Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Avelable Brandfrom Medikaloka Apotheca : Tricor US Brand Name Antara Fenoglide Lipofen Lofibra Tricor Triglide Descriptions Fenofibrate is used together with a proper diet to treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides in the blood. This medicine is available only with your doctor’s prescription. This product is available in the following dosage forms: Tablet Capsule In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: In addition to its helpful effects in treating your medical problem, this type of medicine may have some harmful effects. Results of large studies using other agents that are similar to fenofibrate seem to suggest that fenofibrate may increase the patient’s risk of cancer, pancreatitis (inflammation of the pancreas), gallstones, and problems from gallbladder surgery. Studies with fenofibrate in rats found an increased risk of liver and pancreatic tumors when doses up to 6 times the human dose were given for a long time. Be sure you have discussed this with your doctor before taking this medicine. Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of fenofibrate in the pediatric population. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fenofibrate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving fenofibrate. Pregnancy Information about this fenofibrate-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Drug Interactions Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Acenocoumarol Anisindione Apixaban Argatroban Atorvastatin Bivalirudin Cerivastatin Colchicine Dabigatran Etexilate Dalteparin Danaparoid Desirudin Dicumarol Drotrecogin Alfa Enoxaparin Fluvastatin Fondaparinux Heparin Lepirudin Lovastatin Phenindione Phenprocoumon Pitavastatin Pravastatin Protein C, Human Rivaroxaban Rosuvastatin Simvastatin Tinzaparin Warfarin Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Colestipol Cyclosporine Ezetimibe Glimepiride Rosiglitazone Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism), history of or Muscle pain or tenderness, history of or Muscle weakness, history of—Use with caution. May make these conditions worse. Diabetes or Hypothyroidism (an underactive thyroid) or Kidney disease—Use with caution. May cause side effects to become worse. Gallbladder disease, history of or Kidney disease, severe (including those receiving dialysis) or Liver disease (including cirrhosis) or Liver enzymes, persistently elevated—Should not be used with these conditions. Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered. In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor’s order about any special diet. This medicine is usually taken once a day. Take the medicine at the same time each day to maintain the medication’s effect. Fenoglide®, Lipofen®, and Lofibra™ should be taken with a meal. Antara®, Tricor®, and Triglide® can be taken with or without a meal. Swallow Antara® capsules, Tricor® or Triglide® tablets whole. Do not open, crush, break, chew, or dissolve them. Dosing The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For oral dosage form (capsules): For high cholesterol: Adults— Antara®: At first, 130 milligrams (mg) once a day with a meal. Lipofen®: At first, 150 mg once a day with a meal. Your doctor may adjust your dose as needed. Lofibra™: 200 mg once a day with a meal. Children—Use and dose must be determined by your doctor. For high triglycerides or fats: Adults— Antara®: At first, 43 to 130 milligrams (mg) once a day with a meal. Your doctor may adjust your dose as needed. However, the dose is usually not more than 130 mg per day. Lipofen®: At first, 50 to 150 mg once a day with a meal. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day. Lofibra™: At first, 67 mg once a day with a meal. Your doctor may increase your dose as needed. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): For high cholesterol: Adults— Fenoglide®: At first, 120 milligrams (mg) per day. Your doctor may adjust your dose as needed. Tricor®: At first, 145 mg once a day. Your doctor may adjust your dose as needed. Triglide®: 160 mg once a day. Children—Use and dose must be determined by your doctor. For high triglycerides or fats: Adults— Fenoglide®: At first, 40 to 120 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 120 mg per day. Tricor®: At first, 48 to 145 mg once a day. Your doctor may adjust your dose as needed. Triglide®: At first, 50 to 160 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 160 mg per day. Children—Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects. Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy. Stop using this medicine and check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems. Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness. This medicine may increase your risk of having gallstones. Check with your doctor right away if you have severe stomach pain with nausea and vomiting. Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin, chills, diarrhea, itching, joint or muscle pain, rash, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness. Check with your doctor right away if you have signs of a fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts, which may be caused by this medicine. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Less common Chills or fever hives or skin rash itching muscle aches and pains nausea or vomiting Rare Chronic indigestion dark urine muscle cramps, pain, stiffness, swelling, or weakness troubled breathing unusual bleeding or bruising unusual tiredness yellow eyes or skin Incidence not known Agitation bloating bloody urine decreased frequency or amount of urine lower back or side pain pains in the stomach, side, or abdomen, possibly radiating to the back swelling of the face, fingers, or lower legs swollen joints upper right abdominal or stomach pain Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Runny nose sneezing stuffy nose Less common Back pain diarrhea eye irritation gas increased sensitivity of the skin to sunlight Incidence not known Lack or loss of strength Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.