Rozalet 10MG capsule is a combination of two medicines prescribed for the treatment of patients suffering from cardiovascular diseases who are at an increased risk of stroke or heart attack. It is used in treating patients suffering from acute coronary syndrome (condition that blocks blood flow to the heart muscles), dyslipidaemia by reducing bad cholesterol (LDL) and triglyceride (fat) levels and also for the prevention of ischaemic stroke. It helps in decreasing the formation of blood clots. This medicine is used with a proper healthy diet and exercise program to control high blood pressure for best possible effects. However, the uses mentioned here are not comprehensive, there may be other conditions for which the medication may be used upon your doctor’s discretion.
The active ingredients of Rozalet 10MG capsule are Clopidogrel (75Mg) and Rosuvastatin (10Mg)
Rosuvastatin is a dyslipidaemic (lipid lowering) medication that blocks an enzyme that is required in the liver to produce cholesterol and reduces the levels of bad cholesterol, triglycerides and raises good cholesterol. Clopidogrel works by preventing clot formation in blood vessels and helps in free blood flow.
Patients with following conditions are suggested to seek advice from their healthcare professionals before using Rozalet 10MG capsule:
The following side effects may or may not occur during the usage of Rozalet 10MG capsule. It is usually well tolerated when taken in the recommended dosage guidelines. You may experience one or more of the following side effects:
Rare but more serious adverse effects may include:
Take Rozalet 10MG capsule as instructed by your doctor. Swallow the capsule whole with water, immediately after opening it from the strip. Do not break or crush or chew the capsule.
Avoid missing or forgetting the dose. If you do, take it as soon as you remember; but if it’s almost time for your next dose, skip it and take it according to your normal schedule. Don’t swallow two doses at the same time which is dangerous to your health.
The capsule should be taken with food to avoid stomach upset. Take the capsule at the same time every day as it helps to maintain a consistent level of medicine in the body. The medicine is usually taken not more than once a day.
Do not change the dose or stop taking the medicine before completion of the course or without consulting your doctor. Continue to use this drug until completion of the maximum amount suggested.
Avoid taking medicine more than the prescribed dosage. If you notice any unusual or abnormal reactions after taking the capsule, promptly seek medical attention. Depending on the dosage of Rozalet 10MG capsule, symptoms vary in individuals, you may experience one or more of the following symptoms:
Use this capsule on the advice of medical practitioner. Dose adjustments or complete avoidance of the Rozalet 10MG capsule may be required in the following conditions:
Caution is advised among people with kidney problems. Adjustments of dose of the medicine may be needed. Regular monitoring of kidney function tests is recommended while taking this capsule. If you have any renal problems, it is highly recommended that you consult doctor before the consumption of this medicine. However, use of this capsule is not suggested in patients with severe kidney diseases
Caution is advised among people with liver problems. Dose adjustments of the medicine may be needed. If you have any hepatic problems, it is highly recommended that you consult doctor before the consumption of this medicine. However, use of this capsule is not suggested in patients with severe liver diseases.
Rozalet 10MG capsule might be risky to use during pregnancy as it is known to cause harm to the fetus. Despite the fact that there are limited studies in human beings, animal studies have shown effects on the developing baby. It is recommended that you consult your doctor before consuming this medicine.
The medicine is unsafe to use for nursing mothers. Limited human data suggests that the medication may pass into the breastmilk and harm the infant. Consult your doctor immediately if the baby shows signs of increased sleepiness, breathing problems or difficulty in breast feeding.
Interaction of alcohol with Rozalet 10MG capsule is unknown. Any symptoms of abnormal reactions after taking the medicine should be reported to your doctor immediately. If you consume alcohol on regular basis, relevant dose adjustments of the medicine may be necessary depending on your clinical condition.
The capsule does not cause drowsiness or dizziness. If you notice any abnormal reactions after taking the medicine, do not drive, operate heavy machinery or involve in any works which may demand your attention or physical strength.
Avoid grape fruit juice and alcohol as they may alter serum levels.
Inform your doctor or pharmacist if you are taking any other medicines which includes over-the-counter drugs, herbal tonics, supplements and medicines that you buy without a prescription. Alert your doctor if you are taking Rozalet 10MG capsule with aluminium and magnesium containing antacids, warfarin, heparin, phenindione, gemfibrozil, ciclosporin, colchicine, erythromycin, corticosteroids, probenecid and other NSAIDs.
ategory X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
This medication is an anti-platelet agent, that is, a drug that inhibits the ability of platelets to clump together as part of a blood clot. This medication is prescribed either alone or with other medications for prevention or treatment of stroke and heart attack (which are usually caused by blood clots) in persons who are at high risk.
Clopidogrel stops platelets from getting sticky and clumping.
Oral- Prophylaxis of blood clot events- 75 mg once daily. Acute coronary syndrome For ST-elevation myocardial infarction: with aspirin: 75 mg once daily. For unstable angina, non-ST-elevation myocardial infarction: Initial: 300 mg loading dose, followed by 75 mg once daily (with aspirin 75-325 mg once daily). It comes as a tablet to take by mouth. It is usually taken once a day with or without food.
Itching. Bleeding. Bruising. Nosebleed.
Take a missed dose as soon as you think about it. - If it is close to the time for your next dose, skip the missed dose and go back to your normal time. - Do not take 2 doses at the same time or extra doses. - Do not change the dose or stop this drug. - Talk with the doctor.
