FIBATOR EZ TABLET

Manufacturer : SUN-SUN PHARMACEUTICALS
Composition : FENOFIBRATE-160MG+ATORVASTATIN-10MG+EZETIMIBE-10MG
Dose Form : TABLET
Description : FIBATOR EZ TAB
Route Of Administration : ORAL
Pack : 10
₹190.00
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SKU
FIB0010

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Manufacturer : SUN-SUN PHARMACEUTICALS
Composition : FENOFIBRATE-160MG+ATORVASTATIN-10MG+EZETIMIBE-10MG
Dose Form : TABLET
Description : FIBATOR EZ TAB
Route Of Administration : ORAL
Pack : 10

Drug Ingredient Information

FENOFIBRATE-160MG+ATORVASTATIN-10MG+EZETIMIBE-10MG

FENOFIBRATE

Information for patients
Drug Information Fenofibrate 67mg belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides. Fenofibrate is used, alongside a low fat diet and other non- medical treatments such as exercise and weight loss, to lower levels of fats in the blood. Fenofibrate can be used in addition to other medicines [statins] in some circumstances when levels of fats in the blood are not controlled with a statin alone. Fenofibrate can often also increase the amount of a “good” type of cholesterol, called HDL or high density lipoprotein cholesterol. It is always essential to continue a low-fat diet during treatment with Fenofibrate
Drug Alert
Alert • You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients of Fenofibrate 67 mg. • You suffer from liver or kidney disease or gallbladder disease. • Sunlight or UV light have caused an allergic reaction (photoallergy) or skin damage while you were taking fibrates or an anti- inflammatory drug called ketoprofen in the past
Before Consuming the Medicine
Avoid Drug • You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients of Fenofibrate 67 mg. • You suffer from liver or kidney disease or gallbladder disease. • Sunlight or UV light have caused an allergic reaction (photoallergy) or skin damage while you were taking fibrates or an anti- inflammatory drug called ketoprofen in the past. • You are pregnant, breast-feeding, or planning to get pregnant. • You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain) unless it is caused by high levels of fat in the blood (hypertriglyceridemia).
Drug Special Care Tell your doctor before you start to take this medicine: • If you have any kidney problems. • If you suffer from an under active thyroid gland (hypothyroidism). • If you have diabetes, especially Type 2 diabetes, that is not well controlled. • If you have liver problems. • If you have problems with certain proteins in your blood • If you have an alcohol problem. • You are taking other medicines. • If you or your family have had muscle problems • If you are over 70 years of age (some of the above conditions can lead to high levels of lipids in your blood and need to be corrected before you start therapy with fenofibrate). Your doctor might want to test your blood or urine to check if Fenofibrate is working properly and also if your kidneys, muscles and liver are working properly.
Drug Drug Interactions Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular please let your doctor know if you already take: • Anticoagulants to thin your blood (for example, warfarin). • Other drugs to control lipid (fat) levels in the blood (for example, drugs known as “statins” or “fibrates”). Taking a “statin” (e.g. simvastatin, atorvastatin) at the same time as Fenofibrate can increase the risk of muscle problems. • Ciclosporin (an immunosuppressant)
Drug Pregnancy Interaction Tell your doctor if you are, you think you might be or are planning to become pregnant. Fenofibrate must not be taken if you are pregnant.
Drug Breast feeding Interaction You must not use Fenofibrate if you are breast-feeding or if you are planning to breastfeed your baby
Drug Machinery Interaction This medicine should not affect your ability to drive or use machines
