DENOPSY 14 Tablet 10's
Key Information
Generic Name
Generic Name Teriflunomide 14 mg
Manufacturer
Natco Pharma Ltd
Variant
10 Tablet(s) in a Strip
Country of Origin
India
Detailed Information
Introduction
INTRODUCTIONDENOPSY 14 contains Teriflunomide which belongs to the group of medicines called Immunomodulatory agents. It is used in adults and in children (aged 10 years or older) to manage relapsing remitting multiple sclerosis (MS). Multiple sclerosis is an auto-immune disease in which the immune system destroys the protective covering that surrounds the nerves (myelin sheath). This prevents the nerves from working properly and ca
Uses
vision problems, difficulty in walking, loss of balance, muscle pain, fatigue, dizziness, pins and needles, anxiety, and difficulty in speaking. Relapsing remitting multiple sclerosis is a form of multiple sclerosis in which the symptoms appear and disappears in an alternative manner. People may have repeated attacks (relapses) of physical symptoms for a certain period after which the symptoms may disappear completely and reappear once again after relapses. Teriflunomide is an immune suppressant medicine. It reduces nerve damage by limiting the functions of certain immune cells (T and B lymphocytes) in the body that causes nerve damage. As a result, it reduces nerve inflammation and its associated symptoms. Before taking DENOPSY 14, inform your doctor if you have any liver, kidney, heart, or respiratory problems. You must also inform your doctor if you currently have any infections in your body. DENOPSY 14 is not recommended for use in patients with severe immune related diseases (such as AIDS), bone marrow problems or low WBC or platelet counts in the blood. It is also not suitable for use in children aged below 10 years due to lack of safety data. DENOPSY 14 should not be used during pregnancy. Women of childbearing potential must use a suitable contraception to prevent pregnancy while undergoing therapy with DENOPSY 14. Also, before trying for pregnancy, you must stop the therapy completely and get medically confirmed by your doctor that the levels of DENOPSY 14 are sufficiently reduced in your body. DENOPSY 14 is not suitable for use in breastfeeding women as it may pass through breast milk. The most common
How It Works
DENOPSY 14 protects the nerve cells from damage by limiting the functions of certain immune cells (T and B lymphocytes) in the body that causes nerve damage. As a result, it reduces nerve inflammation and its associated symptoms.
Directions for Use
Take DENOPSY 14 as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. It can be taken with or without food. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Continue to take DENOPSY 14 for the stipulated duration as advised by your doctor without any interruption to achieve maximum benefits.
Side Effects
taking DENOPSY 14 are headache, diarrhea, nausea, increased liver enzymes and hair thinning. Contact your doctor if any of these side effect worsens. USES OF DENOPSY 14It is used in adults and in children (aged 10 years or older) to manage: relapsing remitting multiple sclerosis HOW DENOPSY 14 WORKSDENOPSY 14 protects the nerve cells from damage by limiting the functions of certain immune cells (T and B lymphocytes) in the body that causes nerve damage. As a result, it reduces nerve inflammation and its associated symptoms. DIRECTIONS FOR USETake DENOPSY 14 as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. It can be taken with or without food. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Continue to take DENOPSY 14 for the stipulated duration as advised by your doctor without any interruption to achieve maximum benefits. SIDE EFFECTS OF DENOPSY 14COMMON headache nausea, vomiting, upper stomach pain, diarrhea increase in liver enzymes hair thinning flu-like symptoms, sore throat urinary tract infection, urge to pee infections of the gut oral herpes, tooth infection, tooth pain fungal infection of the foot anemia (low RBC in blood making you feel tired with a pale skin) anxiety, feeling weak numbness, pain or tingling sensation in the lower back or leg, burning sensation in the hands and fingers abnormal heartbeat, high blood pressure skin rash or acne bone pain, joint pain, muscle pain heavy menstrual bleeding weight loss UNCOMMON decrease in the number of blood platelets increased feeling or sensitivity especially in the skin nerve pain in peripheral parts of the body (such as hands and legs) nail disorders post-traumatic pain (pain after an accident or surgery) psoriasis inflammation of mouth or lips abnormal levels of fats (lipids) in the blood inflammation of the colon (colitis) RAREStop taking DENOPSY 14 and contact your doctor immediately if you experience any of the following side effects: inflammation of the pancreas causing symptoms such as pain in the abdominal area, nausea, or vomiting signs of allergic reactions (such as skin rash, itching, swelling of the lips, tongue or face and sudden difficulty in breathing) severe skin reactions causing symptoms such as skin rash, blistering of skin, fever, or ulcers in the mouth severe infections or sepsis causing high fever, shaking, chills, reduced urine flow, or confusion signs of lung inflammation (such as shortness of breath or persistent cough) signs of liver problems (such as yellowing of the skin and whites of the eye, dark urine, nausea, vomiting and stomach pain)