Alert your doctor immediately if you have a history of any of these conditions: - bleeding disorders, for example, haemophilia. - stomach ulcers, especially if you have ever bled from a stomach ulcer. - low blood cell count (platelets, red or white blood cells). - liver disease. Clopidogrel may increase the risk of abnormal bleeding. It is important to alert your doctor if you have any of these illnesses, as the risk of bleeding may be further increased.
If you think there was an overdose, call your local poison control center or ER right away. Signs of a very bad reaction to the drug. These include wheezing; chest tightness; fever; itching; bad cough; blue or gray skin color; seizures; or swelling of face, lips, tongue, or throat. Chest pain or pressure. Change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or blurred eyesight. Trouble breathing. Feeling very tired or weak. Change in thinking clearly and with logic. Sudden change in eyesight. Any bruising or bleeding. Yellow skin or eyes. Change in skin color to black or purple. Any rash. Side effect or health problem is not better or you are feeling worse.
Inform your doctor if you are taking any other medicines, especially these listed here: - other blood-thinning medicines such as warfarin, aspirin and ticlopidine. - painkillers known as NSAIDs, for example, diclofenac, ibuprofen, naproxen, mefenamic acid. - Avoid medicines such as omeprazole, esomeprazole, cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate and fluvoxamine. Alert your doctor if you are taking any of these medicines. Do not take antacids together with Clopidogrel. If you must take antacids, take them at least 1 hour before or 2 hours after you have taken Clopidogrel. Antacids can reduce the effectiveness of Clopidogrel when taken together. Always inform your doctor and pharmacist if you are taking any other medicines, including herbal tonics, supplements and medicines that you buy without a prescription.
Store at 25 °C. Store it in an airtight container and keep away from children.
Category B : Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Anticoagulants and Antiplatelets
The capsule is a combination of two medicines prescribed for the treatment of patients suffering from cardiovascular diseases who are at an increased risk of stroke or heart attack. It is used in treating patients suffering from acute coronary syndrome (condition that blocks blood flow to the heart muscles), dyslipidaemia by reducing bad cholesterol (LDL) and triglyceride (fat) levels and also for the prevention of ischaemic stroke. It helps in decreasing the formation of blood clots. This medicine is used with a proper healthy diet and exercise program to control high blood pressure for best possible effects.
The capsule is well tolerated when taken in prescribed dosage guidelines. Most common side effects include stomach pain, liver enzyme abnormalities, gastric irritation, nausea, vomiting, diarrhea, dizziness, muscle spasm, weakness, constipation, increased glucose levels in blood, pruritis, rash, bronchospasm. Its use may also lead to extreme but uncommon side effects such as peripheral neuropathy, thrombocytopenia, acute renal failure, intracranial bleeding, gastrointestinal haemorrhage, gynaecomastia.
The capsule should be taken with food to avoid stomach upset.
If you ever had impaired kidney function, sever liver impairment or heart disease, let your doctor know before taking this medicine. Inform your doctor about all the medicines you take to ensure that you are healthy. This medicine is contraindicated in patients with hypersensitivity to any of the ingredients used in the capsule or other NSAIDs, acute liver disease, severe renal impairment, pregnancy and lactation, myopathy, persistent elevations of serum transaminases, peptic ulcer, haemorrhagic disease. Caution is advised among patients with hypothyroidism, hereditary of muscular disorders or muscular toxicity, severe respiratory failure, uncontrolled hypertension, platelet and bleeding disorders, dyspepsia or lesion of gastrointestinal mucosa, excessive alcohol consumption, children and elderly patients.
The capsule may decrease alertness, impaired judgement, affect your vision and make you feel dizzy, light headedness, do not drive, operate heavy machinery or involve in any works which may demand your attention or physical strength.
The capsule is usually well tolerated when taken in the recommended dosage guidelines. Over dose of the medicine may lead to dehydration, deafness, increased respiratory rate, sweating, vomiting, vertigo, confusion, hepatic failure, angioedema, rhabdomyolysis with acute renal failure, severe hypoglycaemia, gastrointestinal bleeding.
This medicine might be risky to use during pregnancy as it is known to cause harm to the fetus. Despite the fact that there are limited studies in human beings, animal studies have shown effects on the developing baby. It is recommended that you consult your doctor before consuming this medicine.
No, do not take the medicine without doctor’s prescription.
Interaction of alcohol with this medicine is unknown. Any symptoms of abnormal reactions after taking the medicine should be reported to your doctor immediately. If you consume alcohol on regular basis, relevant dose adjustments of the medicine may be necessary depending on your clinical condition.
Store the medicine at room temperature (20-30 degree Celsius) in a cool and dry place. Keep the tablet according to the instructions mentioned on the pack or label. Store the medicine in the container or the pack it came in, tightly closed.
This tablet is designed to be swallowed with water. If you take them in a way they weren’t intended to be used, you could experience an overdose if the active constituent enters the blood stream too quickly. Alternatively, if it enters your body too slowly, it may never achieve a high enough concentration to be completely functional.
This capsule is not recommended for children below 18 years of age since the safety and efficacy of use are not clinically established.
The amount of time required for this medicine to show its action on the body is 45 minutes after administration.
The duration for which this medicine remains active in the body is not clinically established.
Medicines should always be taken under medical supervision. Take the medicine exactly as prescribed by your doctor: for dosage and duration. Most recommended dose is one capsule per day.
The number of days that any medicine must be taken varies from patient to patient; and case to case. So always stick to your doctor’s suggestion about how many days to take this medicine.
Use the medicine exactly as prescribed by your doctor for the dosage and duration.
Note: All of the above information is for reference purpose only. It is always recommended that you consult a medical professional.
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