Rozalet 20 Mg Tablet (10 Tab)

ROZALET 20 MG TABLET

ROZALET 20 MG TABLET, manufactured by SUN PHARMA LABORATORIES LTD., is a combination medication primarily used for cardiovascular health.

Composition Each tablet contains:

• Rosuvastatin: 20 mg (a statin, which lowers "bad" cholesterol and triglycerides)
• Clopidogrel: 75 mg (an antiplatelet agent, which prevents blood clot formation)

Uses ROZALET 20 MG TABLET is prescribed for:

• Prevention of heart attack, angina (heart-related chest pain), and stroke.
• Lowering "bad" cholesterol (LDL) and triglyceride levels.
• Increasing "good" cholesterol (HDL) levels.
• Reducing the formation of harmful blood clots.
• Management of high cholesterol and triglyceride levels, and prevention of atherosclerosis.

Dosage and Administration Typically, one tablet is taken once daily, with or without food. It is recommended to take the medicine at the same time each day to maintain consistent drug levels. Swallow the tablet whole with a glass of water; do not crush, chew, or break it. Do not stop the medication abruptly, even if symptoms improve, unless advised by a doctor. The dosage and duration of treatment are determined by your doctor based on your medical condition and response to therapy.

Side Effects Common side effects may include:

• Stomach discomfort or pain, indigestion, diarrhea, constipation
• Headache, dizziness
• Muscle pain or weakness
• Increased glucose levels in the blood, increased liver enzymes

Serious side effects that require immediate medical attention include:

• Yellowing of the skin or eyes (jaundice)
• Severe or unexplained muscle pain or weakness
• Dark-colored urine
• Increased risk of bleeding, which may be noticeable as easy bruising or prolonged bleeding from minor injuries.

Precautions

• Contraindications: ROZALET 20 MG TABLET is contraindicated in patients with liver problems, bleeding due to an ulcer or in the brain, and those allergic to rosuvastatin, clopidogrel, or any other ingredients.
• Pregnancy and Breastfeeding: It is highly unsafe for use during pregnancy and probably unsafe during breastfeeding. Consult your doctor if you are pregnant, planning a pregnancy, or breastfeeding.
• Medical Conditions: Inform your doctor if you have kidney disease, thyroid problems, respiratory problems, muscle-related problems, a history of stroke with bleeding in the brain, or a genetic bleeding disorder.
• Interactions: Avoid consuming grapefruit or grapefruit juice, as it can increase the concentration of rosuvastatin and potentially increase side effects. Excessive alcohol consumption may increase the risk of liver damage. Consult your doctor before taking other medications, including over-the-counter drugs, herbal supplements, painkillers (which may increase bleeding risk), or antibiotics like fusidic acid.
• Surgery: Inform your doctor or dentist you are taking this medicine before any surgical procedure, as it may increase the risk of bleeding.
• Lifestyle: Lifestyle changes such as a low-fat diet, regular exercise, and avoiding smoking can enhance the effectiveness of this medication.

Storage Store ROZALET 20 MG TABLET in a cool and dry place, protected from direct sunlight, moisture, and heat. Keep it in its original packaging and out of the reach of children and pets. Store below 30°C.

Here are some frequently asked questions about ROZALET 20 MG TABLET, which is a combination medication containing Rosuvastatin (20mg) and Clopidogrel (75mg):

What is ROZALET 20 MG TABLET used for?

ROZALET 20 MG TABLET is primarily used to lower high cholesterol and triglyceride levels in the blood, and to prevent serious cardiovascular events such as heart attacks, strokes, and angina (heart-related chest pain). It is prescribed for individuals at risk of cardiovascular diseases, including those with a family history of heart disease, diabetes, or hypertension. It also helps in preventing the formation of harmful blood clots.

How does ROZALET 20 MG TABLET work?

ROZALET 20 MG TABLET works through the combined action of its two active ingredients: Rosuvastatin and Clopidogrel. Rosuvastatin belongs to a class of medicines called statins. It works by inhibiting an enzyme in the liver called HMG-CoA reductase, which is crucial for cholesterol production. This reduces the amount of "bad" cholesterol (LDL) and triglycerides the liver produces, while increasing "good" cholesterol (HDL). Clopidogrel is an antiplatelet agent that prevents blood clots by stopping platelets from clumping together, thereby ensuring smoother blood flow and reducing the risk of arterial blockages.

