Rosumac 20 Mg Tablet (15 Tab)

ROSUMAC 20 MG TABLET (15 TAB) by MACLEODS PHARMACEUTICALS LTD.

Name

• Brand Name: Rosumac 20 Tablet
• Common Name (Active Ingredient): Rosuvastatin

Composition

Each film-coated tablet contains Rosuvastatin 20 mg.

Uses

Rosumac 20 Tablet, containing Rosuvastatin, is a statin medication primarily used to manage and treat high cholesterol and triglyceride levels. It is prescribed for:

• Hyperlipidemia and Mixed Dyslipidemia: To lower elevated Total-C, LDL-C ("bad" cholesterol), ApoB, nonHDL-C, and triglycerides, while increasing HDL-C ("good" cholesterol).
• Cardiovascular Risk Reduction: To reduce the risk of major cardiovascular events such as heart attack, stroke, and heart-related chest pain (angina).
• Familial Hypercholesterolemia: Management of high cholesterol in both heterozygous and homozygous familial hypercholesterolemia in adults and children (aged eight years or more for heterozygous, seven years or more for homozygous).
• Atherosclerosis: To slow the progression of atherosclerosis (plaque build-up in arteries).

Dosage and Administration

• Swallow the tablet whole with a glass of water; do not crush, chew, or break it.
• It can be taken with or without food.
• Take the medicine at the same time each day for consistency.
• The typical dosage is once daily, but it varies based on the patient's condition and response, as directed by a healthcare professional. The maximum recommended dose is usually 40 mg.
• If a dose is missed, take it as soon as remembered, but do not take two doses within 12 hours of each other.
• A 2-hour gap should be maintained between taking Rosumac 20 Tablet and antacids containing aluminum and magnesium hydroxide.

Side Effects

Common Side Effects:

• Muscle pain (myalgia)
• Weakness (asthenia) or fatigue
• Nausea
• Headache
• Abdominal pain or discomfort
• Dizziness
• Constipation
• Joint pain
• High blood sugar levels
• Protein loss in urine
• Itching or rash

Serious Side Effects:

• Muscle Problems: Myopathy and rhabdomyolysis (severe muscle breakdown) which can rarely lead to kidney damage and may be fatal. Report unexplained muscle pain, tenderness, or weakness immediately, especially if accompanied by fever or unusual tiredness.
• Liver Problems: Symptoms may include unusual tiredness or weakness, loss of appetite, upper belly pain, dark urine, or yellowing of the skin or eyes. Liver enzyme tests are recommended before and during treatment.
• Allergic Reactions: Widespread rash, fever, and enlarged lymph nodes.
• Memory Loss or Confusion: Rare and generally non-serious, usually resolving within 3 weeks of discontinuing the medication.

Precautions

• Pregnancy and Breastfeeding: Rosumac 20 Tablet is contraindicated during pregnancy as it may harm the unborn baby. It is also not recommended for breastfeeding women as it may pass into breast milk.
• Liver Disease: Contraindicated in patients with active or severe liver disease. Caution is advised, and liver function should be monitored regularly.
• Kidney Problems: Use with caution in patients with kidney problems; dose adjustment may be necessary.
• Diabetes: Rosumac 20 Tablet may slightly increase blood sugar levels. Diabetic patients should monitor their blood sugar closely.
• Alcohol Consumption: Avoid alcohol intake during treatment as it may increase the risk of liver damage and other side effects.
• Drug Interactions: Inform your doctor about all other medications, supplements, or herbal products you are taking, especially:
  • Immunosuppressants (e.g., cyclosporine)
  • HIV protease inhibitors (e.g., lopinavir, ritonavir, atazanavir)
  • Blood thinners/anticoagulants (e.g., warfarin, coumarin)
  • Other lipid-lowering drugs (e.g., fibrates, gemfibrozil, niacin)
  • Colchicine
  • Eluxadoline
• Neuromuscular Disorders: Use with caution in patients with pre-existing neuromuscular disorders like myopathy.
• Driving and Operating Machinery: Rosumac 20 Tablet may cause dizziness, so exercise caution when driving or performing tasks requiring concentration.
• Lifestyle Changes: This medication is part of a comprehensive treatment program that should include a healthy, low-fat diet, regular exercise, and weight reduction.
• Do not stop taking this medicine without consulting your doctor.

Storage

• Store in a cool and dry place, away from direct sunlight.
• Keep out of sight and reach of children.
• Store below 25°C or below 30°C.
• Protect from light.