Drug More Information Contact your doctor quickly if you experience unexplained muscle pain, tenderness or weakness. This is because on rare occasions, there is a risk of muscle problems which may be serious, including muscle breakdown which can cause kidney damage. Your doctor may perform a blood test to check the condition of your muscles before and after starting treatment. The risk of muscle breakdown is greater in certain patients. Tell your doctor if any of the following applies to you: • You have any kidney problems • You have an under active thyroid. • You often drink large amounts of alcohol. • You have ever had muscle problems during treatment with cholesterol lowering medicines called “statins” (such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin) or fibrates (such as fenofibrate, bezafibrate or gemfibrozil). • You or close family members have a hereditary muscle disorder. The risk of muscle problems can be greater if Fenofibrate is taken with cholesterol lowering medicines called “statins” (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, fluvastatin). Tell your doctor if you are taking any of these medicines
How to take the Medicine
Consumption Info Important information about some of the ingredients of Fenofibrate This medicine contains lactose which is a type of sugar. If you have been told by your doctor that you have a intolerance to some sugars, contact your doctor before taking this medicinal product.
Drug quanitty The usual dose for adults is one capsule of Fenofibrate 67 three times a day, taken at mealtimes. The usual dose for children is one capsule of Fenofibrate 67 per 20kg bodyweight per day. Your doctor will work out the dose that is required
Drug Dose Always take Fenofibrate exactly as your doctor has told you. Also, please read the label on the packet. You should check with your doctor if you are not sure. Swallow the capsule with a glass of water. It is important to take the capsule with food, as it will not work as well if your stomach is empty
Excess Drug Consumption If you accidentally take more Fenofibrate than you should or if someone else has taken your medicine, contact your nearest hospital casualty department or tell your doctor immediately
Forgot Drug Consumption Do not take a double dose to make up for a forgotten capsule. Take the next dose with your next meal and then carry on taking your capsules as usual. If you are worried about this talk to your doctor
Stop Drug Consumption Do not stop taking the medicine unless your doctor tells you to, or your medicine makes you feel unwell. This is because raised cholesterol levels need treating for a long period of time. Remember you should also continue with a low-fat diet whilst taking Fenofibrate . If your doctor stops your medicine, do not keep any left over capsules unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor.
Possible Side Effects
General Information
Common Drug Side Effects - Stomach pain, being sick, feeling sick, diarrhoea and wind (flatulence) - Reactions such as rashes, itching, red patches on the skin or increased sensitivity to sunlight, sun lamps and sunbeds - Headache, fatigue, vertigo
Rare Drug Side Effects - Raised levels of various liver enzymes in the blood - Slight increases in blood levels of substances normally excreted by the kidneys (urea and creatinine) - Reduced sex drive - Hair loss - Muscle pain, muscle inflammation, muscle cramps and weakness - Decrease in haemoglobin (oxygen carrying pigment in blood) and decrease in white blood cells
Very Rare Drug Side Effects - Hepatitis (inflammation of the liver), symptoms of which may be mild jaundice (yellowing of the skin and whites of the eyes), stomach pain and itching - Muscle breakdown - Chronic disease of the lung tissues If you develop any unusual discomfort, tell your doctor as soon as possible. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Drug Side Effects Symptoms - Pancreatitis (inflammation of the pancreas leading to abdominal pain) - Blood clot in the lung causing chest pain and breathlessness (pulmonary embolism); blood clot in the leg causing pain, redness or swelling (deep vein thrombosis) - Gallstones
How to Store the Medicine
How to Store the Medicine Keep this medicine in the original package in order to protect from moisture. Do not store above 30°C Keep out of the reach and sight of children. Do not use Fenofibrate after the expiry date which is stated on the carton and the blister pack after EXP. The expiry date refers to the last day of that month Fenofibrate 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 to protect the environment