Warnings & Precautions
& PRECAUTIONSPREGNANCYDENOPSY 14 is not recommended for use in pregnant women. Women of childbearing potential must use a suitable contraception to prevent pregnancy while undergoing therapy with DENOPSY 14. Also, before trying for pregnancy, you must stop the therapy completely and get medically confirmed by your doctor that the levels of DENOPSY 14 are sufficiently reduced in your body. BREASTFEEDINGDENOPSY 14 is not recommended for use in breast-feeding women as it may pass through breast milk. Therefore, consult your doctor before taking it. DRIVING AND USING MACHINESDo not drive or operate any machines if you feel dizzy after taking DENOPSY 14. ALCOHOLAvoid consumption of alcohol while taking DENOPSY 14. KIDNEYDENOPSY 14 is not recommended for use in patients with severe kidney problems (Ex. dialysis). Therefore, consult your doctor before taking it. LIVERDENOPSY 14 is not recommended for use in patients with severe liver problems. It should be used with caution in patients with mild liver problems. Therefore, consult your doctor before taking it. ALLERGYDo not take DENOPSY 14 if you are allergic to Teriflunomide. LUNGSDENOPSY 14 should be used with caution in patients with respiratory problems (such as unexplained cough or shortness of breath). Therefore, consult your doctor before taking it. HEART DISEASEDENOPSY 14 should be used with caution in patients with heart diseases (such as high blood pressure). Therefore, consult your doctor before taking it. OTHERSDENOPSY 14 is not recommended for use if you: suffer from a serious problem which affects your immune system e.g., acquired immunodeficiency syndrome (AIDS) have a serious problem with bone marrow have low numbers of RBC, WBC or platelet counts in the blood are suffering from a serious infection have very low levels of proteins in blood (hypoproteinaemia) Before taking DENOPSY 14, inform your doctor if you: have an infection have severe skin reactions have weakness, numbness and pain in the hands and feet are due to have a specific blood test (calcium level) are going to have a vaccination Use in Pediatrics: DENOPSY 14 should be used in children and adolescents (aged 10 years or older) only if prescribed by the physician. It is not recommended for use in children aged below 10 years due to lack of safety data. However, consult your doctor before taking it. Use in Geriatrics: DENOPSY 14 should be used with caution in elderly patients (aged 65 years or older). Therefore, consult your doctor before taking it.
Drug Interactions
SA. Drug - Drug interactions: Before taking DENOPSY 14, inform your doctor if you are taking any of the following medicines such as: other medicines used for immunosuppression (such as leflunomide or methotrexate) medicines used to manage epilepsy (Ex. carbamazepine, phenobarbital, phenytoin) medicines used to manage diabetes (Ex. pioglitazone, nateglinide, repaglinide or rosiglitazone) medicines used to manage cancer (Ex. doxorubicin, paclitaxel, daunorubicin or topotecan) medicines used to manage bacterial infections (Ex. sulfasalazine, cefaclor, benzylpenicillin, ciprofloxacin) medicines used to manage high blood cholesterol levels (Ex. rosuvastatin, simvastatin, atorvastatin, pravastatin, cholestyramine) St. John’s wort, duloxetine (medicine used to manage depression) alosetron (a medicine used to irritable bowel syndrome) theophylline (a medicine used to manage asthma) tizanidine (a muscle relaxant) warfarin (a medicine used for blood thinning) birth control pills (Ex. ethinylestradiol and levonorgestrel) indometacin, ketoprofen (used to manage pain and inflammation) furosemide (a diuretic used to manage edema or high blood pressure) cimetidine (a medicine used to reduce stomach acid production) zidovudine (a medicine used to manage HIV infection) activated charcoal (a medicine used to manage poisoning) rifampicin (a medicine used to manage tuberculosis) Over dosage: If you or anyone else accidentally took more DENOPSY 14, consult your doctor immediately or visit the nearby hospital. SYNOPSIS Drug : Teriflunomide Pharmacological Category : Immunomodulatory agents Therapeutic Indication : Relapsing remitting multiple sclerosis (MS) Dosage Forms : Tablet MORE INFORMATION Keep DENOPSY 14 out of reach of children Store DENOPSY 14 at room temperature