Here are some frequently asked questions about ROSUMAC 20 MG TABLET (Rosuvastatin 20 mg):

What is ROSUMAC 20 MG TABLET used for?

ROSUMAC 20 MG TABLET is primarily used to manage high cholesterol and triglyceride levels in the blood. It helps to lower "bad" cholesterol (LDL) and triglycerides while increasing "good" cholesterol (HDL). By doing so, it reduces the risk of serious cardiovascular events such as heart attacks and strokes, and can also help slow the progression of atherosclerosis (narrowing of blood vessels due to fat buildup). It is also prescribed for familial hypercholesterolemia, a genetic condition causing very high cholesterol.

How does ROSUMAC 20 MG TABLET work?

ROSUMAC 20 MG TABLET contains rosuvastatin, which belongs to a class of medicines called statins (HMG-CoA reductase inhibitors). Rosuvastatin works by blocking the HMG-CoA reductase enzyme in the liver, which is responsible for producing cholesterol. By inhibiting this enzyme, it effectively reduces the production of cholesterol and harmful fatty substances, thereby lowering blood cholesterol levels and improving the body's ability to remove bad cholesterol from the blood.

What is the usual dosage for ROSUMAC 20 MG TABLET?

For adults, the usual starting dose for managing high cholesterol is 5mg to 10mg once daily, which your doctor may increase up to 20mg a day. For preventing heart attacks and strokes, 20mg once daily is often prescribed, though a lower dose might be used. In cases of very high cholesterol or high risk, a specialist might prescribe a maximum daily dose of 40mg. It should be taken once a day, at the same time each day, and can be taken with or without food. Swallow the tablet whole with water.

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

Common side effects include headache, muscle pain or weakness (myalgia), nausea, abdominal pain or discomfort, dizziness, joint pain, constipation, and fatigue. Some people may also experience high blood sugar levels, protein loss in urine, itching, or rash. In rare cases, more serious side effects like severe muscle breakdown (rhabdomyolysis) which can lead to kidney damage, or liver damage may occur. If you experience persistent or worsening symptoms, or signs of serious issues like dark urine, severe muscle pain, or yellowing of the skin or eyes, contact your doctor immediately.

Is ROSUMAC 20 MG TABLET safe during pregnancy or breastfeeding?

No, ROSUMAC 20 MG TABLET is contraindicated (unsafe) during pregnancy and breastfeeding. It may cause severe harm to the developing baby or nursing infant. Women of childbearing age should use effective contraceptive methods while taking this medicine. If you are pregnant, planning to conceive, or breastfeeding, consult your doctor for suitable alternatives.

Can ROSUMAC 20 MG TABLET be taken with other medications?

ROSUMAC 20 MG TABLET can interact with several other medications. It may enhance the blood-thinning effect of anticoagulants like warfarin, increasing the risk of bleeding. Other lipid-regulating medications (e.g., gemfibrozil, fibrates) can increase the risk of muscle damage. Immunosuppressants (like cyclosporine), certain antibiotics (e.g., erythromycin, fusidic acid), and some anti-HIV medicines can also increase the levels of rosuvastatin in your body, potentially leading to adverse effects. Antacids containing aluminum and magnesium hydroxide may reduce the absorption of rosuvastatin if taken simultaneously; it is generally advised to wait at least 2 hours after taking rosuvastatin before taking these antacids. Oral contraceptives and hormone replacement therapy (HRT) may also interact. Always inform your doctor about all medications, herbal remedies, vitamins, and supplements you are taking.

What precautions should be taken while taking ROSUMAC 20 MG TABLET?

Before starting ROSUMAC 20 MG TABLET, inform your doctor if you have any liver problems (it is contraindicated in active liver disease), kidney problems (caution advised, dose adjustment may be needed), diabetes (blood sugar levels should be monitored regularly as it may affect them), or neuromuscular disorders. Alcohol consumption should be limited or avoided as it can increase the risk of liver damage and side effects. Avoid consuming large amounts of grapefruit juice, as it can increase rosuvastatin levels. Regular liver enzyme tests may be recommended by your doctor.

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

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose (generally 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.

How should ROSUMAC 20 MG TABLET be stored?

ROSUMAC 20 MG TABLET should be stored in a cool, dry place, away from direct sunlight. Keep the medicine at room temperature, generally below 25°C or 30°C. Always keep it out of the reach of children and pets.