ATORVASTATIN

Information for patients
Drug Information Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Atorvastatin can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment
Drug Alert
Alert if you are hypersensitive (allergic) to Atorvastatin or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine – if you have or have ever had a disease which affects the liver if you have had any unexplained abnormal blood tests for liver function
Before Consuming the Medicine
Avoid Drug if you are hypersensitive (allergic) to Atorvastatin or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine – if you have or have ever had a disease which affects the liver if you have had any unexplained abnormal blood tests for liver function if you are a woman able to have children and not using reliable contraception if you are pregnant or trying to become pregnant if you are breast-feeding.
Drug Special Care The following are reasons why Atorvastatin may not be suitable for you: if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes if you have kidney problems if you have an under-active thyroid gland (hypothyroidism) if you have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems if you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines) if you regularly drink a large amount of alcohol if you have a history of liver disease if you are older than 70 years.
Drug Drug Interactions There are some medicines that may change the effect of Atorvastatin or their effect may be changed by Atorvastatin. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis described Medicines used to alter the way your immune system works, e.g. ciclosporin Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine,diltiazem,; medicines to regulate your heart rhythm e.g. digoxin, verapamil, amiodarone Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir,darunavir, etc. Other medicines known to interact with Atorvastatin include ezetimibe (which lowers cholesterol),warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller) and antacids (indigestion products containing aluminium or magnesium) Medicines obtained without a prescription: St John’s Wort Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Drug Pregnancy Interaction Do not take Atorvastatin if you are pregnant, or if you are trying to become pregnant.
Drug Breast feeding Interaction Do not take Atorvastatin if you are able to become pregnant unless you use reliable contraceptive measures.
Drug Machinery Interaction Normally this medicine does not affect your ability to drive or operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.
Drug More Information Grapefruit juice Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Atorvastatin. Alcohol Avoid drinking too much alcohol while taking this medicine. See Section 2 “Take special care with Atorvastatin” for details
How to take the Medicine
Consumption Info If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Drug quanitty The usual starting dose of Atorvastatin is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin is 80 mg once daily for adults and 20 mg once daily for children.
Drug Dose Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin. Atorvastatin tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day. Always take Atorvastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The duration of treatment with Atorvastatin is determined by your doctor. Please ask your doctor if you think that the effect of Atorvastatin is too strong or too weak.
Excess Drug Consumption If you accidently take too many Atorvastatin tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.
Forgot Drug Consumption If you forget to take a dose, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
Stop Drug Consumption If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.
Possible Side Effects
General Information Sexual difficulties •Depression •Breathing problems including persistent cough and/or shortness of breath or fever If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common Drug Side Effects inflammation of the nasal passages, pain in the throat, nose bleed •allergic reactions •increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase •headache •nausea, constipation, wind, indigestion, diarrhoea •joint pain, muscle pain and back pain •blood test results that show your liver function can become abnormal .
Rare Drug Side Effects visual disturbance •unexpected bleeding or bruising •cholestasis (yellowing of the skin and whites of the eyes) •tendon injury
Very Rare Drug Side Effects an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse •hearing loss •gynecomastia (breast enlargement in men and women).
Drug Side Effects Symptoms Like all medicines, Atorvastatin can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.
How to Store the Medicine
How to Store the Medicine Keep out of the reach and sight of children. This medicine does not require any special storage conditions. Do not use Atorvastatin after the expiry date which is stated on the container and outer packaging after {EXP}. The expiry date refers to the last day of that month. 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 to protect the environment.

