contraception
While taking Teriflunomide Ranbaxy 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 should continue to be used after stopping treatment.

• This method should be continued until the blood concentration of Teriflunomide Ranbaxy is sufficiently low (as confirmed by the doctor).
• Discuss with the doctor the most suitable method of contraception for the patient, and also in case a change of contraceptive method is needed.

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

Driving and operating machinery
Teriflunomide Ranbaxy may cause dizziness, which may impair the ability to concentrate and react. Patients experiencing such symptoms should not drive or operate machinery.

Teriflunomide Ranbaxy contains lactose
Teriflunomide Ranbaxy 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 Ranbaxy 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 Ranbaxy

Treatment with Teriflunomide Ranbaxy 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 per day.
Children and adolescents (aged 10 years and above)
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 Ranbaxy is not available in this strength. In cases where doses cannot be achieved with this medicine, other strengths of teriflunomide-containing medicines are available.

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 per day.
Route and method of administration
Teriflunomide Ranbaxy is administered orally. Teriflunomide Ranbaxy should be taken daily, at any time, as a single daily dose. Tablets should be swallowed whole with water.
Teriflunomide Ranbaxy may be taken with food or independently of meals.
Taking more Teriflunomide Ranbaxy than prescribed
If more Teriflunomide Ranbaxy is taken than prescribed, contact your doctor immediately. Adverse effects similar to those described in section 4 below may occur.
Missing a dose of Teriflunomide Ranbaxy
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 Ranbaxy
Do not stop taking Teriflunomide Ranbaxy 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 using this medicine.
Serious adverse reactions
Some adverse reactions may be or may become serious; if any of the following symptoms occur, immediately contact your doctor.
Common (may occur in up to 1 in 10 people)

• Pancreatitis, which may include symptoms such as abdominal pain, nausea, or vomiting (frequency is common in children and adolescents and uncommon in adult patients).

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

• Allergic reactions, which may include symptoms such as rash, urticaria, swelling of the lips, tongue or face, or sudden breathing difficulties;
• Severe skin reactions, which may include 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 include symptoms such as high fever, seizures, chills, reduced urine flow, or confusion;
• Lung inflammation, which may cause symptoms such as shortness of breath or persistent cough.

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

• Severe liver disease, which may include symptoms such as yellowing of the skin or whites of the eyes, dark 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 people)

• Headache;
• Diarrhea, nausea;
• Increased AlAT activity (elevation of certain liver enzyme levels in blood) observed in laboratory tests;
• Hair thinning.

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

• Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort during swallowing, cystitis, viral gastroenteritis, oral herpes, 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 test results: decreased number of red blood cells (anemia), changes in liver function tests and white blood cells (see section 2); increased activity of muscle enzyme (creatine phosphokinase) has also been observed;
• Mild allergic reactions;
• Feeling of anxiety;
• Tingling and pricking sensations, feeling of weakness, numbness, tingling, or pain in the lower back or leg (sciatica), numbness, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome);
• Sensation of "pounding heartbeat";
• Increased blood pressure;
• Vomiting, toothache, epigastric pain;
• Rash, acne;
• Tendon, joint, bone pain, muscle pain (musculoskeletal pain);
• Need to urinate 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 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);
• Nail changes, severe skin reactions;
• Traumatic pain;
• Psoriasis;
• Inflammation of the mucous membrane of the mouth and (or) lips;
• Abnormal levels of fats (lipids) in the blood;
• Colitis.

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

• Liver inflammation or damage.

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

• Pulmonary hypertension.

Children (aged 10 years and above) 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 Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Teriflunomide Ranbaxy

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 pack following "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Teriflunomide Ranbaxy contains
The active substance is teriflunomide.

• Each tablet contains 14 mg of teriflunomide.
• The 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 2910 (E 464), macrogol (E 1521), titanium dioxide (E 171), yellow iron oxide (E 172) and red iron oxide (E 172).

What Teriflunomide Ranbaxy looks like and contents of the pack
Teriflunomide Ranbaxy film-coated tablets are light yellow, round, biconvex, with a diameter of 7 mm, marked with "A" on one side and "14" on the other side.
Teriflunomide Ranbaxy is available in blisters made of Aluminium/OPA/Aluminium/PVC, packed in cardboard boxes containing 30 film-coated tablets.
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
tel. 22 642 07 75
Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Terapia S.A.
124 Fabricii Street
400632 Cluj-Napoca
Romania
This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden: Teriflunomid SUN 14 mg film-coated tablets
Poland: Teriflunomide Ranbaxy
Romania: Teriflunomida Terapia 14 mg film-coated tablets