ROZAVEL EZ 10 mg/10 mg 10 Tablet

Prescription status:

Prescription required

Manufacturer Name:

Sun Pharma Laboratories Ltd

Drug classification:

Hyperlipidemic agents- HMG-CoA reductase inhibitors, Cholesterol-lowering agent

What is this used for:

• Hypertriglyceridemia
• Hyperlipidemia
• Mixed dyslipidemia, or primary dysbetalipoproteinemia
• Prevention of stroke 
• Cardiovascular risk prevention
• Homozygous Familial Hypercholesterolemia
• Slowing of the Progression of Atherosclerosis

When to not take this medicine:

• Hypersensitivity or allergy towards Rosuvastatin or Ezetimibe
• Skeletal Muscle Effects
• Liver Enzyme Abnormalities and Monitoring
• Concomitant Coumarin Anticoagulants
• Proteinuria and Hematuria
• Endocrine Effects 

How should i take the medicine:

Take this medicine with an adequate amount of water as directed by the physician. Do not take this medicine in small or larger amounts than recommended.

How this medicine works:

Rosuvastatin works by reducing the level of cholesterol in the blood. Ezetimibe inhibits the absorption of cholesterol from the small intestine

Side effects

• Headache (Common)
• Weakness(Common)
• Muscle aches(Common)
• Nausea(Common)
• Stomach pain(Common)
• Unexplained muscle pain (Less common)
• Muscle tenderness, or weakness(Less common)
• Confusion(Less common)
• Memory problems(Less common)
• Upper stomach pain (Less common)
• Tiredness (Less common)
• Loss of appetite(Less common)
• Dark urine(Less common)
• Jaundice (yellowing of the skin or eyes)(Less common)

Pregnancy warning: (Not assigned)/ unknown

Use of this medicine is not recommended for individuals who are pregnant or planning to become pregnant unless absolutely necessary as the safety and efficacy of this medicine is not well established. Inform your doctor about the use of either medicines. All the risks and benefits should be discussed with the doctor before taking this medicine.

Lactation warning:

Use of this medicine is not recommended for lactating and breastfeeding mothers unless necessary. Inform your doctor about the use of this medicine. All the risks and benefits should be discussed with the doctor before taking this medicine.

Renal dose adjustments:

Care must be taken for individuals with kidney disease while taking this medicine. Please discuss appropriate dose adjustments with your doctor. Your doctor may also prescribe a suitable alternative based on creatinine clearance values.

Hepatic dose adjustments:

Care must be taken for individuals with liver disease while taking this medicine. Please discuss appropriate dose adjustments with your doctor. Your doctor may also prescribe a suitable alternative.

Drug interactions:

• Dasatinib-Major

Inform your doctor about the use of either medicine. When these medicines are taken together there may be an increased risk of bleeding. close monitoring is required in elderly patients and patients with a known history of liver or kidney disease. If you experience any unusual symptoms like bleeding, bruising, coughing, severe headache, weakness, etc. Inform your doctor on priority. Appropriate dose adjustments or suitable alternatives may be considered based on your condition.

• Ibuprofen-Major

Inform your doctor about the use of either medicine. When these medicines are taken together Ibuprofen may decrease the effectiveness of this medicine. This may increase the risk of developing ulcers in the gastrointestinal tract and bleeding. If you experience any unusual symptoms like bloating, nausea, vomiting, pain in the abdomen, etc  Inform your doctor on priority. Appropriate dose adjustments or suitable alternatives may be considered based on your condition.

• Abciximab-Moderate

Inform your doctor about the use of either medicine. When these medicines are taken together there may be an increased risk of bleeding. close monitoring is required in elderly patients and patients with a known history of liver or kidney disease. If you experience any unusual symptoms like bleeding, bruising, blood in urine, headache, weakness, etc. Inform your doctor on priority. Appropriate dose adjustments or suitable alternative may be considered based on your condition

• Acetazolamide-Major

Inform your doctor about the use of either medicine. When these medicines are taken together this may cause adverse effects like ringing in the ear, nausea, headache, vomiting, confusion, hallucination, convulsions, etc. Inform your doctor on priority. Appropriate dose adjustments or suitable alternatives may be considered based on your condition.

• Celecoxib-Moderate

Inform your doctor about the use of either medicine. When these medicines are taken together there may be an increased risk of bleeding. close monitoring is required in elderly patients and patients with a known history of liver or kidney disease. If you experience any unusual symptoms like pain in the abdomen, bloating, dizziness, nausea, vomiting, etc. Inform your doctor on priority. Appropriate dose adjustments or suitable alternatives may be considered based on your condition.

• Omeprazole-Major

Inform your doctor about the use of either medicine. When these medicines are taken together, the effectiveness of this medicine may be decreased which helps in the prevention of stroke or heart attack.  If you experience any unusual symptoms, inform your doctor on priority. Appropriate dose adjustments or suitable alternatives may be considered based on your condition.

• Cyclosporine-Moderate

Inform your doctor about the use of either medicine. When these medicines are taken together, it may significantly increase the blood levels of ezetimibe. This can increase the risk of side effects such as liver damage and a rare but serious condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue. If you experience any unusual symptoms, inform your doctor on priority. Appropriate dose adjustments or suitable alternatives may be considered based on your condition.

Alcohol interactions:

Consumption of alcohol is not recommended while receiving/taking this medicine as it may cause interactions and lead to serious adverse effects and may worsen the health condition.

Food interactions:

N/A

Expert Advice:

1. These tablets can be taken with food or without food. Do not crush, chew, or break the tablet. Swallow it whole.
2. This medicine is to be taken at the same time of the day. Follow the missed dose instructions in case if you miss a dose.
3. Seek emergency medical help if you experience any of the side effects like muscle weakness, bladder pain, difficulty urination, etc.
4. It is recommended to avoid driving or using heavy machinery immediately after consuming this medicine.

Missed dose instructions:

Take this medicine as soon as you remember. However, if it is almost time for your next dose skip the dose and go back to your regular dosing schedule. Do not double dose to make up for the missed dose.

Overdose Instructions:

Seek emergency treatment or contact your physician in case if you experience any unusual signs and symptoms during the treatment with this medicine.

Storage Instructions:

• Store the medicine in a cool and dry place away from sunlight
• Keep away from the reach of children
• Discard the unused medicine safely after use

References:

1. Crestor 10mg film-coated tablets - Summary of Product Characteristics (SmPC) - (emc) [Internet]. Medicines.org.uk. 2020 [cited 30 November 2020]. Available from: https://www.medicines.org.uk/emc/product/7559/smpc

2. Ezetimibe 10 mg tablets - Summary of Product Characteristics (SmPC) - (emc) [Internet]. Medicines.org.uk. 2020 [cited 23 October 2020]. Available from: https://www.medicines.org.uk/emc/product/9606/smpc#CONTRAINDICATIONS

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Keep away from direct sunlight

Store in a dry place