EZETIMIBE

Information for patients
Drug Information EZETIMIBE is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, EZETIMIBE raises levels of "good" cholesterol (HDL cholesterol). It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. EZETIMIBE works by reducing the cholesterol absorbed in your digestive tract. EZETIMIBE does not help you lose weight.EZETIMIBE adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol your body makes by itself. EZETIMIBE is used in addition to diet if you have: •a raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) •together with a statin, when your cholesterol level is not well controlled with a statin alone •alone, when statin treatment is inappropriate or is not tolerated •a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You will also be prescribed a statin and may also receive other treatments •a hereditary illness (homozygous sitosterolaemia, also known as phytosterolaemia) that increases the levels of plant sterols in your blood.
Drug Alert
Alert •you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of EZETIMIBE.
Before Consuming the Medicine
Avoid Drug •you currently have liver problems •you are pregnant or breast-feeding.
Drug Special Care •Tell your doctor about all your medical conditions including allergies. •Your doctor should do a blood test before you start taking EZETIMIBE with a statin. This is to check how well your liver is working. •Your doctor may also want you to have blood tests to check how well your liver is working after you start taking EZETIMIBE with a statin.If you have moderate or severe liver problems, EZETIMIBE is not recommended. The safety and efficacy of the combined use of EZETIMIBE and fibrates (medicines for lowering cholesterol) have not been established. Children EZETIMIBE is not recommended for children under age of 10.
Drug Drug Interactions Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following: •ciclosporin (a medicine often used in organ transplant patients) •medicines to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants) •colestyramine (a medicine for lowering cholesterol), because it affects the way EZETIMIBE works •fibrates (medicines for lowering cholesterol)
Drug Pregnancy Interaction Do not take EZETIMIBE with a statin if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking EZETIMIBE with a statin, stop taking both medicines immediately and tell your doctor. There is no experience from the use of EZETIMIBE without a statin during pregnancy. Ask your doctor for advice before using EZETIMIBE if you are pregnant.
Drug Breast feeding Interaction Do not take EZETIMIBE with a statin if you are breast-feeding, because it is not known if the medicines are passed into breast milk. EZETIMIBE without a statin should not be used if you are breast-feeding. Ask your doctor for advice.
Drug Machinery Interaction EZETIMIBE is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people may get dizzy after taking EZETIMIBE.
Drug More Information
How to take the Medicine
Consumption Info
Drug quanitty •You should keep on this diet whilst taking EZETIMIBE.Adults and adolescents (10 to 17 years of age): The dose is one EZETIMIBE 10 mg by mouth once a day. Take EZETIMIBE at any time of the day. You can take it with or without food. If your doctor has prescribed EZETIMIBE along with a statin, both medicines can be taken at the same time. In this case, please read the dosage instructions in the package leaflet of that particular medicine. If your doctor has prescribed EZETIMIBE along with colestyramine or any other bile acid sequestrant (medicines for lowering cholesterol), you should take EZETIMIBE at least 2 hours before or 4 hours after taking the bile acid sequestrant.
Drug Dose Always take EZETIMIBE exactly as your doctor has told you. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. You should check with your doctor or pharmacist if you are not sure. •Before starting EZETIMIBE, you should be on a diet to lower your cholesterol.
Excess Drug Consumption Please contact your doctor or pharmacist.
Forgot Drug Consumption Do not take an extra dose, just take your normal amount of EZETIMIBE at the usual time the next day. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Stop Drug Consumption
Possible Side Effects
General Information Allergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which requires treatment right away) have been reported in general use.
Common Drug Side Effects abdominal pain; diarrhoea; flatulence; feeling tired.elevations in some laboratory blood tests of liver function (transaminases); headache; muscle pain; tenderness or weakness.
Rare Drug Side Effects elevations in some laboratory blood tests of liver (transaminases) or muscle (CK) function; cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; hot flush; high blood pressure. tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness, pain in arms and legs; unusual tiredness or weakness; swelling, especially in the hands and feet. When used with fenofibrate, the following common side effect was reported: abdominal pain. Additionally, the following side effects have been reported in general use: dizziness; muscle aches; liver problems; allergic reactions including rash and hives; raised red rash, sometimes with target shaped lesions; muscle pain, tenderness or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas often with severe abdominal pain; constipation; reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopaenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.
Very Rare Drug Side Effects
Drug Side Effects Symptoms
How to Store the Medicine
How to Store the Medicine •Keep out of the reach and sight of children. •Do not use EZETIMIBE after the expiry date stated on the carton or container after "EXP.". The expiry date refers to the last day of that month. •Do not store EZETIMIBE above 30°C. Blisters: Store in the original package. Bottles: Keep bottles tightly closed. These measures will protect the product from moisture.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 to protect the environment.

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