What is the usual dosage for ROZALET 20 MG TABLET?

The dosage for ROZALET 20 MG TABLET is typically individualized by a doctor based on treatment goals and patient response. For adults, the usual starting dose for Rosuvastatin, the cholesterol-lowering component, is often 5 mg or 10 mg once daily, which may be adjusted upwards, with a maximum daily dose usually 40 mg. The 20 mg tablet is a common strength. It is usually taken once a day, and it's best to take it at the same time every day, with or without food.

What are the possible side effects of ROZALET 20 MG TABLET?

Common side effects can include headache, nausea, stomach pain, constipation, and fatigue. More serious, but rare, side effects can include muscle pain, tenderness, or weakness (which could indicate a serious muscle problem like rhabdomyolysis), liver problems (symptoms like yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, and upper right abdominal pain), and increased blood sugar. Clopidogrel can also increase the risk of bleeding. If you experience any severe or persistent side effects, contact your doctor immediately.

Is ROZALET 20 MG TABLET safe during pregnancy or breastfeeding?

No, ROZALET 20 MG TABLET is generally not recommended during pregnancy. Rosuvastatin, one of its components, can harm an unborn baby. If you become pregnant while taking this medication, you should stop taking it and inform your doctor immediately. For breastfeeding, rosuvastatin passes into breast milk in small amounts. While some data suggest low infant exposure, statins generally have the potential for serious adverse reactions in nursing infants. It is generally advised not to breastfeed while taking rosuvastatin, or to discuss with your doctor whether to discontinue breastfeeding or the medication.

Can ROZALET 20 MG TABLET be taken with other medications?

ROZALET 20 MG TABLET can interact with several other medications. It is very important to inform your doctor about all medicines, supplements, and herbal remedies you are taking. Significant interactions include:

• Antacids containing aluminum or magnesium: These should be taken at least 2 hours after ROZALET, as they can reduce its absorption and effectiveness.
• Other lipid-lowering therapies (e.g., gemfibrozil, fenofibrate, niacin): Taking these with rosuvastatin can increase the risk of muscle problems. Your doctor may need to adjust the dose or monitor you closely.
• Certain antiviral medications (e.g., for HIV and hepatitis C): These can increase the levels of rosuvastatin in your body, raising the risk of side effects.
• Warfarin (a blood thinner): Concomitant use increases the risk of bleeding due to Clopidogrel.
• Cyclosporine: The dose of rosuvastatin should not exceed 5 mg once daily when taken with cyclosporine.
• Erythromycin or Fusidic acid (antibiotics): These can interact with rosuvastatin.
• Grapefruit juice: May increase the levels of statins in the blood, leading to an increased risk of side effects. Your doctor may adjust dosages or recommend alternative treatments if interactions are a concern.

What precautions should be taken while on ROZALET 20 MG TABLET?

Before taking ROZALET, inform your doctor if you have liver disease, kidney disease, diabetes, or a history of alcohol abuse, or if you are of Asian descent, as these factors can influence the medication's effect or increase the risk of side effects. Regular blood tests are important to monitor your cholesterol and liver enzyme levels. It is also advised to limit alcohol consumption as it can increase the risk of liver problems. If you are scheduled for surgery, including dental surgery, inform your doctor or dentist that you are taking this medicine, as you may need to stop it temporarily due to the blood-thinning effect of clopidogrel.

What happens if a dose of ROZALET 20 MG TABLET is missed?

If you miss a dose of ROZALET, take it as soon as you remember on the same day. However, if it's almost time for your next scheduled dose (e.g., within 12 hours), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one, as this can increase the risk of side effects.

How should ROZALET 20 MG TABLET be stored?

ROZALET 20 MG TABLET should be stored in a closed container at room temperature, typically between 20 to 25 degrees C (68 to 77 degrees F). It should be kept away from heat, moisture, and direct light, and protected from freezing. Always keep it out of the reach of children and pets. Dispose of any outdated or no longer needed medicine properly.