Product Information:

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

1. Rosuvastatin 10mg – a potent statin that lowers LDL cholesterol and triglycerides
2. Ezetimibe 10mg – a cholesterol absorption inhibitor that blocks dietary and biliary cholesterol uptake in the small intestine

This dual-mechanism therapy provides additive lipid-lowering effects, making it suitable for patients who require more aggressive cholesterol reduction than either agent alone can achieve.

Uses of (ROVISTA EZ 10+10 TABLETS):

1. Treatment of primary hyperlipidemia or mixed dyslipidemia when statin monotherapy is insufficient
2. Management of homozygous familial hypercholesterolemia (as adjunct to other lipid-lowering treatments)
3. Secondary prevention of cardiovascular events (heart attack, stroke) in high-risk patients with inadequate LDL-C control
4. Patients with statin intolerance at higher doses (allows lower statin dose with added efficacy)

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

1. Reduces LDL-C by up to 60–65% (greater than either drug alone)
2. Dual action: decreases liver cholesterol production + intestinal cholesterol absorption
3. Once-daily dosing improves adherence
4. May allow use of lower statin doses, reducing muscle-related side effects

How To Use (ROVISTA EZ 10+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 low-fat diet and heart-healthy lifestyle while on therapy.
4. Lipid profile should be monitored 4–12 weeks after starting and periodically thereafter.

When Not to Use (ROVISTA EZ 10+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 (contraindicated)
4. Concurrent use of cyclosporine (increases levels of both drugs)

⚠️ Note: Ezetimibe does not replace statins in high-risk patients but enhances their effect.

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

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

Rare: Dizziness, rash, elevated liver enzymes.

Serious (rare):

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

Dosage: (ROVISTA EZ 10+10 TABLETS):

1. Adults: One tablet (rosuvastatin 10mg + ezetimibe 10mg) once daily
2. Elderly or mild renal impairment: No dose adjustment needed
3. Severe renal or hepatic impairment: Use with caution; not recommended in active liver disease

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

1. Adults with high cardiovascular risk (e.g., diabetes, prior heart attack) who need intensive LDL-C lowering
2. Patients not reaching LDL goals on rosuvastatin 10–20mg alone
3. Those with familial hypercholesterolemia
4. Individuals requiring combination therapy for optimal lipid control

Warnings & Precautions:

1. Monitor liver function tests (LFTs) before and during therapy
2. Check creatine kinase (CK) if muscle symptoms develop
3. Avoid excessive alcohol consumption
4. Inform your doctor before surgery or if starting new medications (e.g., fibrates, colchicine)

Drug Interactions:

1. Cyclosporine: ↑ Levels of both rosuvastatin and ezetimibe—avoid combination
2. Fibrates: ↑ Risk of myopathy—use with caution
3. Warfarin: Rosuvastatin may slightly ↑ INR; ezetimibe has no significant interaction
4. Bile acid sequestrants (e.g., cholestyramine): Take ezetimibe 2 hours before or 4 hours after to avoid reduced absorption
5. Always inform your doctor about all medications.

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 in Pakistan.