Product Information:

ROVISTA EZ 20+10 Tablets is a fixed-dose combination containing:

1. Rosuvastatin 20mg – a potent statin that inhibits cholesterol synthesis in the liver
2. Ezetimibe 10mg – a selective cholesterol absorption inhibitor that blocks intestinal uptake of dietary and biliary cholesterol

This high-efficacy combination provides dual-pathway lipid-lowering, making it suitable for patients with very high cardiovascular risk or those who have not achieved LDL-C goals with moderate-intensity statin therapy alone.

Uses of (ROVISTA EZ 20+10 TABLETS):

1. Treatment of primary hyperlipidemia or mixed dyslipidemia unresponsive to statin monotherapy
2. Management of heterozygous or homozygous familial hypercholesterolemia
3. Secondary prevention in patients with established atherosclerotic cardiovascular disease (ASCVD) requiring intensive LDL-C lowering
4. Patients needing ≥50% reduction in LDL cholesterol per current guidelines

Key Benefits of (ROVISTA EZ 20+10 TABLETS):

1. Reduces LDL-C by up to 65–70%—among the most effective oral lipid-lowering regimens
2. Dual mechanism: targets both hepatic production and intestinal absorption of cholesterol
3. Once-daily dosing for improved adherence
4. May reduce need for injectable therapies (e.g., PCSK9 inhibitors) in some patients

How To Use (ROVISTA EZ 20+10 TABLETS):

1. Take one tablet once daily, with or without food, at the same time each day.
2. Swallow whole with water—do not crush or chew.
3. Continue a heart-healthy, low-saturated-fat diet and regular exercise.
4. Lipid profile should be assessed 4–12 weeks after initiation and periodically thereafter.

When Not to Use (ROVISTA EZ 20+10 TABLETS):

Do not use if you have:

1. Active liver disease or unexplained persistent elevations in liver enzymes
2. Hypersensitivity to rosuvastatin, ezetimibe, or any excipients
3. Pregnancy or breastfeeding (statins are contraindicated)
4. Concurrent use of cyclosporine (significantly increases drug levels)

⚠️ Dose Caution in South Asians:

Pakistani and other South Asian patients may have higher systemic exposure to rosuvastatin. Use 20+10 only if lower doses (e.g., 10+10) are insufficient and well-tolerated.

Side Effects of (ROVISTA EZ 20+10 TABLETS):

Common: Headache, muscle aches, abdominal pain, nausea, fatigue.

Rare: Dizziness, rash, elevated liver enzymes.

Serious (rare but require monitoring):

1. Myopathy/Rhabdomyolysis: Unexplained muscle pain, tenderness, weakness, or dark urine
2. Liver injury: Jaundice, right upper quadrant pain, unusual fatigue
3. Hypersensitivity reactions: Angioedema, skin rash (ezetimibe-related)
4. Discontinue and seek medical help immediately if severe muscle symptoms or signs of liver dysfunction occur.

Dosage: (ROVISTA EZ 20+10 TABLETS):

1. Adults: One tablet (rosuvastatin 20mg + ezetimibe 10mg) once daily
2. Starting dose: Typically initiated after failure of rosuvastatin 10–20mg alone
3. Elderly or mild renal impairment: Use with caution; monitor for side effects
4. Severe hepatic impairment: Contraindicated

Who It’s For (ROVISTA EZ 20+10 TABLETS):

1. Adults with very high cardiovascular risk (e.g., recent heart attack, stroke, diabetes with complications)
2. Patients with familial hypercholesterolemia
3. Those requiring intensive LDL-C lowering per guidelines (e.g., LDL <55 mg/dL or >50% reduction)
4. Individuals not at goal on maximum tolerated statin therapy

Warnings & Precautions:

1. Monitor liver function tests (LFTs) before starting and as clinically indicated
2. Check creatine kinase (CK) if muscle symptoms develop
3. Avoid excessive alcohol consumption
4. Counsel patients on signs of myopathy and liver injury
5. Use lowest effective dose in South Asian populations

Drug Interactions:

1. Cyclosporine: ↑ Rosuvastatin and ezetimibe levels—avoid combination
2. Fibrates (e.g., fenofibrate): ↑ Risk of myopathy—use with extreme caution
3. Warfarin: Rosuvastatin may slightly ↑ INR; monitor if combined
4. Bile acid sequestrants (e.g., cholestyramine): Administer ezetimibe 2 hours before or 4 hours after
5. Always inform your doctor about all medications and supplements.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiration date. Available by prescription only in Pakistan.